UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050069 |
|---|---|
| Receipt number | R000057038 |
| Scientific Title | Changes in cortisol, oxytocin, mood and facial expression before and after esthetic treatment |
| Date of disclosure of the study information | 2023/01/18 |
| Last modified on | 2023/01/18 13:27:19 |
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Basic information
Public title
Changes in cortisol, oxytocin, mood and facial expression before and after esthetic treatment
Acronym
Changes in cortisol, oxytocin, mood and facial expression before and after esthetic treatment
Scientific Title
Changes in cortisol, oxytocin, mood and facial expression before and after esthetic treatment
Scientific Title:Acronym
Changes in cortisol, oxytocin, mood and facial expression before and after esthetic treatment
Region
| Japan |
Condition
Condition
Relaxation and stress reduction effects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Esthetic treatment is recognized mainly for its relaxation effect, but there have been no papers yet examining its effects on the brain from a medical perspective.
In this age of "100-year life," it is useful to scientifically verify the effects of esthetic treatment from the perspective of happy aging, and the results of this study may serve as basic data for the future application of esthetic treatment know-how to dementia patients and elderly people in the medical and nursing care fields.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of cortisol and oxytocin levels by saliva test
Key secondary outcomes
Mood assessment using the Japanese version of the POMS2 short version for adults.
Evaluation of health-related quality of life using the Japanese version of the SF-8 24-hour version.
Survey of awareness and satisfaction using a questionnaire (VAS).
Facial expression analysis using the Kokoro Sensor.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Facial esthetic treatment
Interventions/Control_2
Facial esthetic treatment
Interventions/Control_3
Facial esthetic treatment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study subjects will be divided into three groups: Group A, Group B, and Group C.
Group A will be the general public who receive facial esthetic treatment from Miss Paris Inc. for the first time; Group B will be the regular treatment applicants who receive facial esthetic treatment from Miss Paris Inc. for the first time; and Group C will be the regular treatment applicants who have undergone Miss Paris' facial esthetic treatment at least three times.
Based on the above, the following selection criteria will be used.
(1) Men and women who are 20 years of age or older at the time of obtaining consent.
(2) Those who entered between February 17, 2023 and March 10, 2023 (however, the entry period may be extended if the number of applicants during the period indicated on the left falls far below the target number of cases).
(3) Those who, after receiving a full explanation of their participation in this study, have obtained the free and voluntary written consent of the research subjects themselves based on a full understanding of the study.
Key exclusion criteria
(1) Those who have a disease that would interfere with the performance of facial esthetics (infectious skin disease, keloids, etc.)
(2) Other subjects whom the principal investigator deems inappropriate as research subjects.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akito |
| Middle name | |
| Last name | Hayashi |
Organization
Juntendo University Graduate School of Medicine
Division name
Neurology
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
hayashi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Emiri |
| Middle name | |
| Last name | Gondo |
Organization
Juntendo University Graduate School of Medicine
Division name
Next-generation Beauty&Wellness Medical Research
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
e-gondo@juntendo.ac.jp
Sponsor or person
Institute
Miss Paris Inc.
Institute
Department
Personal name
Funding Source
Organization
Miss Paris Inc.
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
Juntendo Medical Department Ethics Committee
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
crbjun@juntendo.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
| 2023 | Year | 01 | Month | 18 | 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 | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 18 | Day |
Last modified on
| 2023 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057038
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
