Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK)
NCT ID: NCT01475955
Last Updated: 2016-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
235 participants
INTERVENTIONAL
2011-12-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Broad Area ALA 1-hour incubation
Broad Area ALA 1-hour incubation
Broad Area ALA 1-hour incubation
20% ALA, broad area, 1 hour incubation
Blue Light Treatment
10 J/cm2 blue light delivered at 10 mW/cm2
Broad Area ALA 2-hour incubation
Broad Area ALA 2-hour incubation
Broad Area ALA 2 hour incubation
20% ALA broad area 2-hour incubation
Blue Light Treatment
10 J/cm2 blue light delivered at 10 mW/cm2
Broad Area ALA 3-hour incubation
Broad Area ALA 3-hour incubation
broad area ALA 3-hour incubation
20% ALA broad area 3 hour incubation
Blue Light Treatment
10 J/cm2 blue light delivered at 10 mW/cm2
Spot ALA 2-hour incubation
Spot ALA 2-hour incubation
Spot ALA 2 hour incubation
20% ALA spot 2 hour incubation
Blue Light Treatment
10 J/cm2 blue light delivered at 10 mW/cm2
Vehicle PDT
VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.
Vehicle PDT
Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.
Blue Light Treatment
10 J/cm2 blue light delivered at 10 mW/cm2
Interventions
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Broad Area ALA 1-hour incubation
20% ALA, broad area, 1 hour incubation
Broad Area ALA 2 hour incubation
20% ALA broad area 2-hour incubation
broad area ALA 3-hour incubation
20% ALA broad area 3 hour incubation
Spot ALA 2 hour incubation
20% ALA spot 2 hour incubation
Vehicle PDT
Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.
Blue Light Treatment
10 J/cm2 blue light delivered at 10 mW/cm2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* a history of AK therapy within the treatment area at least twice in the two years prior to study entry
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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DUSA Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stuart Marcus, MD, PhD
Role: STUDY_DIRECTOR
DUSA Pharmaceuticals, Inc.
Locations
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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
Countries
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References
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Piacquadio D, Berman B, Siegel DM, Bhatia N, Brocato J, Squittieri N, Pariser DM. Treatment Satisfaction and Acceptability of 20% Aminolevulinic Acid Photodynamic Therapy for the Treatment of Actinic Keratoses of the Face, Scalp, and Upper Extremities. J Clin Aesthet Dermatol. 2023 Dec;16(12):46-51.
Other Identifiers
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CP0105
Identifier Type: -
Identifier Source: org_study_id