UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051005 |
|---|---|
| Receipt number | R000057866 |
| Scientific Title | Effect on the area around the eyes by continuous use of the EMS facial device for the eyes: single blinded study |
| Date of disclosure of the study information | 2023/05/09 |
| Last modified on | 2023/11/06 14:26:28 |
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Basic information
Public title
Effect on the area around the eyes by continuous use of the EMS facial device for the eyes
Acronym
bomodianji study
Scientific Title
Effect on the area around the eyes by continuous use of the EMS facial device for the eyes: single blinded study
Scientific Title:Acronym
Effect on the area around the eyes by continuous use of the EMS facial device for the eyes
Region
| Japan |
Condition
Condition
Healthy adult Female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Skin whitening effects by using facial device and cosmetic serum in combination
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measuring equipment evaluation (before use, after 4 weeks, after 8 weeks)
Key secondary outcomes
subjective assessment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Use facial device and 2 types of test cosmetics for 8 weeks
Interventions/Control_2
No device, only 2 cosmetics
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
| 40 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Female
Key inclusion criteria
Subjects with a BMI value of 22-23
Key exclusion criteria
1. Subjects who have a smoking habit
2.Subjects who have a history of serious liver disorder, renal disorder, or heart disease
3. Subjects who have 5 or more metal objects (bolts, silver teeth, etc.) for maxillary treatment
4. Subjects who have a history of other serious diseases
5. Subjects who are currently going to the hospital for some kind of disease
6.Subjects who have received treatment such as immunosuppression within the past 3 months
7.Subjects who may have an allergic reaction to the test product ingredients
8. Subjects with chronic skin diseases such as atopic dermatitis
9. Subjects who have scars, warts, pimples, permanent makeup, burns, etc. that affect the evaluation measurement on the face
10. Subjects with claustrophobia
11. Subjects who are receiving "hormone replacement therapy"
12.Subjects who have experience of aesthetic medicine that may affect the test site
13.Subjects who use supplements such as amino acids and proteins on a daily basis
14. Subjects who have difficulty maintaining lifestyle habits (eating, exercising, sleeping, skin care, etc.)
15. Subjects who drink excessively (e.g. 500ml of beer, 1 go of sake (180ml), 2 glasses of wine (200ml) or more)
16. Subjects who have difficulty filling in the subject diary
17.Subjects who are pregnant, breastfeeding, or may be pregnant
18.Subjects who have participating in other clinical trials at the start of this trial
19. Individuals or family members who work for a company that develops, manufactures, or sells beauty equipment or supplements
Target sample size
24
Research contact person
Name of lead principal investigator
| 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
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
info@yakujihou.org
Sponsor or person
Institute
Japan Clinical Trial Association
Institute
Department
Personal name
Funding Source
Organization
YA-MAN Ltd.
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
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
| 2023 | Year | 05 | Month | 09 | 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
14
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
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 04 | 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 | 05 | Month | 08 | Day |
Last modified on
| 2023 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057866
