Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser, Pulsed ElectroMagnetic Fields and Vacuum Assisted Multipolar Radio Frequency for Non-invasive Fat Reduction of the Abdomen and Flanks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 5
- 主要终点
- Change in Aesthetic Appearance From Baseline
研究概览
简要总结
Open-label, baseline-controlled, multi-center study evaluating a 1060 nm diode laser, pulsed electromagnetic fields and vacuum assisted radio frequency for non-invasive fat reduction of the abdomen and flanks.
详细描述
Open-label, baseline-controlled, multi-center study evaluating a 1060 nm diode laser, pulsed electromagnetic fields, and vacuum-assisted radio frequency for non-invasive fat reduction of the abdomen and flanks. The study will enroll up to 200 subjects requesting non-invasive lipolysis of the abdomen and flanks. Each subject will receive 3 study treatments of the diode laser and 3 treatments of the pulsed electromagnetic fields and vacuum assisted radio frequency. Subjects will be followed at twelve weeks post-final diode treatment. The twelve-week post-treatment outcome will be compared to the 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
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
- •1. 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 flanks.
- •3. BMI score is less than
- •Agree to not making any major changes in their diet or lifestyle during the course of the study.
- •5. Able and willing to comply with the treatment/follow-up schedule and requirements.
- •6. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative Urine Pregnancy test at baseline.
排除标准
- •1. Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 6 months.
- •2. Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months.
- •3. History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection) or use of immunosuppressive medications, 6 months prior to and during the course of the study.
- •4. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding.
- •5. Use of antiplatelet medications (81 mg acetylsalicylic acid daily permitted), anticoagulants, thrombolytics or anti-inflammatory medications within 2 weeks of treatment.
- •6. Having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
- •7. Having a permanent implant in the treatment area such as metal plates or an injected chemical substance such as silicone or parenteral gold therapy (gold sodium thiomalate).
- •8. Use of medications, herbs, food supplements, and vitamins known to induce photosensitivity to light exposure at the wavelength used or history of photosensitivity disorder.
- •9. 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.
- •10. Tattoos in the treatment area.
- •Poor skin quality (severe laxity).
- •Abdominal wall, muscular abnormality or hernia on physical examination.
- •Use of retinoids such as oral isotretinoin (Accutane™) within the past six months or during course of the study.
- •14. History of keloid or hypertrophic scar formation or poor wound healing in the treatment area.
- •15. As per the investigator's discretion, any physical or mental condition which may make it unsafe for the subject to participate.
- •16. Unable or unlikely to refrain from sun exposure, artificial tanning, including the use of tanning booths, prior to (six weeks) and during the course of the evaluation.
研究组 & 干预措施
Subject treatment group
Treatment group receiving 3 diode treatments and 3 RF/PEMF treatments at Week 0, 8 and 16 with a follow-up at Week 24.
干预措施: Venus Bliss (Device)
结局指标
主要结局
Change in Aesthetic Appearance From Baseline
时间窗: Week 24
Photographic evaluation by an independent, blinded reviewer with correct identification of pre-treatment baseline images when compared to post-treatment images taken at Week 24 using the Global Aesthetic Improvement Scale (GAIS). A score of 0 is no change, 1 - slight change, 2 - moderate change, 3 - dramatic change. An incorrect identification would result in a negative score (-1 for slight, -2 for moderate and -3 for dramatic change)
次要结局
- Change in Fat Thickness(Week 24)
- Subject Satisfaction: 5-Point Likert Subject Satisfaction Scale(Week 24)