A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Efficacy, Safety, and Duration of Benefit of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 4
- 主要终点
- Percentage of Participants With None or Mild in LCL Severity at Maximum Smile
研究概览
简要总结
A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Treatment of Moderate or Severe Lateral Canthal Lines (LCL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent consistent with International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP) guidelines and local laws, including authorization to release health information, signed prior to any study procedures being performed
- •Be outpatient, male or female subjects, in good general health, 18-65 years old
- •Have a score of moderate (2) or severe (3) LCL at maximum smile effort as assessed by the IGA-LCWS
- •Able to understand the requirements of the study and be willing and able to follow all study procedures, attend all scheduled visits, and successfully complete the study.
排除标准
- •Active skin disease, infections, or inflammation at the injection sites
- •History of clinically significant bleeding disorders
- •Clinically significant laboratory values at screening that may interfere with a subject's ability to complete the study, as determined by the investigator
- •Planned or anticipated need for surgery or hospitalization through the end of the study
- •Pregnant, nursing, or planning a pregnancy during the study; or is Women of Child Bearing Potential (WOCBP) but is not willing to use an effective method of contraception
- •Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to screening through the end of the study
研究组 & 干预措施
Cohort 4: DAXI 48 U
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
干预措施: DaxibotulinumtoxinA for injection (Biological)
Cohort 3: DAXI 36 U
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
干预措施: DaxibotulinumtoxinA for injection (Biological)
Cohort 2: DAXI 24 U
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
干预措施: DaxibotulinumtoxinA for injection (Biological)
Cohort 1: DAXI 12 U
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
干预措施: DaxibotulinumtoxinA for injection (Biological)
结局指标
主要结局
Percentage of Participants With None or Mild in LCL Severity at Maximum Smile
时间窗: Week 4 After LCL Treatment
Percentage of subjects achieving a score or 0 or 1 (none or mild) in LCL severity at maximum smile at Week 4 after LCL treatment on the Investigator Global Assessment Lateral Canthal Wrinkle Severity (IGA-LCWS) scale
次要结局
未报告次要终点