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The purpose of this study is to determine if Levulan PDT is safe and effective in the treatment of actinic keratoses on the upper arms and hands.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALA | Experimental |
| |
| Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aminolevulinic Acid PDT (ALA) | Drug | 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lesion Clearance Rate | Clearance rate for all lesions | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion Clearance Rate | Week 8 | |
| Complete Clearance Rate | proportion of subjects with a count of zero lesions in the treatment area | Week 8 |
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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
unsuccessful outcome from previous ALA-PDT therapy
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)
use of the following topical preparations on the extremities to be treated:
use of systemic retinoid therapy within 6 months of initiation of treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Marcus, MD, PhD | DUSA Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Therapeutics Clinical Research | San Diego | California | 92123 | United States | ||
| Park Avenue Dermatology, PA |
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Recruitment period was from 28November2011 - 4April2012 at 3 medical clinics in the U.S.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aminolevulinic Acid | ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period. |
| FG001 | Vehicle | Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Aminolevulinic Acid | ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period. |
| BG001 | Vehicle | Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lesion Clearance Rate | Clearance rate for all lesions | ITT analysis with LOCF | Posted | Median | Standard Deviation | percentage of lesions cleared | Week 12 | arms | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aminolevulinic Acid | ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Houlihan | DUSA Pharmaceuticals, Inc. | 9147608796 | houlihana@dusapharma.com |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000622 | Aminolevulinic Acid |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Vehicle PDT (VEH) | Drug | Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light |
|
| Complete Clearance Rate | proportion of subjects with a count of zero lesions in the treatment area | Week 12 |
| Partial Clearance Rate | proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline. | Baseline and Week 8 |
| Partial Clearance Rate | proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline. | Baseline and Week 12 |
| Subject Satisfaction Score | Subject satisfaction score
| Week 12 |
| Hyperpigmentation at Baseline | 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 | Baseline |
| Hyperpigmentation at Visit 3 | 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 at Visit 4 | 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 at Visit 5 | 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 at Baseline | 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 | Baseline |
| Hypopigmentation at Visit 3 | 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 | 2 Weeks after PDT #1 |
| Hypopigmentation at Visit 4 | 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 | 8 Weeks after PDT #1 |
| Hypopigmentation at Visit 5 | 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 | 12 Weeks after PDT #1 |
| Erythema at Baseline | 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 Post-Light Treatment | 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 at Visit 3 | 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 at Visit 4 | 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 at Visit 5 | 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 at Baseline | 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 Post-Light Treatment | 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 at Visit 3 | 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 at Visit 4 | 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 at Visit 5 | 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 at Baseline | 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 During Light Treatment | 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 Post Light Treatment | 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 at Visit 3 | 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 at Visit 4 | 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 at Visit 5 | 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 and Dryness at Baseline | 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 and Dryness at Visit 3 | 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 Post PDT #1 |
| Scaling and Dryness at Visit 4 | 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 Post PDT #1 |
| Scaling and Dryness at Visit 5 | 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 Post PDT #1 |
| OOZING/VESICULATION/CRUSTING at Baseline | 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 at Visit 3 | 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 | Week 2 after PDT #1 |
| OOZING/VESICULATION/CRUSTING at Visit 4 | 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 at Visit 5 | 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 |
| Orange Park |
| Florida |
| 32073 |
| United States |
| DermResearch, Inc | Austin | Texas | 78759 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
| OG003 | VEH-OCC | Vehicle application on one extremity unoccluded during the incubation period. |
|
|
| Secondary | Lesion Clearance Rate | ITT LOCF | Posted | Median | Standard Deviation | percentage of lesions cleared | Week 8 | arms | Participants |
|
|
|
| Secondary | Complete Clearance Rate | proportion of subjects with a count of zero lesions in the treatment area | ITT LOCF | Posted | Number | arms 100% cleared | Week 8 | arms | Participants |
|
|
|
| Secondary | Complete Clearance Rate | proportion of subjects with a count of zero lesions in the treatment area | ITT LOCF | Posted | Number | arms 100% cleared | Week 12 | arms | Participants |
|
|
|
| Secondary | Partial Clearance Rate | proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline. | ITT LOCF | Posted | Number | arms >75% cleared | Baseline and Week 8 | arms | Participants |
|
|
|
| Secondary | Partial Clearance Rate | proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline. | ITT LOCF | Posted | Number | arms >75% cleared | Baseline and Week 12 | arms | Participants |
|
|
|
| Secondary | Subject Satisfaction Score | Subject satisfaction score
| ITT | Posted | Number | participants | Week 12 | arms | Participants |
|
|
|
| Secondary | Hyperpigmentation at Baseline | 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 | ITT | Posted | Number | participants | Baseline |
|
|
|
| Secondary | Hyperpigmentation at Visit 3 | 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 | ITT | Posted | Number | participants | 2 weeks after PDT #1 |
|
|
|
| Secondary | Hyperpigmentation at Visit 4 | 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 | ITT | Posted | Number | participants | 8 weeks after PDT #1 |
|
|
|
| Secondary | Hyperpigmentation at Visit 5 | 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 | ITT | Posted | Number | participants | 12 weeks after PDT #1 |
|
|
|
| Secondary | Hypopigmentation at Baseline | 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 | ITT | Posted | Number | participants | Baseline |
|
|
|
| Secondary | Hypopigmentation at Visit 3 | 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 | ITT | Posted | Number | participants | 2 Weeks after PDT #1 |
|
|
|
| Secondary | Hypopigmentation at Visit 4 | 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 | ITT | Posted | Number | participants | 8 Weeks after PDT #1 |
|
|
|
| Secondary | Hypopigmentation at Visit 5 | 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 | ITT | Posted | Number | participants | 12 Weeks after PDT #1 |
|
|
|
| Secondary | Erythema at Baseline | 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 | ITT | Posted | Number | participants | Baseline |
|
|
|
| Secondary | Erythema Post-Light Treatment | 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 | ITT | Posted | Number | participants | 5 Minutes after PDT #1 |
|
|
|
| Secondary | Erythema at Visit 3 | 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 | ITT | Posted | Number | participants | 2 Weeks after PDT #1 |
|
|
|
| Secondary | Erythema at Visit 4 | 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 | ITT | Posted | Number | participants | 8 Weeks after PDT #1 |
|
|
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| Secondary | Erythema at Visit 5 | 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 | ITT | Posted | Number | participants | 12 Weeks after PDT #1 |
|
|
|
| Secondary | Edema at Baseline | 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 | ITT | Posted | Number | participants | Baseline |
|
|
|
| Secondary | Edema Post-Light Treatment | 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 | ITT | Posted | Number | participants | 5 Minutes after PDT #1 |
|
|
|
| Secondary | Edema at Visit 3 | 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 | ITT | Posted | Number | participants | 2 Weeks after PDT #1 |
|
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| Secondary | Edema at Visit 4 | 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 | ITT | Posted | Number | participants | 8 Weeks after PDT #1 |
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| Secondary | Edema at Visit 5 | 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 | ITT | Posted | Number | participants | 12 Weeks after PDT #1 |
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| Secondary | Stinging/Burning at Baseline | 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 | ITT, observed | Posted | Number | participants | Baseline |
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| Secondary | Stinging/Burning During Light Treatment | 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 | ITT, observed | Posted | Number | participants | During PDT #1 |
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| Secondary | Stinging/Burning Post Light Treatment | 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 | ITT, observed | Posted | Number | participants | 5 minutes after PDT #1 |
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| Secondary | Stinging/Burning at Visit 3 | 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 | ITT, observed | Posted | Number | participants | 2 Weeks after PDT #1 |
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| Secondary | Stinging/Burning at Visit 4 | 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 | ITT, observed | Posted | Number | participants | 8 Weeks after PDT #1 |
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| Secondary | Stinging/Burning at Visit 5 | 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 | ITT, observed | Posted | Number | participants | 12 Weeks after PDT #1 |
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| Secondary | Scaling and Dryness at Baseline | 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 | ITT observed | Posted | Number | participants | Baseline |
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| Secondary | Scaling and Dryness at Visit 3 | 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 | ITT observed | Posted | Number | participants | 2 Weeks Post PDT #1 |
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| Secondary | Scaling and Dryness at Visit 4 | 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 | ITT observed | Posted | Number | participants | 8 Weeks Post PDT #1 |
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| Secondary | Scaling and Dryness at Visit 5 | 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 | ITT observed | Posted | Number | participants | 12 Weeks Post PDT #1 |
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| Secondary | OOZING/VESICULATION/CRUSTING at Baseline | 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 | ITT observed | Posted | Number | participants | Baseline |
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| Secondary | OOZING/VESICULATION/CRUSTING at Visit 3 | 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 | ITT observed | Posted | Number | participants | Week 2 after PDT #1 |
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| Secondary | OOZING/VESICULATION/CRUSTING at Visit 4 | 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 | ITT observed | Posted | Number | participants | 8 Weeks after PDT #1 |
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| Secondary | OOZING/VESICULATION/CRUSTING at Visit 5 | 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 | ITT observed | Posted | Number | participants | 12 Weeks after PDT #1 |
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|
|
| 0 |
| 35 |
| 17 |
| 35 |
| EG001 | Vehicle | Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period. | 0 | 35 | 5 | 35 |
| Wound infection | Infections and infestations | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pain | Skin and subcutaneous tissue disorders | Systematic Assessment | PDT Reaction |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment | PDT reaction |
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| Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment | PDT reaction |
|
The first publication of results from multi-center trial will be made by the Sponsor. If publication is not submitted within 12 months after conclusion of the study, 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 60 days before publication so that sponsor can review the publication for confidential information.
| D017437 |
| Skin and Connective Tissue Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| Moderately satisfied |
|
| Slightly satisfied |
|
| Not satisfied |
|
| Grade 1 (light) |
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| Grade 2 (moderate - small) |
|
| Grade 3 (moderate - moderate) |
|
| Grade 1 (light) |
|
| Grade 2 (moderate - small) |
|
| Grade 3 (moderate - moderate) |
|
| Grade 1 (light) |
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| Grade 2 (moderate - small) |
|
| Grade 3 (moderate - moderate) |
|
| Grade 1 (light) |
|
| Grade 2 (moderate - small) |
|
| Grade 3 (moderate - moderate) |
|
| Grade 1 (light) |
|
| Grade 2 (moderate - small) |
|
| Grade 3 (moderate - moderate) |
|
| Grade 1 (light) |
|
| Grade 2 (moderate - small) |
|
| Grade 3 (moderate - moderate) |
|
| Grade 1 (light) |
|
| Grade 2 (moderate - small) |
|
| Grade 3 (moderate - moderate) |
|
| Grade 1 (light) |
|
| Grade 2 (moderate - small) |
|
| Grade 3 (moderate - moderate) |
|
| Grade 1 (minimal) |
|
| Grade 2 (mild) |
|
| Grade 3 (moderate) |
|
| Grade 4 (severe) |
|
| Grade 1 (minimal) |
|
| Grade 2 (mild) |
|
| Grade 3 (moderate) |
|
| Grade 4 (severe) |
|
| Grade 1 (minimal) |
|
| Grade 2 (mild) |
|
| Grade 3 (moderate) |
|
| Grade 4 (severe) |
|
| Grade 1 (minimal) |
|
| Grade 2 (mild) |
|
| Grade 3 (moderate) |
|
| Grade 4 (severe) |
|
| Grade 1 (minimal) |
|
| Grade 2 (mild) |
|
| Grade 3 (moderate) |
|
| Grade 4 (severe) |
|
| Grade 1 (minimal) |
|
| Grade 2 (mild) |
|
| Grade 1 (minimal) |
|
| Grade 2 (mild) |
|
| Grade 1 (minimal) |
|
| Grade 2 (mild) |
|
| Grade 1 (minimal) |
|
| Grade 2 (mild) |
|
| Grade 1 (minimal) |
|
| Grade 2 (mild) |
|
| Grade 1 (mild) |
|
| Grade 2 (moderate) |
|
| Grade 3 (severe) |
|
| Grade 1 (mild) |
|
| Grade 2 (moderate) |
|
| Grade 3 (severe) |
|
| Grade 1 (mild) |
|
| Grade 2 (moderate) |
|
| Grade 3 (severe) |
|
| Grade 1 (mild) |
|
| Grade 2 (moderate) |
|
| Grade 3 (severe) |
|
| Grade 1 (mild) |
|
| Grade 2 (moderate) |
|
| Grade 3 (severe) |
|
| Grade 1 (mild) |
|
| Grade 2 (moderate) |
|
| Grade 3 (severe) |
|
| Grade 1 (minimal) |
|
| Grade 2 (mild) |
|
| Grade 3 (moderate) |
|
| Grade 4 (severe) |
|
| Grade 1 (minimal) |
|
| Grade 2 (mild) |
|
| Grade 3 (moderate) |
|
| Grade 4 (severe) |
|
| Grade 1 (minimal) |
|
| Grade 2 (mild) |
|
| Grade 3 (moderate) |
|
| Grade 4 (severe) |
|
| Grade 1 (minimal) |
|
| Grade 2 (mild) |
|
| Grade 3 (moderate) |
|
| Grade 4 (severe) |
|
| Grade 1 (minimal) |
|
| Grade 2 (mild) |
|
| Grade 3 (moderate) |
|
| Grade 4 (severe) |
|
| Grade 1 (minimal) |
|
| Grade 2 (mild) |
|
| Grade 3 (moderate) |
|
| 0 |
|
| Grade 1 (minimal) |
|
| Grade 2 (mild) |
|
| Grade 3 (moderate) |
|
| 0 |
|
| Grade 1 (minimal) |
|
| Grade 2 (mild) |
|
| Grade 3 (moderate) |
|
| 0 |
|