The Efficacy of Hand Narrow-Band Ultraviolet B (NBUVB) Versus Excilite Treatment in Vitiligo After Minigrafting on the Dorsal Hands

Study Overview
=================
Brief Summary
-----------------
To assess over a 25-week period the efficacy of hand-foot narrow-band ultraviolet B light versus focal 308-nm light treatment in inducing the return of pigment in vitiligo after skin minigraft transplants to the backs of the hands in patients with light brown to black skin. Subject will undergo treatment for 13 weeks.

Detailed Description
-----------------
Prospective investigator-blinded study involving 13 adult male and female subjects with vitiligo on the backs of both hands. Punch minigrafting will be performed on both hands taking skin from the thighs and/or buttocks. Light treatments will be administered starting at week one after grafting. One hand will receive narrow-band ultraviolet B light and the other will receive focal 308-nm light treatments. Light treatments will be administered 3 times per week for 12 weeks. A long term follow-up visit will be completed at week 25. The investigator will evaluate the subjects at week 4, 7, 13 and 25 in addition to screening and baseline evaluations/procedures.

Official Title
-----------------
The Efficacy of Hand-Foot Narrow-Band Ultraviolet B (UVB) Versus Focal 308-nm Treatment in Inducing Repigmentation of Vitiligo After Minigrafting on the Dorsal Hands

Conditions
-----------------
Vitiligo

Intervention / Treatment
-----------------
* Device: NBUVB
* Device: Monochromacitc Excimer light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female subjects 18 years of age or older skin type III-VI vitiligo on both dorsal hands history of stable vitiligo ( no new lesions and no more than 10% enlargement of existing lesions) for six months with an absence of Kebner phenomenon (new lesions appearing after trauma to the skin) refractory to topical steroids and immunomodulators Exclusion Criteria: pregnant and/or breast-feeding females history of skin cancer history of taking photosensitizing medications history of recent phototherapy (light therapy) or topical medications within one month prior to enrollment history of organ transplantation history of failed vitiligo skin transplantation history of segmental vitiligo history of 12 or more continuous light treatments

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Daavlin Right vs. Excilite Left<br>Right hand treated with narrow-band UVB light and left hand treated with focal 308nm light. | Device: NBUVB<br>* NBUVB hand foot box<br>|
| Active Comparator: Excilite Right vs. Daavlin Left<br>Right hand treated with focal 308-nm light and left hand treated with narrow-band UVB light | Device: Monochromacitc Excimer light<br>* Treatment with Monochromacitc Excimer light<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Repigmentation of Target Lesion | This is measured using photography and Scion software calculations. | 25 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitiligo, Light treatment for vitiligo, Excilite