Effect of Microneedling, Bimatoprost and Excimer in Vitiligo Treatment

Medical University of South Carolina (MUSC)

Status and phase: Completed; Early Phase 1

Conditions: Vitiligo

Treatments: Device: Microneedling with a dermaroller; Drug: Bimatoprost; Device: Excimer laser

Study type: Interventional

Funder types: Other

Identifiers

NCT04738149

00104695

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4 participants in 2 patient groups

Area 1: Excimer laser, bimatoprost, and microneedling

Experimental group

Treatment:

Device: Microneedling with a dermaroller

Drug: Bimatoprost

Device: Excimer laser

Area 2: Excimer laser

Active Comparator group

Treatment:

Device: Excimer laser