Effect of Microneedling, Bimatoprost and Excimer in Vitiligo Treatment

Study Overview
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Brief Summary
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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.

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

Conditions
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Vitiligo

Intervention / Treatment
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* Drug: Bimatoprost
* Device: Excimer laser
* Device: Microneedling with a dermaroller


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Area 1: Excimer laser, bimatoprost, and microneedling<br> | Drug: Bimatoprost<br>* Participants will be receiving 2 drops per 4cm2 twice a week for 12 weeks<br>Device: Excimer laser<br>* Participants will be receiving excimer laser 2x a week for 12 weeks<br>Device: Microneedling with a dermaroller<br>* Participants will have 4cm2 area pre-treated with dermaroller 2x per week for 12 weeks<br>|
| Active Comparator: Area 2: Excimer laser<br> | Device: Excimer laser<br>* Participants will be receiving excimer laser 2x a week for 12 weeks<br>|

What is the study measuring?
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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 |