Narrowband UVB Treatment in Patients With Vitiligo
The study offers narrowband UVB light therapy to patients who have 5% of their body involved with vitiligo.
The hypothesis is that Narrowband UVB promotes melanocyte proliferation in vitiligo lesions.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effects of Narrowband UVB Phototherapy on Melanocyte Proliferation in Patients With Vitiligo|
- Number of melanocytes per unit length of skin surface [ Time Frame: pre-treatment, early repigmentation, 75% repigmentation of total body ] [ Designated as safety issue: No ]
- Clinical improvement [ Time Frame: first visit and last visit ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Study Completion Date:||November 2007|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
adult patients (age 18 or greater) with extensive vitiligo warranting treatment with whole body NB-UVB
Device: Narrowband UVB
Treatment three to seven times weekly for a total of 12 to 26 weeks (36 to 168 treatments). Dosing of NB-UVB will begin at 100-280 mJ/cm2, depending on tolerance and skin type, and will be titrated 10-20% per session until clinical efficacy or symptomatic erythema
All patients will receive phototherapy, with narrowband UVB, three times a week for six months, or a total of 78 treatments. 6mm punch skin biopsies (2) will be done prior to starting therapy, once during treatment (2) and at the completion of the study (2). Clinical assessments and photography will be done parallel to the skin biopsies. Results (clinically and histologically) will be analyzed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398723
|United States, New York|
|Rockefeller University Hospital|
|New York, New York, United States, 10021|
|Principal Investigator:||James Krueger, MD||Rockefeller University|