A Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled Study of the Safety and Efficacy of 10XB-101 in Adult Subjects With Submental Fat
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 10xBio, LLC
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Clinician Submental Fat Scale (CSFS)
研究概览
简要总结
The purpose of this research study is to determine the safety and efficacy of 10XB-101 vs. vehicle (placebo) for adults with excessive submental fat (SMF).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is a male or non-pregnant female 18 to 65 years old.
- •Subject has provided written informed consent.
- •Subject has qualifying Submental Fat evaluation score.
- •Subject has had a stable body weight for the past 6 months prior to starting study.
- •Subject is willing to undergo test article injections as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
排除标准
- •Subject is pregnant, lactating, or is planning to become pregnant during the study.
- •Subject has loose skin in the submental area, diffuse SMF, or prominent platysmal bands at rest that may interfere with evaluation of localized fat, in the opinion of the investigator.
- •Subject has had any prior treatment for SMF (e.g., deoxycholic acid, cryotherapy, liposuction, surgery).
- •Subject has any medical condition that affects clotting and/or platelet function
- •Subject has a history of allergy or sensitivity to polidocanol or any of the other ingredients in the test articles.
研究组 & 干预措施
10XB-101 Solution for Injection, 2.0%
Participants receive 10XB-101 Solution for Injection, 2.0% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments.
干预措施: 10XB-101 Solution for Injection (Drug)
10XB-101 Solution for Injection, 3.0%
Participants receive 10XB-101 Solution for Injection, 3.0% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments.
干预措施: 10XB-101 Solution for Injection (Drug)
10XB-101 Solution for Injection, 4.5%
Participants receive 10XB-101 Solution for Injection, 4.5% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments.
干预措施: 10XB-101 Solution for Injection (Drug)
10XB-101 Vehicle Solution for Injection
Participants receive 10XB-101 Vehicle Solution for Injection, via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments.
干预措施: 10XB-101 Vehicle Solution for Injection (Drug)
结局指标
主要结局
Clinician Submental Fat Scale (CSFS)
时间窗: 24 weeks after final injection treatment
Change from Baseline after final treatment. CSFS is a 5 point scale, with a higher score indicating higher severity
Patient Submental Fat Scale (PSFS)
时间窗: 24 weeks after final injection treatment
Change from Baseline after final treatment. PSFS is a 5 point scale, with a higher score indicating higher severity
次要结局
未报告次要终点