NCT01801202已完成不适用
Clinical Evaluation of LightSheer Duet 805nm HS Handpiece
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Hair count
研究概览
简要总结
- The study will re-confirm that the LightSheer Duet HS 805 nm handpiece is safe for removal of unwanted hair, and will result in hair removal and permanent hair count reduction.
- Twenty (20)subjects, Fitzpatrick Skin Type I-IV will be included in a single site.
- Each subject will receive five treatments at four to six week intervals and return for follow-up visits at three and six months after the last treatment for evaluation of the treated areas.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Able to read, understand and provide written Informed Consent;
- •Healthy adult, male or female, 18 years of age or older with skin type I-IV;
- •Having a suitable treatment area for hair removal;
- •Able and willing to comply with the treatment/follow-up schedule and requirements;
- •Women of child-bearing potential (women who have not had a hysterectomy, bilateral oophorectomy or are not postmenopausal) are required to be using a reliable method of birth control at least three months prior to enrollment and throughout the course of the study.
排除标准
- •Pregnant, expectation of pregnancy, postpartum or nursing (<6 months);
- •Hormonal disorders that may affect hair growth;
- •Immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications;
- •Livedo reticularis;
- •Uncontrolled systemic diseases such as diabetes;
- •Active infections in the treated area;
- •Dysplastic nevi;
- •Significant concurrent skin conditions or any inflammatory skin conditions;
- •Active cold sores, open lacerations or abrasions;
- •Chronic or cutaneous viral, fungal, or bacterial diseases;
- •Current cancer;
- •History of skin cancer or pre-cancerous lesions at the treatment areas;
- •Use of Accutane™ (Isotretinoin) within the past six month;
- •Keloid formation in the treatment area;
- •Tattoos in the treatment area;
- •Bleeding coagulopathies or use of anticoagulants;
- •Auto-immune disorders;
- •Erythema ab igne, when identified treatments should be discontinued;
- •Photosensitivity disorder that can be exacerbated by laser or intense light;
- •Herpes simplex in the treatment area;
- •Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light;
- •Poor wound healing;
- •Unable or unlikely to refrain from artificial tanning, including the use of tanning booths, prior (at least a week) and during the course of the evaluation;
- •Prior skin treatment with laser or other devices on the same treated areas within the last six months prior to study enrollment or during the course of the study.
结局指标
主要结局
Hair count
时间窗: 6 monts follow up
To verify hair removal and permanent hair reduction using the LightSheer Duet HS 805 nm handpiece
Number of subjects with Adverse Events
时间窗: 1 year
To evaluate the safety of hair removal using the LightSheer Duet HS 805 nm handpiece
次要结局
- Subject's comfort using VAS(Baseline, 4, 8, 12, 16 weeks;)
- Asses subject's perception of improvement and satisfaction(8, 16 weeks following baseline; 3 and 6 monts follow up)
研究者
研究点 (2)
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