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

Not Applicable

Completed

• Conditions: Vitiligo
• Interventions: Device: Monochromacitc Excimer light; Device: NBUVB

• Registration Number: NCT00622180
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-23
• Study First Submitted QC: 2008-02-11
• Study First Posted: 2008-02-22
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2013-08-30
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-04
• Last Update Submitted: 2019-11-04
• Results First Posted: 2019-11-05
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Excilite Right vs. Daavlin Left	Monochromacitc Excimer light	Right hand treated with focal 308-nm light and left hand treated with narrow-band UVB light
Daavlin Right vs. Excilite Left	NBUVB	Right hand treated with narrow-band UVB light and left hand treated with focal 308nm light.

Primary Outcome Measures

Name	Time	Method
Percent Repigmentation of Target Lesion	25 weeks	This is measured using photography and Scion software calculations.

Trial Locations

Locations (1)

UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials; 🇺🇸 Dallas, Texas, United States