臨床研究等提出・公開システム

Date of registration	April. 10, 2026
Last modified on	July. 16, 2026
Trial ID	jRCT2031260035

Scientific Title	A phase IIb, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group, Dose-Ranging Study of M610101 in Patients with Nonsegmental Vitiligo
Public Title	A phase IIb, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group, Dose-Ranging Study of M610101 in Patients with Nonsegmental Vitiligo

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		April. 10, 2026
Actual date of first enrollment		May. 13, 2026
Target sample size		120
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) Participants aged 12 years and older with a clinical diagnosis of non-segmental vitiligo (2) >=0.5 facial-VASI(F-VASI) score (3) >=3 total body-VASI(F-VASI) score
	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 non-segmental vitiligo or skin pigmentation disorders that may affect the evaluation or safety of the subject
	Age Minimum	12age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Non-segmental vitiligo
Intervention(s)		Apply 2 times a day.
Primary Outcome(s)		Proportion of participants achieving F-VASI75 at Week 24.

Primary Sponsor	Maruho Co.,Ltd.

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
Date of approval	April. 16, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	July. 16, 2026	(this page)	Changes
2	June. 03, 2026	Detail	Changes
1	April. 10, 2026	Detail

List of change history