Randomised controlled trial of topical corticosteroid and home-based narrowband UVB for active and limited vitiligo - results of the HI-Light Vitiligo trial.

Background Evidence for the effectiveness of vitiligo treatments is limited. Objectives To determine effectiveness of (a) hand-held narrowband-UVB (NB-UVB) and (b) combination of potent topical corticosteroid (TCS) and NB-UVB compared to TCS, for localised vitiligo. Methods Pragmatic, 3-arm, placebo-controlled RCT (9 months' treatment; 12 months' follow-up). Adults and children, recruited from secondary care and community, aged ≥5 years with active vitiligo affecting Primary outcome treatment success at 9 months at target patch assessed using participant-reported Vitiligo Noticeability Scale, with multiple imputation for missing data. Results 517 participants were randomised: TCS (n=173), NB-UVB (n = 169), combination (n=175). Primary outcome data were available for 370 (72%) participants. Target patch treatment success was 17% (TCS), 22% (NB-UVB) and 27% (combination). Combination treatment was superior to TCS: adjusted between group difference 10.9% (95% CI 1.0% to 20.9%; p= 0.032; NNT=10). NB-UVB alone was not superior to TCS: adjusted between group difference 5.2% (95% CI -4.4% to 14.9%; p= 0.290; NNT=19). Participants using interventions >75% expected were more likely to achieve treatment success, but effects were lost once treatment stopped. Localised grade 3 or 4 erythema was reported in 62 (12%) participants (including 3 with dummy light). Skin thinning was reported in 13 (2.5%) participants (including 1 with placebo ointment). Conclusion Combination treatment with home-based hand-held NB-UVB plus TCS is likely to be superior to TCS alone for treatment of localised vitiligo. Combination treatment was relatively safe and well tolerated but was only successful in around a quarter of participants.