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

March 10, 2026 updated by: CLASSYS Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single-center, comparative, randomized, evaluator-blinded, superiority, confirmatory clinical trial designed to demonstrate the temporary improvement in skin elasticity and to evaluate the safety of an investigational medical device using radiofrequency current when applied to the face (both cheeks), compared with a control device.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Seoul, South Korea, 06220
        • Recruiting
        • Classys Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Participants who are at least 19 years old and under 65 years of age as of the date of written informed consent.
  2. Participants whose average Cutometer R7 value for both checks is ≤0.6.
  3. Participants who consent to photographic documentation for verification of skin type(Fitzpatrick skin scale) and evaluation of treatment efficacy.
  4. Participants who agree to refrain from receiving any procedures or therapies that could influence skin elasticity improvement throughout the study period.
  5. Participants who agree to employ medically acceptable contraception for up to 4 weeks following the end of the study
  6. 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:

  1. 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.
  2. Participants who have scars or open lesions at the investigational medical

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational Device arm
Participants will receive treatment with the investigational radiofrequency medical device (VOLNEWMER) applied to both cheeks according to the study protocol.
Device: Control arm
Participants receive treatment using the device in training mode that does not deliver radiofrequency energy.
Sham Comparator: Control arm
Subjects assigned to this arm will receive treatment with a sham device applied to both cheeks. The sham device is identical in appearance and operation to the investigational device but does not deliver radiofrequency energy.
Device: Test arm
Participants receive treatment with the investigational device VOLNEWMER applied to both cheeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cutometer R7 values
Time Frame: 12 weeks
Change from baseline in Cutometer R7 value at Week 12 following treatment with the investigational medical device, as assessed by an independent evaluator.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cutometer R7 values
Time Frame: 8 weeks
Change from baseline in Cutometer R7 value at 8 weeks after application of the investigational medical device, as assessed by an independent evaluator.
8 weeks
Percentage change from baseline in Cutometer R7 value
Time Frame: week 8 and week 12
Percent change from baseline in Cutometer R7 value at Weeks 8 and 12 after application of the investigational medical device, as assessed by an independent evaluator.
week 8 and week 12
Global Aesthetic Improvement Scale (GAIS)
Time Frame: 4 weeks, 8 weeks, and 12 weeks
Global Aesthetic Improvement Scale(GAIS) scores at Weeks 4, 8, and 12 after application of the investigational medical device, as assessed by the investigator.
4 weeks, 8 weeks, and 12 weeks
Global Aesthetic Improvement Scale(GAIS) assessment
Time Frame: 4, 8, and 12 weeks
Global Aesthetic Improvement Scale(GAIS) scores assessed by participants at 4, 8, and 12 weeks following treatment with the investigational medical device.
4, 8, and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CLASSYS Inc.

Collaborators

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • el-Domyati M,el-Ammawi TS,Medhat W,Moawad O,Brennan D,Mahoney MG,Uitto J

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2026

Primary Completion (Estimated)

March 16, 2027

Study Completion (Estimated)

March 16, 2027

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VM-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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