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

Sponsored by:	University of Texas Southwestern Medical Center
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00622180

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.

Condition	Intervention
Vitiligo	Device: Daavlin Spectra UVB Hand/Foot Box Device: Excilite Focal 308-nm light

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Foot Health Vitiligo

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	25
Study Start Date:	January 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Right hand treated with narrow-band UVB light and left hand treated with focal 308-nm light	Device: Daavlin Spectra UVB Hand/Foot Box Narrow-band ultraviolet B hand box
2: Active Comparator Right hand treated with focal 308-nm light and left hand treated with narrow-band UVB light	Device: Excilite Focal 308-nm light Excilite Focal 308-nm light

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622180

Locations

United States, Texas
UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials
Dallas, Texas, United States, 75390-8802

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

Principal Investigator:

Amit Pandya, M.D.

UT Southwestern Medical Center at Dallas - Department of Dermatology

More Information

No publications provided

Responsible Party:	UT Southwestern Medical Center at Dallas ( Amit Pandya, M.D. - Professor of Dermatology )
Study ID Numbers:	IRB file number 122007-003, 122007-003
Study First Received:	January 23, 2008
Last Updated:	January 21, 2009
ClinicalTrials.gov Identifier:	NCT00622180 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:

Vitiligo
Light treatment for vitiligo
Excilite

Study placed in the following topic categories:

Hypopigmentation
Skin Diseases
Pigmentation Disorders
Hypomelanotic Disorder
Vitiligo

Additional relevant MeSH terms:

Hypopigmentation
Skin Diseases
Pigmentation Disorders
Vitiligo

ClinicalTrials.gov processed this record on September 03, 2009