A Study to Assess BOTOX Injections in Adult Participants for the Change of Masseter Muscle Prominence

Launched by ABBVIE · Apr 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of BOTOX injections to help reduce the appearance of a prominent masseter muscle, which is the muscle in your jaw used for chewing. Some people feel that having a wider jawline is not aesthetically pleasing, and this study aims to see how safe and effective BOTOX is for adults with this condition. If you are an adult aged between 18 and 65 with a significant prominence in both sides of your jaw, you might be eligible to participate.

During the trial, participants will be divided into two groups: one will receive BOTOX injections, while the other will receive a placebo (a substance with no active treatment). This means there's a chance you could receive the placebo. You will receive injections in both sides of your jaw and may have the option to receive more BOTOX after the initial treatment. Throughout the study, you will attend regular visits to monitor your progress and any side effects. It’s important to note that participation may require more time and visits than standard treatment, as the study aims to thoroughly assess how well the treatment works and how safe it is.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Participant meets the following criteria:
• • Bilateral Grade 4 or Grade 5 Masseter Muscle Prominence (MMP) (identical grades for left and right sides of the face), as determined at by the investigator using the Masseter Muscle Prominence Scale (MMPS).
• • Bilateral Grade 4 or Grade 5 MMP (identical grades for left and right sides of the face), as determined by the participant using the Masseter Muscle Prominence Scale - Participant (MMPS-P).
• • Investigator and participant scoring of MMPS and MMPS-P must be the same.
• • Body mass index (BMI) ≤ 30 kg/m\^2 using the calculation: BMI = weight (kg)/height (m)\^2.
• Exclusion Criteria:
• • Excess lower facial fat, jowling, loose or lax skin in lower face, or parotid gland prominence that could interfere with MMPS or MMPS-P grading.
• • Asymmetry of left and right sides of the face that could prevent identical MMPS or MMPS-P grading on both sides of the face.
• • History of or current temporomandibular disorder (TMJD), or presence of signs/symptoms of possible TMJD.