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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036613
Receipt No. R000041714
Scientific Title Effects of hair restorer on scalp and hair : a randomized, double blind, placebo-controlled study
Date of disclosure of the study information 2019/05/08
Last modified on 2019/10/16

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Basic information
Public title hari growth trial
Acronym hari growth trial
Scientific Title Effects of hair restorer on scalp and hair : a randomized, double blind, placebo-controlled study
Scientific Title:Acronym hari growth trial
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Use test article for 12 weeks to assess the condition of hair and scalp
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes evaluation of scalp condition, hair thickness measurement
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Using test article for 12 consecutive weeks
Interventions/Control_2 Using placebo(A) for 12 consecutive weeks
Interventions/Control_3 Using placebo(B) for 12 consecutive weeks
Interventions/Control_4 Using placebo(C) for 12 consecutive weeks
Interventions/Control_5 Using placebo(D) for 12 consecutive weeks
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
49 years-old >=
Gender Male and Female
Key inclusion criteria 1.Female : who feel that hair has become thin
2.Male ; <II Vertex type> and <III Vertex type> in Hamilton-Norwood classification
Key exclusion criteria 1.Subjects with rash and inflammation throughout the scalp
2.Those planning to receive treatment or special treatment on AGA treatment and scalp / hair during the study period
3.Subjects who plan to start new use and intake of hair restorer and food related to hair growth during the test period
4.Subjects who have a history of food allergies
5.Subjects who is participating in other human exams within the past 4 weeks
6.Subjects who are shortening the hair (because the hair is cut and it is difficult to measure the thickness of the hair) If the length near the top of the head is less than 5 cm
Target sample size 64

Research contact person
Name of lead principal investigator
1st name Masatomo
Middle name
Last name Najima
Organization Japan Clinical Trial Association
Division name N.A.
Zip code 1600022
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Email info@yakujihou.org

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Kaneko
Organization Japan Clinical Trial Association
Division name N.A.
Zip code 1600022
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Homepage URL
Email info@yakujihou.org

Sponsor
Institute Japan Clinical Trial Association
Institute
Department

Funding Source
Organization keeley 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 Institutional Review Board of Pharmaceutical Law Wisdoms
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel 0364574911
Email master@yakujihou.net

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
2019 Year 05 Month 08 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 18 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 07 Day
Last follow-up date
2019 Year 08 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 26 Day
Last modified on
2019 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041714

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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