Vitiligo
Conditions
Keywords
Narrowband UBV Phototherapy, Skin biopsies
Brief summary
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.
Detailed description
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.
Interventions
DEVICENarrowband 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
Sponsors
Mary Sullivan-Whalen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years of age or greater * Vitiligo with extensive skin involvement (\>5% body surface affected).
Exclusion criteria
* No treatment with topical steroids, calcineurin inhibitors or vitamin D analogs for at least 4 weeks prior to entering the study. * No treatment with systemic therapies, including methotrexate, etretinate, PUVA, or cyclosporine 4 weeks prior to entering the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of melanocytes per unit length of skin surface | pre-treatment, early repigmentation, 75% repigmentation of total body |
Secondary
| Measure | Time frame |
|---|---|
| Clinical improvement | first visit and last visit |
Countries
United States
Outcome results
None listed