Why carry out this study?

Difamilast selectively inhibits phosphodiesterase 4 (PDE4), an enzyme involved in the production of pro-inflammatory cytokines that lead to atopic dermatitis (AD).

This phase III, long-term, open-label study was conducted to confirm the safety and efficacy of topical difamilast in Japanese adult and pediatric patients with AD.

What was learned from the study?

This study demonstrates that difamilast ointments are well tolerated and effective in Japanese adult and pediatric patients with AD when applied twice daily for 52 weeks.

Most treatment-emergent adverse events (TEAEs) were mild or moderate in severity, and the discontinuation rates due to TEAEs were generally low in both adult and pediatric patients.

Difamilast ointments are expected to be a long-term treatment option for AD because of the safety and efficacy profiles.