Overview

This trial is active, not recruiting.

Condition vitiligo
Treatments daavlin spectra uvb hand/foot box, excilite focal 308-nm light
Sponsor University of Texas Southwestern Medical Center
Start date January 2008
End date January 2009
Trial size 25 participants
Trial identifier NCT00622180, 122007-003, IRB file number 122007-003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Active Comparator)
Right hand treated with narrow-band UVB light and left hand treated with focal 308-nm light
daavlin spectra uvb hand/foot box
Narrow-band ultraviolet B hand box
(Active Comparator)
Right hand treated with focal 308-nm light and left hand treated with narrow-band UVB light
excilite focal 308-nm light
Excilite Focal 308-nm light

Primary Outcomes

Measure
Percent repigmentation of individual surviving grafts, percent repigmentation of all surviving grafts per hand, and percent repigmentation of lesional skin with each light source.
time frame: 25 weeks

Secondary Outcomes

Measure
Time to initial 10% repigmentation per graft, time to initial 10% repigmentation per lesion, the physician global repigmentation assessment, and an assessment of the safety of each treatment.
time frame: 25 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Efficacy of Hand-Foot Narrow-Band UVB Versus Focal 308-nm Treatment in Inducing Repigmentation of Vitiligo After Minigrafting on the Dorsal Hands
Principal investigator Amit Pandya, M.D.
Description Prospective investigator-blinded study involving 25 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2009.
Information provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center.