UMIN-CTR Clinical Trial

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	Published

Result
URL related to results and publications	https://www.shinryo-to-shinyaku.com/db/pdf/sin_0059_04_0212.pdf
Number of participants that the trial has enrolled	29
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	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	2022 Year 05 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052134