Phase 3
N=377
BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence
Masseter Muscle Prominence
Bottom Line
View on ClinicalTrials.gov: NCT04073303 ↗Enrolled (actual)
377
Serious AEs
4.0%
Results posted
May 2025
Primary outcome: Primary: Achievement of ≥ 2-Grade Improvement From Baseline on the Masseter Muscle Prominence Scale (MMPS) at Day 90 — 2.2; 51.2 percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Botulinum Toxin Type A (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Achievement of ≥ 2-Grade Improvement From Baseline on the Masseter Muscle Prominence Scale (MMPS) at Day 90 |
2.2; 51.2 | <0.0001 sig |
| SECONDARY Achievement of MMPS Grade ≤ 3 at Day 90 |
9.9; 81.1 | <0.0001 sig |
| SECONDARY Achievement of MMPS-P Grade ≤ 3 on Day 90 |
19.5; 76.2 | <0.0001 sig |
| SECONDARY Achievement of MMPS-P ≥ 2-Grade Improvement From Baseline at Day 90 |
9.1; 58.8 | <0.0001 sig |
| SECONDARY Achievement of PSAC Grade ≥ 1 (at Least Minimally Improved From Baseline) on Day 90 |
20.4; 90.8 | <0.0001 sig |
| SECONDARY Change From Baseline in Lower Facial Width (mm) at Day 90 |
-0.04; -5.24 | <0.0001 sig |
| SECONDARY Median Duration of Effect for MMPS Responders |
176.0; 213.0; 268.0 | — |
Summary
This study is designed to evaluate the safety and effectiveness of administering BOTOX for the treatment of Masseter Muscle Prominence (MMP) in adults.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04073303). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.