The Efficacy of Hand Narrow-Band Ultraviolet B (NBUVB) Versus Excilite Treatment in Vitiligo After Minigrafting on the Dorsal Hands
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
2 other identifiers
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 23, 2008
CompletedFirst Posted
Study publicly available on registry
February 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
November 5, 2019
CompletedNovember 5, 2019
November 1, 2019
1.2 years
January 23, 2008
August 30, 2013
November 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Repigmentation of Target Lesion
This is measured using photography and Scion software calculations.
25 weeks
Study Arms (2)
Daavlin Right vs. Excilite Left
ACTIVE COMPARATORRight hand treated with narrow-band UVB light and left hand treated with focal 308nm light.
Excilite Right vs. Daavlin Left
ACTIVE COMPARATORRight hand treated with focal 308-nm light and left hand treated with narrow-band UVB light
Interventions
Treatment with Monochromacitc Excimer light
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials
Dallas, Texas, 75390-8802, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Amit Pandya, M.D.
- Organization
- UT Southwestern Medical Center at Dallas
Study Officials
- PRINCIPAL INVESTIGATOR
Amit Pandya, M.D.
UT Southwestern Medical Center at Dallas - Department of Dermatology
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2008
First Posted
February 22, 2008
Study Start
January 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
November 5, 2019
Results First Posted
November 5, 2019
Record last verified: 2019-11