Phase 2, randomized, double-blind, placebo-controlled, 4-week study to evaluate the safety and efficacy of OPA- 15406 (difamilast), a new topical selective phosphodiesterase type-4 inhibitor, in Japanese pediatric patients aged 2-14 years with atopic dermatitis.

ABSTRACT: The safety and efficacy of OPA-15406 (international non-proprietary name, difamilast; also referred to as MM36), a new topical, selective phosphodiesterase type-4 inhibitor, in Japanese pediatric patients with atopic dermatitis aged 2-14 years were evaluated in a phase 2, randomized, double-blind, vehicle-controlled, 4-week study. Seventy-three patients were randomized 1:1:1 to receive OPA-15406 0.3%, OPA-15406 1% or vehicle ointment twice daily for 4 weeks. The mean age of patients was similar across treatment groups. No deaths or serious treatment-emergent adverse events were reported; all treatment-emergent adverse events were mild or moderate in severity. The incidence of treatment-emergent adverse events leading to treatment discontinuation was 4.2% (1/24) in the OPA-15406 0.3% group,

SUBMITTER: Saeki H 

PROVIDER: S-EPMC6972691 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature