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

NCT06657365 | Completed DMC

• 1 other identifier: CLSSPZLY
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

VOLNEWMER; facial skin treatment; nasolabial folds; marionette line; MRF; facial wrinkles; wrinkles; monopolar radiofrequency device

Outcome Measures

Primary Outcomes (1)

• FWES

  Facial wrinkle improvement was defined as reduction of FWES subgroup score≥1.

  3 months after the treatment

Study Arms (2)

VOLNEWMER

EXPERIMENTAL

A non-invasive skin tightening treatment using the Volnewmer device.

Device: Radiofrequency (RF) Treatment with Volnewmer

Thermage CPT

ACTIVE COMPARATOR

A non-invasive skin tightening treatment using the Thermage CPT device.

Device: Radiofrequency (RF) Treatment with Thermage CPT

Interventions

Radiofrequency (RF) Treatment with Volnewmer DEVICE

Non-invasive radiofrequency-based skin tightening using the Volnewmer device.

VOLNEWMER

Radiofrequency (RF) Treatment with Thermage CPT DEVICE

Non-invasive radiofrequency-based skin tightening using the Thermage CPT device.

Thermage CPT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years old（The date of signing the informed consent shall prevail）, gender is not limited.
• Facial and periorbital wrinkle and elasticity Scale (FWES) Score ≥ 3 points. Both the facial and periorbital FWES should meet the criteria.
• The subject fully understands the benefits and risks of this experiment, and is still willing to participate and sign the informed consent.

You may not qualify if:

• Individuals with skin diseases, scars, open wounds, or metal implants in the area where clinical trial medical devices will be applied.
• Patients with implanted electrical devices (e.g., pacemakers, AICDs).
• Those with a history of hypertrophic scars, keloids, or severe allergic reactions.
• Individuals with excessive facial fat requiring surgical treatment.
• Those with autoimmune diseases, acute viral herpes, or poorly controlled diabetes.
• People with abnormal coagulation function or those taking anticoagulant medications (e.g., aspirin, warfarin) within 1 week of screening.
• Individuals treated with fillers or botulinum toxin within the last 6 months or permanent fillers in the treatment area.
• Those who have received skin treatments (e.g., deep exfoliation, lasers, light therapy) in the treatment area within 6 months.
• Pregnant or lactating women, or women of childbearing potential not using medically accepted contraception.
• Persons deemed inappropriate by the investigator to participate in this clinical trial.

Sponsors & Collaborators

• CLASSYS Inc.: lead

Study Sites (1)

Beijing Anzhen Hospital[北京安贞医院]

Beijing, China

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

• 文志 李

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 24, 2024
• Study Start: September 29, 2024
• Primary Completion: January 11, 2025
• Study Completion: July 3, 2025
• Last Updated: May 4, 2026

Record last verified: 2025-09

Locations

CN (1)