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Completed

NCT Number: NCT00622180

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials

Dallas, Texas, 75390-8802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NBUVB

Device

NBUVB hand foot box

Monochromacitc Excimer light

Device

Treatment with Monochromacitc Excimer light

Primary outcomes

  1. Percent Repigmentation of Target Lesion

    Time frame: 25 weeks

    This is measured using photography and Scion software calculations.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 22, 2008
Registry last updated
Nov 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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