The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy
NCT ID: NCT02594644
Last Updated: 2018-11-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2014-11-06
2016-06-22
Brief Summary
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Detailed Description
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The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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10-minute Incubation with Microneedle Roller & Sham
10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Microneedle Roller
The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 650 micrometers in length.
Aminolevulinic Acid
Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue Light
Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
20-minute Incubation with Microneedle Roller & Sham
20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Microneedle Roller
The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 650 micrometers in length.
Aminolevulinic Acid
Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue Light
Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
Interventions
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Microneedle Roller
The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 650 micrometers in length.
Aminolevulinic Acid
Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue Light
Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
Eligibility Criteria
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Inclusion Criteria
* Subjects has actinic keratoses and qualifies for photodynamic therapy
Exclusion Criteria
* Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition
* Subjects who have established allergy to topical ALA
* Subjects who have had a documented nonmelanoma skin cancer on the face over the past 6 months
18 Years
ALL
No
Sponsors
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University of California, Davis
OTHER
Responsible Party
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Principal Investigators
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Raja Sivamani, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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University of California-Davis, Department of Dermatology
Sacramento, California, United States
Countries
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References
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Petukhova TA, Hassoun LA, Foolad N, Barath M, Sivamani RK. Effect of Expedited Microneedle-Assisted Photodynamic Therapy for Field Treatment of Actinic Keratoses: A Randomized Clinical Trial. JAMA Dermatol. 2017 Jul 1;153(7):637-643. doi: 10.1001/jamadermatol.2017.0849.
Other Identifiers
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553703
Identifier Type: -
Identifier Source: org_study_id
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