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

University of Texas Southwestern Medical Center13 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Vitiligo

Interventions

NBUVBDEVICE

NBUVB hand foot box

Monochromacitc Excimer lightDEVICE

Treatment with Monochromacitc Excimer light

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials

Dallas, Texas, United States

Outcomes

Primary Outcomes

Percent Repigmentation of Target Lesion

This is measured using photography and Scion software calculations.

Time frame: 25 weeks

Data from ClinicalTrials.gov

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