UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Continuous test for thin hair male of hair tonic "Finjia" preparations containing Capixyl and Kopyrrol.
Title of the study (Brief title)	YP-1
Region	Japan

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

Objectives
Narrative objectives1	Clinical evaluation for thin hair male of hair tonic "Finjia".
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Phototrichogram. Evaluation period : pre-administar Finjia, 12 week after, 24 week after
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Subjects apply "Finjia" one to two times per day on the scalp and continue it for 24 weeks.
Interventions/Control_2
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	20 years-old <=
Age-upper limit	39 years-old >=
Gender	Male
Key inclusion criteria	1.Japanese man 39 years or younger 20 years old or older. 2.Those who are concerned about thin hair as of the date of consent. 3.Subject with understanding of this study and obtained informed consent.
Key exclusion criteria	1. Person who dyes white hair 2. Persons conducting hair transplantation and wearing wigs 3. Persons who are likely to have allergic symptoms with test substance components 4. Persons who may show skin allergy symptoms and people with skin hypersensitivity 5. Persons who have experienced serious heart disease, renal disease, liver disease, cancer in the past 6. Currently those who are treating hypertension 7. Persons who routinely use health foods, cosmetics, quasi-drugs, medicines that are likely to affect the results of the examination 8. Other persons who judged that it is inappropriate for the doctor in charge or the person in charge of the examination to incorporate in the exam
Target sample size	10

Research contact person
Name of lead principal investigator	Yoshikazu Matsuda
Organization	Nihon Pharmaceutical University
Division name	Clinical Pharmacology Educational Center
Address	10281 Komuro, Ina-machi, Kitaadachi-gun, Saitama, 362-0806
TEL	048-721-1155
Email	yomatsuda@nichiyaku.ac.jp

Public contact
Name of contact person	Hiromu Katsuta
Organization	Lelife Co., Ltd
Division name	Clinical personnel development Division
Address	1-47-1 Higashi-Ikebukuro, Toshima-ku, Tokyo, 170-0013
TEL	03-5928-2501
Homepage URL
Email	hkatsuta@relife-inc.com

Sponsor
Institute	Nihon Pharmaceutical University
Institute
Department

Funding Source
Organization	Yupiesu Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

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

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 01 Day
Anticipated trial start date	2017 Year 07 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 14 Day
Last modified on	2018 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031803