Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities
NCT ID: NCT02137785
Last Updated: 2015-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
269 participants
INTERVENTIONAL
2014-05-31
2015-03-31
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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ALA
Aminolevulinic Acid (ALA)
20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
Blue Light Photodynamic Therapy Illuminator (BLU-U)
10 J/cm2 blue light delivered at 10mW/cm2
Vehicle
Topical Solution Vehicle
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
Blue Light Photodynamic Therapy Illuminator (BLU-U)
10 J/cm2 blue light delivered at 10mW/cm2
Interventions
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Aminolevulinic Acid (ALA)
20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
Topical Solution Vehicle
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
Blue Light Photodynamic Therapy Illuminator (BLU-U)
10 J/cm2 blue light delivered at 10mW/cm2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* grade 3 and/or atypical \>1cm AKs within Treatment Area
* 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 extremity 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, within 4 weeks of initiation of treatment.
* Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment.
* 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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Center For Dermatology Clinical Research, Inc.
Fremont, California, United States
UCSD Dermatology
San Diego, California, United States
Center for Clinical and Cosmetic Research
Aventura, Florida, United States
MOORE Clinical Research, Inc
Brandon, Florida, United States
Spencer Clinical Services
St. Petersburg, Florida, United States
Altman Dermatology Associates
Arlington Heights, Illinois, United States
Shideler Clinical Research Center
Carmel, Indiana, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
J&S Studies, Inc
College Station, 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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CP0108
Identifier Type: -
Identifier Source: org_study_id
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