NCT02506101

Randomized, Split-body, Single-blinded Clinical Trial of NB-UVB Treatment for Vitiligo

Randomized, Split-Body, Single-Blinded Clinical Trial of Narrow Band-Ultraviolet B (NB-UVB) Treatment for Vitiligo

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the effectiveness and safety of narrowband-ultraviolet B (NB-UVB) treatment in adult subjects with vitiligo.

Detailed description

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: 1. 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. 2. 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.

Conditions

• Vitiligo
• Pigmentation
• Dyschromia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-10-04
• Completion: 2016-10-04
• First posted: 2015-07-22
• Last updated: 2018-04-03
• Results posted: 2017-12-11

Locations

1 site across 1 country: United States