NCT00657085已完成不适用
Evaluation of the LightSheer HS Hand Piece as Compared to the LightSheer ET Hand Piece for the Intended Use of Hair Removal and Permanent Hair Reduction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Follicular damage assessed by histology
研究概览
简要总结
To observe the qualitative comparison of follicular damage between treatment with the LightSheer Duet hand pieces (ET and HS) as assessed by horizontal biopsy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male adult, 18 years of age or older with skin type I-V;
- •Having a suitable treatment area for hair removal with brown or black hair (no gray);
- •Able and willing to comply with the treatment/follow-up schedule and requirements;
- •Able to read, understand and provide written Informed Consent.
排除标准
- •Showing symptoms of hormonal disorders, as per the Investigator's discretion;
- •Use of oral isotretinoin (Accutane®) within 6 months, or off label use of topical isotretinoin in immediate treated area or in its proximity within 3 months, of study enrollment or during the course of the study;
- •Prior skin treatment with laser or other devices on the same treated areas prior to study enrollment or during the course of the study;
- •Adverse reaction to the treatment gel to be used in the evaluation;
- •History of keloid formation or poor wound healing in a previously injured skin area;
- •Significant skin conditions affecting treated area or inflammatory skin conditions;
- •Open laceration, abrasion, active cold sores or herpes sores on area to be treated;
- •History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications;
- •Having a bleeding disorder or taking anticoagulation medications within the preceding 6 months;
- •Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the area to be treated;
- •Significant concurrent illness, such as diabetes, lupus, epilepsy or cardiac disorders, which might be aggravated as a result of treatment;
- •Unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray or cream, during the course of the evaluation;
- •Photosensitivity disorder that can be exacerbated by infrared light;
- •Tattoos in the treatment areas;
- •Dysplastic nevi in the treatment areas;
- •Allergy or history of an allergy to the topical anesthetic used.
- •Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria;
- •Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
- •Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study.
结局指标
主要结局
Follicular damage assessed by histology
时间窗: first visit
次要结局
- Comparison of permanent hair reduction between ET and HS handpieces(2 month follow up visit)
研究者
研究点 (1)
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