Abstract
Evidence for the effectiveness of vitiligo treatments is limited. To determine the effectiveness of (i) handheld narrowband UVB (NB-UVB) and (ii) a combination of potent topical corticosteroid (TCS) and NB-UVB, compared with TCS alone, for localized vitiligo. A pragmatic, three-arm, placebo-controlled randomized controlled trial (9-month treatment, 12-month follow-up). Adults and children, recruited from secondary care and the community, aged≥5years and with active vitiligo affecting<10% of skin, were randomized 1 :1 :1 to receive TCS (mometasone furoate 0·1% ointment+dummy NB-UVB), NB-UVB (NB-UVB+placebo TCS) or a combination (TCS+NB-UVB). TCS was applied once daily on alternating weeks; NB-UVB was administered on alternate days in escalating doses, adjusted for erythema. The primary outcome was treatment success at 9months at a target patch assessed using the participant-reported Vitiligo Noticeability Scale, with multiple imputation for missing data. The trial was registered with number ISRCTN17160087 on 8 January 2015. In total 517 participants were randomized to TCS (n=173), NB-UVB (n=169) and combination (n=175). Primary outcome data were available for 370 (72%) participants. The proportions with target patch treatment success were 17% (TCS), 22% (NB-UVB) and 27% (combination). Combination treatment was superior to TCS: adjusted between-group difference 10·9% (95% confidence interval 1·0%-20·9%; P=0·032; number needed to treat=10). NB-UVB alone was not superior to TCS: adjusted between-group difference 5·2% (95% CI-4·4% to 14·9%; P=0·29; number needed to treat=19). Participants using interventions with≥75% expected adherence were more likely to achieve treatment success, but the effects were lost once treatment stopped. Localized grade 3 or 4 erythema was reported in 62 (12%) participants (including three with dummy light). Skin thinning was reported in 13 (2·5%) participants (including one with placebo ointment). Combination treatment with home-based handheld NB-UVB plus TCS is likely to be superior to TCS alone for treatment of localized vitiligo. Combination treatment was relatively safe and well tolerated but was successful in only around one-quarter of participants.
Highlights
Evidence for the effectiveness of vitiligo treatments is limited
We report the results of the Home Interventions and Light therapy for the treatment of Vitiligo Trial (Hi-Light Vitiligo Trial), which evaluated the comparative safety and
Baseline characteristics were summarized by treatment arms and the availability of primary outcome at 9 months, in order to check the missingat-random assumption of multiple imputation
Summary
To determine the effectiveness of (i) handheld narrowband UVB (NBUVB) and (ii) a combination of potent topical corticosteroid (TCS) and NB-UVB, compared with TCS alone, for localized vitiligo. Adults and children, recruited from secondary care and the community, aged ≥ 5 years and with active vitiligo affecting < 10% of skin, were randomized 1 : 1 : 1 to receive TCS (mometasone furoate 0Á1% ointment + dummy NB-UVB), NB-UVB (NB-UVB + placebo TCS) or a combination (TCS + NB-UVB). Home-based narrowband UVB and topical steroid for vitiligo, K.S. Thomas et al 829. (1) To evaluate the comparative effectiveness and safety of home-based interventions for the management of active, limited vitiligo in adults and children, comparing firstly, handheld NB-UVB vs potent TCS (mometasone furoate 0Á1% ointment); and secondly, a combination of handheld NB-UVB plus potent TCS vs potent TCS alone. Objectives 3 and 4 are reported elsewhere.[30]
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