Masseter Muscle Prominence
Conditions
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.
Interventions
BIOLOGICALBotulinum Toxin Type A
Day 1 Administration of bilateral intramuscular injections into the masseter
OTHERPlacebo
Day 1 Administration of bilateral intramuscular injections of placebo (normal saline) into the masseter
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 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. |
Countries
Canada, China, Taiwan
Participant flow
Recruitment details
A total of 377 participants were enrolled and randomized into the study; 284 to BOTOX and 93 to Placebo. A total of 370 participants were included in the modified ITT (mITT) Population; 278 to BOTOX and 92 to Placebo. A participant was considered to have completed the study if he/she had at least completed the treatment visit and the end of study visit.
Pre-assignment details
The mITT population, consisting of all randomized subjects with at least 1 postbaseline MMPS assessment, comprised 370 subjects.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo was administered as bilateral intramuscular injections into the masseter on Day 1 | 92 |
| BOTOX® BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments | 278 |
| Total | 370 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lost to Follow-up | 6 | 1 |
| Overall Study | Other | 1 | 1 |
| Overall Study | Protocol Deviation | 0 | 4 |
| Overall Study | Withdrawal by Subject | 16 | 36 |
Baseline characteristics
| Characteristic | BOTOX® | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 31.5 years STANDARD_DEVIATION 8.35 | 31.0 years STANDARD_DEVIATION 8.67 | 31.4 years STANDARD_DEVIATION 8.42 |
| Baseline Masseter Muscle Prominence Scale (MMPS) 4 = Marked | 177 Participants | 59 Participants | 236 Participants |
| Baseline Masseter Muscle Prominence Scale (MMPS) 5 = Very Marked | 101 Participants | 33 Participants | 134 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 274 Participants | 91 Participants | 365 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 247 Participants | 76 Participants | 323 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 29 Participants | 15 Participants | 44 Participants |
| Sex: Female, Male Female | 244 Participants | 82 Participants | 326 Participants |
| Sex: Female, Male Male | 34 Participants | 10 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 93 | 0 / 283 |
| other Total, other adverse events | 19 / 93 | 54 / 283 |
| serious Total, serious adverse events | 4 / 93 | 11 / 283 |
Outcome results
Primary
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
Population: mITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Achievement of ≥ 2-Grade Improvement From Baseline on the Masseter Muscle Prominence Scale (MMPS) at Day 90 | 2.2 percentage of participants |
| BOTOX® | Achievement of ≥ 2-Grade Improvement From Baseline on the Masseter Muscle Prominence Scale (MMPS) at Day 90 | 51.2 percentage of participants |
p-value: <0.000195% CI: [40.1, 54.1]Cochran-Mantel-Haenszel
Secondary
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
Population: mITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Achievement of MMPS Grade ≤ 3 at Day 90 | 9.9 percentage of participants |
| BOTOX® | Achievement of MMPS Grade ≤ 3 at Day 90 | 81.1 percentage of participants |
p-value: <0.000195% CI: [60.7, 76.3]Cochran-Mantel-Haenszel
Secondary
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
Population: mITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Achievement of MMPS-P ≥ 2-Grade Improvement From Baseline at Day 90 | 9.1 percentage of participants |
| BOTOX® | Achievement of MMPS-P ≥ 2-Grade Improvement From Baseline at Day 90 | 58.8 percentage of participants |
p-value: <0.000195% CI: [40.6, 57.4]Cochran-Mantel-Haenszel
Secondary
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
Population: mITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Achievement of MMPS-P Grade ≤ 3 on Day 90 | 19.5 percentage of participants |
| BOTOX® | Achievement of MMPS-P Grade ≤ 3 on Day 90 | 76.2 percentage of participants |
p-value: <0.000195% CI: [45.6, 64.5]Cochran-Mantel-Haenszel
Secondary
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
Population: mITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Achievement of PSAC Grade ≥ 1 (at Least Minimally Improved From Baseline) on Day 90 | 20.4 percentage of participants |
| BOTOX® | Achievement of PSAC Grade ≥ 1 (at Least Minimally Improved From Baseline) on Day 90 | 90.8 percentage of participants |
p-value: <0.000195% CI: [59.6, 77.5]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Lower Facial Width (mm) at Day 90
Calculated from standardized images, measured in millimeters (mm)
Time frame: Day 90
Population: mITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Lower Facial Width (mm) at Day 90 | -0.04 millimeters (mm) | Standard Error 0.202 |
| BOTOX® | Change From Baseline in Lower Facial Width (mm) at Day 90 | -5.24 millimeters (mm) | Standard Error 0.121 |
p-value: <0.000195% CI: [-5.64, -4.75]ANCOVA
Secondary
Median Duration of Effect for MMPS Responders
Median duration of effect for BOTOX-treated MMPS responders.
Time frame: Up to Day 360
Population: mITT Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Duration of Effect for MMPS Responders | MMPS ≥ 2-Grade Improvement | 176.0 Days |
| Placebo | Median Duration of Effect for MMPS Responders | MMPS Grade ≤ 3 | 213.0 Days |
| Placebo | Median Duration of Effect for MMPS Responders | MMPS ≥ 1-Grade Improvement | 268.0 Days |