A Study to Assess Adverse Events and Change of Masseter Muscle Prominence Using BOTOX Injections in Adult Participants
Phase 3
Recruiting
- Conditions
- masseter muscle prominence
- Registration Number
- JPRN-jRCT2031230467
- Lead Sponsor
- Yajima Yoko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 250
Inclusion Criteria
Adult Japanese individuals.
Participant with marked or very marked masseter muscle prominence (MMP).
Exclusion Criteria
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Percentage of Participants who Achieve >= 2-Grade Improvement on Investigator-Rated Masseter Muscle Prominence Scale (MMPS)<br>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.<br>[Time Frame: Baseline to Day 90]<br>2. Number of Participants with Adverse Events (AEs)<br>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.<br>[Time Frame: Up to approximately 12 months]
- Secondary Outcome Measures
Name Time Method