NCT04738149

Effect of Microneedling, Bimatoprost and Excimer in Vitiligo Treatment

A Proof of Concept, Split Study Measuring the Effectiveness of Topical ProstaglandinF2alpha, Microneedling and Excimer Laser in the Treatment of Vitiligo

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research is to treat vitiligo with a topical PGF2α, microneedling and excimer laser. The goal is to have greater repigmentation than the standard of care (excimer) after 12 weeks of treatment. 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.

Conditions

• Vitiligo

Interventions

Type	Name	Description
DRUG	Bimatoprost	Participants will be receiving 2 drops per 4cm2 twice a week for 12 weeks
DEVICE	Excimer laser	Participants will be receiving excimer laser 2x a week for 12 weeks
DEVICE	Microneedling with a dermaroller	Participants will have 4cm2 area pre-treated with dermaroller 2x per week for 12 weeks

Timeline

• Start date: 2021-11-02
• Primary completion: 2022-05-15
• Completion: 2022-05-15
• First posted: 2021-02-04
• Last updated: 2022-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study