Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser for Non-invasive Fat Reduction of the Abdomen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Number of Before and After Photograph Sets Correctly Identified by Independent, Blinded Evaluators
研究概览
简要总结
This study is evaluating a 1060nm diode laser for non-invasive fat reduction of the abdomen. The study will enrolled up to 50 subjects requesting non-invasive lipolysis of the abdomen. Each subject will receive a single study treatment. Subjects will be followed at six and twelve weeks post treatment. Twelve week outcomes will be compared to baseline.
详细描述
Open-label baseline controlled evaluator-blind multi-centre study evaluating a 1060nm diode laser for non-invasive fat reduction of the abdomen. The study will enrolled up to 50 subjects requesting non-invasive lipolysis of the abdomen. Each subject will receive a single study treatment which takes approximately 25 minutes. Subjects will be followed at six and twelve weeks post treatment. Twelve week outcomes will be compared to baseline.
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
盲法说明
Blinded reviewer will evaluate the pre and post photos
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 voluntarily provide written informed consent
- •healthy male or female > 18 years of age seeking treatment for unwanted fat in the abdomen
- •BMI score is less then 30
- •agree to not making any major changes in their diet or lifestyle during the course of the study
- •able and willing to comply with the treatment / follow up schedule and requirements
- •women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrolment and for the duration of the study, have a negative urine pregnancy test baseline
排除标准
- •pregnant in the last 3 months intending to become pregnant, postpartum or nursing in the last 6 months
- •any previous liposuction / lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months
- •history of immunosuppression / immune deficiency disorders including AIDS and HIV infection, or use of immunosuppressive medications, 6 month prior to and during the course of the study
- •History of hyperlipidemia, diabetes, hepatitis, blood coagulopathy or excessive bleeding
- •Use of antiplatelet medications (81 mg of acetylsalicylic acid daily is permitted), anticoagulants, thrombocytes or any-inflammatory medications within 2 weeks of treatment
- •Having a history of skin cancer or any other cancer in the area to be treated, including presence of malignant or pre-malignant pigmented lesions
- •Having a permanent implant in the treatment area such as a metal plate or injected chemical substance such as silicone pr parenteral gold therapy (gold sodium thiomalate)
- •Use of medications, herbs or food supplements and vitamins known to induce photosensitivity to light exposure at the wavelength used history of photosensitivity disorder
- •Suffering from significant skin conditions in the treatment area or inflammatory skin conditions including but not limited to open lacerations, abrasions, herpes sores, cold sores, active infections
- •Tattoos in the treatment area
- •Poor quality skin (laxity)
- •Abdominal wall, muscular abnormality or hernia on physical examination
- •Unstable weight within the last 6 months (+ or - 3% weight change in the prior six months)
- •Participation in another clinical study involving the same anatomical areas within the last 6 months
- •History of keloid and hypertrophic scar formation or poor wound healing in the treatment area
- •As per the investigators discretion any physician or mental condition which may make it unsafe for the subject to participate
结局指标
主要结局
Number of Before and After Photograph Sets Correctly Identified by Independent, Blinded Evaluators
时间窗: Week 12 vs baseline
Photographic evaluation by independent blinded evaluators with correct identification of pre-treatment baseline images when compared to post-treatment images taken at 12 weeks
次要结局
- Subject Satisfaction(Week 12)
- Change in Fat Thickness(week 12)
- Treatment Pain(Week 1)