UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060199 |
|---|---|
| Receipt number | R000068813 |
| Scientific Title | Structural Basis of Facial Sagging: A Quantitative Analysis Linking Visual Assessment to Skin, Fat, and Muscle Properties, and Development of a facial morphology and skin condition measurement method using bioelectrical impedance analysis and pressure sensors |
| Date of disclosure of the study information | 2026/01/09 |
| Last modified on | 2025/12/25 11:42:46 |
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Basic information
Public title
A Quantitative Analysis Linking Visual Assessment to Skin, Fat, and Muscle Properties
Acronym
A Quantitative Analysis Linking Visual Assessment to internal skin structure
Scientific Title
Structural Basis of Facial Sagging: A Quantitative Analysis Linking Visual Assessment to Skin, Fat, and Muscle Properties, and Development of a facial morphology and skin condition measurement method using bioelectrical impedance analysis and pressure sensors
Scientific Title:Acronym
Structural Basis of Facial Sagging: A Quantitative Analysis Linking Visual Assessment to Skin, Fat, and Muscle Properties
Region
| Japan |
Condition
Condition
healthy people
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the associations between visually assessed facial sagging scores and quantitative parameters of the skin surface and internal structures, including the dermis, subcutaneous fat, and muscles.
Basic objectives2
Others
Basic objectives -Others
To exploratorily evaluate the usefulness of facial skin condition assessment methods using bioelectrical impedance analysis, skin pressure sensors and image analysis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual assessment score of facial sagging based on facial images
Key secondary outcomes
- Stratum corneum hydration
- Transepidermal water loss (TEWL)
- Skin viscoelasticity
- Melanin index
- erythema index
- Skin color
- Dermal collagen score and dermal thickness
- Skin image analysis parameters
- Nasolabial fold parameters
- Ultrasonographic parameters
- Skin glycation level
- Body composition
- Facial photographic assessment
- Bioelectrical impedance values
- Pressure sensor values
- Questionnaire-based assessments
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 79 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Healthy female participants aged between 20 and 79 years.
(2) Participants with a body mass index (BMI)of 15.0 or higher and less than 30.0.
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
240
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 | 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
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 | 01 | 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
220
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
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special remarks.
Management information
Registered date
| 2025 | Year | 12 | Month | 25 | Day |
Last modified on
| 2025 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068813
