NCT04568187已完成不适用
Clinical Efficacy of Fat Reduction on the Thigh of Korean Women Through Cryolipolysis
Wonik Trade Company, Korea1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2010年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The change of fat amounts in both thighs
研究概览
简要总结
There was no difference in efficacy in removal of local fat on thigh by cryolipolysis through Zeltiq machine.
Cryolipolysis was found to be safe for 12 week clinical trial.
详细描述
this study is conducted to investigate the clinical efficacy and safety of cryolipolysis on fat removal of thigh through cryolipolysis.
Healthy premenopausal volunteered women had been conducted to assess their anthropometrical, social, and cardio-metabolic, and femoral fat amount by computer tomography, and adverse events at initial, 4 week, 12 week visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pre-menopausal healthy women
- •subjects with body mass index ≥ 18
- •subjects with visible fat on both thigh
- •subjects to understand and agree to this study protocol
排除标准
- •subjects with cryoglobulinemia, cold urticaria, or paroxysmal cold hemogobulinemia
- •subjects with pregnancy or lactation within 6 months or next 3 months
- •subjects with any laboratory, or metabolic abnormalities
- •uncooperative subjects to comply with the study protocol
- •women taking any medication/ over the counter/herbal supplements to regulate weight or fat mass over 6 months
- •subjects with menstrual irregularities
- •subjects to change over 10% of the former weight within the past 6 months - any procedure such as liposuction, or another surgical procedure or mesotherapy to reduce fat within 6 months
- •subjects with any dermatologic abnormalities on the target areas (thigh)
- •subjects with any injection into the area of intended treatment (e.g. cortisone) within 6 months
结局指标
主要结局
The change of fat amounts in both thighs
时间窗: 4 weeks
Comparison of cross-sectional areas in both thighs
The change of girths in both thighs
时间窗: 4 weeks
Comparison of circumferences of both thighs
次要结局
- The change of girths in both thighs(12 weeks)
- The change of fat amounts in both thighs(12 weeks)
研究者
研究点 (1)
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