Abstract
BACKGROUND: Vitiligo is an acquired multifactorial depigmentation disorder with dreadful social stigma without any gold standard treatment option. Treatment of unstable vitiligo is, furthermore limited. Hydroxychloroquine has shown promise in a few case reports. OBJECTIVES: The effectiveness, tolerability and safety of narrow-band ultraviolet B (NBUVB)-plus topical clobetasol (group A) versus oral hydroxychloroquine-plus topical clobetasol (0.05%) (group B) were evaluated. METHODS: Single-centre, investigator-blind, randomised, active-controlled, parallel-group phase IV trial (CTRI/2019/07/020345) was conducted on unstable vitiligo of either sex. Patients were randomised into two groups (1:1 allocation ratio), and allocation concealment was ensured by the sequentially numbered, sealed, opaque envelope technique. The assessing physician was unaware regarding treatment allocation. Outcome measures were the vitiligo area scoring index (VASI), vitiligo disease activity score (VIDA) and dermatology life quality index (DLQI). The economic burden of therapy was calculated in terms of travel costs and loss of time for availing of the therapy. Routine haematological and biochemical tests and treatment-emergent adverse events were monitored for safety. The calculated sample size was 82 (5% alpha-error, 80% power, 61.1% and 30% percentage improvement in study groups, 10% drop-out). RESULTS: Intention-to-treat analysis showed significant improvement in VASI (Friedman's analysis of variance, P < 0.01) in group A (1048.00 ± 1450.10 reduced to 933.43 ± 1387.79) and group B (415.00 ± 458.47 reduced to 283.85 ± 386.61) at the end-of-treatment visit (24(th) week). Improvement was noted from 12 weeks onwards in group A and eight weeks onwards in group B (post-hoc Dunn's test, P < 0.001). Within group comparison showed significantly more improvement in group B than group A from eight weeks onwards (P < 0.05, analysis of covariance test with baseline VASI as covariate). A similar result was obtained with VIDA. DLQI significantly improved only in group B. The monthly cost of travel and loss of time were significantly less (Mann-Whitney's test, P < 0.5) in group B than group A. No adverse events were noted in either group. CONCLUSION: Both NBUVB and hydroxychloroquine combined with topical clobetasol are safe and effective agents in the treatment of vitiligo, though the improvement is more and faster with hydroxychloroquine. With hydroxychloroquine, there is no infrastructural requirement, less travel cost and less loss of working hours as opposed to NBUVB, which needs infrastructural set-up.