UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050696 |
|---|---|
| Receipt number | R000057757 |
| Scientific Title | Study on the efficacy and safety of the facial massage device on skin in healthy subjects |
| Date of disclosure of the study information | 2023/03/28 |
| Last modified on | 2023/03/28 14:21:16 |
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Basic information
Public title
Study on the efficacy and safety of the facial massage device on skin in healthy subjects
Acronym
Study on the efficacy and safety of the facial massage device on skin in healthy subjects
Scientific Title
Study on the efficacy and safety of the facial massage device on skin in healthy subjects
Scientific Title:Acronym
Study on the efficacy and safety of the facial massage device on skin in healthy subjects
Region
| Japan |
Condition
Condition
healthy people
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the facial device on healthy skin, a half-side test will be conducted for 8 weeks, in which the facial massage device and basic cosmetics will be used on the right face and only basic cosmetics will be used on the left face.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in skin elasticity at 4 and 8 weeks of initiation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
For 8 weeks, a facial massage device and basic cosmetics are used on the right side of the face.
Interventions/Control_2
Use only basic cosmetics on the left face for 8 weeks.
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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Not currently using a facial massage device
(2) Women of normal health between the ages of 20 and 60
(3) Able to practice the instructed usage by themselves.
(4) No other beauty device treatment must be performed on the face.
(5) Able to make hospital visits in accordance with the research schedule.
(6) The subject must have received a thorough explanation of his/her participation in this study, and must have given written consent of his/her own free will based on a thorough understanding of the subject's situation.
Key exclusion criteria
Persons who meet at least one of the following exclusion criteria are excluded.
(1) Patients who have experienced hypersensitivity or contact dermatitis to materials used in facial massage products.
(2) Persons who have experienced hypersensitivity or contact dermatitis to ingredients contained in basic cosmetics to be used in combination with the product.
(3) Patients with inflammation or scars on the face.
(4) Pregnant or nursing mothers.
(5) Patients with malignant tumors (except in cases where the tumor has been cured by surgery, etc.)
(6) Persons with significantly different skin conditions or symptoms on both sides of the face
(7) Any other person who is deemed inappropriate as a research subject by the principal investigator.
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Ayumi |
| Middle name | |
| Last name | Yoshizaki |
Organization
The university of tokyo hospital
Division name
dermatology
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
omatsuj-der@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Omatsu |
Organization
The university of tokyo hospital
Division name
dermatology
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0338155411
Homepage URL
omatsuj-der@h.u-tokyo.ac.jp
Sponsor or person
Institute
university of tokyo
Institute
Department
Personal name
Funding Source
Organization
university of tokyo
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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 | 03 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 03 | 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 | 03 | Month | 28 | Day |
Last modified on
| 2023 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057757
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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