Phase 3 Study of Levulan With New Blue Light for AK on the Face or Scalp
- Conditions
- Actinic Keratosis
- Interventions
- Registration Number
- NCT03024060
- Lead Sponsor
- DUSA Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on the face OR balding scalp
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Vehicle 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 ALA 20 mW IBL 20 mW ALA + IBL 10J at 20 mW (8min 20 sec) ALA 10 mW IBL 10 mW ALA + IBL 10J at 10 mW (16 min 40 sec) Vehicle IBL 20 mW 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 Vehicle IBL 10 mW 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 ALA 20 mW ALA ALA + IBL 10J at 20 mW (8min 20 sec) ALA 10 mW ALA ALA + IBL 10J at 10 mW (16 min 40 sec)
- Primary Outcome Measures
Name Time Method Complete Clearance Rate Week 12 proportion of subjects in each treatment group with 100% clearance of Baseline target lesions
- Secondary Outcome Measures
Name Time Method Baseline AK Clearance Rate Baseline and Week 4 {1 - \[(number of Baseline target AK lesions at follow-up)/(number of Baseline target AK lesions at Baseline)\]} x 100
1. = Excellent (very satisfied)
2. = Good (moderately satisfied)
3. = Fair (slightly satisfied)
4. = Poor (not satisfied at all)Complete Clearance Rate Week 4 proportion of subjects in each treatment group with 100% clearance of Baseline target lesions
Trial Locations
- Locations (7)
Shideler Clinical Research Center
🇺🇸Carmel, Indiana, United States
Altman Dermatology Associates
🇺🇸Arlington Heights, Illinois, United States
Therapeutics Clinical Research
🇺🇸San Diego, California, United States
Minnesota Clinical Study Center
🇺🇸Fridley, Minnesota, United States
Virginia Clinical Research, Inc.
🇺🇸Norfolk, Virginia, United States
The Indiana Clinical Trials Center, PC
🇺🇸Plainfield, Indiana, United States
DermResearch, Inc.
🇺🇸Austin, Texas, United States