This study is designed to evaluate the safety and effectiveness of administering BOTOX for the treatment of Masseter Muscle Prominence (MMP) in adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
377
Day 1 Administration of bilateral intramuscular injections into the masseter
Day 1 Administration of bilateral intramuscular injections of placebo (normal saline) into the masseter
Duplicate_Beacon Dermatology Inc /ID# 233018
Calgary, Alberta, Canada
Achievement of ≥ 2-Grade Improvement From Baseline on the Masseter Muscle Prominence Scale (MMPS) at 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.
Time frame: Day 90
Achievement of MMPS Grade ≤ 3 at 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.
Time frame: Day 90
Achievement of MMPS-P Grade ≤ 3 on 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.
Time frame: Day 90
Achievement of MMPS-P ≥ 2-Grade Improvement From Baseline at 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.
Time frame: Day 90
Achievement of PSAC Grade ≥ 1 (at Least Minimally Improved From Baseline) on 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.
Time frame: Day 90
Change From Baseline in Lower Facial Width (mm) at Day 90
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Duplicate_Humphrey Cosmetic Dermatology /ID# 232764
Vancouver, British Columbia, Canada
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 Municipality, China
Duplicate_Peking Union Medical College Hospital /ID# 233072
Beijing, Beijing Municipality, China
Chinese PLA General Hospital /ID# 233158
Beijing, Beijing Municipality, China
Peking University First Hospital /ID# 232973
Xicheng District, Beijing Municipality, China
Tianjin Medical University General Hospital /ID# 232961
Tianjin, Guizhou, China
...and 11 more locations
Calculated from standardized images, measured in millimeters (mm)
Time frame: Day 90
Median Duration of Effect for MMPS Responders
Median duration of effect for BOTOX-treated MMPS responders.
Time frame: Up to Day 360