Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Given by Three Dosing Paradigms for the Reduction of Localized Subcutaneous Fat in the Submental Area
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
Phase 2 trial to evaluate the safety and potential efficacy of one concentration of deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the reduction of submental fat (fat beneath the chin).
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Submental fat that was considered undesirable by the subject and graded by the investigator as 2 or 3 using the submental fat (SMF) rating scale
- •Good general health
- •Signed informed consent
排除标准
- •History of any treatment in the neck or chin area
- •Loose skin or prominent platysmal bands in the neck or chin area
- •Recent treatment with anticoagulants
- •Presence of clinically significant health problems
研究组 & 干预措施
Deoxycholic Acid Injection 0.2 mL/0.7 cm
Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
干预措施: Deoxycholic Acid Injection (Drug)
Placebo 0.2 mL/0.7 cm
Participants received placebo administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
干预措施: Placebo (Drug)
Deoxycholic Acid Injection 0.2 mL/1.0 cm
Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
干预措施: Deoxycholic Acid Injection (Drug)
Placebo 0.2 mL/1.0 cm
Participants received placebo administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
干预措施: Placebo (Drug)
Deoxycholic Acid Injection 0.4 mL/1.0 cm
Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
干预措施: Deoxycholic Acid Injection (Drug)
Placebo 0.4 mL/1.0 cm
Participants received placebo administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
The investigator determined the relationship of each adverse event to the administration of study drug. Severity of adverse events was determined using the following scale: * Mild: The participant is aware of a sign or symptom, but it is easily tolerated * Moderate: Discomfort or interference with usual activity * Severe: Incapacitating, with inability to engage in usual activity. A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor's opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that: * was fatal * was life-threatening * required inpatient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * was a congenital anomaly/birth defect * other significant medical hazard
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations
时间窗: From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
次要结局
- Change From Baseline in Submental Fat (SMF) Rating Scale Score(Baseline and 4 weeks after last treatment (up to 16 weeks after first dose))
- Change From Baseline in Subject Satisfaction With Appearance Rating Scale(Baseline and 4 weeks after last treatment (up to 16 weeks after first dose))
- Percentage of Participants With a Response in the Subject Global Improvement Rating(4 weeks after last treatment (up to 16 weeks after first dose))
- Percentage of Participants With an SMF Response(Baseline and 4 weeks after last treatment (up to 16 weeks after first dose))
- Change From Baseline in Skin Laxity Rating(Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment))
- Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score(Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment))
- Change From Baseline in the Cervicomental Angle(Baseline and 4 weeks after last treatment (up to 16 weeks after first dose))
- Visual Analogue Scale Pain Intensity Rating(Approximately 60 minutes after completion of each treatment session at Week 0, Week 4, Week 8 and Week 12)