MedTrace Logo

Effect of Microneedling, Bimatoprost and Excimer in Vitiligo Treatment

NCT04738149 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2022-08-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2022-05-15
Completion
2022-05-15
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04738149 on ClinicalTrials.gov