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Authors
Saeki, Hidehisa https://orcid.org/0000-0002-1095-0355
Ohya, Yukihiro
Baba, Naoko
Imamura, Tomomi
Yokota, Daisuke
Tsubouchi, Hidetsugu https://orcid.org/0000-0002-2926-4603
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Clinical Trials BETA
Clinical trials referenced in this document:
nct05372653 at ClinicalTrials.govDocuments that mention this clinical trial
A Phase 3, Long-Term, Open-Label Study of Difamilast Ointment to Evaluate Efficacy and Safety in Japanese Infants with Atopic Dermatitis
https://doi.org/10.1007/s13555-025-01581-1
An Interim Report of a Phase 3, Long-Term, Open-Label Study to Evaluate Efficacy and Safety of Difamilast Ointment in Japanese Infants with Atopic Dermatitis
https://doi.org/10.1007/s13555-024-01236-7
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Funding
Funding for this research was provided by:
Otsuka Pharmaceutical
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Article History
Received: 23 July 2025
Accepted: 17 October 2025
First Online: 31 October 2025
Declarations
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: Hidehisa Saeki has received grants from AbbVie, Eisai Co., Ltd., LEO Pharma K.K., Maruho Co., Ltd., Taiho Pharmaceutical Co., Ltd., Torii Pharmaceutical Co., Ltd., and Tokiwa Pharmaceutical Co., Ltd., and honoraria from AbbVie, Eli Lilly Japan K.K., Japan Tobacco Inc., LEO Pharma K.K., Maruho Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Novartis Pharma K.K., Otsuka Pharmaceutical Co., Ltd., Sanofi K.K., Taiho Pharmaceutical Co., Ltd., Pfizer Japan Inc., Amgen Inc., and Torii Pharmaceutical Co., Ltd. Yukihiro Ohya has received grants from Fam’s Baby Inc and Maruho Co., Ltd., consulting fees from AbbVie, Eli Lilly Japan K.K., LEO Pharma K. K., Maruho Co., Ltd., Otsuka Pharmaceutical Co., Ltd., and Sanofi K.K., and honoraria from AbbVie, Mitsubishi Tanabe Pharma Corporation, Pfizer, Pola Pharma Inc., Sanofi K.K., Sinopharm, Taiho Pharmaceutical Co., Ltd., Thermo Fisher Scientific, and Torii Pharmaceutical Co., Ltd. Naoko Baba has received honoraria from Otsuka Pharmaceutical Co., Ltd., Maruho Co., Ltd., and Torii Pharmaceutical Co., Ltd. Yukihiro Ohya is now affiliated with Department of Occupational and Environmental Health, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan, and Division of General Allergy, Bantane Hospital, Fujita Health University, Aichi, Japan. Tomomi Imamura, Daisuke Yokota, and Hidetsugu Tsubouchi are employees of Otsuka Pharmaceutical Co., Ltd.
: This phase 3, multicenter, open-label study was conducted from May 23, 2022 to November 29, 2023 (ClinicalTrials.gov identifier NCT05372653) to evaluate the efficacy and safety of topical difamilast in infants with AD aged 3 to < 24 months at five study sites in Japan (Table in Supplementary Material) in accordance with the Declaration of Helsinki and the International Conference on Harmonisation Good Clinical Practice guideline. The study was approved by the institutional review board at each study site (IRB number 23S185). Parents or guardians of infants provided written informed consent before participation in this study.
