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Article History

Received: 26 January 2026

Accepted: 15 April 2026

First Online: 15 May 2026

Declarations

:

: Makoto Kawashima received personal fees from Maruho Co., Ltd., and Sato Pharmaceutical Co., Ltd. Tomoya Maeda, Kotaro Iwasaki, Noriaki Kaneda, and Masashi Takizawa are employees of Maruho Co., Ltd. Kenji Kabashima has received consulting fees, honoraria, grant support, and/or lecture fees from AbbVie, Amgen, Eli Lilly, Kyowa Kirin, Japan Tobacco, LEO Pharma, Maruho, Mitsubishi Tanabe, Ono Pharmaceutical, Pfizer, Procter & Gamble, Sanofi, Regeneron, Taiho, and Torii Pharmaceutical.

: The present study was a post hoc analysis of pooled data from two previously conducted Japanese Phase III clinical trials, Study-JP01 (JapicCTI-173740) and Study-JP02 (JapicCTI-183894), and involved no new recruitment, intervention, or contact with participants. Accordingly, additional ethical approval for the present analysis was not required. The original clinical trials were conducted in accordance with the ethical principles of the Declaration of Helsinki, Good Clinical Practice guidelines, and all other applicable regulatory requirements. The trial protocols and related documentation were approved by the IRBs at each participating center, including the Sapporo Skin Clinic IRB. Written informed consent was obtained from all patients or their legal guardians prior to initiation of any study procedures and treatment. Publicly available ethics committee reference numbers/IRB numbers for the original trials could not be identified from the published reports.