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The purpose of this study is to determine the viability of microneedle lesion preparation (MN) to enhance treatment benefit when performed prior to ALA PDT to an actinic keratosis (AK) field on the face.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALA 25 min 10 Milliwatts (mW) | Experimental | ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. |
|
| MN + ALA 25 min 10 mW | Experimental | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. |
|
| ALA 25 min 20 mW | Experimental | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. |
|
| MN + ALA 25 min 20 mW | Experimental | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. |
|
| ALA 60 min 10 mW | Experimental | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALA | Drug | 20% ALA applied to face prior to light treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Clearance Rate | Number of AK Fields with 0 lesions | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Clearance Rate | Number of AK Fields with 0 Lesions | Week 8 |
| Subject Satisfaction Score | Subject satisfaction score
|
| Measure | Description | Time Frame |
|---|---|---|
| Hyperpigmentation | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas |
Inclusion Criteria:
Exclusion Criteria:
Pregnancy
history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
Subject is immunosuppressed
currently enrolled in an investigational drug or device study
has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment
known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)
has an active herpes simplex infection OR a history of 2 or more outbreaks within the past 12 months, on the face
use of the following topical preparations on the extremity to be treated:
use of systemic retinoid therapy within 6 months
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Marcus, MD, PhD | DUSA Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Dermatology | San Diego | California | 92122 | United States | ||
| Therapeutics Clinical Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | MN + ALA 25 Min 10 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| MN + ALA 60 min 10 mW | Experimental | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. |
|
| ALA 60 min 20 mW | Experimental | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. |
|
| MN + ALA 60 min 20 mW | Experimental | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. |
|
| VEH | Placebo Comparator | Vehicle (VEH) PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. |
|
| MN + VEH | Placebo Comparator | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. |
|
|
| Topical Solution Vehicle | Drug | Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment |
|
| IBL 10 mW | Device | 10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds |
|
|
| Microneedle lesion preparation | Procedure | Microneedling of all visible/palpable AK lesions prior to solution application. |
|
| IBL 20 mW | Device | 10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds |
|
|
| Week 12 |
| Baseline AKCR | AK clearance rate (AKCR) for only those lesions present at Baseline | Baseline and Week 8 |
| Baseline AKCR | AK clearance rate for only those lesions present at Baseline | Baseline and Week 12 |
| Percent Change | Percent change in the total AK number as compared with Baseline | Baseline and Week 8 |
| Percent Change | Percent change in the total AK number as compared with Baseline | Baseline and Week 12 |
| Baseline |
| Hyperpigmentation | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas | 24-48 hours after PDT #1 |
| Hyperpigmentation | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas | 2 Weeks after PDT #1 |
| Hyperpigmentation | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas | 8 Weeks after PDT #1 |
| Hyperpigmentation | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas | 12 Weeks after PDT #1 |
| Hypopigmentation | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas | Baseline |
| Hypopigmentation | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas | 24-48 hours after PDT #1 |
| Hypopigmentation | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas | 2 Weeks after PDT #1 |
| Hypopigmentation | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas | 8 Weeks after PDT #1 |
| Hypopigmentation | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas | 12 Weeks after PDT #1 |
| Erythema | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | Baseline |
| Erythema | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | 5 minutes after PDT #1 |
| Erythema | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | 24-48 hours after PDT #1 |
| Erythema | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | 2 Weeks after PDT #1 |
| Erythema | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | 8 Weeks after PDT #1 |
| Erythema | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | 12 Weeks after PDT #1 |
| Edema | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | Baseline |
| Edema | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | 5 minutes after PDT #1 |
| Edema | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | 24-48 hours after PDT #1 |
| Edema | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | 2 weeks after PDT #1 |
| Edema | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | 8 Weeks after PDT #1 |
| Edema | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | 12 Weeks after PDT #1 |
| Stinging/Burning | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | Baseline |
| Stinging/Burning | Immediately after PDT, the most intensive, acute perception of Stinging/Burning DURING treatment will be recorded. STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | During PDT #1 |
| Stinging/Burning | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | 5 minutes after PDT #1 |
| Stinging/Burning | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | 24-48 Hours after PDT #1 |
| Stinging/Burning | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | 2 Weeks after PDT #1 |
| Stinging/Burning | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | 8 Weeks after PDT #1 |
| Stinging/Burning | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | 12 Weeks after PDT #1 |
| Scaling & Dryness | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | Baseline |
| Scaling & Dryness | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | 24-48 hours after PDT #1 |
| Scaling & Dryness | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | 2 Weeks after PDT #1 |
| Scaling & Dryness | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | 8 Weeks after PDT #1 |
| Scaling & Dryness | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | 12 Weeks after PDT #1 |
| Oozing/Vesiculation/Crusting | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | Baseline |
| Oozing/Vesiculation/Crusting | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | 24-48 hours after PDT #1 |
| Oozing/Vesiculation/Crusting | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | 2 Weeks after PDT #1 |
| Oozing/Vesiculation/Crusting | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | 8 Weeks after PDT #1 |
| Oozing/Vesiculation/Crusting | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | 12 Weeks after PDT #1 |
| San Diego |
| California |
| 92123 |
| United States |
| MOORE Clinical Research, Inc | Brandon | Florida | 33609 | United States |
| Altman Dermatology Associates | Arlington Heights | Illinois | 60005 | United States |
| Shideler Clinical Research Center | Carmel | Indiana | 46032 | United States |
| The Indiana Clinical Trials Center, PC | Plainfield | Indiana | 46168 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23507 | United States |
| FG001 | ALA 25 Min 10 mW | Aminolevulinic acid photodynamic therapy (ALA-PDT), 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle (MN): one actinic keratosis (AK) Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. Investigational Blue Light (IBL) 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| FG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| FG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| FG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| FG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| FG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| FG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| FG008 | MN + VEH 60 Min 10 mW | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application |
| FG009 | VEH 60 Min 10 mW | Vehicle (VEH) PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to VEH application. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ALA 25 Min 10 mW | ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| BG001 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| BG002 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| BG003 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| BG004 | VEH 60 Min 10 mW | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to VEH application. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Skin Type | Fitzpatrick Skin Type staging: Skin Type I - Burns easily, never tans Skin Type II - Burns easily, tans minimally Skin Type III - Burns moderately, tans gradually Skin Type IV - Burns minimally, tans well | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Complete Clearance Rate | Number of AK Fields with 0 lesions | Split-face study | Posted | Count of Units | AK Fields | Week 12 | AK Fields | AK Fields |
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| Secondary | Complete Clearance Rate | Number of AK Fields with 0 Lesions | split-face. Week 8 number of participants and units analyzed is based on observed data at that Visit. Number of subjects at Week 8 may differ from number of subjects completing study as noted in participant flow. | Posted | Count of Units | AK Fields | Week 8 | AK Fields | AK Fields |
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| Secondary | Subject Satisfaction Score | Subject satisfaction score
| split-face. | Posted | Count of Units | AK Fields | Week 12 | AK Fields | AK Fields |
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| Secondary | Baseline AKCR | AK clearance rate (AKCR) for only those lesions present at Baseline | split-face. Week 8 number of participants and units analyzed is based on observed data at that Visit. Number of subjects at Week 8 may differ from number of subjects completing study as noted in participant flow. | Posted | Mean | Standard Deviation | percentage cleared | Baseline and Week 8 | AK Fields | AK Fields |
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| Secondary | Baseline AKCR | AK clearance rate for only those lesions present at Baseline | split-face | Posted | Mean | Standard Deviation | percentage cleared | Baseline and Week 12 | AK Fields | AK Fields |
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| Secondary | Percent Change | Percent change in the total AK number as compared with Baseline | split face. Week 8 number of participants and units analyzed is based on observed data at that Visit. Number of subjects at Week 8 may differ from number of subjects completing study as noted in participant flow. | Posted | Mean | Standard Deviation | percent change | Baseline and Week 8 | AK Fields | AK Fields |
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| Secondary | Percent Change | Percent change in the total AK number as compared with Baseline | split-face | Posted | Mean | Standard Deviation | percent change | Baseline and Week 12 | AK Fields | AK Fields |
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| Other Pre-specified | Hyperpigmentation | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas | split-face | Posted | Count of Units | AK Fields | Baseline | AK Fields | AK Fields |
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| Other Pre-specified | Hyperpigmentation | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 24-48 hours after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Hyperpigmentation | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 2 Weeks after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Hyperpigmentation | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 8 Weeks after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Hyperpigmentation | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 12 Weeks after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Hypopigmentation | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas | Posted | Count of Units | AK Fields | Baseline | AK Fields | AK Fields |
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| Other Pre-specified | Hypopigmentation | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 24-48 hours after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Hypopigmentation | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 2 Weeks after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Hypopigmentation | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 8 Weeks after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Hypopigmentation | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 12 Weeks after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Erythema | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | split face | Posted | Count of Units | AK Fields | Baseline | AK Fields | AK Fields |
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| Other Pre-specified | Erythema | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | Posted | Count of Units | AK Fields | 5 minutes after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Erythema | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 24-48 hours after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Erythema | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 2 Weeks after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Erythema | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 8 Weeks after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Erythema | Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 12 Weeks after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Edema | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | Posted | Count of Units | AK Fields | Baseline | AK Fields | AK Fields |
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| Other Pre-specified | Edema | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | Posted | Count of Units | AK Fields | 5 minutes after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Edema | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 24-48 hours after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Edema | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 2 weeks after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Edema | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 8 Weeks after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Edema | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 12 Weeks after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Stinging/Burning | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | Posted | Count of Units | AK Fields | Baseline | AK Fields | AK Fields |
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| Other Pre-specified | Stinging/Burning | Immediately after PDT, the most intensive, acute perception of Stinging/Burning DURING treatment will be recorded. STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | Posted | Count of Units | AK Fields | During PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Stinging/Burning | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | Posted | Count of Units | AK Fields | 5 minutes after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Stinging/Burning | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 24-48 Hours after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Stinging/Burning | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 2 Weeks after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Stinging/Burning | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 8 Weeks after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Stinging/Burning | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 12 Weeks after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Scaling & Dryness | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | Posted | Count of Units | AK Fields | Baseline | AK Fields | AK Fields |
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| Other Pre-specified | Scaling & Dryness | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 24-48 hours after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Scaling & Dryness | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 2 Weeks after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Scaling & Dryness | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 8 Weeks after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Scaling & Dryness | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 12 Weeks after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Oozing/Vesiculation/Crusting | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | Posted | Count of Units | AK Fields | Baseline | AK Fields | AK Fields |
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| Other Pre-specified | Oozing/Vesiculation/Crusting | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 24-48 hours after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Oozing/Vesiculation/Crusting | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 2 Weeks after PDT #1 | AK Fields | AK Fields |
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| Other Pre-specified | Oozing/Vesiculation/Crusting | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 8 Weeks after PDT #1 | AK Fields | AK Fields |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Oozing/Vesiculation/Crusting | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above | split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow. | Posted | Count of Units | AK Fields | 12 Weeks after PDT #1 | AK Fields | AK Fields |
|
3 months
This was a split face study where one AK Field on a subjects was randomized to MN lesion pretreatment and the other AK Field was randomized to no pretreatment, but both Fields received the same drug/light treatment. Local skin tolerability effects were presented separately for +MN and -MN, but AEs were evaluated on a per SUBJECT basis, not on a per FIELD basis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ALA 25 Min 10 mW | ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds | 0 | 25 | 0 | 25 | 1 | 25 |
| EG001 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds | 0 | 27 | 0 | 27 | 1 | 27 |
| EG002 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds | 0 | 29 | 0 | 29 | 4 | 29 |
| EG003 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds | 0 | 26 | 1 | 26 | 7 | 26 |
| EG004 | VEH 60 Min 10 mW | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to VEH application. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds | 0 | 30 | 0 | 30 | 2 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| unstable angina | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pain | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
|
First publication of results will be made by the Sponsor. If publication is not submitted within 12 months after the date of study final report, the PI may publish the results from the site individually, subject to compliance with the other terms of the clinical trial agreement, including a requirement that the PI provide a draft of the publication for the sponsor's review 30 days before submission for publication so that sponsor can review the publication for confidential information
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Houlihan | DUSA Pharmaceuticals Inc., a Sun Pharma Co. | 9147608796 | anna.houlihan@sunpharma.com |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000622 | Aminolevulinic Acid |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Type II - Burns easily, tans minimally |
|
| Type III - Burns moderately, tans gradually |
|
| Type IV - Burns minimally, tans well |
|
| AK Fields |
|
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
|
|
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
|
|
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
|
|
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
|
|
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
|
|
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
|
|
Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
|
|
| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
ALA: 20% ALA applied to face prior to light treatment
Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.
IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| MN + ALA 25 Min 20 mW |
Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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| OG002 | MN + ALA 25 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG003 | ALA 25 Min 20 mW | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG004 | MN + ALA 60 Min 10mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG005 | ALA 60 Min 10 mW | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
| OG006 | MN + ALA 60 Min 20 mW | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG007 | ALA 60 Min 20 mW | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds |
| OG008 | MN + VEH | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. |
| OG009 | VEH PDT | Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds |
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