Cryolipolisis for Subcutaneous Abodomen and Flank Fat Reduction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fat layer thickness changes measured by ultrasound
研究概览
简要总结
Sixty healthy subjects aged between 18 and 50 will be randomly allocated into three treatment groups: Conventional Cryolipolysis, Contrast Cryolipolysis or Recovery Reperfusion Cryolipolysis. The region will be treated according to the individual need, in the region of abdomen and flanks. Assessments of body composition will be performed at baseline and 30, 60 and 90 days after randomization. Blood collections will also be performed at baseline and between 14 and 21 days after randomization for evaluation of lipid profile and liver function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
- •Body mass index > 29.9 Kg/m2
排除标准
- •Pregnancy
- •Vascular diseases
- •Heart diseases
- •Liposuction or other surgical procedures for body contouring
- •Active infection
- •Paroxysmal cold hemoglobinuria
- •Cold urticaria
- •Significant weight changes in the past 3 months or during treatment
研究组 & 干预措施
Conventional Cryolipolysis
Subjects will receive one treatment session of conventional cryolipolisys. Subcutaneous fat tissue will be cooled with the cryolipolitic device for 60 minutes. The treatmente area will be the abdomen and/or flanks according to each patient's needs (pragmatic treatment).
干预措施: Conventional Cryolipolysis (Device)
Contrast Cryolipolysis
Subjects will receive one treatment session of contrast cryolipolisys. Subcutaneous fat tissue will be heated for 10 minutes, cooled for 60 minutes, and heated again for 10 minutes with the cryolipolitic device. The treatmente area will be the abdomen and/or flanks according to each patient's needs (pragmatic treatment).
干预措施: Contrast Cryolipolysis (Device)
Reperfusion Cryolipolysis
Subjects will receive one treatment session of Reperfusion Cryolipolysis. Subcutaneous fat tissue will be cooled with the cryolipolitic device for 60 minutes and heated for 10 minutes. The treatmente area will be the abdomen and/or flanks according to each patient's needs (pragmatic treatment).
干预措施: Reperfusion Cryolipolysis (Device)
结局指标
主要结局
Fat layer thickness changes measured by ultrasound
时间窗: 90 days after randomization
次要结局
- Changes in skin viscoelasticity measured by a cutometer(90 days after randomization)
- Changes in circumference measurements(90 days after randomization)
- Fat layer thickness changes measured by ultrasound(60 days after randomization)
- Changes in cholesterol levels(21 days after randomization)
- Changes in triglyceride levels(21 days after randomization)
- Changes in blood levels of alanine aminotransferase (ALT)(21 days after randomization)
- Changes in blood levels of aspartate transaminase (AST)(21 days after randomization)
- Subject's satisfaction with regard to treatment measued by a numeric scale ranging from 1 to 3.(90 days after randomization)
- Subject's tolerance with regard to treatment measued by a numeric scale ranging from 1 to 3.(90 days after randomization)
- Changes in fasting blood glucose(21 days after randomization)
- Changes in body weight(90 days after randomization)
- Changes in body weight(60 days after randomization)
- Fat layer thickness changes measured by ultrasound(30 days after randomization)
- Changes in skin viscoelasticity measured by a cutometer(30 days after randomization)
- Changes in skin viscoelasticity measured by a cutometer(60 days after randomization)
- Changes in circumference measurements(30 days after randomization)
- Changes in circumference measurements(60 days after randomization)
- Changes in body weight(30 days after randomization)
研究者
Richard Eloin Liebano
PT, PhD
Universidade Cidade de Sao Paulo