Tacrolimus 0.03% ointment in labial discoid lupus erythematosus: A randomized, controlled clinical trial.

Abstract

In this randomized, controlled clinical trial to compare efficacy and safety, 41 patients with labial discoid lupus erythematosus (DLE) were randomized to 2 groups, either receiving tacrolimus 0.03% ointment (n = 22) or triamcinolone acetonide 0.1% cream (n = 19). Each patient was treated with 3, 2, and 1 daily doses in the first, second, and third weeks, respectively, for 1 course. After the 3 week treatment, patients with complete disappearance of erosion were followed up for 3 months. After the 3 week application, 20 participants in the tacrolimus group and 19 in the triamcinolone acetonide group completed the study. The rates of complete response were 70% and 89.5% in tacrolimus-treated and triamcinolone acetonide-treated patients, respectively, with no significant difference (P = .235). Reduction in erosion and erythema showed no significant difference between groups (P > .05). Final reduction in reticulation areas and numeric rating scale scores were significantly greater in the tacrolimus group than in the triamcinolone acetonide group (P = .013; P = .048, respectively). Only 1 patient receiving tacrolimus presented with slight discomfort. There was no significant difference in 3 month recurrence rate between the groups (P > .05). Topical tacrolimus is considered as effective as triamcinolone acetonide for the management of labial DLE.