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

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

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

Study Overview

• Status: Completed
• Conditions: Masseter Muscle Prominence
• Intervention / Treatment: Biological: Botulinum Toxin Type A; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 377
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3E 0B2
      • Duplicate_Beacon Dermatology Inc /ID# 233018
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 1K9
      • Project Skin MD LTD /ID# 232763
    • Vancouver, British Columbia, Canada, V6H 4E1
      • Pacific Derm /ID# 233156
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • Duplicate_Humphrey Cosmetic Dermatology /ID# 232764
  • Ontario
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • The Center For Dermatology /ID# 233001
• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital /ID# 233148
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital /ID# 233158
    • Beijing, Beijing, China, 100730
      • Duplicate_Peking Union Medical College Hospital /ID# 233072
    • Xicheng District, Beijing, China, 100034
      • Peking University First Hospital /ID# 232973
  • Guizhou
    • Tianjin, Guizhou, China, 300052
      • Tianjin Medical University General Hospital /ID# 232961
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 233008
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University /ID# 233027
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital /ID# 233016
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University /ID# 232836
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 232656
  • Shanxi
    • Xi'an, Shanxi, China, 710038
      • Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 233087
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University /ID# 233107
• Taiwan
  • Taipei City, Taiwan, 11031
    • Taipei Medical University Hospital /ID# 233009
  • Taipei City, Taiwan, 11490
    • Tri-Service General Hospital /ID# 233080
  • Keelung
    • Kaohsiung, Keelung, Taiwan, 807
      • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 233033
  • Taipei
    • Taipei City, Taipei, Taiwan, 100
      • National Taiwan University Hospital /ID# 233133

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Botulinum Toxin Type A (BOTOX®); Botulinum Toxin Type A (BOTOX ®) will be administered on Day 1 as bilateral intramuscular injections into the masseter with the possibility of 2 additional treatments	Biological: Botulinum Toxin Type A; Day 1 Administration of bilateral intramuscular injections into the masseter; Other Names: OnabotulinumtoxinA; BOTOX®
Placebo Comparator: Placebo; Placebo (normal saline) will be administered on Day 1 as bilateral intramuscular injections into the masseter	Other: Placebo; Day 1 Administration of bilateral intramuscular injections of placebo (normal saline) into the masseter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achievement of ≥ 2-Grade Improvement From Baseline on the Masseter Muscle Prominence Scale (MMPS) at 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.	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achievement of MMPS Grade ≤ 3 at 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.	Day 90
Achievement of MMPS-P Grade ≤ 3 on 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.	Day 90
Achievement of MMPS-P ≥ 2-Grade Improvement From Baseline at 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.	Day 90
Achievement of PSAC Grade ≥ 1 (at Least Minimally Improved From Baseline) on 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.	Day 90
Change From Baseline in Lower Facial Width (mm) at Day 90	Calculated from standardized images, measured in millimeters (mm)	Day 90
Median Duration of Effect for MMPS Responders	Median duration of effect for BOTOX-treated MMPS responders.	Up to Day 360

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ALLERGAN INC., Allergan

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2019
• Primary Completion (Actual): November 10, 2022
• Study Completion (Actual): November 10, 2022

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 29, 2019

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: April 18, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Neurotransmitter Agents; Membrane Transport Modulators; Cholinergic Agents; Neuromuscular Agents; Acetylcholine Release Inhibitors; Botulinum Toxins, Type A; abobotulinumtoxinA; Botulinum Toxins
• Other Study ID Numbers: 1789-301-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No