UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy Confirmation Test of Hair Growth and Nurturing Composition (HGT) in Continuous Use
Acronym	RHG01
Scientific Title	Efficacy Confirmation Test of Hair Growth and Nurturing Composition (HGT) in Continuous Use
Scientific Title:Acronym	RHG01
Region	Japan

Condition
Condition	thinning hair
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study the effectiveness of the hair growth agent HGT (containing carrot extract, soy protein hydrolysate, and seaweed extract) for women with thinning hair. To study the effectiveness of the hair growth agent HGT (containing carrot extract, soy protein hydrolysate, and seaweed extract)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percent change in hair diameter after 24 weeks of treatment
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Use hair growth products (active) twice daily for up to 24 weeks. Phototrichograms will be performed prior to dosing, after 12 weeks of dosing, and after 24 weeks of dosing.
Interventions/Control_2	Use hair growth products (placebo) twice daily for up to 24 weeks. Phototrichograms will be performed prior to dosing, after 12 weeks of dosing, and after 24 weeks of dosing.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	70 years-old >=
Gender	Female
Key inclusion criteria	(1) Japanese between the ages of 40 and 70 years old (2) Women with thinning hair equivalent to Ludwig Scale I-2 to II-2 as of the date of consent. (3) The purpose and content of the study will be explained to the research subjects prior to the study, and the research subjects themselves are capable of making decisions and have given their written consent.
Key exclusion criteria	(1) Those who have hair transplants or wear wigs. (2) Those who may show allergic symptoms to the components of the test substance. (3) Those who may show allergic symptoms to the test substance or those who have skin hypersensitivity. Those who have a history of serious heart disease, renal disease, liver disease, cancer, or thyroid dysfunction. (5) Those who have not used health foods, cosmetics, quasi-drugs, or medicines (e.g., hair growth products) that may affect the test results for more than 6 months. (6) Women who are pregnant or may become pregnant, and women who are breastfeeding. (7) Others whom the principal investigator deems inappropriate to be included in the study.
Target sample size	68

Research contact person
Name of lead principal investigator	1st name Akio Middle name Last name Sato
Organization	TMC Medical Corporation Tokyo Memorial Clinic
Division name	board chairman
Zip code	151-0053
Address	16-7, Yoyogi 2-chome, Shibuya-ku, Tokyo
TEL	03-5351-0309
Email	drsato@crux.ocn.ne.jp

Public contact
Name of contact person	1st name Hiromu Middle name Last name Katsuta
Organization	ReLife-inc
Division name	Clinical Development Division
Zip code	170-0013
Address	5F Koshin Building, 1-47-1 Higashi-Ikebukuro, Toshima-ku, Tokyo
TEL	03-5928-2501
Homepage URL
Email	hkatsuta@relife-inc.com

Sponsor
Institute	ROHTO Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization	ROHTO Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	ReLife-inc
Address	5F Koshin Building, 1-47-1 Higashi-Ikebukuro, Toshima-ku, Tokyo
Tel	03-5928-2501
Email	hkatsuta@relife-inc.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人社団TMC　東京メモリアルクリニック（東京都）

Other administrative information
Date of disclosure of the study information	2021 Year 07 Month 12 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	67
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 06 Month 03 Day
Date of IRB	2021 Year 06 Month 17 Day
Anticipated trial start date	2021 Year 07 Month 12 Day
Last follow-up date	2022 Year 03 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 06 Month 17 Day
Last modified on	2022 Year 03 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050917