Phase 3 Study of Levulan With New Blue Light for AK on the Face or Scalp

Study Overview
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Brief Summary
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The purpose of this study is to prove the safety and efficacy of Levulan Kerastick (aminolevulinic acid HCl) for Topical Solution 20% followed by 10 J/cm2 of blue light delivered at 10 mW/cm2 or 20 mW/cm2 in the treatment of multiple actinic keratosis on the face or balding scalp (the Treatment Area), utilizing a 14-18 hour incubation period.

Official Title
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A RANDOMIZED, VEHICLE-CONTROLLED PHASE 3 STUDY TO PROVE THE SAFETY AND EFFICACY OF LEVULAN KERASTICK (AMINOLEVULINIC ACID HCl) FOR TOPICAL SOLUTION, 20% AND 10 J/CM2 OF BLUE LIGHT DELIVERED AT 10 MW/CM2 OR 20 MW/CM2 BY A NEW LIGHT SOURCE FOR THE TREATMENT OF ACTINIC KERATOSES ON THE FACE OR SCALP

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: ALA
* Drug: Vehicle
* Device: IBL 20 mW
* Device: IBL 10 mW


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 the face OR balding scalp Exclusion Criteria: Pregnancy grade 3 and/or atypical >1cm AKs within Treatment Area and/or more than 15 AKs of any Grade within the 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) has active herpes simplex infection in the Treatment Area OR a history of 2 or more outbreaks within past 12 months, in the Treatment Area 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. Curettage or 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 20 mW<br>ALA + IBL 10J at 20 mW (8min 20 sec) | Drug: ALA<br>* 20% ALA applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light<br>* Other names: Aminolevulinic Acid;Device: IBL 20 mW<br>* 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds<br>* Other names: Investigational Blue Light;|
| Experimental: ALA 10 mW<br>ALA + IBL 10J at 10 mW (16 min 40 sec) | Drug: ALA<br>* 20% ALA applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light<br>* Other names: Aminolevulinic Acid;Device: IBL 10 mW<br>* 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds<br>* Other names: Investigational Blue Light;|
| Placebo Comparator: Vehicle<br>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving light treatment delivered at 20 mW/cm2 OR 10 mW/cm2. Subjects receiving VEH will be considered a single treatment group | Drug: Vehicle<br>* Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light<br>* Other names: Topical Solution Vehicle;Device: IBL 20 mW<br>* 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds<br>* Other names: Investigational Blue Light;Device: IBL 10 mW<br>* 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds<br>* Other names: Investigational Blue Light;|

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 100% clearance of Baseline target lesions | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline AK Clearance Rate | {1 - [(number of Baseline target AK lesions at follow-up)/(number of Baseline target AK lesions at Baseline)]} x 100 | Baseline and Week 12 | 
| Baseline AK Clearance Rate | {1 - [(number of Baseline target AK lesions at follow-up)/(number of Baseline target AK lesions at Baseline)]} x 100 | Baseline and Week 8 | 
| Complete Clearance Rate | proportion of subjects in each treatment group with 100% clearance of Baseline target lesions | Week 8 | 
| Baseline AK Clearance Rate | {1 - [(number of Baseline target AK lesions at follow-up)/(number of Baseline target AK lesions at Baseline)]} x 100 = Excellent (very satisfied) = Good (moderately satisfied) = Fair (slightly satisfied) = Poor (not satisfied at all) | Baseline and Week 4 | 
| Complete Clearance Rate | proportion of subjects in each treatment group with 100% clearance of Baseline target lesions | Week 4 | 

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