BOTOX for Enlarged Jaw Muscles

(MMP US P3 416 Trial)

Not currently recruiting at 21 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Excess facial fat, TMJD, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of BOTOX, a muscle-relaxing injection, for treating Masseter Muscle Prominence (MMP), which can enlarge jaw muscles and widen the lower face. Participants will receive either BOTOX or a placebo injected into their jaw muscles to assess its impact on reducing prominence. Individuals with noticeable MMP on both sides of their face and a body mass index (BMI) of 30 or less may qualify. The study requires regular hospital or clinic visits and monitoring for side effects. As a Phase 3 trial, it represents the final step before FDA approval, allowing participants to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more information.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BOTOX is usually well-tolerated for reducing the size of the masseter muscle, located in the jaw. Studies have found that BOTOX can shrink this muscle without harming the jaw or teeth. Some participants experienced temporary muscle weakness and decreased bite strength, but these effects were not permanent and typically resolved over time. Overall, the treatment has been safe for most participants, making it a promising option for those seeking to reduce jaw muscle size for cosmetic reasons. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using BOTOX for enlarged jaw muscles because it offers a minimally invasive approach with potentially fewer side effects compared to surgical options like jaw reshaping or reduction. While most treatments for this condition involve significant recovery time and risk, BOTOX works by temporarily relaxing the masseter muscles, which can reduce size and improve facial aesthetics without surgery. This treatment could offer a quick, outpatient solution that allows for adjustments over time, providing personalized results with each injection.

What evidence suggests that BOTOX might be an effective treatment for Masseter Muscle Prominence?

Research has shown that BOTOX, which participants in this trial may receive, can effectively shrink the masseter muscle, potentially making the lower face appear slimmer. One study found that people who received BOTOX experienced a noticeable decrease in the size of this muscle without affecting jaw or teeth function. Another study found that changes in facial shape were visible and lasted for 6 to 9 months. These results suggest that BOTOX is a promising option for those seeking to reduce jaw muscle size for cosmetic reasons. ^{2 3 4 5 6}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with Masseter Muscle Prominence, which causes a widened lower face, can join this study. They'll be randomly assigned to receive either BOTOX or a placebo injection. Participants must be willing to attend monthly visits and may have the option for additional BOTOX treatment.

Inclusion Criteria

Investigator and participant scoring of MMPS and MMPS-P must be the same

I have severe jaw muscle prominence as I rated myself on the MMPS-P.

Body mass index (BMI) must be ≤ 30 kg/m^2 using the calculation: BMI = weight (kg)/height (m)^2

Exclusion Criteria

I have noticeable lower facial fat or loose skin that might affect facial 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

I have or might have jaw joint (TMJ) problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-Blind Treatment

Participants receive intramuscular injections of either BOTOX or placebo across both the right and left masseter muscle on Day 1

90 days

Monthly visits (in-person)

Open-Label Retreatment

Eligible participants receive BOTOX injections on either Day 180, 210, 240, or 270 and are followed for up to 6 months

6 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• BOTOX

Trial Overview The trial is testing if BOTOX injections are safe and effective in reducing the size of masseter muscles compared to a placebo. It involves two periods: initial random assignment to BOTOX or placebo, followed by an optional phase where eligible participants can get more BOTOX treatments.

How Is the Trial Designed?

Group I: Open-Label Period: BOTOX Experimental Treatment 1 Intervention

Participants who are eligible for re-treatment will receive BOTOX injections on either the Day 180, 210, 240, or 270 visit and will be followed for up to 6 months.

Group II: Double-Blind Period: BOTOX Experimental Treatment 1 Intervention

Participants will receive BOTOX injections across both the right and left masseter muscle on Day 1.

Group III: Double-Blind Period: Placebo Placebo Group 1 Intervention

Participants will receive placebo injections across both the right and left masseter muscle on Day 1.

BOTOX is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Botox for:

• Chronic migraine
• Involuntary muscle contractions or twitching
• Excessive sweating
• Increased saliva
• Overactive bladder
• Crow's Feet
• Glabellar Lines
• Facial Wrinkles
• Orbicularis Oculi
• Platysma Bands

Approved in United States as Botox for:

• Chronic migraine
• Involuntary muscle contractions or twitching
• Excessive sweating
• Increased saliva
• Overactive bladder
• Crow's Feet
• Glabellar Lines
• Facial Wrinkles
• Orbicularis Oculi
• Platysma Bands
• Cervical Dystonia
• Blepharospasm
• Chronic Spasticity
• Bruxism
• Dystonia
• Headache

Approved in Canada as Botox for:

• Similar to those in the United States and European Union, specific details may vary

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

Botulinum toxin type A was successfully used to treat a patient with bilateral masseteric hypertrophy in a double-blind placebo-controlled study, demonstrating its efficacy for this condition.

The treatment showed no significant side effects and the benefits lasted for at least 6 months, indicating a safe and effective long-term solution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The medical management of masseteric hypertrophy with botulinum toxin type A. Moore, AP., Wood, GD.[2022]

A total of 188 adverse events related to facial cosmetic Botulinum toxin A (BoNT-A) injections were reported to the UK Medicines & Healthcare products Regulatory Agency (MHRA) from 1991 to 2020, indicating a need for better monitoring of these procedures.

The complication rate for aesthetic BoNT-A injections was found to be 16% in a meta-analysis of 30 studies, which is significantly higher than the rates reported to the MHRA, suggesting that the agency may be underestimating the risks associated with these treatments and highlighting the need for improved reporting and patient safety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of facial cosmetic botulinum toxin A injection: analysis of the UK Medicines & Healthcare Products Regulatory Agency registry and literature review. Zargaran, D., Zoller, FE., Zargaran, A., et al.[2022]

In a study involving 25 Korean patients, abobotulinum toxin A showed slightly better clinical improvement in treating masseter muscle hypertrophy compared to onabotulinum toxin A, with mean improvement scores of 2.8 vs 2.7 at 8 weeks and 2.9 vs 2.7 at 12 weeks.

The results suggest that abobotulinum toxin A may be more effective for some patients, as 20% showed more pronounced improvement with it compared to onabotulinum toxin A, providing valuable dosing information for future treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abobotulinum toxin A and onabotulinum toxin A for masseteric hypertrophy: a split-face study in 25 Korean patients. Lee, SH., Wee, SH., Kim, HJ., et al.[2022]

In a study involving 6 patients with masseter muscle hypertrophy, treatment with botulinum toxin type A resulted in satisfactory reduction of muscle size and relief from mild pain.

The therapy was deemed safe and effective, although recurrence of hypertrophy occurred in 2 out of the 6 patients, suggesting that while the treatment is beneficial, some patients may require additional interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A in the management of masseter muscle hypertrophy. Castro, WH., Gomez, RS., Da Silva Oliveira, J., et al.[2019]

In a study involving 120 patients treated with Botulinum Toxin A (BTxA) for bruxism, 95% reported good to excellent improvement in their symptoms, indicating high efficacy of the treatment.

The treatment was well-tolerated with no significant side effects reported, suggesting that BTxA is a safe option for managing bruxism, although further research is needed to evaluate its long-term effects on dental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum Toxin A in bruxers. One year experience. Redaelli, A.[2011]

In a study involving 18 fresh cadaver heads, it was found that injecting 1 ml of botulinum neurotoxin A into the masseter muscle resulted in significantly greater spreading of the substance compared to a 0.5 ml injection, which could lead to undesirable effects like a sunken lateral cheek.

The research indicates that the volume of the injection directly affects the spread of the neurotoxin, with the 1 ml injection causing upward spreading in 94.44% of cases, suggesting that careful volume control is crucial to avoid aesthetic complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pivotal role of injection volume on sunken cheek prevention in masseter muscle BoNT-A injection: A cadaver study. Yu, P., Zhai, H., Li, Z., et al.[2021]

Botulinum toxin A (BTXA) is widely used for cosmetic procedures and generally has a favorable safety profile, but it still carries inherent risks associated with any medical intervention.

The review discusses various adverse effects of aesthetic BTXA, both for approved and off-label uses, and provides strategies for their prevention and management based on published data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin complications in registered and off-label aesthetic indications. Landau, M., Nestor, MS., de Almeida, AT., et al.[2021]

Botulinum toxin injections are an effective and innovative treatment for bilateral masseteric hypertrophy, providing a non-surgical alternative with several advantages over traditional surgery.

The treatment has shown no significant side effects, making it a safe option for routine use in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin treatment of bilateral masseteric hypertrophy. Smyth, AG.[2019]

A meta-analysis of 1678 participants from multiple studies confirmed that onabotulinumtoxinA is safe and well-tolerated for treating facial lines, with no significant difference in overall adverse event incidence compared to placebo.

The most common treatment-related adverse events were mild to moderate, including eyelid sensory disorder and eyelid ptosis, but these were infrequent and decreased with repeated treatments, indicating a favorable long-term safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of onabotulinumtoxinA in the treatment of facial lines: a meta-analysis of individual patient data from global clinical registration studies in 1678 participants. Brin, MF., Boodhoo, TI., Pogoda, JM., et al.[2022]

Botulinum toxin was used to treat cases of masseteric hypertrophy, which is an enlargement of the masseter muscle, often leading to facial pain.

The treatment effectively alleviated muscular facial pain associated with the hypertrophy, suggesting that botulinum toxin can be a safe and effective intervention for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The medical management of masseteric hypertrophy with botulinum toxin. Finn, S., Ryan, P., Sleeman, D.[2010]

In a study of 24 patients with bruxism, botulinum toxin type A (BTX-A) significantly reduced myofascial pain at rest and during chewing compared to placebo and control groups, indicating its efficacy in pain management.

BTX-A treatment also led to a significant decrease in maximum occlusal force, suggesting it can effectively modify the force exerted by masticatory muscles in bruxism patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of botulinum toxin in treating myofascial pain and occlusal force characteristics of masticatory muscles in bruxism. Jadhao, VA., Lokhande, N., Habbu, SG., et al.[2018]

A systematic review of 10 studies involving various cosmetic uses of abobotulinumtoxinA (aboBoNT-A) showed positive outcomes in reducing wrinkles and improving facial aesthetics, with no serious adverse events reported.

Patient satisfaction was high across the studies, indicating that aboBoNT-A is a safe and effective option for cosmetic treatments in the middle and lower face and neck, warranting further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of AbobotulinumtoxinA for Cosmetic Treatments in the Neck, and Middle and Lower Areas of the Face: A Systematic Review. Galadari, H., Galadari, I., Smit, R., et al.[2021]

OnabotulinumtoxinA (ONA) injections significantly improved the appearance of downturned mouths in subjects, with notable improvements observed at Weeks 4 and 12 after treatment, compared to a placebo group.

The treatment was well tolerated, with 100% of ONA-treated subjects reporting improvement at Week 4 and 90% at Week 12, indicating that the effects of the injections can last for at least 12 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel 3-Point Injection Technique for OnabotulinumtoxinA in the Upper Depressor Anguli Oris. Moradi, A., Khalifian, S., Alghoul, MS., et al.[2023]

AbobotulinumtoxinA, approved by the FDA in 2009 for facial aesthetics, is generally well tolerated and has a safety profile similar to other botulinum neurotoxin type A products.

The article discusses various clinical applications and indications for abobotulinumtoxinA, along with important information on handling, storage, and dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of AbobotulinumtoxinA (Dysport). Lorenc, ZP., Kenkel, JM., Fagien, S., et al.[2016]

Citations

1. nature.com nature.com/articles/s41598-024-65395-5

Exploring botulinum toxin's impact on masseter hypertrophy The present study aimed to assess the effectiveness and functional adverse effects of a single and multiple injections of botulinum toxin A ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9225551/

Botox Therapy for Hypertrophy of the Masseter Muscle ... In the present study, we observed that the temporalis muscle became slightly enlarged on the second follow-up visit after treatment with Botox.

3. jaad.org jaad.org/article/S0190-9622(24)03112-8/fulltext

Reduction of masseter muscle prominence after treatment ... OnabotulinumtoxinA was well tolerated and significantly reduced masseter muscle volume without negatively impacting mandible/teeth, supporting ...

4. academic.oup.com academic.oup.com/asj/article/45/10/1043/8088127

Controlled Phase 2b Trial to Assess the Efficacy and Safety of ... 0001). Improvements in lower facial volume, width, and angle were significantly greater for onabotA vs placebo at all time points. At Day 90, the proportion of ...

5. news.abbvie.com news.abbvie.com/2024-09-11-Allergan-Aesthetics-Launches-BOTOX-R-Cosmetic-onabotulinumtoxinA-for-Masseter-Muscle-Prominence-MMP-in-Adults-in-China

Allergan Aesthetics Launches BOTOX® Cosmetic ... Results typically lasted 6-9 months following BOTOX® Cosmetic treatment. Improvement was also seen in all secondary endpoints, as measured by ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11196657/

Exploring botulinum toxin's impact on masseter hypertrophy These temporary adverse effects include muscle weakness, a reduction in maximum bite force of up to 20% and a decrease in masticatory ...