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RecruitingNot ApplicableNCT07471399

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

Safety and Efficacy Assessment for the Temporary Facial(Both Cheeks) Skin Tightening Improvement Effect Using the Monopolar Radiofrequency Device: Prospective, Single Center, Compared, Randomized, Evaluator-Blinded, Superiority, Pivotal Clinical Trial

Sponsor

CLASSYS Inc.

Enrollment

96 participants

Start Date

Feb 23, 2026

Study Type

INTERVENTIONAL

Conditions

Lifting Efficacy

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.

Eligibility

Min Age: 19 YearsMax Age: 65 Years

Inclusion Criteria6

  • 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 Criteria2

  • 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

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Interventions

DEVICETest arm

Participants receive treatment with the investigational device VOLNEWMER applied to both cheeks.

DEVICEControl arm

Participants receive treatment using the device in training mode that does not deliver radiofrequency energy.

Locations(1)

Classys Inc

Seoul, South Korea

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NCT07471399