Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK)

Completed · Phase 2

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 keratosis when applied to broad areas on the face and scalp for 1, 2 and 3 hours.

Key facts

Study ID: NCT01475955
Run by: DUSA Pharmaceuticals, Inc.
People needed: 235
Starts: 2011-12-01
Expected to finish: 2012-11-01
Last updated by the study team: 2016-10-28

Who can join

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

You may qualify if…

6-20 Grade 1/2 AKs on the face or scalp
a history of AK therapy within the treatment area at least twice in the two years prior to study entry

You may not qualify if…

Pregnancy
Grade 3 AKs or atypical AKs (e.g., AK > 1 cm2 in size) within the Treatment Area
lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
plans to be exposed to artificial tanning devices or excessive sunlight during the trial
Subject is immunosuppressed
unsuccessful outcome from previous ALA-PDT therapy
history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
any condition which would make it unsafe for the subject to participate in this research study
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)
Subject has;
an active herpes simplex infection OR
a history of 2 or more outbreaks within the past 12 months, in the Treatment Area
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

UCSD Dermatology Perlman Ambulatory Clinic — La Jolla, California, United States
Dermatology Research Associates — Los Angeles, California, United States
Therapeutics Clinical Research — San Diego, California, United States
Northwest Clinical Trials, Inc. — Boise, Idaho, United States
Altman Dermatology Associates — Arlington Heights, Illinois, United States
The Indiana Clinical Trials Center, PC — Plainfield, Indiana, United States
Minnesota Clinical Study Center — Fridley, Minnesota, United States
Dermatology Research Center of Cincinnati — Cincinnati, Ohio, United States
Oregon Medical Research Center, PC — Portland, Oregon, United States
Tennessee Clinical Research Center — Nashville, Tennessee, United States
DermResearch, Inc. — Austin, 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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