UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060725 |
|---|---|
| Receipt number | R000069451 |
| Scientific Title | Evaluation of the Effect of Combined HIFU and RF Treatment on Skin Elasticity in Healthy Subjects: A Prospective Randomized Split-Face Controlled Trial with Cutometer as the Primary Endpoint |
| Date of disclosure of the study information | 2026/02/21 |
| Last modified on | 2026/02/21 12:25:41 |
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Basic information
Public title
Evaluation of the Effect of Combined HIFU and RF Treatment on Skin Elasticity in Healthy Subjects:
A Prospective Randomized Split-Face Controlled Trial with Cutometer as the Primary Endpoint
Acronym
Evaluation of the Effect of Combined HIFU and RF Treatment on Skin Elasticity in Healthy Subjects:
A Prospective Randomized Split-Face Controlled Trial with Cutometer as the Primary Endpoint
Scientific Title
Evaluation of the Effect of Combined HIFU and RF Treatment on Skin Elasticity in Healthy Subjects:
A Prospective Randomized Split-Face Controlled Trial with Cutometer as the Primary Endpoint
Scientific Title:Acronym
Evaluation of the Effect of Combined HIFU and RF Treatment on Skin Elasticity in Healthy Subjects:
A Prospective Randomized Split-Face Controlled Trial with Cutometer as the Primary Endpoint
Region
| Japan |
Condition
Condition
This study does not target any specific disease and is intended to evaluate skin elasticity in healthy subjects.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to objectively evaluate the effect of combined HIFU and RF treatment on skin elasticity in healthy subjects and to assess its efficacy as a preventive aesthetic intervention against skin aging.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline in skin elasticity parameters (R2, R5, R7, F3) measured by Cutometer.
Key secondary outcomes
･Facial volume changes assessed by VECTRA
･Pore characteristics assessed by NeoVoir
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Left and right facial sides will be randomized 1:1.
Treatment side: Combined HIFU and RF therapy
Control side: No treatment
Interventions/Control_2
Left and right facial sides will be randomized 1:1.
Treatment side: Combined HIFU and RF therapy
Control side: No treatment
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
･Healthy subjects without clinically evident facial skin disease
･Ability to attend scheduled study visits
･Provision of written informed consent
Key exclusion criteria
･Pregnant, possibly pregnant, or breastfeeding individuals
･Individuals with active facial skin disease (infection, eczema, severe acne, etc.)
･Individuals who have undergone facial HIFU, RF, high-energy laser treatment, thread lift, or facial surgery within 6 months
･Individuals who have received injectable treatments affecting facial contour within 3 months
･Individuals judged inappropriate for participation by the principal investigator
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Teranishi |
Organization
Tokyo Chuo Beauty Clinic (TCB), Umeda Osaka Ekimae Clinic
Division name
Director
Zip code
5300057
Address
3rd Floor, K's Square Building, 2-8-15 Sonezaki, Kita-ku, Osaka-city, Osaka, Japan
TEL
06-6147-2581
umeda.office@tcb.or.jp
Public contact
Name of contact person
| 1st name | Taichi |
| Middle name | |
| Last name | tamura |
Organization
Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
Division name
vice chief
Zip code
5300057
Address
3rd Floor, K's Square Building, 2-8-15 Sonezaki, Kita-ku, Osaka-city, Osaka, Japan
TEL
06-6147-2581
Homepage URL
dr.tamura.taichi@tcb.or.jp
Sponsor or person
Institute
Tokyo Chuo Beauty Clinic (TCB), Umeda Osaka Ekimae Clinic
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
TCB Academic Committee and IRB
Address
3rd Floor, K's Square Building, 2-8-15 Sonezaki, Kita-ku, Osaka-city, Osaka, Japan
Tel
06-6147-2581
irb@tcb.or.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
| 2026 | Year | 02 | Month | 21 | 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 | 02 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | 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 | 21 | Day |
Last modified on
| 2026 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069451
