NCT01282866已完成不适用
Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Hair Count
研究概览
简要总结
The objective of this clinical study is to verify hair count reduction, associated comfort/discomfort and treatment time using the LightSheer Duet System with the High Speed (HS) handpieces for temporary hair removal and permanent hair reduction. It is anticipated that the larger treatment size of the HS handpiece will result in faster treatment of larger areas; and that the lower energy levels will result in greater comfort.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy adult, female, 18 years of age or older with skin type I-IV;
- •Having at least one suitable treatment area for hair removal with brown hair;
- •Able and willing to comply with the treatment/follow-up schedule and requirements;
- •Able to read, understand and provide written Informed Consent.
- •Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to market preference test enrollment and throughout the course of the study treatment.
排除标准
- •Showing symptoms of hormonal disorders, as per the Investigator's discretion;
- •Use of oral isotretinoin (Accutane®) within 6 months
- •Prior skin treatment with laser or other devices on the same treated areas prior to study enrollment or during the course of the study;
- •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 history of bleeding disorder or taking anticoagulation medications before the washout period, per the package insert, and at the physician's discretion;
- •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, personal history of melanoma;
- •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;
- •Tattoos in the treatment areas;
- •Dysplastic nevi in the treatment areas;
- •Participation in a study of another device or drug within 3 month 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;
- •Allergy or history of an allergy to any topical anesthetic used;
- •Pregnant, expectation of pregnancy, postpartum (<3 months) or nursing (<6 weeks);
- •History of livedo reticularis, an autoimmune vascular disease;
- •Hypersensitivity at the treatment site to any agents, solutions, or gel used in the treatment (applies to ET handpiece only), if no alternative exists;
结局指标
主要结局
Hair Count
时间窗: 6 month following last treatment
The hair at the treatment area is counted at Baseline and 6 months following the last treatment. Hair clearance is determined by the percentage of Hair left 6 months following the last treatment compared to the hair number at baseline.
次要结局
- Level of Comfort Associated With Treatment(Each treatment)
- Treatment Time(Each treatment)
- Hair Count(15 month following last treatment)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Study of effectiveness and safety on the hair loss restraint by scalp cooling with scalp cooling device in the breast cancer chemotherapyBreast cancerJPRN-UMIN000031534ational Hospital Organization Kyushu Cancer Center120
暂停
2 期
Hair loss restraint by scalp cooling enforcementBreast cancerJPRN-jRCTs072180051TOKUNAGA Eriko21
Unknown
不适用
The Effect of Hair Removal on Intraoperative ContaminationIntraoperative ComplicationsNCT04256928Herlev and Gentofte Hospital200
已完成
不适用
A Prospective Study of Axillary Hair Loss in Patients Treated With the miraDry SystemUnderarm HairNCT01732497Miramar Labs56
已完成
不适用
Efficacy and Safety of a Dietary Supplement on Hair Growth and Hair Health in Female With Acute Telogen EffluviumHealthyTelogen EffluviumNCT06545552Activ'inside66