RecruitingNot Applicable

Safety and Efficacy Assessment for the Temporary Facial Skin Tightening Improvement Effect Using the Monopolar Radiofrequency Device

South Korea96 participantsStarted 2026-02-23

Plain-language summary

The purpose of this clinical trial is to demonstrate the temporary improvement in skin elasticity and to evaluate the safety of the investigational medical device that uses radiofrequency current when applied to the face (both cheeks), compared with the control device.

Who can participate

Age range19 Years – 65 Years

SexALL

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Inclusion criteria

✓. Participants who are at least 19 years old and under 65 years of age as of the date of written informed consent.
✓. Participants whose average Cutometer R7 value for both checks is ≤0.6.
✓. Participants who consent to photographic documentation for verification of skin type(Fitzpatrick skin scale) and evaluation of treatment efficacy.
✓. Participants who agree to refrain from receiving any procedures or therapies that could influence skin elasticity improvement throughout the study period.
✓. Participants who agree to employ medically acceptable contraception for up to 4 weeks following the end of the study
✓. Participants who have adequately understood the objectives and procedures of the clinical trial, voluntarily consent in writing to participate, and are able to complete the study as required.

Exclusion criteria

✕. Participants who have any medical or dermatologic condition at the investigational medical device application area that may influence the conduct or results of the study.
✕. Participants who have scars or open lesions at the investigational medical

What they're measuring

Change in Cutometer R7 values

Timeframe: 12 weeks

Trial details

NCT IDNCT07471399

SponsorCLASSYS Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-16

Contact for this trial

Jihye Min

82-2-6313-2242 mins0131@classys.com

View on ClinicalTrials.gov More Lifting Efficacy trials