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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 234
- 试验地点
- 15
- 主要终点
- 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
研究概览
简要总结
To evaluate the safety and efficacy of MT10109L in the treatment of glabellar lines (GL) in participants with moderate to severe GL.
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
MT10109L will be injected into the GL: initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
干预措施: MT10109L (Drug)
Placebo
Placebo will be injected into the GL: initial double-blind treatment on Day 1.
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) According to INVESTIGATOR AND PARTICIPANT Assessments of Glabellar Lines (GL) Severity at Maximum Frown at Day 30
时间窗: Day 30
The primary efficacy measure is a composite endpoint and a participant is considered responder only if both the investigator and participant independently report a ≥ 2-grade improvement at Day 30 of Double-Blind Period from baseline. Both participant and investigator used FWS to assess GL severity. FWS is 4-grade scale (0 to 3): 0=none and 3=severe. The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline.
次要结局
- 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 Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Glabellar Lines (GL)(Day 60)
- The Duration of Glabellar Lines (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)
- Mean Change From Baseline in Vital Signs - Systolic Blood Pressure (BP)(Baseline to Study exit (Day 360 or early exit))
- Mean Change From Baseline in Vital Signs - Diastolic Blood Pressure (BP)(Baseline to Study exit (Day 360 or early exit))
- Mean Change From Baseline in Vital Signs - Pulse Rate(Baseline to Study exit (Day 360 or early exit))
- Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate(Baseline to Study Exit (Day 360 or early exit))
- Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval(Baseline to Study Exit (Day 360 or early exit))
- The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS).(Day 30)
- Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration(The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).)
- Mean Change From Baseline in Vital Signs - Respiratory Rate(Baseline to Study exit (Day 360 or early exit))
- Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval(Baseline to Study Exit (Day 360 or early exit))
- Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration(Baseline to Study Exit (Day 360 or early exit))
- Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval(Baseline to Study Exit (Day 360 or early exit))
- Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval(Baseline to Study Exit (Day 360 or early exit))
- Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval(Baseline to Study Exit (Day 360 or early exit))
- Number of Participants With Binding and Neutralizing Antibodies(Up to Study Exit (Day 360 or early exit))