Based on the results of the Phase 2 Study 191622-130 \[NCT02010775\], the current Phase 2b study is designed to further evaluate the safety and efficacy of BOTOX® for the treatment of Masseter Muscle Prominence (MMP) in adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
OnabotulinumtoxinA (botulinum toxin Type A;BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1.
Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles on Day 1.
Total Skin & Beauty Dermatology Center, PC
Birmingham, Alabama, United States
Westside Aesthetics
Los Angeles, California, United States
Percentage of Participants Who Achieved Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 at Day 90 as Assessed by the Investigator
The investigator assessed the severity of the participant's masseter muscle prominence (MMP) using the MMPS 5-point scale where: 1=minimal (best), 2=mild, 3=moderate, 4=marked, and 5=very marked (worst). The percentage of participants where the investigator selected 1=minimal, 2=mild, or 3=moderate are reported.
Time frame: Day 90
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE is an AE that occurs or worsens after receiving study drug.
Time frame: First dose (Day 1) to the End of Study (Up to Day 180)
Change From Baseline in Systolic Blood Pressure
Time frame: Baseline (Day 1) to the End of Study (Up to Day 180)
Change From Baseline in Diastolic Blood Pressure
Time frame: Baseline (Day 1) to the End of Study (Up to Day 180)
Change From Baseline in Respiratory Rate
Respiratory rate is calculated as number of breaths (inhalation and exhalation) in one minute.
Time frame: Baseline (Day 1) to the End of Study (Up to Day 180)
Change From Baseline in Pulse Rate
Pulse rate measures the number of times your heart beats per minute.
Time frame: Baseline (Day 1) to the End of Study (Up to Day 180) ]
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Skin Care and Laser Physicians of Beverly Hills
Los Angeles, California, United States
Cosmetic Laser Dermatology
San Diego, California, United States
Baumann Cosmetic and Research Institute
Miami, Florida, United States
DeNova Research
Chicago, Illinois, United States
Etre, Cosmetic Dermatology and Laser Center
New Orleans, Louisiana, United States
Saint Louis University Dermatology
St Louis, Missouri, United States
Skin Specialists, PC
Omaha, Nebraska, United States
Nashville Centre for Laser and Facial Surgery
Nashville, Tennessee, United States
...and 4 more locations
Percentage of Participants Who Achieved Participant Masseter Muscle Prominence Scale-Participant (MMPS-P) Grade ≤ 3 at Day 90 as Assessed by the Participant
The participant assessed the severity of their MMP using the MMPS-P 5-point scale where: 1=not at all pronounced (best), 2=mildly pronounced, 3=moderately pronounced, 4=pronounced, and 5=very pronounced (worst). The percentage of participants who selected 1=not at all pronounced, 2=mildly pronounced, or 3=moderately pronounced are reported.
Time frame: Day 90
Percentage of Participants Who Achieved ≥ 2-grade MMPS Improvement From Baseline at Day 90 as Assessed by the Investigator
The investigator assessed the severity of the participant's MMP using the MMPS 5-point scale where: 1=minimal (best), 2=mild, 3=moderate, 4=marked, and 5=very marked (worst). The percentage of participants who achieved a ≥ 2-grade improvement (decrease) from Baseline as assessed by the investigator are reported.
Time frame: Baseline (Day 1) to Day 90
Percentage of Participants Who Achieved ≥ 2-grade MMPS-P Improvement From Baseline at Day 90 as Assessed by the Participant
The participant assessed the severity of their MMP using the MMPS-P 5-point scale where: 1=not at all pronounced (best), 2=mildly pronounced, 3=moderately pronounced, 4=pronounced, and 5=very pronounced (worst). The percentage of participants who achieved a ≥ 2-grade improvement (decrease) from Baseline as assessed by the participant are reported.
Time frame: Baseline (Day 1) to Day 90
Percentage of Participants Who Achieved Participant Self-Assessment of Change (PSAC) in MMP Grade ≥ 2 (at Least Moderately Improved From Baseline) at Day 90
The participants assessed the degree of change of their MMP using a single item composed of 7 grades (3 to -3) where: 3=much improved, 2=moderately improved, 1=minimally improved, 0=no change, -1=minimally worse, -2=moderately worse, and -3=much worse. The percentage of participants where the participant selected 2=moderately improved, or 3=much improved as compared to Baseline are reported.
Time frame: Baseline (Day 1) to Day 90
Change From Baseline in Lower Facial Volume at Day 90 Using Landmark Area of Interest (AOI) Analysis
Lower facial volume was calculated from 3-dimensional (3D) surface images captured at Baseline and Day 90. The analysis region is defined using a series of anatomical landmarks placed on the baseline surface that are then projected mathematically to the posttreatment surface and verified by a technician. The difference in volume is measured between the select region of the baseline surface to the posttreatment surface. The lower facial volume is summed for both the left side and the right side of the face. An analysis of covariance (ANCOVA) model was used for analyses.
Time frame: Baseline (Day 1) to Day 90
Change From Baseline in Lower Facial Volume at Day 90 Using Statistical MMP AOI Analysis
Lower facial volume was calculated from 3D surface models of the full area of the lower face captured at Baseline and Day 90. The statistical MMP AOI method is based on a statistical shape averaging of the area of change post masseter treatment from multiple facial models. The difference in volume is calculated between the two 3D surface models at Baseline and Day 90. An ANCOVA model was used for analyses.
Time frame: Baseline (Day 1) to Day 90