UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060652 |
|---|---|
| Receipt number | R000069300 |
| Scientific Title | Verification Test on Effects of Home Esthetic Machine (SAQINA Corebelle) Use on Skin Function - Open-label Before-and-After Comparison Test - |
| Date of disclosure of the study information | 2026/02/12 |
| Last modified on | 2026/02/05 18:52:28 |
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Basic information
Public title
Verification Test on Effects of Home Esthetic Machine (SAQINA Corebelle) Use on Skin Function
- Open-label Before-and-After Comparison Test -
Acronym
Verification Test on Effects of Home Esthetic Machine (SAQINA Corebelle) Use on Skin Function
Scientific Title
Verification Test on Effects of Home Esthetic Machine (SAQINA Corebelle) Use on Skin Function
- Open-label Before-and-After Comparison Test -
Scientific Title:Acronym
Verification Test on Effects of Home Esthetic Machine (SAQINA Corebelle) Use on Skin Function
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this test is to evaluate the effects on skin function and confirm the safety of the test product (home aesthetic machine) when used.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
*Efficacy Evaluation Items
1) Stratum corneum moisture content
2) Dermal moisture content
3) Trans epidermal water loss (TEWL)
4) Skin viscoelasticity
5) Collagen score
6) Skin texture evaluation (skin surface and morphological assessment)
7) VISIA facial image analysis
8) Skin tone evaluation
9) Visual wrinkle grade assessment
10) Subjective questionnaire
*Safety Evaluation Items
1) Daily Activity Log
2) Physician Interview and Adverse Event Investigation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Every day, perform approximately 15 minutes of skincare using the test equipment and the provided cleansers, facial washes, and cosmetics.
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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1) Women aged 35 to 64 at the time of obtaining consent to participate in the trial.
2) Healthy individuals with no chronic physical conditions, including skin diseases.
3) Individuals who are aware of skin concerns such as dryness.
4) Individuals capable of performing daily skin care at home using a home beauty device for approximately 15 minutes.
5) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer to participate after fully understanding, and can provide written consent to participate in this trial.
6) Individuals who can attend the designated examination date and undergo the examination.
7) Individuals deemed suitable for participation in this trial by the principal investigator.
Key exclusion criteria
Individuals
1) currently suffering from any disease and undergoing drug therapy.
2) using implantable medical electronic devices such as pacemakers, wearable medical electronic devices such as electrocardiographs, or life-sustaining electronic devices such as artificial hearts.
3) with cosmetic allergies (cosmetic dermatitis) or those at risk of developing such allergies due to switching cosmetics.
4) receiving hormone replacement therapy.
5) with skin disease symptoms such as atopic dermatitis.
6) with a history of ingesting or applying medications for disease treatment within the past month.
7) with a history or current condition of serious disorders of the digestive organs, liver, kidneys, heart, lungs, blood, or mental disorders.
8) with a BMI of 30.0 kg/m2 or higher.
9) whose average weekly alcohol consumption exceeds 20 g of pure alcohol per day for women.
10) with smoking habits.
11) who may work night shifts or alter their daily routines during the trial period.
12) who may experience facial symptoms such as redness, itching, dryness, or swelling during the trial period due to seasonal allergies like hay fever. Also, individuals who may take anti-allergy medications or use nasal sprays.
13) who cannot avoid intentional exposure to direct sunlight, such as through sunbathing, during the trial period.
14) who regularly use home aesthetic devices or receive aesthetic treatments.
15) with a history of cosmetic procedures or treatments, such as aesthetic treatments or hyaluronic acid injections, on the evaluation site within the past 6 months.
16) who are pregnant, breastfeeding, or may become pregnant during the trial period.
17) currently participating in another human clinical trial, or individuals who have not completed 3 months since participation in another human clinical trial.
18) Other individuals deemed unsuitable for this trial by the principal investigator.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Shigemo |
Organization
FUYOSAQINA Co., Ltd.
Division name
Development Division 1
Zip code
060-0061
Address
Fuyo Daiichi Building, 1-12-4 Minami, Chuo-ku, Sapporo
TEL
011-272-5670
shigemo@saqina.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
FUYOSAQINA Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
COMET ELECTRIC Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.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 | 12 | 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 | 03 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 28 | 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 | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069300
