The Efficacy of Hand NBUVB Versus Excilite Treatment in Vitiligo After Minigrafting on the Dorsal Hands

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by University of Texas Southwestern Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00622180
First received: January 23, 2008
Last updated: January 21, 2009
Last verified: February 2008

January 23, 2008
January 21, 2009
January 2008
January 2009   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00622180 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Efficacy of Hand NBUVB Versus Excilite Treatment in Vitiligo After Minigrafting on the Dorsal Hands
The Efficacy of Hand-Foot Narrow-Band UVB Versus Focal 308-nm Treatment in Inducing Repigmentation of 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Vitiligo
  • Device: Daavlin Spectra UVB Hand/Foot Box
    Narrow-band ultraviolet B hand box
  • Device: Excilite Focal 308-nm light
    Excilite Focal 308-nm light
  • Active Comparator: 1
    Right hand treated with narrow-band UVB light and left hand treated with focal 308-nm light
    Intervention: Device: Daavlin Spectra UVB Hand/Foot Box
  • Active Comparator: 2
    Right hand treated with focal 308-nm light and left hand treated with narrow-band UVB light
    Intervention: Device: Excilite Focal 308-nm light
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
April 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00622180
IRB file number 122007-003, 122007-003
No
Amit Pandya, M.D. - Professor of Dermatology, UT Southwestern Medical Center at Dallas
University of Texas Southwestern Medical Center
Not Provided
Principal Investigator: Amit Pandya, M.D. UT Southwestern Medical Center at Dallas - Department of Dermatology
University of Texas Southwestern Medical Center
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP