BOTOX for Prominent Jaw Muscles

(MMP US P3 417 Trial)

No longer recruiting at 21 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of BOTOX (OnabotulinumtoxinA) in reducing prominent jaw muscles, which some individuals find aesthetically undesirable. Participants will receive either BOTOX or a placebo to determine if BOTOX effectively reduces the appearance of large jaw muscles. Individuals with noticeable, symmetrical jaw prominence on both sides of the face may be suitable for this study. Participation involves regular clinic visits and medical assessments to monitor effects and side effects. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.

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 shows that Botox injections for treating large jaw muscles are generally safe. Studies have found that Botox, when used on the jaw muscles, is well-tolerated with few problems. For example, one study found that injections given in the recommended safe area greatly reduce the risk of side effects. Other research has shown that Botox can effectively shrink muscle size with few negative effects, even with repeated treatments.

In summary, Botox has a strong safety record for this type of treatment, with most side effects being mild and temporary. This makes it a promising option for those considering joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Masseter Muscle Prominence?

Researchers are excited about using BOTOX for prominent jaw muscles because it offers a non-surgical option to relax and reduce the size of the masseter muscles. Unlike traditional treatments like surgery or oral medications, BOTOX works by temporarily blocking nerve signals to the muscles, leading to a reduction in muscle activity and size. This provides a less invasive alternative with potentially quicker recovery times and fewer risks compared to surgical options. The precision of BOTOX injections allows for targeted treatment, which can lead to more natural-looking results without affecting other areas of the face.

What evidence suggests that BOTOX is effective for Masseter Muscle Prominence?

Research shows that BOTOX, which participants in this trial may receive, effectively reduces the size of the masseter muscle, making the lower face appear less wide. Studies have found that BOTOX significantly decreases muscle size without affecting jaw function or dental health, helping achieve a more desired facial shape. This trial will compare improvements in facial volume and width between participants receiving BOTOX and those receiving a placebo. Some temporary side effects, such as reduced bite strength, have been noted but are generally well-tolerated. ^{3 5 6 7 8}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

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

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]

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 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]

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]

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. 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 ...

2. 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0190962224031128

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

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

Botox Therapy for Hypertrophy of the Masseter Muscle ... The study shows that Botox injections reduce stiffness of the masticatory muscles which, in turn, increases the stiffness of the temporalis muscles.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29250900/

Complications of botulinum toxin injection for masseter ... Masseter injections remain very safe. To further decrease the incidence rate, injections should only be inside the recommended safety zone, a quadrilateral ...

7. 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 (BoNT-A) for ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2096691125000470

Botulinum toxin in orofacial muscle hypertonicity This review explores the pharmacological mechanisms, anatomical considerations, and clinical applications of BoNT-A in the treatment of functional disorders ...