APHRODITE-1: A Phase 2, Open Label, Self-Controlled Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks in Adult Females
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 13
- 主要终点
- Percentage of Participants With at Least 1-Level Lower Score 3 to 5 Days After Initial CCH-aaes Injection, as Assessed by the Investigator Assessment of Bruising Severity Scale (IABSS) After Initial CCH-aaes Injection
研究概览
简要总结
The study will evaluate the effect of different doses, strengths (concentrations), diluent additives, depths of injection, and methods of injection on the severity of bruising potentially induced by QWO (collagenase clostridium histolyticum-aaes [CCH-aaes]).
详细描述
The study will comprise a Screening Period (28 days), Treatment Period (90 days), and Follow-up Period (90 days). Participants will receive CCH-aaes in different doses, concentrations, diluent additives, depths of injection, and methods of injection in a split buttock arrangement, with the right buttock serving as the control, and the left buttock (investigational side) receiving a study intervention.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have a body mass index of 18 to <32 kilograms (kg)/meter (m)^2 and intends to maintain stable body weight during the study.
- •Have both buttocks with moderate or severe cellulite as reported by the investigator using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
- •Have a Hexsel Cellulite Severity Scale (CSS) Total Score of ≤
- •Has a Fitzpatrick Skin Type of I-IV
- •Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of participation in the study.
- •Be willing and able to comply with the requirements of the study.
排除标准
- •Has systemic conditions (coagulation disorders, skin pigmentation disorders, malignancy, keloidal scarring, abnormal wound healing) that restricts study participation.
- •Is pregnant and/or is breast-feeding or plans to become pregnant and/or to breast-feed during the course of the study.
- •Has any local (in the areas to be treated) conditions (thrombosis, post-thrombosis syndrome, vascular disorder, inflammation, active infection, active cutaneous alteration, tattoo or mole) that restricts study participation.
- •Requires antiplatelet medication, anticoagulants, or non-steroidal anti-inflammatory drugs during the study.
- •Any medications, supplements, or foods that have, or have been reported to have anticoagulant effects within 14 days of treatment.
- •Has received treatment with investigational treatment within 30 days before treatment.
- •Has used or intends to use any of the local applications, therapies, injections, or procedures for the treatment of cellulite on either buttock that would restrict study participation.
- •Intends to initiate an intensive sport or exercise program or intensive weight reduction program during the study.
- •Intends to engage in strenuous activity within 48 hours of study intervention administration.
- •Has recently tanned or intends to tan (outdoors or indoors) during the study.
- •Has a history of hypersensitivity or allergy to collagenase or any other excipient of CCH.
- •Has any condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.
- •Has participated in a previous investigational study of CCH or received any collagenase treatments at any time prior to treatment in this study for the treatment of cellulite of the buttocks.
- •In addition to the applicable aforementioned exclusion criteria, participants enrolling in Cohort 7 will be excluded from study participation if the participant:
- •Has any of the following medical conditions:
- •history of venous or arterial thromboembolism or current thromboembolic disease.
- •history of or current renal impairment.
- •serum creatinine concentration > 1.4 milligram/deciliter at Screening.
- •Requires the following concomitant medications during the study and cannot discontinue these medications within the time specified before CCH-aaes treatment:
- •concurrently taking combination hormonal contraceptives.
- •concurrently undergoing hormone replacement therapy.
- •is a current smoker of nicotine or cannabinoids.
- •Participants in Cohort 7 should avoid smoking (including vaping, nicotine, or marijuana cigarettes) during the study.
研究组 & 干预措施
Cohort 1: CCH-aaes Dose Evaluation
Participants will be administered CCH-aaes at different doses. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
干预措施: CCH-aaes (Drug)
Cohort 2: CCH-aaes Concentration Evaluation
Participants will be administered CCH-aaes at different concentrations. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
干预措施: CCH-aaes (Drug)
Cohort 3: CCH-aaes Injection Depth Evaluation
Participants will be administered CCH-aaes using different injection depths. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
干预措施: CCH-aaes (Drug)
Cohort 4: CCH-aaes Injection Method Evaluation
Participants will be administered CCH-aaes using different injection methods. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
干预措施: CCH-aaes (Drug)
Cohort 5: CCH-aaes and Diluent Additive Evaluation
Participants will be administered CCH-aaes and diluent additive. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
干预措施: CCH-aaes (Drug)
Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation
Participants will be administered CCH-aaes using a different treatment schedule and different doses and concentrations. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
干预措施: CCH-aaes (Drug)
Cohort 7: CCH-aaes and Antifibrinolytic Agent
Participants will be administered CCH-aaes and an antifibrinolytic agent. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
干预措施: CCH-aaes (Drug)
Cohort 7: CCH-aaes and Antifibrinolytic Agent
Participants will be administered CCH-aaes and an antifibrinolytic agent. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
干预措施: Antifibrinolytic Agent (Drug)
结局指标
主要结局
Percentage of Participants With at Least 1-Level Lower Score 3 to 5 Days After Initial CCH-aaes Injection, as Assessed by the Investigator Assessment of Bruising Severity Scale (IABSS) After Initial CCH-aaes Injection
时间窗: 3 to 5 days after initial CCH-aaes injection of left buttock (test) and right buttock (control)
The investigator assessed the severity of bruising using the IABSS, The IABSS is a 5-point scale ranging from 0-4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcomes. The investigator compared the bruising of the left (test) buttock to the right (control) buttock. Responders were participants whose left buttock/test side demonstrated at least a 1-level lower IABSS score versus the right buttock/control side. Percentages are based on the number of participants with an assessment at specified timepoint.
次要结局
- Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS(Follow-up 1, 2, 3, and 4 after CCH-aaes injection of left buttock (test) and right buttock (control))
- Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection(Day 22 and Day 43 for Cohorts 1 to 5, Day 43 for Cohort 6, Day 22, Day 43, and Day 64 for Cohort 7, and Day 90, Day 135, and Day 180 for all cohorts)
- Percentage of Participants With Injection Site Reactions(From Day 1 (after dose) through Day 180)