Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)

Completed · Phase 2

Conditions studied: Keratosis, Actinic

In brief

The purpose of this study is to determine if Levulan PDT is safe and effective in the treatment of actinic keratoses on the upper arms and hands.

Key facts

Study ID

NCT01458587

Run by

DUSA Pharmaceuticals, Inc.

People needed

70

Starts

2011-11-01

Expected to finish

2012-07-01

Last updated by the study team

2013-03-14

Who can join

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

You may qualify if…

• At least 4 Grade 1/2 AKs on each upper extremity

You may not qualify if…

• Pregnancy
• 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 extremities 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, retinol, within 4 weeks of initiation of treatment.
• Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment.
• Two or more ALA PDT treatments in the past 6 months
• use of systemic retinoid therapy within 6 months of initiation of treatment.

Where it is running

• Therapeutics Clinical Research — San Diego, California, United States
• Park Avenue Dermatology, PA — Orange Park, Florida, United States
• DermResearch, Inc — Austin, Texas, United States

Full record on ClinicalTrials.gov

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