NCT07471399

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: CLASSYS Inc. · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Lifting Efficacy

Interventions

Type	Name	Description
DEVICE	Test arm	Participants receive treatment with the investigational device VOLNEWMER applied to both cheeks.
DEVICE	Control arm	Participants receive treatment using the device in training mode that does not deliver radiofrequency energy.

Timeline

• Start date: 2026-02-23
• Primary completion: 2027-03-16
• Completion: 2027-03-16
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: South Korea