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

Vitiligo Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00622180
• Other study ID #: IRB file number 122007-003
• Secondary ID: 122007-003
• Status: Completed
• Phase: N/A
• Start date: January 2008
• Est. completion date: March 2009

Study information

• Verified date: November 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vitiligo

Intervention

Device:
• NBUVB
NBUVB hand foot box
• Monochromacitc Excimer light
Treatment with Monochromacitc Excimer light

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Repigmentation of Target Lesion	This is measured using photography and Scion software calculations.	25 weeks