A Pilot, Open-Label, Single-Center, Single-Treatment, Safety And Effectiveness Evaluation Of Percutaneous-Temperature Controlled-Radiofrequency Electrocoagulation Used To Contract Tissue Associated With Axillary Sweat Glands
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Dermatology Life Quality Index (DLQI) improvement post treatment
研究概览
简要总结
This is a pilot, open-label, and single-center, single-treatment prospective evaluation of the electrocoagulation of axillary sweat gland tissue using the ThermiRF device to improve excessive sweating of the axilla(s).
In this study, "Temporary Relief" is defined as improvement on the DLQI.
Twenty male and female subjects between 18 and 50 years old will be enrolled. A total of five visits are planned for this study.
A punch biopsy will be collected (prior to and post treatment and analyzed to determine the degree of impact to the tissue after the electrocoagulation treatment.
Safety assessments will be collected using the Numerical Rating Scale (NRS) a 10-point scale, and adverse events reports (observed or reported).
The total length of the study is approximately 4 months.
详细描述
This is a pilot, open-label, and single-center, single-treatment prospective evaluation of the electrocoagulation of axillary sweat gland tissue using the ThermiRF device to alleviate or improve symptoms associated with axillary sweating.
In this study, "Temporary Relief" is defined as improvement on the DLQI.
A total of 20 male and female healthy volunteers between the age of 18 and 50 will be enrolled in this study. Subjects who sign the informed consent form and meet all entry criteria will be assigned a unique number/code to preserve confidentiality.
A total of five visits are planned for this study as described below:
- Visit 1: Screening visit - (Day 0)
- Visit 2: Single Treatment
- Visit 3: Day 30 (± 7 days)
- Visit 4: Day 60 (± 7 days)
- Visit 5: Day 90 (± 7 days)
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
single treatment
Percutaneous-Temperature Controlled-Radiofrequency Electrocoagulation Used To Contract Tissue Associated With Axillary Sweat Glands
干预措施: Thermi Radiofrequency (Device)
结局指标
主要结局
Dermatology Life Quality Index (DLQI) improvement post treatment
时间窗: Day 60
subjective improvement from initial to post questionnaire on the DLQI
次要结局
未报告次要终点