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
- 2
- 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
研究组 & 干预措施
Treatment subjects
Single group of subjects which will have the treatment of a 1060nm diode laser administered to them.
干预措施: 1060nm diode laser (Device)
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)