MedTrace Logo

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

NCT06657365 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2026-05-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • CLASSYS Inc.

    lead INDUSTRY

Principal Investigators

  • 文志 李 · Beijing Anzhen Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-29
Primary Completion
2025-01-11
Completion
2025-07-03

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06657365 on ClinicalTrials.gov