Expired Study
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Dallas, Texas 75390


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00622180


Primary Contact:

Principal Investigator
Amit Pandya, M.D.
UT Southwestern Medical Center at Dallas - Department of Dermatology


Backup Contact:

N/A


Location Contact:

Dallas, Texas 75390
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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