Microneedle Lesion Preparation Prior to Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) for AK on Face
NCT ID: NCT02632110
Last Updated: 2018-01-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
137 participants
INTERVENTIONAL
2016-03-31
2016-09-12
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 25 min 10 Milliwatts (mW)
ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
ALA
20% ALA applied to face prior to light treatment
IBL 10 mW
10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds
MN + ALA 25 min 10 mW
Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
ALA
20% ALA applied to face prior to light treatment
IBL 10 mW
10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds
Microneedle lesion preparation
Microneedling of all visible/palpable AK lesions prior to solution application.
ALA 25 min 20 mW
ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
ALA
20% ALA applied to face prior to light treatment
IBL 20 mW
10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds
MN + ALA 25 min 20 mW
Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
ALA
20% ALA applied to face prior to light treatment
Microneedle lesion preparation
Microneedling of all visible/palpable AK lesions prior to solution application.
IBL 20 mW
10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds
ALA 60 min 10 mW
ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
ALA
20% ALA applied to face prior to light treatment
IBL 10 mW
10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds
MN + ALA 60 min 10 mW
Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
ALA
20% ALA applied to face prior to light treatment
IBL 10 mW
10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds
Microneedle lesion preparation
Microneedling of all visible/palpable AK lesions prior to solution application.
ALA 60 min 20 mW
ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
ALA
20% ALA applied to face prior to light treatment
IBL 20 mW
10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds
MN + ALA 60 min 20 mW
Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
ALA
20% ALA applied to face prior to light treatment
Microneedle lesion preparation
Microneedling of all visible/palpable AK lesions prior to solution application.
IBL 20 mW
10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds
VEH
Vehicle (VEH) PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
Topical Solution Vehicle
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment
IBL 10 mW
10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds
MN + VEH
Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
Topical Solution Vehicle
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment
IBL 10 mW
10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds
Microneedle lesion preparation
Microneedling of all visible/palpable AK lesions prior to solution application.
Interventions
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ALA
20% ALA applied to face prior to light treatment
Topical Solution Vehicle
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment
IBL 10 mW
10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds
Microneedle lesion preparation
Microneedling of all visible/palpable AK lesions prior to solution application.
IBL 20 mW
10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
* 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 an active herpes simplex infection OR a history of 2 or more outbreaks within the past 12 months, on the face
* 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
* Curettage or Cryotherapy within 2 weeks of initiation of treatment
* Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks
* Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5 fluorouracil, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks
* use of systemic retinoid therapy within 6 months
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
San Diego, California, United States
Therapeutics Clinical Research
San Diego, California, United States
MOORE Clinical Research, Inc
Brandon, 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
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Countries
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Other Identifiers
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CP0112
Identifier Type: -
Identifier Source: org_study_id
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