Innovative Facial Contouring Using a Monopolar Radiofrequency Device With Continuous Water Cooling: An Integrated Clinical and Preclinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Jawline lifting
研究概览
简要总结
The goal of this clinical trial is to assess whether a single RF-CWC (radiofrequency - continous water cooling) session can produce significant improvements in jawline contour and facial volume in women aged 38-50 years over 8 weeks. The main questions it aims to answer are:
- Can one session of RF-CWC elevate the jawline after 8 weeks?
- Can one session of RF-CWC contour the lower face after 8 weeks? Researchers will compare the jawline lifting effect and mandibular volume at 2, 4, and 8 weeks to baseline values.
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
- 38 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 38-50 years
- •Agreed to abstain from any dermatological procedures, including facial lifting, during the study
- •Able to adhere to the study protocol.
排除标准
- •Pregnancy or breastfeeding
- •Failure to comply with contraception
- •Facial lesions
- •Hypersensitivity
- •Inflammatory or infectious facial conditions
- •Recent use of systemic steroids or phototherapy (within 1 month)
- •Recent cosmetic procedures (within 3 months)
- •Any condition deemed unsuitable by the investigator.
结局指标
主要结局
Jawline lifting
时间窗: From baseline to the end of the study at 8 weeks
Jawline lifting was evaluated using Morpheus3D® (Morpheus Co., Ltd., Gyeonggi, Republic of Korea), an LED-based 3D facial imaging system. Jawline lifting was measured as the curved distance (mm) from the chin to the earlobe; a decrease in length indicated improvement.
Facial volume
时间窗: From baseline to the end of the study at 8 weeks
Facial volume was evaluated using Morpheus3D® (Morpheus Co., Ltd., Gyeonggi, Republic of Korea), an LED-based 3D facial imaging system. Facial volume (ml) was assessed for two regions: the midface (between the eyes and the area from philtrum to nose), where an increase indicated volumization, and the lower face (philtrum to chin), where a decrease indicated contouring.
次要结局
未报告次要终点
研究者
Ngoc Ha Nguyen
Principal Investigator
Yonsei University