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Jaw-dropping results? BOTOX tested for square face fix

NCT ID NCT06068855

Symptom relief Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether BOTOX injections can safely reduce the size of the jaw muscle, making the lower face look slimmer and more oval. About 249 adults with a very prominent jaw muscle received either BOTOX or a placebo. The goal was to see if BOTOX could improve the appearance as judged by both doctors and participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

249 people

The number who actually took part.

Started

Oct 2023

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

masticatory muscles, hypertrophy of

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Masseter muscle prominence

Contacts and locations

Locations

  • Azienda Unita Sanitaria Locale Latina /ID# 246835

    Latina, 04100, Italy

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

    Verona, 37134, Italy

  • Cabinet Dermatologie et Esthetique /ID# 246871

    Cannes, 06400, France

  • Cabinet de Chirurgie Plastique et Esthétique /ID# 246872

    Toulouse, 31000, France

  • Cabinet médical /ID# 246873

    Paris, 75007, France

  • Clinica Alejandria /ID# 247380

    Valencia, Valencia, 46004, Spain

  • Clinica Robega /ID# 252239

    Madrid, 28008, Spain

  • Da Vinci Clinic /ID# 246731

    Beerse, Antwerpen, 2340, Belgium

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

    Plovdiv, 4000, Bulgaria

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

    Edinburgh, EH3 6RS, United Kingdom

  • Evolve Clinic /ID# 246729

    Schilde, Antwerpen, 2970, Belgium

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

    Roma, 00128, Italy

  • Gavín Dermatólogos /ID# 252120

    Vigo, Pontevedra, 36201, Spain

  • Grupo Pedro Jaen /ID# 246485

    Madrid, 28006, Spain

  • Hautok and Hautok-cosmetics /ID# 246600

    Munich, Bavaria, 80333, Germany

  • Hautzentrum Koeln /ID# 247502

    Cologne, North Rhine-Westphalia, 50996, Germany

  • Interface Aesthetics Training Limited /ID# 248115

    London, W1H 6AZ, United Kingdom

  • Lightfalls Clinic /ID# 247335

    Melle, Oost-Vlaanderen, 9090, Belgium

  • MediZen /ID# 246431

    Sutton Coldfield, B74 2UG, United Kingdom

  • Medical Center Derma Vita EOOD /ID# 247327

    Sofia, 1407, Bulgaria

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

    Sofia, 1700, Bulgaria

  • Mediti /Id# 246875

    Antibes, 06160, France

  • Privatpraxis Dr. Hilton & Partner /ID# 246602

    Düsseldorf, North Rhine-Westphalia, 40212, Germany

  • Studienzentrum Theatiner46 /ID# 246601

    Munich, Bavaria, 80333, Germany

  • Universitaet Hamburg /ID# 247503

    Hamburg, 20146, Germany

  • Universitair Ziekenhuis Brussel /ID# 246311

    Jette, Brussels Capital, 1090, Belgium

  • Waverley Medical Practice /ID# 246432

    Coatbridge, North Lanarkshire, ML5 3AP, United Kingdom

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