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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044834
Receipt No. R000051213
Scientific Title Examination of usability of beauty function devices
Date of disclosure of the study information 2021/12/01
Last modified on 2021/07/12

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Basic information
Public title Examination of usability of beauty function devices
Acronym Examination of usability of beauty function devices
Scientific Title Examination of usability of beauty function devices
Scientific Title:Acronym Examination of usability of beauty function devices
Region
Japan

Condition
Condition None
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examine the effects of cosmetological devices on the skin.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes In the 3rd time of the 2nd week and the 3rd time of the 4th week, we will conduct a questionnaire about the effects of beauty function devices.
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
Other
Interventions/Control_1 The test period is 4 weeks per subject, and 3 times a week, only the beauty essence is applied, and the beauty essence application + beauty function device is applied to the designated area for the specified time.
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
30 years-old >
Gender Female
Key inclusion criteria 10 women in their 20s who wish to participate in the study after reading the consent manual
Those who are subjectively and objectively healthy and have no symptoms at the skin test site at the time of the test.
Key exclusion criteria Heart disease.
There are blood abnormalities such as bleeding disorders and hemophilia disorders.
Infants, growing children, and unable to express their intentions on their own.
Currently have skin allergic symptoms.
If you have skin disease or atopic dermatitis.
For atopic dermatitis, symptoms that require medication are excluded.
It is within one month of permanent hair removal.
During pregnancy and within 1 month after childbirth.
I can't feel the temperature.
I am taking steroid hormones, immunosuppressive drugs, and drowsiness-inducing drugs.
There are scars or eczema swelling on the skin at the test site.
There are abnormalities on the skin such as dermatitis and excessive sunburn.
Within 1 month after hair removal or hair removal treatment.
Has a history of surgery (formation, cosmetology, etc.).
Those who cannot express their will
Those who cannot communicate
Persons judged by the principal investigator or researcher to be inappropriate as subjects
Those who did not get consent
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Maki
Middle name
Last name Hosoki
Organization Tokushima University
Division name Institute of Biomedical Sciences
Zip code 770-8504
Address 3-18-15 Kuramoto-cho tokushima
TEL 088-633-7350
Email hosoki@tokushima-u.ac.jp

Public contact
Name of contact person
1st name Maki
Middle name
Last name Hosoki
Organization Tokushima University
Division name Institute of Biomedical Sciences
Zip code 770-8504
Address 3-18-15 Kuramoto-cho tokushima
TEL 088-633-7350
Homepage URL
Email hosoki@tokushima-u.ac.jp

Sponsor
Institute Department of Stomatognathic Function and Occlusal Reconstruction
Institute of Biomedical Sciences
Tokushima University Graduate School
Institute
Department

Funding Source
Organization Panasonic
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 Tokushima University Hospital Central Clinical Facilities
Address 2-50-1 Kuramoto-cho tokushima
Tel 088-633-9294
Email awachiken@tokushima-u.ac.jp

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 12 Month 01 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 07 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 09 Month 01 Day
Last follow-up date
2022 Year 02 Month 28 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 07 Month 12 Day
Last modified on
2021 Year 07 Month 12 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051213

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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