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

Completed · Phase 3

Conditions studied: Actinic Keratosis

In brief

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

Key facts

Study ID

NCT02137785

Run by

DUSA Pharmaceuticals, Inc.

People needed

269

Starts

2014-05-01

Expected to finish

2015-03-01

Last updated by the study team

2015-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on one upper extremity

You may not qualify if…

• 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.

Where it is running

• Center For Dermatology Clinical Research, Inc. — Fremont, California, United States
• UCSD Dermatology — San Diego, California, United States
• Center for Clinical and Cosmetic Research — Aventura, Florida, United States
• MOORE Clinical Research, Inc — Brandon, Florida, United States
• Spencer Clinical Services — St. Petersburg, Florida, United States
• Altman Dermatology Associates — Arlington Heights, Illinois, United States
• Shideler Clinical Research Center — Carmel, Indiana, United States
• The Indiana Clinical Trials Center, PC — Plainfield, Indiana, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Oregon Dermatology and Research Center — Portland, Oregon, United States
• J&S Studies, Inc — College Station, Texas, United States
• Suzanne Bruce and Associates, P.A.,The Center for Skin Research — Houston, Texas, United States
• Virginia Clinical Research, Inc. — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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