UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044834 |
|---|---|
| Receipt number | R000051213 |
| Scientific Title | Examination of usability of beauty function devices |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2024/01/15 23:54:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hosoki@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Stomatognathic Function and Occlusal Reconstruction
Institute of Biomedical Sciences
Tokushima University Graduate School
Institute
Department
Personal name
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
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
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
0
Results
The event was canceled due to lack of approval from the ethics committee.
Results date posted
| 2024 | Year | 01 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No participants
Participant flow
No participants
Adverse events
None
Outcome measures
None
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
Canceled
Management information
Registered date
| 2021 | Year | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
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 |
