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): 376
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3E 0B2
      • Beacon Dermatology Inc /ID# 233018
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • Humphrey Cosmetic Dermatology /ID# 232764
    • Vancouver, British Columbia, Canada, V6H 1K9
      • Project Skin MD LTD /ID# 232763
    • Vancouver, British Columbia, Canada, V6H 4E1
      • Pacific Derm /ID# 233156
  • Ontario
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • The Center For Dermatology /ID# 233001
• China
  • Shanghai, China, 200011
    • Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 232656
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital /ID# 232961
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital /ID# 233148
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital /ID# 233072
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital /ID# 233158
    • Xicheng District, Beijing, China, 100034
      • Peking University First Hospital /ID# 232973
  • 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
  • Shaanxi
    • Xi'an, Shaanxi, 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
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 233033
  • Taipei City, Taiwan, 100
    • National Taiwan University Hospital /ID# 233133
  • Taipei City, Taiwan, 11031
    • Taipei Medical University Hospital /ID# 233009
  • Taipei City, Taiwan, 11490
    • Tri-Service General Hospital /ID# 233080

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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
Proportion of responders that show change in masseter muscle prominence (MMP)	Investigator assessment of severity of MMP using the Masseter Muscle Prominence Scale (MMPS). Score ranges from 1 = minimal to 5 = very marked	Baseline, Day 90
Incidence of Adverse Events (AEs)	The number of patients who experienced one or more AEs during the study	Up to 18 Months
Change from baseline in vital sign values (blood pressure, respiratory rate, and pulse rate)	Summary statistics of change from baseline vital sign values	Up to 18 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of responders who achieve a clinical target on a MMP scale	Investigator assessment of MMP using a scale ranging from minimal to very marked	Baseline, Day 90
Proportion of responders who achieve improvement using a self-assessment scale	Improvement of MMP is self-assessed by the participant using a scale ranging from not at all pronounced to very pronounced.	Baseline, Day 90
Proportion of responders that show improvement in MMP	Improvement of MMP is self-assessed by the participant using a scale for change in MMP ranging from much improved to much worse	Baseline, Day 90
Change from baseline in lower facial width	Calculated from standardized images, measured in millimeters (mm)	Baseline, Day 90
Duration of treatment effect	Improvement from baseline of MMP	Baseline, Day 90

Collaborators and Investigators

• Sponsor: Allergan
• 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): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

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