Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities

Study Overview
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Brief Summary
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The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratoses on the upper arms and hands

Official Title
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A Phase 3 Study of Photodynamic Therapy With Levulan Kerastick Topical Solution + Blue Light Versus Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: Aminolevulinic Acid (ALA)
* Drug: Topical Solution Vehicle
* Device: Blue Light Photodynamic Therapy Illuminator (BLU-U)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on one upper extremity Exclusion Criteria: Pregnancy grade 3 and/or atypical >1cm AKs within Treatment Area 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 extremity to be treated: Keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g.glycolic acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within 2 days of initiation of treatment. Cryotherapy within 2 weeks of initiation of treatment Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks of initiation of treatment. Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment. use of systemic retinoid therapy within 6 months of initiation of treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALA<br> | Drug: Aminolevulinic Acid (ALA)<br>* 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light<br>* Other names: Levulan Kerastick;Device: Blue Light Photodynamic Therapy Illuminator (BLU-U)<br>* 10 J/cm2 blue light delivered at 10mW/cm2<br>|
| Placebo Comparator: Vehicle<br> | Drug: Topical Solution Vehicle<br>* Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light<br>Device: Blue Light Photodynamic Therapy Illuminator (BLU-U)<br>* 10 J/cm2 blue light delivered at 10mW/cm2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Clearance Rate | proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AK Clearance Rate | {1 - [(number of AK lesions at follow-up)/(number of AK lesions at Baseline)]} x 100 | Baseline and Week 12 | 
| AK Clearance Rate | {1 - [(number of AK lesions at follow-up)/(number of AK lesions at Baseline)]} x 100 | Baseline and Week 8 | 
| Complete Clearance Rate | proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area | Week 8 | 
| Subject Satisfaction Score | Subject satisfaction score = Excellent (very satisfied) = Good (moderately satisfied) = Fair (slightly satisfied) = Poor (not satisfied at all) | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Actinic Keratosis