Long-term Follow-up Study of Subjects Who Completed Kythera-sponsored Trials of ATX-101 (Sodium Deoxycholate Injection) 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
- 205
- 试验地点
- 20
- 主要终点
- Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
研究概览
简要总结
This was a long-term follow-up study of participants who completed Kythera-sponsored trials of ATX-101 (06-03, 07-07, 09-15)
详细描述
No study medication was administered in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •Any subject who successfully completed a Kythera-sponsored clinical trial of ATX-101 (06-03, 07-07, 09-15)
- •Signed informed consent
- •Willingness to comply with schedule and procedures of the study
排除标准
- •Subjects who have had or are undergoing treatment that may affect the evaluation of the submental area will be excluded
研究组 & 干预措施
Placebo
Participants treated with placebo in previous ATX-101 studies
干预措施: Placebo (Drug)
ATX-101 (1 mg/cm^2)
Participants treated with ATX-101 (1 mg/cm^2) in previous phase 2 studies
干预措施: ATX-101 (1 mg/cm^2) (Drug)
ATX-101 (2 mg/cm^2)
Participants treated with ATX-101 (2 mg/cm^2) in previous phase 2 studies
干预措施: ATX-101 (2 mg/cm^2) (Drug)
ATX-101 (4 mg/cm^2)
Participants treated with ATX-101 (4 mg/cm^2) in previous phase 2 studies
干预措施: ATX-101 (4 mg/cm^2) (Drug)
结局指标
主要结局
Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
时间窗: Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)
The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.
Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
时间窗: Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)
The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.
Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
时间窗: Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)
The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.
Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
时间窗: Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)
The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.
次要结局
未报告次要终点