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

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.

Inclusion Criteria:

• Subjects who are aged 19 to under 65 at the time of consent.
• Subjects who seek improvement in facial skin elasticity (both cheeks).
• Subjects who agree not to undergo other procedures affecting skin elasticity during the study.
• Subjects who provide written consent and commit to full trial participation.

Exclusion Criteria:

• Subjects with conditions at the investigational device application site (e.g., scars, open wounds, metal stents, or implants, that could affect the trial)
• Subjects with inappropriate skin conditions or treatment history
• Subjects with allergies or predispositions
• Subjects using inappropriate medications that have the potential to increase the risk of bleeding or delay skin healing.
• Subjects with lifestyle or other unsuitable conditions (Smoking history, participation in another interventional clinical trial prior to screening, not agreeing to use medically acceptable contraception, pregnant or breastfeeding women)
• Subjects deemed inappropriate by the investigator