Effect of Microneedling, Bimatoprost and Excimer in Vitiligo Treatment

Early Phase 1

Completed

• Conditions: Vitiligo
• Interventions: Device: Excimer laser; Drug: Bimatoprost; Device: Microneedling with a dermaroller

• Registration Number: NCT04738149
• Lead Sponsor: Medical University of South Carolina

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-22
• Study First Submitted QC: 2021-01-29
• Study First Posted: 2021-02-04
• Study Start: 2021-11-02
• Primary Completion: 2022-05-15
• Study Completion: 2022-05-15
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• All patients 18 years and older with the diagnosis of Vitiligo.

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Exclusion Criteria

• Female patients currently pregnant or lactating
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Area 2: Excimer laser	Excimer laser	-
Area 1: Excimer laser, bimatoprost, and microneedling	Excimer laser	-
Area 1: Excimer laser, bimatoprost, and microneedling	Microneedling with a dermaroller	-
Area 1: Excimer laser, bimatoprost, and microneedling	Bimatoprost	-

Primary Outcome Measures

Name	Time	Method
Percentage of skin repigmentation after 12 weeks	Post treatment (at week 12)	A blinded outcome accessor will compare photographs of patients before and after treatment.
Number of patients with perceived improvement after 12 weeks.	Week 12	Patients will be completing the Vitiligo Noticeability Scale that encompasses a series of questions assessing patient perceived change of before and after photographs.

Secondary Outcome Measures

Name	Time	Method
Change in quality of life	Baseline and post treatment approximately 12 weeks	To access quality of life via a validated general Dermatology Life Quality Index Scale.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States