Effect of Microneedling, Bimatoprost and Excimer in Vitiligo Treatment
NCT ID: NCT04738149
Last Updated: 2022-08-05
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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COMPLETED
EARLY_PHASE1
4 participants
INTERVENTIONAL
2021-11-02
2022-05-15
Brief Summary
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The study is a pilot, split study meaning the patient will receive one experimental and one standard of care treatment on symmetric lesions of similar location, geometrics and size.
Enrolled subjects will present biweekly to clinic on the same two days for twelve weeks. One lesion will be treated with microneedling, topical PGF2α and calibrated excimer laser, while the parallel lesion will be excimer laser alone. Physical exam, photographs, and a review of of the subjects medical records will occur in the study. Changes in size, appearance, and adverse events will be monitored throughout the study. The patient will also agree to close up photographs of their lesions throughout the study.
The possible benefit of joining this study is that the treatment received may be more effective than the other study treatment or then other available treatments for vitiligo, although this cannot be guaranteed.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Area 1: Excimer laser, bimatoprost, and microneedling
Bimatoprost
Participants will be receiving 2 drops per 4cm2 twice a week for 12 weeks
Excimer laser
Participants will be receiving excimer laser 2x a week for 12 weeks
Microneedling with a dermaroller
Participants will have 4cm2 area pre-treated with dermaroller 2x per week for 12 weeks
Area 2: Excimer laser
Excimer laser
Participants will be receiving excimer laser 2x a week for 12 weeks
Interventions
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Bimatoprost
Participants will be receiving 2 drops per 4cm2 twice a week for 12 weeks
Excimer laser
Participants will be receiving excimer laser 2x a week for 12 weeks
Microneedling with a dermaroller
Participants will have 4cm2 area pre-treated with dermaroller 2x per week for 12 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Female patients with plans to come pregnant during the next 3 months
* Allergic reactions to topical or oral prostaglandins
* Uncontrolled skin disease
* History of glaucoma
* Concomitant disease or therapy that interferes with the diagnosis that might interfere with vitiligo diagnosis sand evaluation.
* Patients currently using other treatments for Vitiligo, such as topical steroids, calcineurin inhibitors, and Vitamin D analogs within 2 weeks of study initiation
* Inability or unwillingness of subject or legal guardian/representative to give
18 Years
ALL
Yes
Sponsors
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Medical University of South Carolina
OTHER
Responsible Party
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Joni Mazza Mccrann
Associate Professor
Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Other Identifiers
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00104695
Identifier Type: -
Identifier Source: org_study_id
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