UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053609 |
|---|---|
| Receipt number | R000061175 |
| Scientific Title | Comparative evaluation of medical RF beauty devices and home-use facial device in continuous use: single blinded study |
| Date of disclosure of the study information | 2024/02/15 |
| Last modified on | 2024/08/19 11:23:45 |
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Basic information
Public title
Comparative evaluation of medical RF beauty devices and home-use facial device in continuous use
Acronym
Y-RF30 study
Scientific Title
Comparative evaluation of medical RF beauty devices and home-use facial device in continuous use: single blinded study
Scientific Title:Acronym
Comparative evaluation of medical RF beauty devices and home-use facial device in continuous use
Region
| Japan |
Condition
Condition
Healthy adult Female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects on skin condition of using specific cosmetics and facial equipment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of devices that measure, Physician Evaluation (Before use / 2 weeks later / 4 weeks later / 8 weeks later)
Key secondary outcomes
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
8
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Daily use of certain cosmetics and once every two weeks, on one side of the face, a treatment with a medical RF beauty device
Interventions/Control_2
The other side of the face is not treated with medical RF beauty device and certain cosmetic products are used
Interventions/Control_3
Use specific cosmetics daily and use a home-use facial device A on one side of the face 5 times a week.
Interventions/Control_4
The other side of the face does not use home-use facial device A, but uses specific cosmetics
Interventions/Control_5
Use specific cosmetics daily and use a home-use facial device B on one side of the face 5 times a week.
Interventions/Control_6
The other side of the face does not use home-use facial device B, but uses specific cosmetics
Interventions/Control_7
Use specific cosmetics daily and use a home-use facial device C on one side of the face 5 times a week.
Interventions/Control_8
The other side of the face does not use home-use facial device C, but uses specific cosmetics
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Female
Key inclusion criteria
1. Subjects who are concerned about sagging, swelling, and lines on the face.
2. Subjects who can use facial/beauty equipment on their face
3. Subjects who are tolerant to heat/electrical stimulation
4. No significant weight fluctuation of more than plus minus 3 kg from 4 weeks prior to the start of the study and able to maintain the weight from the start of the study to the end of the study.
5. Subjects who can agree not to change the cosmetics (skin care and make-up) used from 4 weeks prior to the start of the study to the end of the study.
6. The applicant agrees not to undergo any facial treatment or care at an esthetic or medical institution from the start date of the examination until the end of the examination.
Key exclusion criteria
1. Subjects with serious underlying diseases (diabetes, dyslipidemia, cardiovascular disease, osteoporosis, autoimmune disease, etc.)
2. Subjects with chronic skin diseases such as atopic dermatitis
3. Subjects with a history of other serious diseases
4. Currently undergoing hospitalization, medication, or treatment for any disease.
5. Subjects have sensitive skin.
6. Subjects, lactating, or possibly pregnant.
7. Subjects who have undergone immunosuppression or other procedures within the past 3 months.
8. Subjects who have gold threads implanted or are taking or have a history of taking gold preparations (Siozol, Glelease, Rizasto, Ridora, etc.)
9. Subjects who are using a pacemaker or implantable cardioverter defibrillator
10. Subjects who have scars, warts, pimples, art makeup, burns, etc. on the face that may affect the evaluation measurement.
11. Subjects who have any experience of cosmetic or other medical treatment that may affect the subject area (including hyaluronic acid injections, Botox, etc.)
12. Subjects who have more than 5 metallic objects (bolts, silver teeth, etc.) in the treatment of the upper jaw.
13. Subjects who are undergoing dental treatment (braces, implants, etc.)
14. Subjects who may have allergic reactions to test product ingredients.
15. Claustrophobia
16. Subjects who have a smoking habit.
17. Subjects who have difficulty in maintaining their lifestyle (diet, exercise, sleep, skin care, etc.)
18. Subjects who drink excessively (e.g., more than 500 ml of beer, 1 cup (180 ml) of sake, 2 glasses (200 ml) of wine)
Target sample size
16
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
| 2024 | Year | 02 | Month | 15 | 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
16
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
| 2024 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 13 | Day |
Last modified on
| 2024 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061175
