A Study to Assess the Effectiveness of BOTOX (Botulinum Toxin Type A) Injections for the Change of Masseter Muscle Prominence in Adult Participants

NCT06068855 | Completed Phase 3

• 2 other identifiers: M23-1232022-500568-37-00
• Study Type: interventional
• Target: 249
• Locations: 7 countries
• Sites: 27

Brief Summary

The masseter muscle is one of the muscles in the lower face used for chewing. Prominence of the masseter muscle can appear as a widened and square lower face shape, which is an aesthetic concern for individuals who prefer a narrower and more ovoid lower face shape. Treatments are available for masseter muscle prominice (MMP), but researchers are looking for new non-surgical treatments. This study will assess adverse events and effectiveness of BOTOX in adult participants with MMP. BOTOX is being investigated for the treatment of MMP. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is 1 in 4 chance that participants will be assigned to placebo. Around 248 adult participants with MMP will be enrolled in the study at approximately 30 sites in Europe. Participants will receive either BOTOX or Placebo administered as 6 intramuscular injections to the masseter on Day 1. Participants who are eligible for retreatment will be given BOTOX on Day 180 and will be followed for up to 6 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Conditions

Masseter Muscle Prominence

Keywords

Masseter Muscle Prominence; BOTOX; Botulinum Toxin Type A

Outcome Measures

Primary Outcomes (2)

• Achievement of 2-grade or more improvement from baseline on the Masseter Muscle Prominence Scale (MMPS) as assessed by the Investigator

  The investigator assessed the severity of the participant's MMP using the MMPS 5-point scale where: 1=minimal (best), 2=mild, 3=moderate, 4=marked, and 5=very marked (worst).

  Day 90

• Achievement of 2-grade or more improvement from baseline on the Masseter Muscle Prominence Scale - Participant (MMPS-P) as assessed by the Participant

  The participant assessed the severity of their MMP using the MMPS-P 5-point scale where: 1=not at all pronounced (best), 2=mildly pronounced, 3=moderately pronounced, 4=pronounced, and 5=very pronounced (worst).

  Day 90

Secondary Outcomes (5)

• Response of "Very Satisfied" or "Satisfied" on the Lower Facial Shape Questionnaire - Treatment Satisfaction Assessment (LFSQ-TXSAT)

  Day 90 to Day 180

• Response of "Not at all bothered" or "A little bothered" on the Bother Impact Assessment for Masseter Muscle Prominence (BIA-MMP)

  Day 90 to Day 180

• Change from baseline in lower facial volume (cm^3)

  Day 90

• Change from baseline in lower facial width (mm)

  Day 90

• Change from baseline in Lower Facial Shape Questionnaire - Impact Assessment (LFSQ-IA) summary score

  Day 90 to Day 180

Study Arms (3)

Double-Blind Period: Botox

EXPERIMENTAL

Participants will receive 6 intramuscular injections of BOTOX to the masseter on Day 1.

Drug: BOTOX

Open-Label Period: Botox

EXPERIMENTAL

Participants who are eligible for retreatment will be given open-label BOTOX on Day 180 and will be followed for up to 6 months

Drug: BOTOX

Double Blind Period: Placebo

PLACEBO COMPARATOR

Participants will receive 6 intramuscular injections of Placebo to the masseter on Day 1.

Drug: Placebo

Interventions

BOTOX DRUG

Intramuscular Injections

Also known as: Botulinum Toxin Type A

Double-Blind Period: Botox; Open-Label Period: Botox

Placebo DRUG

Intramuscular Injections

Double Blind Period: Placebo

Eligibility Criteria

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

You may qualify if:

• Body mass index \< 30 kg/m\^2 using the calculation: BMI = weight (kg)/height (m)\^2, rounded to the nearest whole number.
• Participants meets the following criteria:
• Bilateral Grade 4 or Grade 5 MMP (identical grades for left and right side of the face), as determined at screening and at the Day 1 visit by the investigator using the MMPS.
• Bilateral Grade 4 or Grade 5 MMP (identical grades for left and right sides of the face), as determined at the Day 1 visit by the participant using the MMPS-P.
• MMP grades, as assessed by investigator and participant, do not need to be identical but have to be a minimum of Grade 4 with bilateral symmetry at Day 1.
• Participants who responded "A lot" or "Extremely" bothered by the appearance of their MMP as measured by the Bother Impact Assessment for Masseter Muscle Prominence (BIA-MMP) and attain a total score of ≥ 15 on the Lower Facial Shape Questionnaire - Impact Assessment (LFSQ-IA), determined at the Day 1 visit.

You may not qualify if:

• Has current intraoral infection, including infection of the mouth or gums, or facial skin infection requiring medical treatment in the opinion of the investigator.
• Has weakness of the masseter, pterygoid, or temporalis muscles due to trauma, facial nerve injury, or other condition that could interfere with normal chewing and jaw clenching, as determined by the investigator.
• Excess lower facial fat, jowling, loose or lax skin in lower face, or parotid gland prominence that could interfere with MMPS or MMPS-P grading, as determined by the investigator.
• Has 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.
• History of dental or surgical procedure for lower facial shaping or masseter muscle reduction.
• History of any soft tissue fillers in the jawline.
• Has prior exposure to botulinum toxin of any serotype to any part of the body (not including masseter muscle) within the 3 months prior to Day 1.
• History of or current TMJD, or presence of signs/symptoms of possible TMJD in the opinion of the investigator.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (27)

Da Vinci Clinic /ID# 246731

Beerse, Antwerpen, 2340, Belgium

Location

Evolve Clinic /ID# 246729

Schilde, Antwerpen, 2970, Belgium

Location

Universitair Ziekenhuis Brussel /ID# 246311

Jette, Brussels Capital, 1090, Belgium

Location

Lightfalls Clinic /ID# 247335

Melle, Oost-Vlaanderen, 9090, Belgium

Location

Dermavist - Group Practice for Specialized Medical Care for Skin Disease /ID# 247630

Plovdiv, 4000, Bulgaria

Location

Medical Center Derma Vita EOOD /ID# 247327

Sofia, 1407, Bulgaria

Location

Medical Centre Dermatology Dr. Denkova EOOD /ID# 246591

Sofia, 1700, Bulgaria

Location

Mediti /Id# 246875

Antibes, 06160, France

Location

Cabinet Dermatologie et Esthetique /ID# 246871

Cannes, 06400, France

Location

Cabinet médical /ID# 246873

Paris, 75007, France

Location

Cabinet de Chirurgie Plastique et Esthétique /ID# 246872

Toulouse, 31000, France

Location

Hautok and Hautok-cosmetics /ID# 246600

Munich, Bavaria, 80333, Germany

Location

Studienzentrum Theatiner46 /ID# 246601

Munich, Bavaria, 80333, Germany

Location

Hautzentrum Koeln /ID# 247502

Cologne, North Rhine-Westphalia, 50996, Germany

Location

Privatpraxis Dr. Hilton & Partner /ID# 246602

Düsseldorf, North Rhine-Westphalia, 40212, Germany

Location

Universitaet Hamburg /ID# 247503

Hamburg, 20146, Germany

Location

Azienda Unita Sanitaria Locale Latina /ID# 246835

Latina, 04100, Italy

Location

Fondazione Policlinico Universitario Campus Bio-Medico /ID# 246836

Roma, 00128, Italy

Location

CRC - Centro Ricerche Cliniche di Verona S.r.l. /ID# 246834

Verona, 37134, Italy

Location

Gavín Dermatólogos /ID# 252120

Vigo, Pontevedra, 36201, Spain

Location

Clinica Alejandria /ID# 247380

Valencia, Valencia, 46004, Spain

Location

Grupo Pedro Jaen /ID# 246485

Madrid, 28006, Spain

Location

Clinica Robega /ID# 252239

Madrid, 28008, Spain

Location

Waverley Medical Practice /ID# 246432

Coatbridge, North Lanarkshire, ML5 3AP, United Kingdom

Location

Dr Nestor's Medical Cosmetic Centre /ID# 246437

Edinburgh, EH3 6RS, United Kingdom

Location

Interface Aesthetics Training Limited /ID# 248115

London, W1H 6AZ, United Kingdom

Location

MediZen /ID# 246431

Sutton Coldfield, B74 2UG, United Kingdom

Location

Related Links

• Related Info

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

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 5, 2023
• Study Start: October 17, 2023
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

FR (4); GB (4); ES (4); DE (5); BE (4); BU (3); IT (3)