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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CLASSYS Inc.
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- FWES
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Thermage CPT
A non-invasive skin tightening treatment using the Thermage CPT device.
干预措施: Radiofrequency (RF) Treatment with Thermage CPT (Device)
VOLNEWMER
A non-invasive skin tightening treatment using the Volnewmer device.
干预措施: Radiofrequency (RF) Treatment with Volnewmer (Device)
结局指标
主要结局
FWES
时间窗: 3 months after the treatment
Facial wrinkle improvement was defined as reduction of FWES subgroup score≥1.
次要结局
未报告次要终点