BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence

Phase 3

Completed

Brief Summary: This study is designed to evaluate the safety and effectiveness of administering BOTOX for the treatment of Masseter Muscle Prominence (MMP) in adults.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo (normal saline) will be administered on Day 1 as bilateral intramuscular injections into the masseter
Botulinum Toxin Type A (BOTOX®)	Botulinum Toxin Type A	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

Primary Outcome Measures

Name	Time	Method
Achievement of ≥ 2-Grade Improvement From Baseline on the Masseter Muscle Prominence Scale (MMPS) at Day 90	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.

Secondary Outcome Measures

Name	Time	Method
Achievement of MMPS Grade ≤ 3 at Day 90	Day 90	Proportion of participants who achieve MMPS Grade of ≤ 3 at Day 90, per investigator assessments of MMP using the Masseter Muscle Prominence Scale (MMPS). MMPS ranges from 1 = minimal to 5 = very marked.
Achievement of MMPS-P Grade ≤ 3 on Day 90	Day 90	Proportion of participants who achieve MMPS-P Grade ≤ 3 at Day 90, according to participant, per Masseter Muscle Prominence Scale-Participant (MMPS-P) MMPS-P ranges from 1 = not at all pronounced to 5 = very pronounced.
Achievement of MMPS-P ≥ 2-Grade Improvement From Baseline at Day 90	Day 90	Proportion of participants who achieve ≥ 2-grade improvement from baseline at Day 90, per Masseter Muscle Prominence Scale-Participant (MMPS-P) MMPS-P ranges from 1 = not at all pronounced to 5 = very pronounced.
Achievement of PSAC Grade ≥ 1 (at Least Minimally Improved From Baseline) on Day 90	Day 90	Proportion of participants who achieve Grade ≥ 1 on Participant Self-Assessment of Change (PSAC) (at least minimally improved from baseline) at Day 90 PSAC ranges from 3 = much improved to -3 = much worse.
Change From Baseline in Lower Facial Width (mm) at Day 90	Day 90	Calculated from standardized images, measured in millimeters (mm)
Median Duration of Effect for MMPS Responders	Up to Day 360	Median duration of effect for BOTOX-treated MMPS responders.

Locations (21): Duplicate_Beacon Dermatology Inc /ID# 233018
🇨🇦
Calgary, Alberta, Canada
Duplicate_Humphrey Cosmetic Dermatology /ID# 232764
🇨🇦
Vancouver, British Columbia, Canada
Duplicate_Peking Union Medical College Hospital /ID# 233072
🇨🇳
Beijing, Beijing, China
Project Skin MD LTD /ID# 232763
🇨🇦
Vancouver, British Columbia, Canada
Pacific Derm /ID# 233156
🇨🇦
Vancouver, British Columbia, Canada
The Center For Dermatology /ID# 233001
🇨🇦
Richmond Hill, Ontario, Canada
Peking University Third Hospital /ID# 233148
🇨🇳
Beijing, Beijing, China
Chinese PLA General Hospital /ID# 233158
🇨🇳
Beijing, Beijing, China
Peking University First Hospital /ID# 232973
🇨🇳
Xicheng District, Beijing, China
Tianjin Medical University General Hospital /ID# 232961
🇨🇳
Tianjin, Guizhou, China
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Duplicate_Beacon Dermatology Inc /ID# 233018
🇨🇦Calgary, Alberta, Canada