NCT06657365

Safety and Efficacy Evaluation of the Monopolar Radiofrequency Device for the Improvement of Facial Wrinkles

Safety and Efficacy Evaluation of the Monopolar Radiofrequency Device for the Improvement of the Facial Wrinkles, a Prospective, Multicenter, Evaluator Blinded, Randomized, Parallel-controlled, Non-inferior Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: CLASSYS Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of the monopolar radiofrequency therapy device developed by CLASSYS Inc. for improving facial and periorbital wrinkles. This is a prospective, multicenter, evaluator-blinded, randomized, parallel-controlled, non-inferiority clinical trial. The main questions the study aims to answer are: Does the monopolar radiofrequency device improve the appearance of facial and periorbital wrinkles? Is the safety profile of the monopolar radiofrequency device acceptable? Researchers will compare the investigational device to the Thermage CPT System (Solta Medical Co., Ltd.) to see if the monopolar radiofrequency device is non-inferior in terms of wrinkle improvement. Participants will: Undergo a single treatment session with either the investigational device or the control device. Be followed up for a period of 3 months to assess wrinkle improvement and safety outcomes. The primary outcome will be the improvement in facial and periorbital wrinkles, measured by the Facial Wrinkle and Elasticity Scale (FWES), 3 months post-treatment. Secondary outcomes include the Global Aesthetic Improvement Scale (GAIS) and a Visual Analog Scale (VAS) for pain. Safety evaluations will include adverse event (AE) and serious adverse event (SAE) monitoring.

Conditions

• Facial Wrinkles
• Anti-Aging
• Wrinkles and Rhytides
• Wrinkles Such as Nasolabial Folds
• Wrinkles

Interventions

Type	Name	Description
DEVICE	Radiofrequency (RF) Treatment with Volnewmer	Non-invasive radiofrequency-based skin tightening using the Volnewmer device.
DEVICE	Radiofrequency (RF) Treatment with Thermage CPT	Non-invasive radiofrequency-based skin tightening using the Thermage CPT device.

Timeline

• Start date: 2024-09-29
• Primary completion: 2025-01-11
• Completion: 2025-07-03
• First posted: 2024-10-24
• Last updated: 2025-09-30

Locations

1 site across 1 country: China