Masseter Muscle Prominence

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

BOTOX®

Botulinum Toxin Type A

injection

100 U/vial

Primary Outcome Measures :
Proportion of responders that show change in masseter muscle prominence (MMP) [ Time Frame: Baseline, Day 90 ]
Investigator assessment of severity of MMP using the Masseter Muscle Prominence Scale (MMPS). Score ranges from 1 = minimal to 5 = very marked

Incidence of Adverse Events (AEs) [ Time Frame: Up to 18 Months ]
The number of patients who experienced one or more AEs during the study

Change from baseline in vital sign values (blood pressure, respiratory rate, and pulse rate) [ Time Frame: Up to 18 Months ]
Summary statistics of change from baseline vital sign values


Secondary Outcome Measures :
Proportion of responders who achieve a clinical target on a MMP scale [ Time Frame: Baseline, Day 90 ]
Investigator assessment of MMP using a scale ranging from minimal to very marked

Proportion of responders who achieve improvement using a self-assessment scale [ Time Frame: Baseline, Day 90 ]
Improvement of MMP is self-assessed by the participant using a scale ranging from not at all pronounced to very pronounced.

Proportion of responders that show improvement in MMP [ Time Frame: Baseline, Day 90 ]
Improvement of MMP is self-assessed by the participant using a scale for change in MMP ranging from much improved to much worse

Change from baseline in lower facial width [ Time Frame: Baseline, Day 90 ]
Calculated from standardized images, measured in millimeters (mm)

Duration of treatment effect [ Time Frame: Baseline, Day 90 ]
Improvement from baseline of MMP

1. Be a male or female at least 18 years of age (in Taiwan, all subjects participating in this study must be above 20 years old) at the time of signing this consent document
2. Be healthy as determined by medical evaluation
3. Have large masseter muscles, as determined by the study doctor and the participant at the Day 1 visit using the Masseter Muscle Prominence Scale and Masseter Muscle Prominence Scale-Participant, respectively
4. Have a BMI of ≦ 30 kg/m2
5. Be willing to minimize risk of becoming pregnant if female for the duration of the study and follow-up periods
6. Have a negative pregnancy test result prior to randomization, not breastfeeding, at at least one of the following
o Not a women of childbearing potential
o A women of childbearing potential who agrees to contraceptive guidance during treatment and follow-up period
7. Give written informed consent and written authorization for use and release of health and research study information
8. Be willing and able to remove all facial jewelry and make-up at the study visits if needed
9. Be willing to complete all required study visits
10. Meet all of the additional relevant inclusion criteria
11. You are able to understand and willing to follow study instructions and likely to complete all required visits and procedures

1. You have a medical condition that may put you at increased medical risk with exposure to BOTOX including diagnosed myasthenia gravis (an autoimmune neuromuscular disease leading to fluctuating muscle weakness and fatigue), Eaton-Lambert syndrome (rare autoimmune disorder that is characterized by muscle weakness of the limbs), amyotrophic lateral sclerosis (a disorder that causes muscle weakness and does not enable it to function), or any other condition that might interfere with neuromuscular function
2. Any uncontrolled medical condition
3. You have an anticipated need for surgery or overnight hospitalization during the study
4. You have had any prior botulinum toxin treatment to the masseter muscle or lower face at any time, or to any other part of the body within the 6 months before Day 1
5. You have history of an allergic reaction to any type of botulinum toxin or sensitivity to any of the components of the study treatments or any materials used in the study
6. You have current or planned dental or facial procedures during the study period (eg. braces, dental implants, surgery) that could interfere with study-specific facial assessments, as determined by the study doctor
7. You have prior facial treatment with nonpermanent soft tissue fillers, synthetic implantations, or fat transplants within the 6 months before Day 1
8. You have prior facial shaping procedures, including fat reduction injections or skin-tightening laser treatments within the 6 months before Day 1
9. You have particular conditions affecting your facial muscles that could interfere with normal chewing, as determined by the study doctor
10. You have facial hair, scarring (eg, acne scarring), excess lower facial fat or loose skin, or parotid gland prominence that is significant enough to interfere with the study doctor’s evaluation of your face. You must remove any excess facial hair before each study visit.
11. You are currently participating in another investigational drug or device study or have participated in a study within 30 days of entry into this study
12. You have any current infection of the mouth or gums or facial skin requiring treatment with antibiotics
13. You have a history of temporomadibular joint disease (TMJD), a problem with your temporomadibular joint, which connects your lower jaw to your skull, or have signs/symptoms of possible TMJD in the opinion of the study doctor. The study doctor may refer you to a dentist for further evaluation and diagnosis of TMJD if you are suspected to have this condition
14. You have significant unevenness of left and right sides of the face that could prevent physical assessment grading on both sides of the face
15. Your body weight has changed > 10% over the 6 months prior to the screening visit or you have anticipated body weight change > 10% during the study period
16. You are unwilling to be photographed or unwilling to have your study photos used for evaluation of the study results and/or for general research, education, or informational purposes
17. You have a condition or situation, in the study doctor’s opinion, that may affect the study results, or may interfere significantly with your participation in the study
18. You will not be able to take part in the study if you are a woman who is pregnant, nursing, or planning a pregnancy
19. You are a woman who could become pregnant and are not willing to use contraceptives
20. You will not be able to take part in this study if you have history of alcohol or drug abuse within 12 months of the study entry
21. In addition to the above, the study doctor or study staff will discuss with you other reasons why you may not be eligible to take part in the study