Evaluation of Safety and Efficacy of TriPollar Device for Treatment of Wrinkles and Rhytides
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Safety of TriPollar
研究概览
简要总结
The TriPollar is intended for non invasive treatment of facial wrinkles and rhytides. This study was designed in order to evaluate the safety and efficacy of the TriPollar.
详细描述
The TriPollar technology is based on three or more electrodes designed to deliver RF current focused into the skin, thus generating heat in the dermal layer. Selective and focused electro-heating of the skin is intended to stimulate collagen remodeling in the dermal layer resulting in non invasive wrinkle treatment.
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject read, discussed and signed the Consent Form,
- •Healthy female/male aged 35 65 years,
- •Has facial wrinkles,
- •Capable of reading, understanding and following instructions of the procedure to be applied,
- •Able and willing to comply with the treatment and follow-up schedule.
排除标准
- •Listed in approved protocol, and ICF
结局指标
主要结局
Safety of TriPollar
时间窗: 6 months
Safety will be established by physician's assessment/observation of adverse events.
Efficacy of TriPollar
时间窗: 6 months
Efficacy will be established by level of wrinkle reduction at 3 m fu based on photos evaluation by independent physicians.
次要结局
未报告次要终点