BOTOX® Treatment of Masseter Muscle Hypertrophy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 187
- 试验地点
- 14
- 主要终点
- Change From Baseline in Lower Facial Volume Using VECTRA 3D Images
研究概览
简要总结
This study will evaluate the safety and efficacy of a range of doses of botulinum toxin Type A (BOTOX®) for the treatment of patients with bilateral Masseter Muscle Hypertrophy (MMH).
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with Masseter Muscle Hypertrophy
排除标准
- •Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
- •Prior botulinum toxin treatment of any serotype to the masseter muscle or lower face
- •History of dental or surgical procedure for lower facial shaping or masseter muscle reduction
- •History of or current temporomandibular joint disorder (TMJD)
研究组 & 干预措施
BOTOX® 24U
Botulinum Toxin Type A (BOTOX®) 24U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
干预措施: botulinum toxin Type A (Biological)
BOTOX® 48U
Botulinum Toxin Type A (BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
干预措施: botulinum toxin Type A (Biological)
BOTOX® 72U
Botulinum Toxin Type A (BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
干预措施: botulinum toxin Type A (Biological)
BOTOX® 96U
Botulinum Toxin Type A (BOTOX®) 96U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
干预措施: botulinum toxin Type A (Biological)
Placebo
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
干预措施: Normal saline (Drug)
结局指标
主要结局
Change From Baseline in Lower Facial Volume Using VECTRA 3D Images
时间窗: Baseline (Day 1) to Day 90 of Treatment Cycle 1
Lower facial volume was calculated from 3-dimensional (3D) images captured with the VECTRA M3 3D Stereophotogrammetry imaging system and was analyzed using computer assisted systems and predetermined facial landmarks. The difference in volume was measured between the select region of the baseline surface 3D model and the select region of the posttreatment surface 3D model. A negative change from Baseline (decrease in volume) indicates improvement.
次要结局
- Percentage of Participants Who Achieved a Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 as Assessed by the Investigator(Day 90 of Treatment Cycle 1)