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GENERAL OBJECTIVE The general objective is to assess the safety and efficacy of photodynamic therapy (PDT) in the treatment of neurofibromatosis 1 (NF1) tumors in the skin.
SPECIFIC OBJECTIVE This is a light dose escalation pilot study to determine the safety and efficacy of PDT using 5-aminolevulinic acid (ALA) and 633 nm light in the treatment of benign dermal neurofibromas.
Specifically, the primary goal of the current study is to determine the maximum tolerable light doses that can be administered to subjects undergoing topical photoillumination photodynamic therapy with standard application of Levulan Kerastick (ALA) for Topical Solution.
STUDY DESIGN This protocol is a Phase I light dose escalation pilot study to determine the safety and, secondarily, the efficacy of PDT using Levulan and 633 nm light in the treatment of benign dermal neurofibromas. This protocol represents the first two parts of a planned three part study including both pediatric and adult subjects. Part 1 will consist of studying the penetration and uptake of the PS in neurofibromas that are scheduled for excision. These tumors will be excised for therapeutic reasons unrelated to this study, and so this study will place no further burden on the subject other than a 3-24 hr incubation of the Levulan on the tumor prior to excision. The primary hypothesis to be tested is whether Levulan will accumulate, and be converted to PpIX, by the tumor tissue more than by the surrounding normal tissue. Secondary hypotheses are that tumors incubated with Levulan will show greater fluorescence than untreated tumors and tumors incubated with vehicle only (placebo application).
As the Institutional Review Boards involved generally desire pilot data on adult populations first, we will with then proceed with the adult clinical trial portion of this protocol as part 2. Part 2 will use the optimum incubation time, if one has been identified in part 1, and add a dose escalation study of the amount of red light used to activate the Levulan. Part 3, with pediatric subjects, will commence at a future date, pending review of the initial adult study results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Levulan injection | Experimental | 5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) injection and 3 hr incubation, and by Levulan treated lesions after 3 or 24 hr incubation. |
|
| Part 1 Levulan painting | Experimental | 5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application and 3 hr incubation, and by Levulan treated lesions and 3 or 24 hr incubation. |
|
| Part 1 Levulan painted twice | Experimental | 5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice or by Levulan treated lesions twice and 24 hr incubation. |
|
| Part 1 Levulan painted twice with microneedling | Experimental | 5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice or by Levulan treated lesions twice and 24 hr incubation. All lesions prepared with microneedling. |
|
| Part 2 Dose level 1 50 J/cm^2 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Part 1 Levulan injection | Drug | Control or treatment lesions will be injected with Levulan vehicle only or active drug and incubated under occlusion for 3 or 24 hrs. A minimum of three lesions per group on the same subject will be treated. Lesions will then be excised in the normal manner, sectioned vertically, and checked for Protoporphyrin IX using fluorescence microscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Photosensitizer Uptake and Conversion to Protoporphyrin IX | The average fluorescence value for PpIX positive tumor areas in excised, sectioned tumors, as determined by fluorescence microscopy. PpIX signals were detected with excitation at 405 nm and emission with a 600 nm long pass filter. PpIX positive areas were determined to be those exhibiting fluorescence above background levels. | 24 hours |
| Part 2: Maximum Tolerated Dose (MTD) of 633 nm Red Light | MTD was determined by testing increasing doses up to 200 J/cm^2 on dose escalation cohorts 1 to 3 with 3 to 6 participants each. MTD reflects the highest dose of red light that did not cause a Dose-Limiting Toxicity (DLT) in > 33% of participants. DLT was defined as pain during irradiation requiring cessation of the light treatment, or any serious cutaneous adverse events. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Optimal Occlusion Time | An optimal occlusion time may be apparent from the results of the three time points. If no optimal occlusion time is seen, any occlusion time from 3-24 hours may be chosen for part 2. This secondary outcome measure is not critical to continuing the study, but may be useful in guiding treatment protocols | 24 hours |
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Inclusion Criteria:
Subjects with NF1 will be selected for photodynamic therapy on the following criteria.
Exclusion Criteria:
Subjects will be excluded from participation in the study on the basis of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Harry T Whelan, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33470897 | Derived | Quirk B, Olasz E, Kumar S, Basel D, Whelan H. Photodynamic Therapy for Benign Cutaneous Neurofibromas Using Aminolevulinic Acid Topical Application and 633 nm Red Light Illumination. Photobiomodul Photomed Laser Surg. 2021 Jun;39(6):411-417. doi: 10.1089/photob.2020.4957. Epub 2021 Jan 20. |
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A prospective, controlled, nonrandomized phase I clinical trial was conducted between March 2012 and July 2016. This study included adult patients from Froedtert Hospital in Milwaukee, Wisconsin. NF1 patients were recruited through referral by their physician.
| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 Levulan Injection | 5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) injection and 3 hr incubation, and by Levulan treated lesions after 3 or 24 hr incubation. |
| FG001 | Part 1 Levulan Painting |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1 Levulan Injection |
|
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Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 1 - 50 J/cm^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
|
| Part 2 Dose level 2 100 J/cm^2 | Experimental | Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 2 - 100 J/cm^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements. |
|
| Part 2 Dose level 3 200 J/cm^2 | Experimental | Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 3 - 200 J/cm^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements. |
|
|
| Part 1 Levulan surface application | Drug | Control or treatment lesions will be painted with Levulan vehicle only or active drug, allowed to dry, and incubated under occlusion for 3 or 24 hrs. A minimum of three lesions per group on the same subject will be treated. Lesions will then be excised in the normal manner, sectioned vertically, and checked for Protoporphyrin IX using fluorescence microscopy. |
|
| Part 1 Levulan surface application twice | Drug | Control or treatment lesions will be painted twice with Levulan vehicle only or active drug, allowed to dry between and after applications, and incubated under occlusion for 3 hrs. A minimum of three tumors per group on the same subject will be treated. Lesions will then be excised in the normal manner, sectioned vertically, and checked for Protoporphyrin IX using fluorescence microscopy. |
|
| Part 1 Levulan surface application twice with microneedling | Drug | Control or treatment lesions will be prepared with microneedling, painted twice with Levulan vehicle only or active drug, allowed to dry between and after applications, and incubated under occlusion for 24 hrs. A minimum of three tumors per group on the same subject will be treated. Lesions will then be excised in the normal manner, sectioned vertically, and checked for Protoporphyrin IX using fluorescence microscopy. |
|
| Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 1 | Drug | 2-6 adult subjects with 3-8 lesions per (Levulan or control) group per subject. Controls will consist of lesions treated with vehicle only and light illumination, and will be paired with treatment lesions by the study doctor. Control lesions will be treated on the same subject as study lesions. Levulan will be incubated for 3-24 hours under occlusion, then gently rinsed with water and patted dry. Photoactivation of lesions treated with Levulan is then accomplished with 633 nm red light illumination. 633 nm light will be applied for 8 minutes to achieve a dose of 50 J/cm^2. There will be one treatment session per subject. Treatments will include a minimum of three test lesions and an additional three control lesions. |
|
| Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 2 | Drug | 2-6 adult subjects with 3-8 lesions per (Levulan or control) group per subject. Controls will consist of lesions treated with vehicle only and light illumination, and will be paired with treatment lesions by the study doctor. Control lesions will be treated on the same subject as study lesions. Levulan will be incubated for 3-24 hours under occlusion, then gently rinsed with water and patted dry. Photoactivation of lesions treated with Levulan is then accomplished with 633 nm red light illumination. 633 nm light will be applied for 16 minutes to achieve a dose of 100 J/cm^2. There will be one treatment session per subject. Treatments will include a minimum of three test lesions and an additional three control lesions. |
|
| Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 3 | Drug | 2-6 adult subjects with 3-8 lesions per (Levulan or control) group per subject. Controls will consist of lesions treated with vehicle only and light illumination, and will be paired with treatment lesions by the study doctor. Control lesions will be treated on the same subject as study lesions. Levulan will be incubated for 3-24 hours under occlusion, then gently rinsed with water and patted dry. Photoactivation of lesions treated with Levulan is then accomplished with 633 nm red light illumination. 633 nm light will be applied for 32 minutes to achieve a dose of 200 J/cm^2. There will be one treatment session per subject. Treatments will include a minimum of three test lesions and an additional three control lesions. |
|
| Part 2: Efficacy - Lesion Area Growth Rate | Average lesion growth rates observed in ALA-treated lesions compared to vehicle-treated lesions within the same subjects. | 12 weeks |
| Part 2: Cosmetic Improvement | Potential cosmetic improvement using subject satisfaction scale. | 1 year |
| Part 2: Pain Reduction | Potential pain reduction, as measured by standard visual analog 1-10 scale. | 1 year |
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application and 3 hr incubation, and by Levulan treated lesions and 3 or 24 hr incubation.
| FG002 | Experimental: Part 1 Levulan Painted Twice | 5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice or by Levulan treated lesions twice and 24 hr incubation. |
| FG003 | Part 1 Levulan Painted Twice With Microneedling | 5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice or by Levulan treated lesions twice and 24 hr incubation. All lesions prepared with microneedling. |
| FG004 | Part 2 Dose Level 1 50 J/cm^2 | Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 1 - 50 J/cm^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements. |
| FG005 | Part 2 Dose Level 2 100 J/cm^2 | Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 2 - 100 J/cm^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements. |
| FG006 | Part 2 Dose Level 3 200 J/cm^2 | Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 3 - 200 J/cm^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements. |
| Control |
|
| Treated 3 Hours |
|
| Treated 24 Hours |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Part 1 Levulan Painting |
|
| Part 1 Levulan Painted Twice |
|
| Part 1 Levulan Paint Twice Microneedling |
|
| Part 2 Dose Level 1 |
|
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| Part 2 Dose Level 2 |
|
|
| Part 2 Dose Level 3 |
|
No subjects were enrolled into Part 2 Dose Level 3 as maximum tolerable dose had been established.
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Part 1 Levulan Injection | 5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) injection and 3 hr incubation, and by Levulan treated lesions after 3 or 24 hr incubation. |
| BG001 | Part 1 Levulan Painting | 5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application and 3 hr incubation, and by Levulan treated lesions and 3 or 24 hr incubation. |
| BG002 | Part 1 Levulan Painted Twice | 5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice or by Levulan treated lesions twice and 24 hr incubation. |
| BG003 | Part 1 Levulan Painted Twice With Microneedling | 5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice or by Levulan treated lesions twice and 24 hr incubation. All lesions prepared with microneedling. |
| BG004 | Part 2 Dose Level 1 50 J/cm^2 | Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 1 - 50 J/cm^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements. |
| BG005 | Part 2 Dose Level 2 100 J/cm^2 | Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 2 - 100 J/cm^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements. |
| BG006 | Part 2 Dose Level 3 200 J/cm^2 | Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 3 - 200 J/cm^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| lesions |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
| |||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants | Participants |
|
| 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 | Part 1: Photosensitizer Uptake and Conversion to Protoporphyrin IX | The average fluorescence value for PpIX positive tumor areas in excised, sectioned tumors, as determined by fluorescence microscopy. PpIX signals were detected with excitation at 405 nm and emission with a 600 nm long pass filter. PpIX positive areas were determined to be those exhibiting fluorescence above background levels. | The first participant contributed three lesions to each of the first three groups. The second participant likewise for the second three groups. The next two participants contributed three lesions each to each of the next two groups. The next two participants contributed likewise for the last two groups. PpIX positive areas were detected only in the last group. | Posted | Mean | Standard Deviation | Densitometry units/micrometer squared | 24 hours | PpIX positive areas | PpIX positive areas |
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| Primary | Part 2: Maximum Tolerated Dose (MTD) of 633 nm Red Light | MTD was determined by testing increasing doses up to 200 J/cm^2 on dose escalation cohorts 1 to 3 with 3 to 6 participants each. MTD reflects the highest dose of red light that did not cause a Dose-Limiting Toxicity (DLT) in > 33% of participants. DLT was defined as pain during irradiation requiring cessation of the light treatment, or any serious cutaneous adverse events. | Of the 14 enrolled in Part 2, 5 did not receive red light treatment per protocol. No subjects were enrolled in cohort 3 (200 J/cm^2) due to marked pain in cohort 2. In the opinion of the clinical dermatologist, higher dose levels would likely not be tolerable, and it would be unethical to escalate the light dose further. It was decided that the MTD would be set at 100 J/cm^2, and the highest dose level foregone. | Posted | Number | joules/cm squared | 48 hours |
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| Secondary | Part 1: Optimal Occlusion Time | An optimal occlusion time may be apparent from the results of the three time points. If no optimal occlusion time is seen, any occlusion time from 3-24 hours may be chosen for part 2. This secondary outcome measure is not critical to continuing the study, but may be useful in guiding treatment protocols | The first participant contributed three lesions to each of the first three groups. The second participant contributed three lesions to each of the second three groups. Only the six groups in the first two arms are relevant to this outcome measure. | Posted | Number | hours | 24 hours | lesions | lesions |
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| Secondary | Part 2: Efficacy - Lesion Area Growth Rate | Average lesion growth rates observed in ALA-treated lesions compared to vehicle-treated lesions within the same subjects. | Only 5 participants from Part 2 dose level 1 of the study had lesion sizes monitored during follow-up visits. | Posted | Mean | Standard Deviation | millimeter squared/day post-treatment | 12 weeks | lesions | lesions |
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| Secondary | Part 2: Cosmetic Improvement | Potential cosmetic improvement using subject satisfaction scale. | No cosmetic improvement data was collected. | Posted | 1 year |
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| Secondary | Part 2: Pain Reduction | Potential pain reduction, as measured by standard visual analog 1-10 scale. | No pain reduction data was collected. | Posted | 1 year |
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| Post-Hoc | TUNEL Assay. | Average number of apoptotic cells per visual field among all TUNEL-evaluated lesion samples. | Only 5 participants from Part 2 dose level 1 of the study had biopsies performed and lesions analyzed. | Posted | Mean | Standard Deviation | apoptotic cells/visual field | 48 hours | Lesions | Lesions |
|
|
3 weeks.
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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 | Part 1 Levulan (5-aminolevulinic Acid) Uptake. | Tumors will be incubated with Levulan or vehicle under occlusion for 3 or 24 hrs. A minimum of three tumors per treatment or control group will be treated on the same subject. Tumors will then be excised in the normal manner. Tumors will be sectioned vertically and checked for PpIX using fluorescence microscopy. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG001 | Experimental: Part 2 Dose Level 1 50 J/cm^2 | Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 1 - 50 J/cm^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements. | 0 | 11 | 0 | 11 | 1 | 11 |
| EG002 | Part 2 Dose Level 2 100 J/cm^2 | Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 2 - 100 J/cm^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements. | 0 | 3 | 0 | 3 | 0 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin burning with PDT - resolved | Skin and subcutaneous tissue disorders | Non-systematic Assessment | One participant in the first dose level cohort experienced pain upon red-light irradiation requiring cessation of PDT treatment. The pain resolved upon PDT cessation, with no sequelae. |
|
No participants in part 2 completed 1 year of follow-up visits, and are reported as lost to follow-up. This necessarily limits all outcome measurements for part 2 other than the maximum tolerable dose measurement.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Harry T. Whelan MD, Bleser Professor of Neurology | Medical College of Wisconsin | 414-266-7544 | hwhelan@mcw.edu |
| ID | Term |
|---|---|
| D017253 | Neurofibromatoses |
| ID | Term |
|---|---|
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D020752 | Neurocutaneous Syndromes |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000097244 | Percutaneous Collagen Induction |
| D000622 | Aminolevulinic Acid |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D011677 | Punctures |
| D012046 | Rehabilitation |
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
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| Protocol Violation |
|
| Lost to Follow-up |
|
| lesions |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| lesions |
|
|
| lesions |
|
|
| lesions |
|
|
| PpIX positive areas |
|
|
| OG003 |
| Part 1 Levulan Paint Control Lesions |
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application and 24 hr incubation. |
| OG004 | Part 1 Levulan Paint Treated Lesions 3 Hours | 5-aminolevulinic acid uptake by treated lesions after Levulan surface application and 3 hr incubation. |
| OG005 | Part 1 Levulan Paint Treated Lesions 24 Hours | 5-aminolevulinic acid uptake by treated lesions after Levulan surface application and 24 hr incubation. |
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| Participants |
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| lesions |
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