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BOTOX for a sharper jawline? phase 3 trial tests Muscle-Weakening shots

NCT ID NCT06399718

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This completed Phase 3 study tested whether BOTOX injections can safely reduce the appearance of a widened lower face caused by prominent masseter (chewing) muscles. About 207 adults with moderate-to-severe muscle prominence received either BOTOX or a placebo in both sides of the jaw. The study measured changes in muscle size and participant satisfaction over several months, with an option for repeat treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
onabotulinumtoxinA (BOTOX)
What this could lead to
If it works, this could offer a non-surgical option to slim the lower face by relaxing the chewing muscles.
What could go wrong
This is a cosmetic treatment, not a cure for a disease. Results may be modest, temporary, and side effects like injection-site reactions or asymmetry are possible.

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

207 people

The number who actually took part.

Started

Apr 2024

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: * Participant meets the following criteria: * Bilateral Grade 4 or Grade 5 Masseter Muscle Prominence (MMP) (identical grades for left and right sides of the face), as determined by the investigator using the Masseter Muscle Prominence Scale (MMPS). * Bilateral Grade 4 or Grade 5 MMP (identical grades for left and right sides of the face), as determined by the participant using the Masseter Muscle Prominence Scale - Participant (MMPS-P). * Investigator and participant scoring of MMPS and MMPS-P must be the same. * Body mass index (BMI) ≤ 30 kg/m\^2 using the calculation: BMI = weight (kg)/height (m)\^2. Exclusion Criteria: * 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. * Asymmetry of left and right sides of the face that could prevent identical MMPS or MMPS-P grading on both sides of the face. * History of or current temporomandibular disorder (TMJD), or presence of signs/symptoms of possible TMJD.

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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

  • Aesthetic Center at Woodholme /ID# 248481

    Baltimore, Maryland, 21208-6391, United States

  • Austin Institute for Clinical Research at SBA Dermatology /ID# 248228

    Houston, Texas, 77056-4129, United States

  • DeNova Research /ID# 248237

    Chicago, Illinois, 60610, United States

  • DelRicht Research /ID# 250313

    Baton Rouge, Louisiana, 70809, United States

  • DermResearch Inc. /ID# 248227

    Austin, Texas, 78759, United States

  • Etre Cosmetic Dermatology and Laser Center /ID# 248229

    New Orleans, Louisiana, 70130-4353, United States

  • Kavali Plastic Surgery and Skin Renewal Center /ID# 248480

    Atlanta, Georgia, 30328, United States

  • Laser & Skin Surgery Center of New York /ID# 248479

    New York, New York, 10016-4974, United States

  • Luxurgery /ID# 248236

    New York, New York, 10021, United States

  • Michigan Center for Research Corporation /ID# 249145

    Clinton Township, Michigan, 48038, United States

  • Pacific Clinical Innovations /ID# 248231

    Vista, California, 92083-6030, United States

  • Private Practice - Dr. Steven G. Yoelin /ID# 268046

    Newport Beach, California, 92663, United States

  • Sherber + RAD /ID# 248894

    Washington D.C., District of Columbia, 20005-5002, United States

  • Sherman Aesthetic Center /ID# 248482

    Nashville, Tennessee, 37205-2205, United States

  • Skin Research Institute LLC /ID# 248230

    Coral Gables, Florida, 33146-1837, United States

  • Skin Specialists /ID# 248233

    Omaha, Nebraska, 68144, United States

  • Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 248478

    Boca Raton, Florida, 33431-6465, United States

  • The Practice of Brian S. Biesman MD PLLC /ID# 248226

    Nashville, Tennessee, 37203, United States

  • Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 249875

    Austin, Texas, 78746-4720, United States

  • Westside Aesthetics /ID# 248232

    Los Angeles, California, 90025-1708, United States

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