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Completed

NCT Number: NCT04073303

BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence

This study is designed to evaluate the safety and effectiveness of administering BOTOX for the treatment of Masseter Muscle Prominence (MMP) in adults.

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Key information

Conditions

Masseter Muscle Prominence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Duplicate_Beacon Dermatology Inc /ID# 233018, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin type A

Biological

Day 1 Administration of bilateral intramuscular injections into the masseter

Other names: OnabotulinumtoxinA, BOTOX®

Placebo

Other

Day 1 Administration of bilateral intramuscular injections of placebo (normal saline) into the masseter

Primary outcomes

  1. Achievement of ≥ 2-Grade Improvement From Baseline on the Masseter Muscle Prominence Scale (MMPS) at Day 90

    Time frame: Day 90

    Proportion of participants who achieve ≥ 2-grade improvement from baseline at Day 90, per investigator assessments of MMP using the Masseter Muscle Prominence Scale (MMPS).

    MMPS ranges from 1 = minimal to 5 = very marked.

Secondary outcomes

  1. Achievement of MMPS Grade ≤ 3 at Day 90

    Time frame: Day 90

    Proportion of participants who achieve MMPS Grade of ≤ 3 at Day 90, per investigator assessments of MMP using the Masseter Muscle Prominence Scale (MMPS).

    MMPS ranges from 1 = minimal to 5 = very marked.

  2. Achievement of MMPS-P Grade ≤ 3 on Day 90

    Time frame: Day 90

    Proportion of participants who achieve MMPS-P Grade ≤ 3 at Day 90, according to participant, per Masseter Muscle Prominence Scale-Participant (MMPS-P)

    MMPS-P ranges from 1 = not at all pronounced to 5 = very pronounced.

  3. Achievement of MMPS-P ≥ 2-Grade Improvement From Baseline at Day 90

    Time frame: Day 90

    Proportion of participants who achieve ≥ 2-grade improvement from baseline at Day 90, per Masseter Muscle Prominence Scale-Participant (MMPS-P)

    MMPS-P ranges from 1 = not at all pronounced to 5 = very pronounced.

  4. Achievement of PSAC Grade ≥ 1 (at Least Minimally Improved From Baseline) on Day 90

    Time frame: Day 90

    Proportion of participants who achieve Grade ≥ 1 on Participant Self-Assessment of Change (PSAC) (at least minimally improved from baseline) at Day 90

    PSAC ranges from 3 = much improved to -3 = much worse.

  5. Change From Baseline in Lower Facial Width (mm) at Day 90

    Time frame: Day 90

    Calculated from standardized images, measured in millimeters (mm)

  6. Median Duration of Effect for MMPS Responders

    Time frame: Up to Day 360

    Median duration of effect for BOTOX-treated MMPS responders.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 29, 2019
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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