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

NCT04073303 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 1789-301-008
• Study Type: interventional
• Target: 377
• Locations: 3 countries
• Sites: 21

Brief Summary

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

Conditions

Masseter Muscle Prominence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Achievement of MMPS Grade ≤ 3 at Day 90

  Day 90

• Achievement of MMPS-P Grade ≤ 3 on Day 90

  Day 90

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

  Day 90

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

  Day 90

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

  Day 90

Study Arms (2)

Botulinum Toxin Type A (BOTOX®)

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Placebo (normal saline) will be administered on Day 1 as bilateral intramuscular injections into the masseter

Other: Placebo

Interventions

Botulinum Toxin Type A BIOLOGICAL

Day 1 Administration of bilateral intramuscular injections into the masseter

Also known as: OnabotulinumtoxinA, BOTOX®

Botulinum Toxin Type A (BOTOX®)

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (21)

Duplicate_Beacon Dermatology Inc /ID# 233018

Calgary, Alberta, T3E 0B2, Canada

Location

Duplicate_Humphrey Cosmetic Dermatology /ID# 232764

Vancouver, British Columbia, V5Z 4E1, Canada

Location

Project Skin MD LTD /ID# 232763

Vancouver, British Columbia, V6H 1K9, Canada

Location

Pacific Derm /ID# 233156

Vancouver, British Columbia, V6H 4E1, Canada

Location

The Center For Dermatology /ID# 233001

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Peking University Third Hospital /ID# 233148

Beijing, Beijing Municipality, 100191, China

Location

Duplicate_Peking Union Medical College Hospital /ID# 233072

Beijing, Beijing Municipality, 100730, China

Location

Chinese PLA General Hospital /ID# 233158

Beijing, Beijing Municipality, 100853, China

Location

Peking University First Hospital /ID# 232973

Xicheng District, Beijing Municipality, 100034, China

Location

Tianjin Medical University General Hospital /ID# 232961

Tianjin, Guizhou, 300052, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 233008

Wuhan, Hubei, 430022, China

Location

Xiangya Hospital Central South University /ID# 233027

Changsha, Hunan, 410008, China

Location

Nanjing Drum Tower Hospital /ID# 233016

Nanjing, Jiangsu, 210008, China

Location

Zhongda Hospital Southeast University /ID# 232836

Nanjing, Jiangsu, 210009, China

Location

Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 232656

Shanghai, Shanghai Municipality, 200011, China

Location

Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 233087

Xi’an, Shanxi, 710038, China

Location

West China Hospital, Sichuan University /ID# 233107

Chengdu, Sichuan, 610041, China

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 233033

Kaohsiung City, Keelung, 807, Taiwan

Location

National Taiwan University Hospital /ID# 233133

Taipei City, Taipei, 100, Taiwan

Location

Taipei Medical University Hospital /ID# 233009

Taipei, 11031, Taiwan

Location

Tri-Service General Hospital /ID# 233080

Taipei, 11490, Taiwan

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: ABBVIE CALL CENTER
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

844-663-3742

Study Officials

• ALLERGAN INC.

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 29, 2019
• Study Start: August 29, 2019
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2022
• Last Updated: May 6, 2025
• Results First Posted: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• 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/

Locations

TW (4); CA (5); CN (12)