Phase 2
N=187
Botulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy
Masseter Muscle Hypertrophy
Bottom Line
View on ClinicalTrials.gov: NCT02010775 ↗Enrolled (actual)
187
Serious AEs
3.2%
Results posted
May 2019
Primary outcome: Primary: Change From Baseline in Lower Facial Volume Using VECTRA 3D Images — -8.20; -7.41; -6.84; -4.40 cubic centimeter (cm^3) — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- botulinum toxin Type A (Biological); Normal saline (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Lower Facial Volume Using VECTRA 3D Images |
-8.20; -7.41; -6.84; -4.40; -0.52 | < 0.001 sig |
| SECONDARY Percentage of Participants Who Achieved a Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 as Assessed by the Investigator |
89.5; 89.5; 83.3; 66.7; 35.1 | 0.008 sig |
Summary
This study will evaluate the safety and efficacy of a range of doses of botulinum toxin Type A (BOTOX®) for the treatment of patients with bilateral Masseter Muscle Hypertrophy (MMH).
Eligibility Criteria
Inclusion Criteria
-Participants with Masseter Muscle Hypertrophy
Exclusion Criteria
- Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
- Prior botulinum toxin treatment of any serotype to the masseter muscle or lower face
- History of dental or surgical procedure for lower facial shaping or masseter muscle reduction
- History of or current temporomandibular joint disorder (TMJD)
Data sourced from ClinicalTrials.gov (NCT02010775). 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.