Cutera UHAIR for Hair Removal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 主要终点
- Reduction in Hair Count in the Treated Area
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the Cutera UHAIR ultrasound device for hair removal.
详细描述
The purpose of this study is to evaluate the Cutera UHAIR device for safety and efficacy for removal and long term reduction of unwanted hair on subjects with Fitzpatrick skin types I-IV and dark (black or brown), red, and blonde colored hair.
At investigator's discretion, each subject will receive treatments and will be scheduled for follow-up visits after the final treatment. The treated area(s) will be photographed at each visit for analysis.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female at least 18 years of age
- •Fitxpatrick skin type I-IV
- •Area with unwanted hair
- •Subject must be able to read, understand and sign the consent form
- •Subject must adhere to the follow-up schedule and study instruction
排除标准
- •Simultaneous participation in any other clinical study
- •Inability or unwillingness to follow the treatment schedule
- •Inability or unwillingness to sign the informed consent
- •Infection in the target area
- •Any disease or condition that could impair wound healing
- •History of keloid formation
- •History of malignant tumors in the target area
- •Skin abnormalities in the target area, e.g. cuts, scrapes, wounds, scars, large moles
- •History of hair removal in target area (light based or electrolysis)
- •Pregnant or lactating
结局指标
主要结局
Reduction in Hair Count in the Treated Area
时间窗: baseline and 3 months post final treatment (up to 28 weeks)
Percent hair reduction 3 months post final treatment compared to baseline in the treated areas
次要结局
未报告次要终点