Evidence map›Paper›PMID 41092464›Full record

Trial reportAesthetic surgery journal2026

OnabotulinumtoxinA Treatment for Masseter Muscle Prominence: 6-Month Safety and Efficacy Results, Including Patient-Reported Outcomes, From a Phase 3, Randomized, Placebo-Controlled, Multiregional Trial.

Jiaming Sun, Lei Wang, Yan Wu, Shannon Humphrey, Shyi-Gen Chen, William McGillivray, Shu-Hung Huang, Yuguang Zhang, Grace Pan, Catherine Foley and 6 more

Abstract readMulticenter StudyRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Aesthetic surgery journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Jiaming Sun
Lei Wang
Yan Wu
Shyi-Gen Chen
William McGillivrayORCID 0009-0005-4799-7455
Yuguang Zhang
Grace Pan
Elisabeth Lee
Joan-En Chang-Lin
Vaishali Patel
Beta Bowen
Mitchell F Brin

Funding

AbbVie IncAllergan Aesthetics, an AbbVie companyLLCShenavia Balcom-Luker
6 · The paper itself

Abstract

backgroundMasseter muscle prominence (MMP) may be aesthetically bothersome to some individuals, leading them to seek treatment for a slimmer lower face.

objectivesThe aim of this study was to evaluate the safety and efficacy of onabotulinumtoxinA for the treatment of MMP, including patient-reported outcomes (PROs).

methodsThis was a prospective, multicenter trial including a randomized, double-blind, placebo-controlled period (Days 1-180) in which adults rated Grade 4 or 5 (marked/very marked) on the investigator-assessed MMP Scale (MMPS) were randomized to onabotulinumtoxinA 72 U or placebo. Efficacy endpoints were assessed at Day 90. The primary endpoint was ≥2-grade improvement from baseline on the investigator-assessed MMPS. Secondary endpoints included achieving Grade ≤3 on the MMPS and participant-assessed MMPS-Participant (MMPS-P), ≥2-grade improvement on the participant-assessed MMPS-P, and change from baseline in lower-facial width. Outcomes were assessed using validated measures. Adverse events (AEs) were monitored.

resultsOf 376 enrolled participants (onabotulinumtoxinA, n = 283; placebo, n = 93), 310 (82.4%) completed the study. At Day 90, a greater proportion of onabotulinumtoxinA-treated participants vs placebo achieved MMPS ≥2-grade improvement (51.2% vs 2.2%, P < .0001), and more onabotulinumtoxinA-treated participants vs placebo achieved the secondary endpoints (all P < .0001), with a mean lower-facial width reduction of -5.24 mm for onabotulinumtoxinA vs -0.04 mm for placebo (P < .0001). Participants reported benefits for onabotulinumtoxinA vs placebo in self-perceived change in MMP, treatment satisfaction, and psychosocial impact. Improvements were sustained through Day 180. Most AEs were mild, nonserious, and resolved.

conclusionsOnabotulinumtoxinA effectively reduced the appearance of MMP and improved PROs, with effects lasting up to 6 months and a favorable safety profile. LEVEL OF EVIDENCE: 1 (THERAPEUTIC):

Indexed as

Botulinum Toxins, Type AMasseter MuscleNeuromuscular AgentsAdultAgedDouble-Blind MethodFemaleHumansInjections, IntramuscularMaleMiddle AgedPatient Reported Outcome MeasuresProspective StudiesTreatment OutcomeBotulinum Toxins, Type ANeuromuscular Agentsonabotulinum toxin A

Identifiers

PMID41092464
PMCPMC13064654

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.