臨床研究等提出・公開システム

Date of registration	June. 24, 2026
Last modified on	June. 24, 2026
Trial ID	jRCT2051260093

Scientific Title	Double-blind comparative trial of TP-1222
Public Title	Double-blind comparative trial of TP-1222

Contact for Scientific Queries	Name	Seiji Mita
	Affiliation	Taisho Pharmaceutical Co., LTD.
	Address	TOSHIMA-KU,TOKYO 170-8633 JAPAN
	Telephone	+81-3-3985-1128
	E-mail	rinsho_group@taisho.co.jp
Contact for Public Queries	Name	Self-Medication Clinical Development Department
	Affiliation	Taisho Pharmaceutical Co., LTD.
	Address	TOSHIMA-KU,TOKYO 170-8633 JAPAN
	Telephone	+81-3-3985-1128
	E-mail	rinsho_group@taisho.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Feb. 01, 2023
Actual date of first enrollment		Mar. 05, 2023
Target sample size		360
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Age at the time of obtaining informed consent: 20 years or older. (2) Subjects diagnosed with androgenetic alopecia classified as Ludwig Class I or II. (3) Subjects with disease onset within a specified period (4) Subjects meeting predefined hair criteria required for efficacy evaluation
	Exclusion Criteria	(1) Subjects with serious comorbidities, or with a history of serious hepatic, renal, cardiac, or hematologic disease. (2) Subjects receiving treatment for hypotension or hypertension. (3) Subjects with concomitant skin diseases at the application site other than androgenetic alopecia. (4) Subjects who have participated in another clinical trial and received an investigational product within 16 weeks prior to the start of investigational product administration in this study. (5) Subjects with alopecia other than androgenetic alopecia. (6) Subjects who have received treatments that may affect hair growth (e.g., minoxidil, hormonal treatments, hair regeneration therapies) (7) Pregnant or breastfeeding women
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		Androgenetic Alopecia (Female Pattern Hair Loss)
Intervention(s)		TP-1222 or 1% minoxidil lotion, administered at a dose of 1 mL per application, twice daily, to the affected areas of the scalp for 24 weeks.
Primary Outcome(s)		Change from baseline in the number of non-vellus hairs

Primary Sponsor	Taisho Pharmaceutical Co., LTD.

Name of Certified Review Board	Medical Corporation Heishinkai OPHAC Hospital IRB
Address	4-1-29 Miyahara,Yodogawa-ku,Osaka-shi,Osaka 532-0003 JAPAN, Osaka, Osaka
Telephone	+81-6-6395-9000
E-Mail	ophach_irb@heishinkai.com
Approval Status	Approval
Date of approval	Jan. 12, 2023

Plan to share IPD	No

Secondary ID(s)	なし

Countries of Recruitment（Except Japan）	none