Randomized, Split-body, Single-blinded Clinical Trial of NB-UVB Treatment for Vitiligo
|Vitiligo Pigmentation Dyschromia||Device: narrow-band ultraviolet B phototherapy||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized, Split-Body, Single-Blinded Clinical Trial of Narrow Band-Ultraviolet B (NB-UVB) Treatment for Vitiligo|
- Vitiligo Area Scoring Index (VASI) [ Time Frame: 24 weeks ]VASI scores of treated versus untreated symmetrical body sites
- Dermatology Life Quality Index (DLQI) [ Time Frame: 24 weeks ]Quality of life assessment
- Skindex-29 Questionnaire [ Time Frame: 24 weeks ]Quality of life assessment
- response stability index [ Time Frame: 24 weeks ]
- number of participants with histological change in tissue samples [ Time Frame: 24 weeks ]
|Study Start Date:||July 2015|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Experimental: narrow-band ultraviolet B phototherapy
We will use the 3 Series PC & SP Phototherapy Cabinet for treatment of vitiligo.
Device: narrow-band ultraviolet B phototherapy
There are two types of UVB: broad band and narrow band, with the major difference being that narrow band emits a smaller range of ultraviolet light, typically 311-312 nm. NB-UVB is a clinically indicated treatment for vitiligo lesions and treatments are usually administered in an outpatient setting 3 times a week.
No Intervention: no intervention
Vitiligo is a chronic acquired cutaneous disease of pigmentation that affects patients' quality of life across all degrees of involvement and severity. Phototherapy is a clinically indicated treatment for skin lesions. Treatments are usually administered in an outpatient setting, typically three times per week. This is a proof-of-concept study as there are few well-designed prospective clinical studies showing the efficacy of NB-UVB phototherapy in the treatment of vitiligo in terms of repigmentation and quality of life. The following are the proposed objectives of this study:
- NB-UVB phototherapy improves vitiligo with at least 50% repigmentation compared to no treatment on affected areas of the trunk and extremities over 24 weeks.
- NB-UVB phototherapy leads to improvement in quality of life as measured by standardized quality of life metrics (DLQI and Skindex-29) over 24 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02506101
|United States, Maryland|
|Johns Hopkins Dept. of Dermatology|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Ginette Okoye, MD||Johns Hopkins School of Medicine|