Skip to main content
OpenTrials
Completed

NCT Number: NCT04738149

Effect of Microneedling, Bimatoprost and Excimer in Vitiligo Treatment

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29407, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bimatoprost

Drug

Participants will be receiving 2 drops per 4cm2 twice a week for 12 weeks

Excimer Laser

Device

Participants will be receiving excimer laser 2x a week for 12 weeks

Microneedling with a dermaroller

Device

Participants will have 4cm2 area pre-treated with dermaroller 2x per week for 12 weeks

Primary outcomes

  1. Percentage of skin repigmentation after 12 weeks

    Time frame: Post treatment (at week 12)

    A blinded outcome accessor will compare photographs of patients before and after treatment.

  2. Number of patients with perceived improvement after 12 weeks.

    Time frame: 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 outcomes

  1. Change in quality of life

    Time frame: Baseline and post treatment approximately 12 weeks

    To access vitiligo patient specifically though a QOL reliable and valid scale.

  2. Change in quality of life

    Time frame: Baseline and post treatment approximately 12 weeks

    To access quality of life via a validated general Dermatology Life Quality Index Scale.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 4, 2021
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.