A Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat in Non-Obese Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Evofem Inc.
- 入组人数
- 793
- 试验地点
- 35
- 主要终点
- Percentage of Subjects Who Achieved a Composite P-GAPS1/CPnS2 Response
研究概览
简要总结
This is a multi-center, randomized, double-blinded, placebo-controlled study evaluating the safety and efficacy of LIPO-202 for the reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects.
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
- •Healthy male or non-pregnant female subjects
- •Capable of providing written consent.
- •BMI < 30 kg/m2
- •Stable diet and exercise routine
- •Central abdominal bulging that is evaluated by the clinician at least slight bulge, not flat
排除标准
- •Have had any treatment of the fat around your abdomen, including surgical procedures (tummy tuck, liposuction), injections for fat loss or treatments with devices to reduce fat in your abdomen.
- •Plan on starting a weight loss or exercise program during the study.
- •Known hypersensitivity to study drugs
研究组 & 干预措施
LIPO-202
Experimental arm
干预措施: LIPO-202 (Drug)
Placebo
Placebo comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Subjects Who Achieved a Composite P-GAPS1/CPnS2 Response
时间窗: Baseline and End of Study (1 week post last treatment, 9 weeks after first treatment)
The composite P-GAPS1/CPnS2 response was defined as at least a 1 point (grade) improvement in P-GAPS and at least a 2 point (grade) improvement in CPnS from baseline after 8 weeks of treatment. Patient - Global Abdominal Perception Scale (P-GAPS) - a patient views and assesses the contour of their abdomen on a 5-point verbal scale ranging from "Flat" to "Big Bulge". Clinician Photonumeric Scale (CPnS) - a trained clinician rater examines the subject's abdomen and matches the subject's abdominal bulge/profile to the nearest gender-specific abdominal photo on the 6-point scale.
Percent Change in the Patient Reported Global Abdominal Perception Score
时间窗: 8 weeks post the start of treatment
1 equals much improved, 7 equals much worse. The higher the scores the worse the outcome.
次要结局
- Percent Change in Waist Circumference(8 weeks post the start of treatment)