Abstract: Objective To evaluate the safety and efficacy of tranilast capsule in the treatment of atopic dermatitis. Methods This multicenter, randomized, double-blind, parallel, placebo-controlled clinical trial was conducted at 3 research sites in China. Patients with atopic dermatitis were randomly assigned to 4 weeks of treatment with tranilast capsule or placebo three times daily. Efficacy evaluations were performed at baseline and at each weekly visit for 4 weeks. The primary efficacy parameter was the Severity Scoring of Atopic Dermatitis(SCORAD).Secondary parameters included the extent of skin inflammation index, visual analog scores of pruritus, and sleep disturbance score. Results A total of 144 patients with atopic dermatitis were enrolled in the study. Of these, 139 patients(70 on tranilast and 69 on placebo)who received at least one dose of study medication and completed at least one efficacy evaluation were included in the full analysis set(FAS).At the end of study, tranilast had significantly greater efficacy than placebo as assessed by improvement in SCORAD(61.43% vs 24.64%, P=0.0001).Furthermore, tranilast-treated patients experienced significantly greater improvement than placebo-treated patients in SCORAD, visual analog scores of pruritus, and sleep disturbance score at weeks 2, 3, and 4(P<0.05).There was no significant difference in the incidence of adverse events between the tranilast and placebo groups(8.45% vs 11.43%, P=0.5864).The adverse events in the tranilast-treated group included chest tightness, drowsiness, and eyelid edema, etc. Conclusion Tranilast capsule is safe and effective in the treatment of atopic dermatitis.

Key words: Dermatitis, atopic, Tranilast, Randomized controlled trails