DUSA Pharmaceuticals, Inc.
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.
- Drug: ALA20% ALA applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light
- Levulan Kerastick
- Aminolevulinic Acid
- Drug: VehicleLevulan 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
- Topical Solution Vehicle
- Device: IBL 20 mW10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds
- Investigational Blue Light
- Device: IBL 10 mW10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
- Investigational Blue Light
|Ages eligible for Study||18 Years and older|
|Genders eligible for Study||All|
|Accepts Healthy Volunteers||No|
- Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on the face OR balding scalp
- 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.
United States (7)
- Therapeutics Clinical Researchnot yet recruitingSan Diego, California, United States, 92123
- Altman Dermatology Associatesnot yet recruitingArlington Heights, Illinois, United States, 60005
- Shideler Clinical Research Centernot yet recruitingCarmel, Indiana, United States, 46032
- The Indiana Clinical Trials Center, PCnot yet recruitingPlainfield, Indiana, United States, 46168
- Minnesota Clinical Study Centernot yet recruitingFridley, Minnesota, United States, 55432
- DermResearch, Inc.not yet recruitingAustin, Texas, United States, 78759
- Virginia Clinical Research, Inc.not yet recruitingNorfolk, Virginia, United States, 23507
not yet recruiting
28 February, 2017
06 February, 2017