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

Last updated: December 9, 2024
Sponsor: AbbVie
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

Placebo

BOTOX

Clinical Study ID

NCT06068855
M23-123
2022-500568-37-00
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 ofthe face), as determined at screening and at the Day 1 visit by theinvestigator using the MMPS.

  • Bilateral Grade 4 or Grade 5 MMP (identical grades for left and right sides ofthe face), as determined at the Day 1 visit by the participant using theMMPS-P.

  • MMP grades, as assessed by investigator and participant, do not need to beidentical 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 oftheir 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.

Exclusion

Exclusion Criteria:

  • Has current intraoral infection, including infection of the mouth or gums, or facialskin infection requiring medical treatment in the opinion of the investigator.

  • Has weakness of the masseter, pterygoid, or temporalis muscles due to trauma, facialnerve injury, or other condition that could interfere with normal chewing and jawclenching, as determined by the investigator.

  • Excess lower facial fat, jowling, loose or lax skin in lower face, or parotid glandprominence that could interfere with MMPS or MMPS-P grading, as determined by theinvestigator.

  • Has medical condition that may put the participant at increased medical risk withexposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome,amyotrophic lateral sclerosis, or any other condition that might interfere withneuromuscular function.

  • History of dental or surgical procedure for lower facial shaping or masseter musclereduction.

  • History of any soft tissue fillers in the jawline.

  • Has prior exposure to botulinum toxin of any serotype to any part of the body (notincluding masseter muscle) within the 3 months prior to Day 1.

  • History of or current TMJD, or presence of signs/symptoms of possible TMJD in theopinion of the investigator.

Study Design

Total Participants: 249
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
October 17, 2023
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Da Vinci Clinic /ID# 246731

    Beerse, Antwerpen 2340
    Belgium

    Site Not Available

  • Evolve Clinic /ID# 246729

    Schilde, Antwerpen 2970
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Brussel /ID# 246311

    Jette, Bruxelles-Capitale 1090
    Belgium

    Site Not Available

  • Lightfalls Clinic /ID# 247335

    Melle, Oost-Vlaanderen 9090
    Belgium

    Site Not Available

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

    Plovdiv, 4000
    Bulgaria

    Site Not Available

  • Medical Centre Dermatology Dr. Denkova EOOD /ID# 246591

    Sofia, 1700
    Bulgaria

    Site Not Available

  • Medical Center Derma Vita EOOD /ID# 247327

    Sofiya, 1407
    Bulgaria

    Site Not Available

  • Mediti /Id# 246875

    Antibes, 06160
    France

    Site Not Available

  • Cabinet Dermatologie et Esthetique /ID# 246871

    Cannes, 06400
    France

    Site Not Available

  • Cabinet médical /ID# 246873

    Paris, 75007
    France

    Site Not Available

  • Cabinet de Chirurgie Plastique et Esthétique /ID# 246872

    Toulouse, 31000
    France

    Site Not Available

  • Hautok and Hautok-cosmetics /ID# 246600

    Muenchen, Bayern 80333
    Germany

    Site Not Available

  • Studienzentrum Theatiner46 /ID# 246601

    Muenchen, Bayern 80333
    Germany

    Site Not Available

  • Privatpraxis Dr. Hilton & Partner /ID# 246602

    Duesseldorf, Nordrhein-Westfalen 40212
    Germany

    Site Not Available

  • Hautzentrum Koeln /ID# 247502

    Koeln, Nordrhein-Westfalen 50996
    Germany

    Site Not Available

  • Universitaet Hamburg /ID# 247503

    Hamburg, 20146
    Germany

    Site Not Available

  • Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 246836

    Rome, Roma 00128
    Italy

    Site Not Available

  • Azienda Unita Sanitaria Locale Latina /ID# 246835

    Latina, 04100
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 246836

    Roma, 00128
    Italy

    Site Not Available

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

    Verona, 37134
    Italy

    Site Not Available

  • Gavín Dermatólogos /ID# 252120

    Vigo, Pontevedra 36201
    Spain

    Site Not Available

  • Clinica Alejandria /ID# 247380

    València, Valencia 46004
    Spain

    Site Not Available

  • Clinica Robega /ID# 252239

    Madrid, 28008
    Spain

    Site Not Available

  • Grupo Pedro Jaen /ID# 246485

    Madrid, 28006
    Spain

    Site Not Available

  • Waverley Medical Practice /ID# 246432

    Coatbridge, Lanarkshire ML5 3AP
    United Kingdom

    Site Not Available

  • Dr Nestor's Medical Cosmetic Centre /ID# 246437

    Edinburgh, EH3 6RS
    United Kingdom

    Site Not Available

  • Interface Aesthetics Training Limited /ID# 248115

    London, W1H 6AZ
    United Kingdom

    Site Not Available

  • MediZen /ID# 246431

    Sutton Coldfield, B74 2UG
    United Kingdom

    Site Not Available

  • MediZen Premier Aesthetic Clinic /ID# 246431

    Sutton Coldfield, B74 2UG
    United Kingdom

    Active - Recruiting

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