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

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.

Study Overview

• Status: Completed
• Conditions: Vitiligo
• Intervention / Treatment: Drug: Bimatoprost; Device: Excimer laser; Device: Microneedling with a dermaroller

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Area 1: Excimer laser, bimatoprost, and microneedling	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
Active Comparator: Area 2: Excimer laser	Device: Excimer laser; Participants will be receiving excimer laser 2x a week for 12 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	To access vitiligo patient specifically though a QOL reliable and valid scale.	Baseline and post treatment approximately 12 weeks
Change in quality of life	To access quality of life via a validated general Dermatology Life Quality Index Scale.	Baseline and post treatment approximately 12 weeks

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Actual): May 15, 2022
• Study Completion (Actual): May 15, 2022

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo; Antihypertensive Agents; Bimatoprost
• Other Study ID Numbers: 00104695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No