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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048051
Receipt No. R000054765
Scientific Title Effect of using brush-type beauty equipment on muscles : open trial
Date of disclosure of the study information 2022/06/16
Last modified on 2022/06/14

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Basic information
Public title Effect of using brush-type beauty equipment on muscles
Acronym DB muscle study
Scientific Title Effect of using brush-type beauty equipment on muscles : open trial
Scientific Title:Acronym Effect of using brush-type beauty equipment on muscles
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 muscles
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes muscle hardness
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Use test article on shoulders and calves
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
25 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria 1. Subjects who feel stiffness, firmness and weight of shoulders and calves
2. Subjects who are feeling muscle fatigue in the shoulders and calves
Key exclusion criteria 1.Subjects who use implantable medical electronic devices such as pacemakers
2.Subjects who use life-supporting electronic devices such as heart-lung machines, and subjects who use wearable medical electronic devices such as electrocardiographs.
3.Subjects with acute disease, heart disease, febrile disease, blood pressure abnormality, infectious disease disease, tuberculous disease, malignant tumor, hemophilia disease
4.Pregnant / menstruating
5.Subjects with atopic dermatitis / allergic constitution
6.Subjects who have been instructed by a doctor to refrain from using
7.Subjects with particularly sensitive skin and scalp
8.Subjects with long-term use of steroidal anti-inflammatory drugs or telangiectasia due to liver dysfunction
9.Subjects taking medicine
10.Subjects who are very tired and who are not particularly good at health
11.Subjects who have had a rash from chemical fibers
12.Subjects who are inflamed by sunburn
13.Subjects with inflammation, scars, abnormalities, or sensory impairment on the head, face, or lower limbs
14.Subjects who have experience of plastic surgery on the head, face, lower limbs, those who have metal embedded
15.Subjects with inflammation, scars, or abnormalities on the skin around the eyes and eyeballs
16.Subjects with facial melasma
Target sample size 12

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
2022 Year 06 Month 16 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
2022 Year 05 Month 23 Day
Date of IRB
2022 Year 06 Month 02 Day
Anticipated trial start date
2022 Year 06 Month 16 Day
Last follow-up date
2022 Year 06 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 06 Month 14 Day
Last modified on
2022 Year 06 Month 14 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054765

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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