Evaluation of Thermal Outcome and Safety of Nuera Tight RF System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 3
- 主要终点
- tissue heating
研究概览
简要总结
The purpose of the study is to verify tissue heating, temperature stability and safety of the Nuera Tight RF device during and after treatment session applied on the face.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects of either gender, 18 years of age or older
- •Subject is able to read, understand and sign an informed consent form
- •Subject is willing to comply with all study procedures
排除标准
- •Subjects taking medicines that increase skin sensitivity to heat
- •Subjects taking medicines that change skin metabolism
- •Cancer or any pigmentary or vascular lesions in the planned treatment area
- •Subjects with Herpes simplex in the area to be treated
- •Pregnant women
- •Subjects wearing pacemakers and/or any other type of implanted electronics
- •Subjects with any inflammatory skin conditions
- •Subjects with active cold sores, open lacerations, abrasions
- •Chronic or acute skin infections
- •Subjects with active local or systemic infections
- •Subjects with any disease in which an increase of skin temperature is contraindicated
- •Subjects wearing piercing in the area to be treated
- •Subjects have nerve insensitivity to heat in the area to be treated
- •Subjects have metal implants in the area to be treated, excluding dental implants
- •Subjects allergic to glycerin, paraffin, parfum, parabens, nuts, vegetable oils, calendula, or chamomile
- •Any condition where the study investigator determined that the subject is not adequate for this study
- •Subjects participating in other studies
结局指标
主要结局
tissue heating
时间窗: 12 minutes
To verify tissue heating throughout the treatment duration applied on the face. The temperature will be set at 42 C, the operator will move the electrode in a continuous motion until the skin temperature reached the target temperature, then the treatment will continue for another 12 minutes. the skin temperature will be measured using an infrared thermometer to verify tissue heating
temperature stability
时间窗: 12 minutes
To verify temperature stability throughout the treatment duration applied on the face. the skin temperature will be measured using an infrared thermometer every 3 minutes to verify temperature stability
次要结局
未报告次要终点