Status:
COMPLETED
Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)
Lead Sponsor:
DUSA Pharmaceuticals, Inc.
Conditions:
Keratosis, Actinic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- At least 4 Grade 1/2 AKs on each upper extremity
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01458587
Start Date
November 1 2011
End Date
July 1 2012
Last Update
March 14 2013
Active Locations (3)
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1
Therapeutics Clinical Research
San Diego, California, United States, 92123
2
Park Avenue Dermatology, PA
Orange Park, Florida, United States, 32073
3
DermResearch, Inc
Austin, Texas, United States, 78759