A Study to Assess Adverse Events and Change of Masseter Muscle Prominence Using BOTOX Injections in Adult Participants
← catalyst calendarSponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
259actual
Sites
18
Country
Japan
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 | 2023-11-22 | actual | When the study began enrolling |
| Primary completion | 2025-07-31 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-07-31 | actual | The whole study's end, after follow-up |
| First posted | 2023-11-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-06 | 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 BOTOX VISTA, OnabotulinumtoxinA
- Drug: Placebo for BOTOX
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants who Achieve >= 2-Grade Improvement on Investigator-Rated Masseter Muscle Prominence Scale (MMPS)
measured Baseline to Day 90
Number of Participants with Adverse Events (AEs)
measured Up to approximately 12 months
Permalink · ABBV's whole pipeline · Catalyst calendar · Every registered study · What changed