臨床研究等提出・公開システム

Date of registration	June. 22, 2026
Last modified on	June. 22, 2026
Trial ID	jRCT2031260244

Scientific Title	A Phase III, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study of M610101 in Patients with Atopic Dermatitis
Public Title	A Phase III Study of M610101 in Patients with Atopic Dermatitis

Contact for Scientific Queries	Name	Nishiura Tomoyuki
	Affiliation	Maruho Co.,Ltd. Kyoto R&D Center
	Address	93 Chudoji Awatacho, Shimogyo-ku, Kyoto
	Telephone	+81-75-325-3279
	E-mail	ctinfo@mii.maruho.co.jp
Contact for Public Queries	Name	- Clinical Trials Information
	Affiliation	Maruho Co.,Ltd. Kyoto R&D Center
	Address	93 Chudoji Awatacho, Shimogyo-ku, Kyoto
	Telephone	+81-75-325-3279
	E-mail	ctinfo@mii.maruho.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 22, 2026
Target sample size		150
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1)Patients with atopic dermatitis aged 2 years to 12 years (2)Patients with an IGA score of 2 or 3 for atopic dermatitis (3)Patients with 3% to 20% BSA involvement of atopic dermatitis
	Exclusion Criteria	(1)Patients complicated with diseases considered inappropriate for participation in clinical trials such as serious cardiac / hepatic / renal / pulmonary / hematologic disease (2)Patients with skin diseases other than atopic dermatitis that affect the evaluation of atopic dermatitis or the safety of the subject
	Age Minimum	2age old over
	Age Maximum	12age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Atopic dermatitis
Intervention(s)		Apply 2 times a day.
Primary Outcome(s)		Proportion of participants achieving an IGA score of 0 or 1 with at least a 2-point improvement from baseline at week 8

Primary Sponsor	Maruho Co.,Ltd.

Secondary Sponsor

Name of Certified Review Board	Medical corporation Shintoukai Yokohamaminoru Clinic IRB
Address	1-13-8, Bessho Minami-ku Yokohama-shi, Kanagawa
Telephone	+81-42-648-5551
E-Mail	yminoru-irb@eps.co.jp
Approval Status	Not approval

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none