A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines With or Without Concurrent Treatment of Lateral Canthal Lines
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 415
- 试验地点
- 21
- 主要终点
- The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS)
研究概览
简要总结
To evaluate the safety and efficacy of MT10109L for the treatment of glabellar lines (GL) with or without concurrent treatment of lateral canthal lines (LCL) in participants with moderate to severe GL and LCL.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MT10109L Dose 1 + Placebo
MT10109L Dose 1 will be injected into the Glabellar Lines (GL) and Placebo into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
干预措施: MT10109L (Drug)
MT10109L Dose 1 + Placebo
MT10109L Dose 1 will be injected into the Glabellar Lines (GL) and Placebo into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
干预措施: Placebo (Drug)
MT10109L Dose 1 + MT10109L Dose 2
MT10109L Dose 1 will be injected into the Glabellar Lines (GL) and MT10109L Dose 2 into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
干预措施: MT10109L (Drug)
Placebo
Placebo will be injected into the Glabellar Lines (GL) and into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
干预措施: Placebo (Drug)
结局指标
主要结局
The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS)
时间窗: Day 30
The outcome measured is the percentage of participants with a ≥ 2-grade improvement from baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) according to investigator and participant assessments of Glabellar Lines (GL) severity at maximum frown at Day 30. The investigator and participant evaluates the participant's GL severity using a Facial Wrinkle Scale With Photonumeric Guide (FWS) at maximum frown on Day 30. The scale ranges from (0 to 3) where 0=none and 3 = severe.
次要结局
- Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval(Baseline to Day 360)
- Mean Change From Baseline in Systolic Blood Pressure (BP)(Baseline to Day 360 (Study exit))
- Mean Change From Baseline in Respiratory Rate(Baseline to Day 360 (Study exit))
- Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate(Baseline to Day 360)
- The Duration of Glabellar Line (GL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in GL Severity at Maximum Frown at Day 30 According to Investigator Assessments Using the Facial Wrinkle Scale (FWS)(Day 1 (first treatment) to Day 180)
- The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS)(Day 30)
- The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS)(Day 30)
- Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval(Baseline to Day 360)
- The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Glabellar Lines (GL)(Day 60)
- Mean Change From Baseline in Diastolic Blood Pressure (BP)(Baseline to Day 360 (Study exit))
- Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval(Baseline to Day 360)
- Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval(Baseline to Day 360)
- Number of Participants With Binding and Neutralizing Antibodies(Day 360)
- Secondary Safety: Number of Patients Who Experienced an Adverse Event (AE)(The time frame for AEs is after the first dose (Day 1) and up to 30 days after their last visit or study exit (Day 360 unless participant exits earlier))
- Mean Change From Baseline in Pulse Rate(Baseline to Day 360 (Study exit))
- Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration(Baseline to Day 360)
- Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval(Baseline to Day 360)