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

NCT ID: NCT00622180

Last Updated: 2019-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-03-31

Brief 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.

Detailed 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.

Conditions

Vitiligo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Daavlin Right vs. Excilite Left

Right hand treated with narrow-band UVB light and left hand treated with focal 308nm light.

Group Type: ACTIVE_COMPARATOR

NBUVB

Intervention Type: DEVICE

NBUVB hand foot box

Excilite Right vs. Daavlin Left

Right hand treated with focal 308-nm light and left hand treated with narrow-band UVB light

Group Type: ACTIVE_COMPARATOR

Monochromacitc Excimer light

Intervention Type: DEVICE

Treatment with Monochromacitc Excimer light

Interventions

NBUVB

NBUVB hand foot box

Intervention Type: DEVICE

Monochromacitc Excimer light

Treatment with Monochromacitc Excimer light

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amit Pandya, M.D.

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center at Dallas - Department of Dermatology

Locations

UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials

Dallas, Texas, United States

Countries

United States

Other Identifiers

122007-003

Identifier Type: -

Identifier Source: secondary_id

IRB file number 122007-003

Identifier Type: -

Identifier Source: org_study_id