NCT05249257已完成不适用
A Phase 2, Multicenter, Observational Study to Assess the Durability and Safety of Collagenase Clostridium Histolyticum Injected With GRID Technique in Buttocks or Thigh Cellulite With Laxity in Adult Females
Endo Pharmaceuticals3 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年1月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh
研究概览
简要总结
All participants who completed the EN3835-224 study will be invited to participate in this observational study to evaluate long term durability of response and safety.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have participated in and completed study EN3835-224 (parent study).
- •Be willing and able to cooperate with the requirements of the study.
排除标准
- •Has received any collagenase treatments (eg, Santyl® Ointment) at any time since
- •Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment in the area treated during the EN3835-224 study since the completion of that study.
- •Has any other conditions that, in the investigator's opinion, might indicate the participant to be unsuitable for the study
结局指标
主要结局
Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh
时间窗: Day 540
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-level scale ranging from "+3" (very much improved) to "-3" (very much worse) to determine the degree of improvement of the treated areas
次要结局
- Proportion of 1-level responders (+1 or better score) on the S-GAIS for either buttock or either thigh(Day 360 and Day 540)
- I-GAIS ratings(Day 360 and Day 540)
- Change from Day 1 (pre-treatment) of the parent study and each study visit in Subsection D of the Hexsel CSS(Day 360 and Day 540)
研究者
研究点 (3)
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