Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis

Phase 3 Completed 366 enrolled Otsuka Pharmaceutical Co., Ltd.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

To demonstrate the safety of 1% OPA-15406 ointment in adult patients with AD and of 0.3% and 1% OPA-15406 ointments in pediatric patients with AD administered twice daily for 52 weeks.

Timeline

Start: 2019-05-14
Primary completion: 2020-11-11
Completion: 2020-11-11

Publications

Saeki H, Imamura T, Yokota D, Tsubouchi H. Difamilast Ointment in Japanese Adult and Pediatric Patients with Atopic Dermatitis: A Phase III, Long-Term, Open-Label Study. Dermatol Ther (Heidelb). 2022 Jul;12(7):1589-1601. doi: 10.1007/s13555-022-00751-9. Epub 2022 Jun 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Difamilast	Small molecule	0.3 %	Topical
Subject	Difamilast	Small molecule	1 %	Topical

Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis

Summary

Timeline

Publications

Drugs

Indications