A Study to Assess Adverse Events and Change of Masseter Muscle Prominence Using BOTOX Injections in Adult Participants

Study Overview
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Brief Summary
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The masseter muscle is one of the muscles in the lower face used for chewing. Prominence of the masseter muscle can appear as a widened and square lower face shape, which is an aesthetic concern for individuals who prefer a narrower and more ovoid lower face shape. Treatments are available for masseter muscle prominence (MMP), but researchers are looking for new non-surgical treatments. This study will assess adverse events and effectiveness of BOTOX in adult participants with MMP. BOTOX is being investigated for the treatment of MMP. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is 1 in 5 chance that participants will be assigned to placebo. Around 250 adult participants with MMP will be enrolled in the study at approximately 20 sites in Japan. Participants will receive either BOTOX or Placebo administered as 6 intramuscular injections to each masseter muscle on Day 1. Participants who are eligible for retreatment will be given BOTOX on either Day 180, 210, 240, or 270 and will be followed until approximately Day 360. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, facial photography, checking for side effects and completing questionnaires.

Official Title
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BOTOX VISTA® (onabotulinumtoxinA) for Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

Conditions
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Masseter Muscle Prominence

Intervention / Treatment
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* Drug: BOTOX
* Drug: Placebo for BOTOX


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>In Period 1, participant will receive 6 injections of BOTOX VISTA Dose A on Day 1. In Period 2, participants who meet the retreatment criteria will receive 6 injections of BOTOX VISTA Dose A on either Day 180, 210, 240, or 270. | Drug: BOTOX<br>* Intramuscular Injection<br>* Other names: OnabotulinumtoxinA;|
| Experimental: Group 2<br>In Period 1, participant will receive 6 injections of BOTOX VISTA Dose B on Day 1. In Period 2, participants who meet the retreatment criteria will receive 6 injections of BOTOX VISTA Dose B on either Day 180, 210, 240, or 270. | Drug: BOTOX<br>* Intramuscular Injection<br>* Other names: OnabotulinumtoxinA;|
| Experimental: Group 3<br>In Period 1, participant will receive 6 injections of BOTOX VISTA placebo on Day 1. In Period 2, participants who meet the retreatment criteria will receive 6 injections of BOTOX VISTA Dose A on either Day 180, 210, 240, or 270. | Drug: BOTOX<br>* Intramuscular Injection<br>* Other names: OnabotulinumtoxinA;Drug: Placebo for BOTOX<br>* Intramuscular Injection<br>|
| Experimental: Group 4<br>In Period 1, participant will receive 6 injections of BOTOX VISTA placebo on Day 1. In Period 2, participants who meet the retreatment criteria will receive 6 injections of BOTOX VISTA Dose B on either Day 180, 210, 240, or 270. | Drug: BOTOX<br>* Intramuscular Injection<br>* Other names: OnabotulinumtoxinA;Drug: Placebo for BOTOX<br>* Intramuscular Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants who Achieve >= 2-Grade Improvement on Investigator-Rated Masseter Muscle Prominence Scale (MMPS) | 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. | Baseline to Day 90 | 
| Number of Participants with Adverse Events (AEs) | 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 | Up to approximately 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Lower Facial Volume (cm^3) | Photographic technologies developed to provide 3D quantitative analysis of facial morphology include image subtraction technique, moire topography, liquid crystal scanning, light luminance scanning, laser scanning, stereo-lithography, and passive stereophotogrammetry, which all measure change to the lower facial contour. | Baseline to Day 90 | 
| Change from Baseline in Lower Facial Width (mm) | Photographic technologies developed to provide 3D quantitative analysis of facial morphology include image subtraction technique, moire topography, liquid crystal scanning, light luminance scanning, laser scanning, stereo-lithography, and passive stereophotogrammetry, which all measure change to the lower facial contour. | 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 | The LFSQ-TXSAT at follow-up measures the participant's satisfaction with the effect of treatment on the appearance of their lower face based on a 5-point scale where 2 = very satisfied and -2 = very dissatisfied. | 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) | The BIA-MMP is a single item evaluation of how bothered the participant is by the appearance of their lower face using a 5-point scale where 0 = not at all bothered and 4 = extremely bothered. | Day 90 | 
| Percentage of Participants who Achieve >= 2-Grade Improvement on Masseter Muscle Prominence Scale - Participant (MMPS-P) | The MMPS-P is a patient reported outcomes (PRO) measure with an accompanying photo guide used to assess MMP severity from the participant perspective using a 5-grade scale where 1 = the muscle is not at all noticeable and 5 = the muscle is extremely noticeable. | Baseline to Day 90 | 
| Change from Baseline in Lower Facial Shape Questionnaire - Impact Assessment (LFSQ-IA) Summary Score | The LFSQ-IA is a 6-item assessment that measures psychosocial impact of the appearance of the lower face using a 5-point scale where 0 = not at all and 4 = extremely. | Baseline to Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Masseter Muscle Prominence, OnabotulinumtoxinA, BOTOX VISTA, BOTOX