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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027755
Receipt No. R000031803
Scientific Title Continuous test for thin hair male of hair tonic "Finjia" preparations containing Capixyl and Kopyrrol.
Date of disclosure of the study information 2017/06/18
Last modified on 2018/02/28

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Basic information
Public title Continuous test for thin hair male of hair tonic "Finjia" preparations containing Capixyl and Kopyrrol.
Acronym YP-1
Scientific Title Continuous test for thin hair male of hair tonic "Finjia" preparations containing Capixyl and Kopyrrol.
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshikazu Matsuda
Organization Nihon Pharmaceutical University
Division name Clinical Pharmacology Educational Center
Zip code
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
1st name
Middle name
Last name Hiromu Katsuta
Organization Lelife Co., Ltd
Division name Clinical personnel development Division
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
2017 Year 06 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000031803

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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