A phase 2, randomized, double-blind, vehicle-controlled trial of tapinarof cream in Japanese pediatric patients with atopic dermatitis.

ABSTRACT: Tapinarof is a nonsteroidal, topical, aryl hydrocarbon receptor agonist approved for the treatment of atopic dermatitis (AD) in Japanese patients aged ≥12 years. We evaluated the efficacy and safety of tapinarof in Japanese pediatric patients aged 2 to 11 years with AD in a phase 2, multicenter, randomized, double-blind, vehicle-controlled trial. Eligible patients (N = 121) were randomized 1:1:1 to receive tapinarof cream 0.5%, tapinarof cream 1%, or vehicle cream once daily for 8 weeks. At week 8, the least-squares mean percent change from baseline in Eczema Area and Severity Index (EASI) score (the primary endpoint) was -81.29% in the tapinarof 0.5% group, -77.62% in the tapinarof 1% group, and - 18.56% in the vehicle group. Reductions in EASI score at week 8 were significantly greater i

SUBMITTER: Igarashi A 

PROVIDER: S-EPMC11807361 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature