A Phase 3, Long-Term, Open-Label Study of Difamilast Ointment to Evaluate Efficacy and Safety in Japanese Infants with Atopic Dermatitis.

ABSTRACT:

Introduction

Difamilast is the first selective phosphodiesterase 4 inhibitor approved for atopic dermatitis (AD) in Japan. A phase 3, 52-week, open-label study was conducted to evaluate efficacy and safety of difamilast ointments in Japanese infants with AD aged 3 to < 24 months, because the clinical study in this population has not been conducted.

Methods

Infants (n = 41) received difamilast 0.3% ointment twice daily in a 4-week primary evaluation period, and subsequently received difamilast 0.3% or 1% ointment on the basis of the existing clinical symptoms in a 48-week, long-term extension period.

Results

The response rate in Investigator's Global Assessment score was 56.1% at week 4, and it increased to 75.6% at week 52. The response rate in Eczema Area and Severit

SUBMITTER: Saeki H 

PROVIDER: S-EPMC12873051 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature