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

• Status: Withdrawn
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: DUSA Pharmaceuticals, Inc.
• Treatments: Aminolevulinic Acid; Pharmaceutical Solutions

Criteria

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.