A Randomized, Double-Blind, Vehicle-Controlled, Right/Left Comparative Study of the Efficacy of Acitretin with and without the Co-Administration of 0.1% Tacrolimus Topical Ointment in the Treatment of Moderate to Severe Psoriasis

Abstract

Background Topical tacrolimus is effective as monotherapy for inverse psoriasis. Its use in combination with other systemic agents may be an effective treatment for psoriasis in less sensitive areas. Objective To determine if topical tacrolimus in combination with oral acitretin is more effective than oral acitretin and vehicle ointment. Methods All patients received oral acitretin; subjects were randomized to apply topical tacrolimus to one side of their body and vehicle to the other. Results Topical tacrolimus was more effective than vehicle ointment as early as week 4. There were no serious adverse events thought to be due to drug or dose changes during the study. Limitations Due to the short time horizon of the study, it may not be appropriate to generalize the results to longer treatment periods. Conclusions Topical tacrolimus is an effective psoriasis treatment and was well-tolerated when combined with systemic acitretin in the treatment of psoriasis.