NCT06816069

Study on Safety and Efficacy of Monopolar Radio Frequency Device for Facial Skin Tightening

Early Stage Safety and Efficacy Assessment for the Temporary Facial(both Cheeks) Skin Tightening Improvement Effect Using the Monopolar Radiofrequency Device: Prospective, Open-label, Single Center, Single-arm, Pilot Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: CLASSYS Inc. · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Objective: The goal of this clinical trial is to evaluate the safety and efficacy of the VOLNEWMER monopolar radiofrequency device developed by CLASSYS Inc. This study is a prospective, single-center, single-arm, pilot clinical trial. Research Questions: 1. Does the VOLNEWMER device improve skin elasticity? 2. Is the safety profile of the VOLNEWMER device acceptable? Subject Procedures: Subjects will: * Receive a single treatment session using the VOLNEWMER device. * Attend follow-up visits over a 12-week period to assess improvements in elasticity and safety. The primary outcome is the improvement in skin elasticity of the face and cheeks, measured 12 weeks after treatment using the Cutometer R7. Secondary outcomes include the Global Aesthetic Improvement Scale (GAIS). Safety assessments involve monitoring treatment-emergent adverse events (TEAEs) associated with the application of the investigational medical device.

Conditions

• Skin Aging

Interventions

Type	Name	Description
DEVICE	VOLNEWMER	Monopolar radiofrequency device

Timeline

• Start date: 2024-11-10
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2025-02-10
• Last updated: 2025-02-18

Locations

1 site across 1 country: South Korea