UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060661 |
|---|---|
| Receipt number | R000069362 |
| Scientific Title | Evaluation of skin condition improvement and skin safety using facial beauty devices: Development of beauty technology targeting the adipose layer |
| Date of disclosure of the study information | 2026/02/16 |
| Last modified on | 2026/02/10 17:26:32 |
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Basic information
Public title
Study on the comprehensive evaluation of skin condition and safety related to the use of facial beauty devices
Acronym
Study on the comprehensive evaluation of skin condition and safety related to the use of facial beauty devices
Scientific Title
Evaluation of skin condition improvement and skin safety using facial beauty devices: Development of beauty technology targeting the adipose layer
Scientific Title:Acronym
Evaluation of skin condition improvement and skin safety using facial beauty devices: Development of beauty technology targeting the adipose layer
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects on skin condition by using facial device and cosmetics in combination
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of devices that measure (before use, after 4 weeks, after 8 weeks, after 12 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 |
Interventions/Control_1
For 12 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 12 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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Healthy female participants aged between 40 and 65 years.
(2) Participants with a body mass index (BMI)of 15.0 or higher and less than 35.0.
(3) Subjects who have not had excessive sunburn within the past 4 weeks.
Key exclusion criteria
(1) History of cosmetic medical treatments .
(2) Serious underlying diseases or facial skin disorders.
(3) Pregnancy or breastfeeding.
(4) Facial inflammation or wounds.
(5) Other conditions judged inappropriate by the principal investigator.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Yamazaki |
Organization
YA-MAN LTD.
Division name
HYOJO Science Lab
Zip code
1350016
Address
2-4-2 Toyo Koto-ku, Tokyo 1350016 JAPAN
TEL
0356657321
k.yamazaki@ya-man.com
Public contact
Name of contact person
| 1st name | Kentato |
| Middle name | |
| Last name | Yamazaki |
Organization
YA-MAN LTD.
Division name
HYOJO Science Lab
Zip code
1350016
Address
2-4-2 Toyo Koto-ku, Tokyo 1350016 JAPAN
TEL
0356657321
Homepage URL
k.yamazaki@ya-man.com
Sponsor or person
Institute
YA-MAN LTD.
Institute
Department
Personal name
Funding Source
Organization
YA-MAN LTD.
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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
0354081599
rinri@s-palace-clinic.com
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
ヤーマン株式会社
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 16 | 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
| 2026 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 12 | Day |
Last modified on
| 2026 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069362
