BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 2b, Multicenter, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 150
- 试验地点
- 14
- 主要终点
- Percentage of Participants Who Achieved Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 at Day 90 as Assessed by the Investigator
研究概览
简要总结
Based on the results of the Phase 2 Study 191622-130 [NCT02010775], the current Phase 2b study is designed to further evaluate the safety and efficacy of BOTOX® for the treatment of Masseter Muscle Prominence (MMP) in adults.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BOTOX® 72U
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72 units (U) total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
干预措施: OnabotulinumtoxinA (Biological)
BOTOX® 48U
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
干预措施: OnabotulinumtoxinA (Biological)
Placebo
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
干预措施: Normal saline (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 at Day 90 as Assessed by the Investigator
时间窗: Day 90
The investigator assessed the severity of the participant's masseter muscle prominence (MMP) using the MMPS 5-point scale where: 1=minimal (best), 2=mild, 3=moderate, 4=marked, and 5=very marked (worst). The percentage of participants where the investigator selected 1=minimal, 2=mild, or 3=moderate are reported.
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
时间窗: First dose (Day 1) to the End of Study (Up to Day 180)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE is an AE that occurs or worsens after receiving study drug.
Change From Baseline in Systolic Blood Pressure
时间窗: Baseline (Day 1) to the End of Study (Up to Day 180)
Change From Baseline in Diastolic Blood Pressure
时间窗: Baseline (Day 1) to the End of Study (Up to Day 180)
Change From Baseline in Respiratory Rate
时间窗: Baseline (Day 1) to the End of Study (Up to Day 180)
Respiratory rate is calculated as number of breaths (inhalation and exhalation) in one minute.
Change From Baseline in Pulse Rate
时间窗: Baseline (Day 1) to the End of Study (Up to Day 180) ]
Pulse rate measures the number of times your heart beats per minute.
次要结局
- Percentage of Participants Who Achieved ≥ 2-grade MMPS Improvement From Baseline at Day 90 as Assessed by the Investigator(Baseline (Day 1) to Day 90)
- Percentage of Participants Who Achieved Participant Self-Assessment of Change (PSAC) in MMP Grade ≥ 2 (at Least Moderately Improved From Baseline) at Day 90(Baseline (Day 1) to Day 90)
- Change From Baseline in Lower Facial Volume at Day 90 Using Statistical MMP AOI Analysis(Baseline (Day 1) to Day 90)
- Percentage of Participants Who Achieved ≥ 2-grade MMPS-P Improvement From Baseline at Day 90 as Assessed by the Participant(Baseline (Day 1) to Day 90)
- Percentage of Participants Who Achieved Participant Masseter Muscle Prominence Scale-Participant (MMPS-P) Grade ≤ 3 at Day 90 as Assessed by the Participant(Day 90)
- Change From Baseline in Lower Facial Volume at Day 90 Using Landmark Area of Interest (AOI) Analysis(Baseline (Day 1) to Day 90)