Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (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: Actinic Keratosis
Intervention: Broad Area ALA 1-hour incubation (Drug); Broad Area ALA 2 hour incubation (Drug); broad area ALA 3-hour incubation (Drug); Spot ALA 2 hour incubation (Drug); Vehicle PDT (Drug); Blue Light Treatment (Device)
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 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.
Clinical Details
Official title: A Phase II Study of Photodynamic Therapy With LEVULANŽ Topical Solution + Blue Light Versus LEVULANŽ Topical Solution Vehicle + Blue Light Using Spot and Broad Area Application and Incubation Times of 1, 2 and 3 Hours for the Treatment of Multiple Actinic Keratoses on the Face or Scalp
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Complete Clearance Rate
Secondary outcome: Complete Clearance RateComplete Clearance Rate Complete Clearance Rate Partial Clearance Rate Partial Clearance Rate Partial Clearance Rate Partial Clearance Rate AK Clearance Rate AK Clearance Rate AK Clearance Rate AK Clearance Rate Subject Satisfaction Score Hyperpigmentation at Baseline Hyperpigmentation at Visit 2 Hyperpigmentation at Visit 3 Hyperpigmentation at Visit 4 Hyperpigmentation at Visit 5 Hyperpigmentation at Visit 6 Hyperpigmentation at Visit 7 Hypopigmentation at Baseline Hypopigmentation at Visit 2 Hypopigmentation at Visit 3 Hypopigmentation at Visit 4 Hypopigmentation at Visit 5 Hypopigmentation at Visit 6 Hypopigmentation at Visit 7 Erythema at Baseline Erythema Post-Light Treatment Erythema at Visit 2 Erythema at Visit 3 Erythema at Visit 4 Erythema at Visit 5 (Pre-drug) Erythema at Visit 5 (Post-light) Erythema at Visit 6 Erythema at Visit 7 Edema at Baseline Edema Post-Light Treatment Edema at Visit 2 Edema at Visit 3 Edema at Visit 4 Edema at Visit 5 (Pre-drug) Edema Post PDT #2 Edema at Week 12 Edema at Week 24 Stinging/Burning at Baseline Stinging/Burning During Light Treatment Stinging/Burning Post Light-Treatment Stinging/Burning at Visit 2 Stinging/Burning at Visit 3 Stinging/Burning at Visit 4 Stinging/Burning at Visit 5 (Pre-drug) Stinging/Burning at Visit 5 During PDT#2 Stinging/Burning at Visit 5 Post PDT#2 Stinging/Burning at Visit 6 Stinging/Burning at Visit 7 Scaling and Dryness at Baseline Scaling and Dryness at Visit 2 Scaling and Dryness at Visit 3 Scaling and Dryness at Visit 4 Scaling and Dryness at Visit 5 Scaling and Dryness at Visit 6 Scaling and Dryness at Visit 7 Oozing/Vesiculation/Crusting at Baseline Oozing/Vesiculation/Crusting at Visit 2 Oozing/Vesiculation/Crusting at Visit 3 Oozing/Vesiculation/Crusting at Visit 4 Oozing/Vesiculation/Crusting at Visit 5 Oozing/Vesiculation/Crusting at Visit 6 Oozing/Vesiculation/Crusting at Visit 7
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Locations and Contacts
UCSD Dermatology Perlman Ambulatory Clinic, La Jolla, California 92037, United States
Dermatology Research Associates, Los Angeles, California 90045, United States
Therapeutics Clinical Research, San Diego, California 92123, United States
Northwest Clinical Trials, Inc., Boise, Idaho 83704, United States
Altman Dermatology Associates, Arlington Heights, Illinois 60005, United States
The Indiana Clinical Trials Center, PC, Plainfield, Indiana 46168, United States
Minnesota Clinical Study Center, Fridley, Minnesota 55432, United States
Dermatology Research Center of Cincinnati, Cincinnati, Ohio 45220, United States
Oregon Medical Research Center, PC, Portland, Oregon 97223, United States
Tennessee Clinical Research Center, Nashville, Tennessee 37215, United States
DermResearch, Inc., Austin, Texas 78759, United States
Suzanne Bruce and Associates, P.A.,The Center for Skin Research, Houston, Texas 77056, United States
Virginia Clinical Research Inc, Norfolk, Virginia 23507, United States
Additional Information
Starting date: December 2011
Last updated: November 26, 2013
|