A Phase 2b, Open-label Long-term Durability Study of CCH Following Treatment of Edematous Fibrosclerotic Panniculopathy (Cellulite)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- CR-PCSS change from baseline (Day 1) and reference time point (Day 71) from the EN3835-201 study
研究概览
简要总结
This study will evaluate the long-term safety and duration of efficacy of CCH in the treatment of women with cellulite. This study will be a single day evaluation, approximately 48 months after the first dose of study drug was received in the EN3835-201.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have participated in and completed studies EN3835-201, EN3835-202 and EN3835-219 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-
- •Be willing and able to cooperate with the requirements of the study.
排除标准
- •Has had retreatment with CCH in the area initially treated during the EN3835-201 study since the completion of study EN3835-
- •Has received collagenase treatments (eg, Santyl® Ointment and/or Xiaflex®/Xiapex®) since the completion of study EN3835-
- •Has had liposuction on the body region treated during the EN3835-201 study since the completion of that study.
- •Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment in the area treated during the EN3835-201 study since the completion of that study.
- •Has any other condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.
研究组 & 干预措施
No Treatment
Subjects who participated in and completed study EN3835-201 and had composite improvement of at least 2-levels on both the Clinician Reported-Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported-Photonumeric Cellulite Severity Scale (PR-PCSS) in EN3835-201 study will be eligible for this study. The study will consist of a single day evaluation approximately 4 years after the first dose of the study drug was received in the EN3835-201 study.
干预措施: Previously Treated with EN3835 (Drug)
结局指标
主要结局
CR-PCSS change from baseline (Day 1) and reference time point (Day 71) from the EN3835-201 study
时间窗: Approximately 4 weeks
Clinician Reported-Photonumeric Cellulite Severity Scale is a 5-level photonumeric scale with ratings ranging from 0 (None) to 4 (Severe)
PR-PCSS change from baseline (Day 1) and reference time point (Day 71) from the EN3835-201 study
时间窗: Approximately 4 weeks
Patient Reported-Photonumeric Cellulite Severity Scale is a 5-level photonumeric scale with ratings ranging from 0 (None) to 4 (Severe)
次要结局
未报告次要终点