An Open-Label Non-Randomized Preliminary Noninferiority Study Comparing Home-Based Handheld Narrow-Band UVB Comb Device with Standard Hospital-Based Whole-Body Narrow-Band UVB Therapy in Localized Vitiligo.

Abstract

Narrow-band ultraviolet B (NB-UVB) is the standard therapy for vitiligo. The objective of this study is to compare the safety and clinical efficacy of a handheld NB-UVB comb device with the standard whole-body NB-UVB therapy in localized stable vitiligo. Thirty-one vitiligo patients were allocated to either daily therapy with a home-based handheld comb device (group A, n = 17) or thrice-weekly hospital-based whole-body NB-UVB therapy (group B, n = 14) for 4 months, based on their preference. The primary and secondary outcomes were assessed at each follow-up, and appropriate statistical tools were used for analysis. Of the 31 patients enrolled, 26 patients (study groups A/B: 15/11) completed the study. Primary outcome: Median percentage repigmentation of the representative patch in groups A and B were 51.35% and 63.85%, respectively (P = 0.64). The median size reduction of the representative patch in both groups was statistically significant (P < 0.05). The mean difference between "per protocol analysis" and "intention to treat" showed noninferiority. Secondary outcomes: Both groups were comparable on Lund and Browder score, patient global assessment and investigator global assessment scores, adverse events, color match, and change in the quality of life. The comparison group had a significantly greater number of missed sessions (P = 0.02). The majority of patients had a "good" response in both groups. Handheld NB-UVB comb device daily with a fixed dose of fluence was found to be noninferior with better compliance to standard whole-body NB-UVB therapy.