NCT01801202已完成不适用
Clinical Evaluation of LightSheer Duet 805nm HS Handpiece
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 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.
研究组 & 干预措施
Hair removal
Experimental
hair removal treatment using 805nm LightSheer Duet HS handpiece
干预措施: LightSheer Duet HS handpiece (Device)
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 (1)
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