Clinical Efficacy of Local Fat Reduction on the Thigh of Korean Women Through Cryolipolysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in Cross Sectional Area of Fat in Both Thighs
研究概览
简要总结
The aim of this study is to evaluate the clinical efficacy of reduction of local fat on ipsilateral thigh through cryolipolysis (zeltiq) and controlateral thigh using by amplitude modulated frequency (conventional) method.
详细描述
Cryolipolysis is a new concept to reduce fat since Zeltiq machine had been introduced several years ago. Several different trials such as high frequency, liposuction and chemical lipolysis to remove fat had been emerged and tried. Therefore, we would like to know the clinical efficacy of cryolipolysis through comparative experiment with former frequency method on each thigh on healthy Korean women.
Healthy premenopausal women who want to reduce the fat on thigh were included. 28 healthy volunteered women recruited for this study, 15 subjects among participated after interviewing, sampling their metabolic variables at initial visit. A total of 15 subjects would be investigated through food diary(24hour), femoral CT, anthropometric, metabolic variables at initial, 4th, 12th week. Histological examination under skin(initial and 12th week), questionnaire(4th, 12th week) for satisfaction, adverse events would be monitored during 3 month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •premenopausal healthy women
- •subjects with body mass index >=
- •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 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 area (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
Change in Cross Sectional Area of Fat in Both Thighs
时间窗: 4 weeks
reduction of fat amounts on both thighs measured by computerizing tomography
Change of the Girths in Both Thighs
时间窗: 4 weeks
Mean differences of the circumferences of both thighs measured by inches
次要结局
- Weight Change for 12 Weeks(baseline and 12 weeks)
- Change of Girths in Both Thighs for 12 Weeks(12 weeks)
- Change of the Fat Amount of Both Thighs Between Baseline and 12 Weeks(baseline and 12 weeks)