NCT01802723已完成2 期
A Dose Ranging Study of the Safety and Efficacy of LIPO-202 Healthy Patients With Subcutaneous Fat in the Periumbilical Area
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 472
- 试验地点
- 22
- 主要终点
- Safety
研究概览
简要总结
Dose Ranging Study
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •>18 years of age inclusive Subcutaneous fat in the periumbilical area BMI <30 kg/msq Stable diet and exercise and body weight
排除标准
- •Prior treatment of subcutaneous fat in the periumbilical area (liposuction, abdominoplasty, etc.) Known hypersensitivity to drugs
结局指标
主要结局
Safety
时间窗: 8 weeks treatment
physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events
Change in global clinician abdominal perception scale score (baseline and 9 weeks)
时间窗: 9 weeks
Change in global patient abdominal perception scale score (baseline and 9 weeks)
时间窗: 9 weeks
Change in abdominal circumference (baseline and 9 weeks)
时间窗: 9 weeks
abdominal circumference
次要结局
- Change in Patient Reported Outcome for abdominal perception score (baseline and 9 weeks)(9 weeks)
- Change in Photonumeric abdominal perception scale score (baseline and 9 weeks)(9 weeks)
研究者
研究点 (22)
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