UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027755 |
|---|---|
| Receipt number | 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 09:01:09 |
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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
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
hkatsuta@relife-inc.com
Sponsor or person
Institute
Nihon Pharmaceutical University
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
