A prospective study comparing the safety and efficacy of combination of topical tacrolimus 0.1% and mometasone furoate 0.01% with topical tacrolimus 0.1% alone in vitiligo

Abstract

Background: Vitiligo is a common acquired skin disorder. Corticosteroids are considered to be the first line treatment for vitiligo, but have side effects on prolonged use. Calcineurin inhibitors like Tacrolimus are found to be effective which is used either alone or in combination with steroids. The advantage of combination therapy of Tacrolimus with Mometasone is that it provides additional benefit for the disease as well as the adverse effects of steroids can be minimised. The main objective of this study is to compare the safety and efficacy of combination of topical Tacrolimus 0.1% and Mometasone furoate 0.01% with topical Tacrolimus 0.1% alone in vitiligo.Methods: In this study 90 patients were divided into two groups to receive either combination treatment of topical Tacrolimus 0.1% and Mometasone furoate 0.01% or topical Tacrolimus 0.1% alone. The efficacy was measured in terms of mean improvement in VASI (Vitiligo Area Scoring Index) scores at 2weeks, 4weeks, 6weeks, 12weeks, and 24weeks from the start of therapy. Safety of the drugs were measured in terms of adverse effects reported during therapy.Results: At the start of the study, mean VASI scores of both groups were comparable. At the endpoint, mean VASI improvement score was statistically significant among the combination group (57.82vs31.45, p <0.001). Adverse effects were found to be less in combined treatment group (p= 0.046).Conclusions: Combination treatment (Tacrolimus+ Mometasone) found to be superior to Tacrolimus alone in the treatment of vitiligo in terms of efficacy and safety.