A Study to Assess BOTOX Injections in Adult Participants for the Change of Masseter Muscle Prominence
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
202actual
Sites
20
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-04-22 | actual | When the study began enrolling |
| Primary completion | 2025-11-25 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-11-25 | actual | The whole study's end, after follow-up |
| First posted | 2024-04-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Masseter Muscle Prominence
Interventions
- Drug: BOTOX — also filed as OnabotulinumtoxinA
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFComposite Achievement of MMP Severity Improvement and at Least a 2-Grade Improvement from Baseline by Both Investigator-Rated MMPS and Participant-Rated MMPS-P
measured Day 90
Number of Participants with Adverse Events (AEs)
measured Baseline to Day 360
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