Effect of Microneedling, Bimatoprost and Excimer in Vitiligo Treatment

NCT04738149 | Completed Early Phase 1 FDA Drug FDA Device

• 1 other identifier: 00104695
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in quality of life

  Baseline and post treatment approximately 12 weeks

• Change in quality of life

  Baseline and post treatment approximately 12 weeks

Study Arms (2)

Area 1: Excimer laser, bimatoprost, and microneedling

EXPERIMENTAL

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

Area 2: Excimer laser

ACTIVE COMPARATOR

Device: Excimer laser

Interventions

Bimatoprost DRUG

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

Area 1: Excimer laser, bimatoprost, and microneedling

Excimer laser DEVICE

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

Area 1: Excimer laser, bimatoprost, and microneedling; Area 2: Excimer laser

Microneedling with a dermaroller DEVICE

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

Area 1: Excimer laser, bimatoprost, and microneedling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29407, United States

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Bimatoprost; Lasers, Excimer; Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: February 4, 2021
• Study Start: November 2, 2021
• Primary Completion: May 15, 2022
• Study Completion: May 15, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)