A Real World, Multicenter, Open-Label, Multiple Dose Study to Assess the Effectiveness of, and Satisfaction With, CCH Treatment of Buttocks or Thigh Cellulite in Adult Females
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 12
- 主要终点
- The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh
研究概览
简要总结
This is a multicenter, open-label, multiple dose, 2 cohort, Phase 3b study to assess the safety and efficacy of CCH in adult women with mild or moderate edematous fibrosclerotic panniculopathy (EFP).
Cohort 1 will include approximately 80 subjects with mild or moderate EFP in the posterolateral thighs and Cohort 2 will include approximately 70 subjects with mild or moderate EFP in the buttocks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Have both buttocks or both posterolateral thighs with:
- •A score of 2 or 3 (mild or moderate) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
- •A Hexsel Cellulite Severity Scale (CSS) Subsection D "Grade of Laxity, Flaccidity, or Sagging Skin" score of 0 (absence of laxity, flaccidity, or sagging skin), or 1 (slightly draped appearance) at the Screening Visit only.
- •Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study.
- •Be judged to be in good health.
- •Have a negative pregnancy test.
- •Be willing and able to cooperate with the requirements of the study.
排除标准
- •Is from a vulnerable population, as defined by the United States (US) Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full-time, etc.) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
- •Has a history of sensitivity or allergy to collagenase or any other excipient of CCH.
- •Has systemic conditions (coagulation disorders, malignancy, keloidal scarring, abnormal wound healing) that restricts study participation.
- •Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
- •Has skin laxity or linear undulations on the treatment region (both buttocks or both thighs) that can be effaced by lifting skin.
- •Has a Hexsel CSS Subsection D "Grade of laxity, flaccidity, or sagging skin" of 2 (moderate draped appearance) or 3 (severe draped appearance).
- •Requires anticoagulant or antiplatelet medication during the study.
- •Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation.
- •Has received any collagenase treatments at any time prior to treatment in this study and/or has received previous treatment with EN3835 or CCH for cellulite.
- •Has received treatment with an investigational product within 30 days (or 5 half-lives, whichever is longer) of the Screening Visit.
- •Is pregnant and/or is providing breast milk in any manner, or plans to become pregnant and/or to provide breast milk during the course of the study.
- •Has any other condition(s) that, in the investigator's opinion, might indicate the subject to be unsuitable for the study.
研究组 & 干预措施
Cohort 1: Posterolateral Thigh
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
干预措施: EN3835 (Drug)
Cohort 2: Buttocks
EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
干预措施: EN3835 (Drug)
结局指标
主要结局
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh
时间窗: 90 Days
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
时间窗: 90 Days
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
次要结局
- Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh)(Day 1, 90 and 180)
- Mean Change From Baseline in CR-PCSS for Each Buttock(Day 22, 43, 90 and 180)
- Mean Change From Baseline in Body Q Appraisal of Cellulite for Posterolateral Thigh Based on Total Score(Day 90, Day 180)
- Mean Change From Baseline in Body Q Appraisal of Cellulite for Buttock Based on Total Score(Day 90, Day 180)
- The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh(Day 22, 43, and 180)
- The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock(Day 22, 43, and 180)
- Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh)(Day 1, 90, and 180)
- Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks)(Day 1, 90 and 180)
- Presence of NAb Anti AUX-I and AUX-II (Buttocks)(Day 1, 90 and 180)