Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)
Information source: DUSA Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Keratosis, Actinic
Intervention: Aminolevulinic Acid PDT (ALA) (Drug); Vehicle PDT (VEH) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: DUSA Pharmaceuticals, Inc. Official(s) and/or principal investigator(s): Stuart Marcus, MD, PhD, Study Director, Affiliation: DUSA Pharmaceuticals, Inc.
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.
Clinical Details
Official title: A Phase II Study of Photodynamic Therapy (PDT)With LEVULANŽ Topical Solution + Blue Light Versus LEVULANŽ Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Lesion Clearance Rate
Secondary outcome: Lesion Clearance RateComplete Clearance Rate Complete Clearance Rate Partial Clearance Rate Partial Clearance Rate Subject Satisfaction Score Hyperpigmentation at Baseline Hyperpigmentation at Visit 3 Hyperpigmentation at Visit 4 Hyperpigmentation at Visit 5 Hypopigmentation at Baseline Hypopigmentation at Visit 3 Hypopigmentation at Visit 4 Hypopigmentation at Visit 5 Erythema at Baseline Erythema Post-Light Treatment Erythema at Visit 3 Erythema at Visit 4 Erythema at Visit 5 Edema at Baseline Edema Post-Light Treatment Edema at Visit 3 Edema at Visit 4 Edema at Visit 5 Stinging/Burning at Baseline Stinging/Burning During Light Treatment Stinging/Burning Post Light Treatment Stinging/Burning at Visit 3 Stinging/Burning at Visit 4 Stinging/Burning at Visit 5 Scaling and Dryness at Baseline Scaling and Dryness at Visit 3 Scaling and Dryness at Visit 4 Scaling and Dryness at Visit 5 OOZING/VESICULATION/CRUSTING at Baseline OOZING/VESICULATION/CRUSTING at Visit 3 OOZING/VESICULATION/CRUSTING at Visit 4 OOZING/VESICULATION/CRUSTING at Visit 5
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- At least 4 Grade 1/2 AKs on each upper extremity
Exclusion Criteria:
- 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.
Locations and Contacts
Therapeutics Clinical Research, San Diego, California 92123, United States
Park Avenue Dermatology, PA, Orange Park, Florida 32073, United States
DermResearch, Inc, Austin, Texas 78759, United States
Additional Information
Starting date: November 2011
Last updated: March 12, 2013
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