ArticleIndian journal of dermatology
Effectiveness, Tolerability and Safety of Topical Clobetasol with Oral Hydroxychloroquine versus Topical Clobetasol with NBUVB Phototherapy in Unstable Vitiligo: Investigator Blind, Randomized Controlled Trial.
Article in Indian journal of dermatology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
8 authors.
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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, 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.
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