Tokyo, Feb. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060652) titled 'Verification Test on Effects of Home Esthetic Machine (SAQINA Corebelle) Use on Skin Function
- Open-label Before-and-After Comparison Test -' on Feb. 12.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - TES Holdings Co., Ltd.
Condition:
Condition - No
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Every day, perform approximately 15 minutes of skincare using the test equipment and the provided cleansers, facial washes, and cosmetics.
Eligibility:
Age-lower limit - 35
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 Size - 25
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069300
Disclaimer: Curated by HT Syndication.
