Phase 3 Study of Levulan With New Blue Light for AK on the Face or Scalp
NCT ID: NCT03024060
Last Updated: 2017-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2017-03-31
2018-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ALA 20 mW
ALA + IBL 10J at 20 mW (8min 20 sec)
ALA
20% ALA applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light
IBL 20 mW
10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds
ALA 10 mW
ALA + IBL 10J at 10 mW (16 min 40 sec)
ALA
20% ALA applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light
IBL 10 mW
10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Vehicle
Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving light treatment delivered at 20 mW/cm2 OR 10 mW/cm2. Subjects receiving VEH will be considered a single treatment group
Vehicle
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light
IBL 20 mW
10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds
IBL 10 mW
10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Interventions
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ALA
20% ALA applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light
Vehicle
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light
IBL 20 mW
10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds
IBL 10 mW
10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
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 and/or more than 15 AKs of any Grade within the 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)
* has active herpes simplex infection in the Treatment Area OR a history of 2 or more outbreaks within past 12 months, in the Treatment Area
* 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.
* Curettage or 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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Therapeutics Clinical Research
San Diego, California, 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
DermResearch, Inc.
Austin, Texas, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Countries
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Other Identifiers
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CP0114
Identifier Type: -
Identifier Source: org_study_id