Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Dose-Escalation Study of the Pharmacokinetics, Safety, and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Intralipomal Injections for the Treatment of Superficial Lipomas
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Assessments of Safety with Laboratory tests
研究概览
简要总结
The purpose of this research is to compare the safety and effectiveness of 4 different concentrations of deoxycholic acid injection against a placebo in the treatment of superficial lipomas.
详细描述
A lipoma is a fatty lump typically located on the trunk, shoulder, arms or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)
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
- Double (Participant, Investigator)
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
- 否
入选标准
- •One or more lipomas, based on clinical diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics:
- •History of slow growth followed by dormancy, and stable for at least 6 months.
- •Greatest length by greatest perpendicular width between 1 and 16 square centimeters, inclusive
- •Discrete, oval to rounded in shape, not hard or attached to underlying tissue
- •Located on the trunk, arms, legs, or neck
- •Stable body weight with a body mass index of less than 30 kg/m²
- •Signed informed consent
排除标准
- •Absence of significant medical conditions that could affect safety
- •History of surgical treatment for lipomas
- •Treatment with an investigational agent within 30 days before ATX-101 treatment
研究组 & 干预措施
Deoxycholic Acid Injection 0.5%
Participants received 0.5% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
干预措施: Deoxycholic Acid Injection (Drug)
Deoxycholic Acid Injection 1.0%
Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
干预措施: Deoxycholic Acid Injection (Drug)
Deoxycholic Acid Injection 2.0%
Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
干预措施: Deoxycholic Acid Injection (Drug)
Deoxycholic Acid Injection 4.0%
Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
干预措施: Deoxycholic Acid Injection (Drug)
Placebo
Participants received matching vehicle placebo administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
干预措施: Placebo (Drug)
结局指标
主要结局
Assessments of Safety with Laboratory tests
时间窗: up to 16 weeks
Assessments of Safety with ECG
时间窗: up to 16 weeks
Assessments of Safety with Medical Evaluations
时间窗: up to 16 weeks
次要结局
- Lipoma size reduction(up to 16 weeks)