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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045670
Receipt No. R000052134
Scientific Title Effect on hair by continuous use of brush-type beauty equipment for 3 months : single blinded study
Date of disclosure of the study information 2021/10/08
Last modified on 2021/10/05

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Basic information
Public title Effect on hair by continuous use of brush-type beauty equipment for 3 month
Acronym DB Brush study
Scientific Title Effect on hair by continuous use of brush-type beauty equipment for 3 months : single blinded study
Scientific Title:Acronym Effect on hair by continuous use of brush-type beauty equipment for 3 month
Region
Japan

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

Objectives
Narrative objectives1 Effect of using Test article on hair diameter
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes hair diameter, subjective evaluation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Use the test article for 3 consecutive months
Interventions/Control_2 No using test article
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
35 years-old <=
Age-upper limit
59 years-old >=
Gender Male and Female
Key inclusion criteria Subjects suffering from hair health (thinning hair, lack of firmness and elasticity, awareness of thinning hair)
Key exclusion criteria 1. Subjects who are not good at stimulating electricity such as EMS equipment
2. Subjects with cosmetic allergies
3. Pregnant women and lactating women
4. Subjects who have wigs or hair growth treatment
5. Subjects with inflammation or skin disease on the face
6. Subjects who are currently going to the hospital or have a doctor's prescription
7. Subjects who are receiving hormone replacement therapy
8. Subjects who have started taking supplements / medicines that affect hair growth / growth within the last month, Subjects who are planning to start during the test
9. Subjects who plan to change their lifestyle (sleep, eating, drinking, smoking, exercise, etc.) during the test period
10. Subjects who have participated in human clinical trials within the past month and those who plan to do so during the trial period
Target sample size 24

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 GM CORPORATION
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
2021 Year 10 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
2021 Year 09 Month 17 Day
Date of IRB
2021 Year 09 Month 24 Day
Anticipated trial start date
2021 Year 10 Month 08 Day
Last follow-up date
2022 Year 01 Month 07 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 10 Month 05 Day
Last modified on
2021 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052134

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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