A Phase 2 Multicenter, Open-label, Randomized, Parallel-group, Multiple-dose Study to Assess the Effectiveness, Safety and Satisfaction With Collagenase Clostridium Histolyticum Grid Technique Injections of Buttock or Thigh Cellulite With Laxity in Adult Females
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- Percentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh
研究概览
简要总结
This study is designed to investigate the safety and efficacy of collagenase clostridium histolyticum (CCH) for the treatment of mild to moderate edematous fibrosclerotic panniculopathy (cellulite) in participants with moderate to severe dermal laxity in the buttocks or thighs with comparison between two (2) different CCH injection techniques.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Have a body mass index of 18 to <29.9 kilograms/square meters
- •Have either both buttocks or both posterolateral thighs with:
- •Score of 2 or 3 (mild or moderate cellulite) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS)
- •Hexsel Cellulite Severity Scale (CSS) Subsection D "Grade of Laxity, Flaccidity, or Sagging Skin" score of 2 or 3 (moderate or severe) as determined by the investigator
- •Have a negative pregnancy test or be of non-childbearing potential
- •Be willing and able to cooperate with the requirements of the study
- •Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study (from the Screening Visit through the Day 180/Early Termination Visit).
排除标准
- •Has a history of hypersensitivity or allergy to collagenase or any other excipients of CCH.
- •During Screening has a CR-PCSS score of less than 2 or greater than 3 for the area to be treated (buttocks or thighs) and/or has a Hexsel CSS Subsection D "Grade of Laxity, Flaccidity, or Sagging Skin" score of less than 2 or greater than 3 (severe) for the areas to be treated (buttocks or thighs).
- •Has a coagulation disorder, which requires anticoagulant or antiplatelet medication during the study (except for ≤150 mg aspirin daily), or has taken anticoagulant or antiplatelet medication(s) within 14 days before injection of study treatment (except for ≤150 mg aspirin daily).
- •Is a prisoner, an individual with impaired decision making capacity, 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), or in the judgment of the investigator the participant is disadvantaged and vulnerable to coercion due to lack of education, or due to poor economic circumstances.
- •Has received any collagenase treatments at any time prior to treatment in this study and/or has received EN3835 or CCH in a previous investigational study for cellulite.
- •Is pregnant and/or is breast-feeding or plans to become pregnant and/or to breast-feed during the course of the study.
- •Has a history of scarring due to keloids or abnormal wound healing.
- •Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation
- •Has history of drug or alcohol abuse within the 5 years prior to the Screening Visit.
- •Has evidence of clinically significant abnormalities, as judged by the investigator, in any of the following: physical examination findings, electrocardiogram (ECG), clinical laboratory values, or vital signs.
- •The sponsor's medical monitor will be required to review the results for confirmation of eligibility in the case of any of the following: abnormalities in electrocardiograms indicating corrected QT interval (QTc) prolongation of 470 milliseconds or greater; and clinical laboratory values of liver enzymes
- •Has used or intends to use any of the local application/therapies/injections/procedures that restricts study participation.
- •Has any other condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.
- •For the subset of participants participating in the collection of ultrasound data, the following exclusions will apply: participants will be excluded who have: a history of a spinal laminectomy, a previous history or presence of vascular abnormalities (for example, deep vein thrombosis, thrombophlebitis), a healing fracture, an impaired sensation within, or near, the planned treatment area, or any implants within, or near, the planned treatment area.
研究组 & 干预措施
Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thigh)
Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area)
干预措施: collagenase clostridium histolyticum (Drug)
Uniform 0.1-milliliters (mL) 1-Aliquot Grid Injection Technique (Buttock)
Dose per participant per treatment visit = up to 1.68 milligrams (mg) of CCH (0.84 mg in each treatment area)
干预措施: collagenase clostridium histolyticum (Drug)
Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttock)
Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area)
干预措施: collagenase clostridium histolyticum (Drug)
Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thigh)
Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area)
干预措施: collagenase clostridium histolyticum (Drug)
结局指标
主要结局
Percentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh
时间窗: Day 180
I-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator ranging from "Very Much Worse" (-3), "Much Worse" (-2), "Worse" (-1), "No Change" (0), "Improved" (+1), "Much Improved" (+2), and "Very Much Improved" (+3). One-level I-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented.
次要结局
- Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh(Days 28, 56, 84, 112, and 140)
- Change From Baseline in Body-Q Appraisal of Cellulite Total Score(Baseline, Day 180)
- Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh(Days 28, 56, 84, 112, 140, and 180)
- Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score(Baseline, Days 28, 56, 84, 112,140, and 180)
- Percentage of Participants Positive for Neutralizing Antibodies to AUX-I and AUX-II(Day 180)
- Percentage of Participants Positive for Anti-AUX-I and Anti-AUX-II Antibodies(Day 180)