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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital[北京安贞医院]

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 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.

Exclusion criteria

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.

Treatment and study plan

Radiofrequency (RF) Treatment with Volnewmer

Device

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

Radiofrequency (RF) Treatment with Thermage CPT

Device

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

Primary outcomes

FWES

Time frame: 3 months after the treatment

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

Sponsors and collaborators

Lead sponsor

CLASSYS Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Oct 24, 2024
Registry last updated: May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed