BOTOX for Prominent Jaw Muscles

(MMP US P3 417 Trial)

Recruiting at 20 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Facial fat, Asymmetry, 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

Duration: 12 weeks

207 Participants Needed

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 a BOTOX injection 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.

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.

What data supports the effectiveness of the drug BOTOX for prominent jaw muscles?

Research shows that botulinum toxin type A, similar to BOTOX, effectively reduces the size of prominent jaw muscles (masseteric hypertrophy) with benefits lasting up to 6 months and high patient satisfaction. ^{1 2 3 4 5}

Is BOTOX safe for use in humans?

BOTOX, also known as onabotulinumtoxinA, has a strong safety record for cosmetic uses, with no known long-term adverse effects. Minor side effects like mild pain at the injection site, headache, or flu-like symptoms are uncommon and usually go away on their own. ^{6 7 8 9 10}

How does the drug BOTOX differ from other treatments for prominent jaw muscles?

BOTOX (OnabotulinumtoxinA) is unique because it offers a non-surgical, minimally invasive option for treating prominent jaw muscles by temporarily relaxing them, which can help avoid more invasive procedures like surgery or prolonged use of occlusal splints. This approach is also used effectively in other conditions like bruxism and gummy smile, providing cosmetic and pain relief benefits with high patient satisfaction. ^{5 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 must be willing to receive injections and attend monthly visits at the clinic or hospital. People who don't meet these requirements or have conditions that could interfere with the trial may not participate.

Inclusion Criteria

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

My jaw muscles are very prominent, rated as the highest on a specific scale.

Participant's Body mass index (BMI) must be ≤ 30 kg/m^2

Exclusion Criteria

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

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 noticeable lower facial fat or loose skin that might affect facial grading.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

12 weeks

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Monthly visits (in-person)

Open-label extension (optional)

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

6 months

Treatment Details

Interventions

• BOTOX

Trial Overview The trial is testing BOTOX injections against a placebo to see if they can safely reduce the size of masseter muscles in adults. Participants are randomly assigned to get either BOTOX or a placebo, with a follow-up period where eligible participants might receive additional 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 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

Findings from Research

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]

In a study involving 23 subjects, incobotulinumtoxinA effectively reduced the appearance of platysmal bands, with 100% of participants showing improvement by Day 8 after treatment.

The treatment was well-tolerated with no serious adverse events reported, and subjects reported significant satisfaction with their results, particularly at maximum tension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IncobotulinumtoxinA for the treatment of platysmal bands: a single-arm, prospective proof-of-concept clinical study. Prager, W., Bee, EK., Havermann, I., et al.[2014]

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]

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]

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]

A systematic review of 364 papers identified 86 relevant studies on the safety and patient satisfaction of abobotulinumtoxinA for aesthetic use, indicating a thorough examination of its effects.

The review also considered the potential risks of neutralizing antibodies and systemic toxicity, highlighting the importance of understanding these factors in special populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Patient Satisfaction of AbobotulinumtoxinA for Aesthetic Use: A Systematic Review. Cohen, JL., Scuderi, N.[2022]

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. 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]

2. Scotland pubmed.ncbi.nlm.nih.gov

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

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

IncobotulinumtoxinA for the treatment of platysmal bands: a single-arm, prospective proof-of-concept clinical study. [2014]

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

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

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

A simplified method for smile enhancement: botulinum toxin injection for gummy smile. [2022]

6. 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]

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

Complications with the use of botulinum toxin type A for cosmetic applications and hyperhidrosis. [2010]

8. England pubmed.ncbi.nlm.nih.gov

A review of AbobotulinumtoxinA (Dysport). [2016]

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

Adverse Events Associated With Botox as Reported in a Food and Drug Administration Database. [2021]

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

Safety and Patient Satisfaction of AbobotulinumtoxinA for Aesthetic Use: A Systematic Review. [2022]

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

Surface anatomy of the lip elevator muscles for the treatment of gummy smile using botulinum toxin. [2022]

12. India pubmed.ncbi.nlm.nih.gov

Assessment of Electromyographic Changes in a Patient with Masseter Hypertrophy and Muscle Pain after Botulinum Injections: A Case Report and 5 Months Follow-up. [2022]

13. France pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A for the treatment of excessive gingival display - A systematic review. [2023]

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]