Metabolic And Structural Effects Of Phosphatidylcholine And Deoxycholate Injections On Subcutaneous Fat
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Subcutaneous fat thickness with calipers and MRI.
研究概览
简要总结
The combination of phosphatidylcholine (PPC) and deoxycholate (DC) injected into subcutaneous fat is often popularly referred to as "Lipodissolve" therapy. Despite its attractiveness as an easy and noninvasive cosmetic treatment, the safety, effectiveness, and how the injections might work remain unclear. This study will investigate the hypothesis that injections of PPC/DC will reduce the amount body fat in the treated area. If so, the mechanisms responsible for the fat loss will be explored to find out whether fat cells die from toxic effects or are broken apart by the PPC/DC. Patients will receive at least 2 (no more than 4) treatments with PPC/DC injections every 2 months. Several methods of measuring fat loss will be used in the study, including photography and measurement of patients, tissue biopsy, blood tests, and MRI. The study will also record side effects of the treatments as well as patient satisfaction.
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
- 21 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer
- •Body Mass Index (BMI) no greater than 30
- •Excess fat in the lower abdomen area
排除标准
- •Cigarette smoker
- •Pregnant or breast feeding
- •Use anticoagulants (blood thinner), aspirin or other non-steroidal anti-inflammatory drugs that cannot be discontinued
研究组 & 干预措施
1
干预措施: phosphatidylcholine and deoxycholate (Drug)
结局指标
主要结局
Subcutaneous fat thickness with calipers and MRI.
时间窗: Before and 8 weeks after final treatment
次要结局
未报告次要终点
