BOTOX VISTA (onabotulinumtoxinA) for Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AbbVie GK
- 入组人数
- 250
- 主要终点
- Percentage of Participants who Achieve >= 2-Grade Improvement on Investigator-Rated Masseter Muscle Prominence Scale (MMPS)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 65age old not（—）
- 性别
- All
入选标准
- •Adult Japanese individuals.
- •Participant with marked or very marked masseter muscle prominence (MMP).
排除标准
- •Asymmetry of left and right sides of the face that could prevent identical Masseter Muscle Prominence Scale (MMPS) or MMPS-P grading on both sides of the face, as determined by the investigator.
- •History of permanent soft tissue fillers in the jawline.
结局指标
主要结局
Percentage of Participants who Achieve >= 2-Grade Improvement on Investigator-Rated Masseter Muscle Prominence Scale (MMPS)
时间窗: Baseline to Day 90
The MMPS is a photonumeric scale encompassing visual inspection of the masseter muscles as performed by the investigator, where the masseter muscle prominence (MMP) is rated at rest, by separately evaluating the left and right side of the participant's face. The evaluation is on a 5-grade scale where 1 = the masseter muscle prominence is minimal and 5 = the masseter muscle prominence is very marked.
Number of Participants with Adverse Events (AEs)
时间窗: Up to approximately 12 months
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
次要结局
- Change from Baseline in Lower Facial Volume (cm^3)(Baseline to Day 90)
- Change from Baseline in Lower Facial Width (mm)(Baseline to Day 90)
- Percentage of Participants with Responses of Very Satisfied or Satisfied on the Lower Facial Shape Questionnaire - Treatment Satisfaction (LFSQ-TXSAT) Follow-Up Version(Day 90)
- Responses of Not at All Bothered or A Little Bothered on the Bother Impact Assessment for Masseter Muscle Prominence (BIA-MMP) (for Subjects Somewhat Bothered, A Lot Bothered, or Extremely Bothered at Baseline)(Day 90)
- Percentage of Participants who Achieve >= 2-Grade Improvement on Masseter Muscle Prominence Scale - Participant (MMPS-P)(Baseline to Day 90)
- Change from Baseline in Lower Facial Shape Questionnaire - Impact Assessment (LFSQ-IA) Summary Score(Baseline to Day 90)