Early Stage Safety and Efficacy Assessment for the Temporary Facial(both Cheeks) Skin Tightening Improvement Effect Using the Monopolar Radiofrequency Device: Prospective, Open-label, Single Center, Single-arm, Pilot Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- CLASSYS Inc.
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Cutometer R7 values
研究概览
简要总结
Objective:
The goal of this clinical trial is to evaluate the safety and efficacy of the VOLNEWMER monopolar radiofrequency device developed by CLASSYS Inc. This study is a prospective, single-center, single-arm, pilot clinical trial.
Research Questions:
- Does the VOLNEWMER device improve skin elasticity?
- Is the safety profile of the VOLNEWMER device acceptable?
Subject Procedures:
Subjects will:
- Receive a single treatment session using the VOLNEWMER device.
- Attend follow-up visits over a 12-week period to assess improvements in elasticity and safety.
The primary outcome is the improvement in skin elasticity of the face and cheeks, measured 12 weeks after treatment using the Cutometer R7. Secondary outcomes include the Global Aesthetic Improvement Scale (GAIS). Safety assessments involve monitoring treatment-emergent adverse events (TEAEs) associated with the application of the investigational medical device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who are aged 19 to under 65 at the time of consent.
- •Subjects who seek improvement in facial skin elasticity (both cheeks).
- •Subjects who agree not to undergo other procedures affecting skin elasticity during the study.
- •Subjects who provide written consent and commit to full trial participation.
排除标准
- •Subjects with conditions at the investigational device application site (e.g., scars, open wounds, metal stents, or implants, that could affect the trial)
- •Subjects with inappropriate skin conditions or treatment history
- •Subjects with allergies or predispositions
- •Subjects using inappropriate medications that have the potential to increase the risk of bleeding or delay skin healing.
- •Subjects with lifestyle or other unsuitable conditions (Smoking history, participation in another interventional clinical trial prior to screening, not agreeing to use medically acceptable contraception, pregnant or breastfeeding women)
- •Subjects deemed inappropriate by the investigator
结局指标
主要结局
Change in Cutometer R7 values
时间窗: baseline, 12 weeks
The change in Cutometer R7 values measured on the cheeks at 12 weeks after the application of the investigational medical device compared to baseline will be evaluated.
次要结局
- Change in Cutometer R7 values(baseline, 8 weeks)
- Global Aesthetic Improvement Scale (GAIS)(4 weeks, 8 weeks, 12 weeks)
- Numeric Rating Scale (NRS) for Pain(Baseline, 4 weeks, 8 weeks, 12 weeks)