BOTOX for Enlarged Jaw Muscles

(MMP US P3 416 Trial)

Recruiting at21 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AbbVie

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The masseter muscle is one of the muscles in the lower face used for chewing. The prominence of the masseter muscle can appear as a widened lower face which some individuals deem as aesthetically undesirable and can be treated by selectively weakening the masseter muscles with small quantities of botulinum toxin. The purpose of this study is to assess how safe and effective injection of onabotulinumtoxinA (BOTOX) is in adult participants with Masseter Muscle Prominence (MMP). BOTOX is being investigated for the treatment of Muscle Masseter Prominence. In Period 1, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment, placebo or BOTOX. There is a 1 in 4 chance that participants will be assigned to placebo. In Period 2, eligible participants can receive an optional open-label retreatment of BOTOX. Approximately 200 adult participants with MMP will be enrolled in the study at approximately 20 sites in the United States. Participants will receive intramuscular injections across both the right and left masseter muscle of either BOTOX or placebo on Day 1. Participants who are eligible for re-treatment will be given BOTOX injections on either the Day 180, 210, 240, or 270 visit and will be followed up 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 monthly 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.

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.

What data supports the idea that BOTOX for Enlarged Jaw Muscles is an effective treatment?

The available research shows that BOTOX, specifically botulinum toxin type A, is effective for treating enlarged jaw muscles. One study reported successful treatment with no significant side effects, and the benefits lasted for 6 months. Another study compared two types of botulinum toxin A in 25 patients and found noticeable improvement in muscle size after 8 and 12 weeks. These studies suggest that BOTOX can effectively reduce the size of enlarged jaw muscles. ^{1 2 3 4 5}

What safety data exists for BOTOX in treating enlarged jaw muscles?

The safety data for BOTOX, also known as onabotulinumtoxinA, indicates that it is generally well-tolerated with a favorable benefit:risk profile, especially in cosmetic applications like facial lines. Adverse events are similar to those reported with other botulinum toxin A products. Studies and regulatory reviews, such as those by the UK Medicines & Healthcare Products Regulatory Agency, support its safety in aesthetic uses, although all medical interventions carry some risks. ^{6 7 8 9 10}

Is the drug BOTOX a promising treatment for enlarged jaw muscles?

Yes, BOTOX is a promising treatment for enlarged jaw muscles. It has been shown to effectively reduce the size of the muscles without significant side effects, and the benefits can last for several months. It is also a noninvasive alternative to surgery, making it a convenient option for patients. ^{4 11 12 13 14}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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.

Treatment Details

Interventions

• BOTOX (Neuromodulator)

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.

Participant Groups

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 Canada for the following indications:

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

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Abobotulinum toxin A and onabotulinum toxin A for masseteric hypertrophy: a split-face study in 25 Korean patients. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A in the management of masseter muscle hypertrophy. [2019]

3. Switzerland 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. [2021]

4. Scotland pubmed.ncbi.nlm.nih.gov

The medical management of masseteric hypertrophy with botulinum toxin type A. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Novel 3-Point Injection Technique for OnabotulinumtoxinA in the Upper Depressor Anguli Oris. [2023]

6. England pubmed.ncbi.nlm.nih.gov

A review of AbobotulinumtoxinA (Dysport). [2016]

7. Saudi Arabia pubmed.ncbi.nlm.nih.gov

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

8. United States 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. [2022]

9. Netherlands 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. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Botulinum toxin complications in registered and off-label aesthetic indications. [2021]

11. Ireland pubmed.ncbi.nlm.nih.gov

The medical management of masseteric hypertrophy with botulinum toxin. [2010]

12. Scotland pubmed.ncbi.nlm.nih.gov

Botulinum toxin treatment of bilateral masseteric hypertrophy. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Pivotal role of injection volume on sunken cheek prevention in masseter muscle BoNT-A injection: A cadaver study. [2021]

14. India pubmed.ncbi.nlm.nih.gov

Efficacy of botulinum toxin in treating myofascial pain and occlusal force characteristics of masticatory muscles in bruxism. [2018]