NCT04073303已完成3 期
BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
AbbVie21 个研究点 分布在 3 个国家目标入组 377 人开始时间: 2019年8月29日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 377
- 试验地点
- 21
- 主要终点
- Achievement of ≥ 2-Grade Improvement From Baseline on the Masseter Muscle Prominence Scale (MMPS) at Day 90
研究概览
简要总结
This study is designed to evaluate the safety and effectiveness of administering 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
- 否
入选标准
- •Inclusion Criteria:
- •Masseter prominence at the Day 1 visit
- •BMI ≤ 30 kg/m2 using the calculation: BMI = weight (kg)/[height (m)]2
- •A female participant must be willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up periods
排除标准
- •Any medical condition that may put the participant at increased medical risk with exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
- •An anticipated need for surgery or overnight hospitalization during the study
- •An anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention)
- •History of dental or surgical procedure for lower facial shaping or masseter muscle reduction
- •Prior mid-facial and/or lower facial treatment with nonpermanent soft tissue fillers, synthetic implantations, autologous fat transplantation, fat-reducing injectables, and/or skin-tightening laser treatments within 6 months prior to Day 1
- •Prior exposure to botulinum toxin of any serotype to the masseter muscle or lower face at any time, or to any other part of the body within the 6 months prior to Day 1
- •History of temporomandibular joint disorder (TMJD)
- •Masseter prominence due to other etiologies (eg, parotid gland infection, parotiditis, malignancy)
- •Known allergy or sensitivity to any of the components of the study treatments or any materials used in the study procedures
- •History of alcohol or drug abuse within 12 months of Day 1
研究组 & 干预措施
Botulinum Toxin Type A (BOTOX®)
Active Comparator
Botulinum Toxin Type A (BOTOX ®) will be administered on Day 1 as bilateral intramuscular injections into the masseter with the possibility of 2 additional treatments
干预措施: Botulinum Toxin Type A (Biological)
Placebo
Placebo Comparator
Placebo (normal saline) will be administered on Day 1 as bilateral intramuscular injections into the masseter
干预措施: Placebo (Other)
结局指标
主要结局
Achievement of ≥ 2-Grade Improvement From Baseline on the Masseter Muscle Prominence Scale (MMPS) at Day 90
时间窗: Day 90
Proportion of participants who achieve ≥ 2-grade improvement from baseline at Day 90, per investigator assessments of MMP using the Masseter Muscle Prominence Scale (MMPS). MMPS ranges from 1 = minimal to 5 = very marked.
次要结局
- Median Duration of Effect for MMPS Responders(Up to Day 360)
- Achievement of MMPS Grade ≤ 3 at Day 90(Day 90)
- Achievement of MMPS-P Grade ≤ 3 on Day 90(Day 90)
- Achievement of MMPS-P ≥ 2-Grade Improvement From Baseline at Day 90(Day 90)
- Achievement of PSAC Grade ≥ 1 (at Least Minimally Improved From Baseline) on Day 90(Day 90)
- Change From Baseline in Lower Facial Width (mm) at Day 90(Day 90)
研究者
研究点 (21)
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