Clinical trial NCT06657365: Safety and Efficacy Evaluation of the Monopolar Radiofrequency Device for the Improvement of Facial Wrinkles
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: CLASSYS Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-24
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 18 to 65 years old（The date of signing the informed consent shall prevail）, gender is not limited.
2. Facial and periorbital wrinkle and elasticity Scale (FWES) Score ≥ 3 points. Both the facial and periorbital FWES should meet the criteria.
3. The subject fully understands the benefits and risks of this experiment, and is still willing to participate and sign the informed consent.

Exclusion Criteria:

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

Primary outcomes:
measure: FWES
timeFrame: 3 months after the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital[北京安贞医院]
Study officials:
affiliation: Beijing Anzhen Hospital
name: 文志 李
role: PRINCIPAL_INVESTIGATOR
References: