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

NCT07471399 | Recruiting

• 1 other identifier: VM-02
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lifting Efficacy

Keywords

monopolar radiofrequency; facial skin tightening

Outcome Measures

Primary Outcomes (1)

• Change in Cutometer R7 values

  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 Outcomes (4)

• Change in Cutometer R7 values

  8 weeks

• Percentage change from baseline in Cutometer R7 value

  week 8 and week 12

• Global Aesthetic Improvement Scale (GAIS)

  4 weeks, 8 weeks, and 12 weeks

• Global Aesthetic Improvement Scale(GAIS) assessment

  4, 8, and 12 weeks

Study Arms (2)

Investigational Device arm

EXPERIMENTAL

Participants will receive treatment with the investigational radiofrequency medical device (VOLNEWMER) applied to both cheeks according to the study protocol.

Device: Control arm

Control arm

SHAM COMPARATOR

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

Interventions

Test arm DEVICE

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

Control arm

Control arm DEVICE

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

Investigational Device arm

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 device application area that may influence the conduct or results of the study.
• Participants who have metal stents or implants at the investigational medical device application area.
• Participants with severe solar elastosis.
• Participants judged by the investigator to have excessive facial subcutaneous fat requiring surgical intervention.
• Participants with a history of anaphylaxis or severe complex allergic reactions.
• Participants with a history of or predisposition to hypertrophic scars or keloid formation.
• Participants with a history of adverse reactions to EMLA cream or local anesthetics (However, this criterion does not apply to participants who will not use anesthetics such as EMLA cream).
• Participants who have clinically significant disorders in the cardiovascular, gastrointestinal, respiratory, endocrine, or central nervous system that are not controlled by medication, or who have a history of or are currently receiving treatment for psychiatric disorders that may significantly affect this study.
• Participants with active herpes virus infection or autoimmune disease.
• Participants currently diagnosed with diabetes mellitus or epilepsy.
• Participants taking more than 100 mg of aspirin or aspirin-containing medication per day.
• Participants with bleeding disorders or blood coagulation-related diseases, such as thrombosis.
• Participants who have received Botox or filler injections at the investigational medical device application area\* within 24 weeks prior to screening (\*Investigational medical device application area: For participants undergoing facial (both cheeks) treatment - Mid-face (eyes to upper lip), Lower-face (lower lip to chin)) (However, if Botox or fillers were injected into the face but not within the application area, at least 12 weeks must have elapsed since the procedure).
• Participants who have undergone laser or light therapy at the investigational medical device application area within 24 weeks prior to screening.

Sponsors & Collaborators

• CLASSYS Inc.: lead
• Chung-Ang University Hospital: collaborator

Study Sites (1)

Classys Inc

Seoul, 06220, South Korea

RECRUITING

Related Publications (1)

• el-Domyati M, el-Ammawi TS, Medhat W, Moawad O, Brennan D, Mahoney MG, Uitto J. Radiofrequency facial rejuvenation: evidence-based effect. J Am Acad Dermatol. 2011 Mar;64(3):524-35. doi: 10.1016/j.jaad.2010.06.045.

  PMID: 21315951 RESULT

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Central Study Contacts

Hanyong Ghang

CONTACT

82-2-2094-2116; hy.ghang@classys.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: evaluator-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: pivotal medical device clinical trial

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): March 16, 2027
• Study Completion (Estimated): March 16, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Locations

KR (1)