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Neurotoxin

Botulinum Toxin Type A (BOTOX®) for Masseter Muscle Hypertrophy

Phase 3

Waitlist Available

Research Sponsored by Allergan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 months

Awards & highlights

Study Summary

This trial will test whether Botox can safely and effectively treat people with enlarged masseter muscles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in vital sign values (blood pressure, respiratory rate, and pulse rate)

Incidence of Adverse Events (AEs)

Proportion of responders that show change in masseter muscle prominence (MMP)

Secondary outcome measures

Change from baseline in lower facial width

Duration of treatment effect

Proportion of responders that show improvement in MMP

+2 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Botulinum Toxin Type A (BOTOX®)Active Control1 Intervention

Botulinum Toxin Type A (BOTOX ®) will be administered on Day 1 as bilateral intramuscular injections into the masseter with the possibility of 2 additional treatments

Group II: PlaceboPlacebo Group1 Intervention

Placebo (normal saline) will be administered on Day 1 as bilateral intramuscular injections into the masseter

Do I qualify?Apply below to find out

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Who is running the clinical trial?

AllerganLead Sponsor

781 Previous Clinical Trials

275,429 Total Patients Enrolled

1 Trials studying Masseter Muscle Hypertrophy

187 Patients Enrolled for Masseter Muscle Hypertrophy

ALLERGAN INC.Study DirectorAllergan

75 Previous Clinical Trials

78,119 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some of the primary medical conditions that Botulinum Toxin Type A (BOTOX®) has been shown to help alleviate?

"Botulinum Toxin Type A, marketed as BOTOX®, can be used to help patients with urinary incontinence, spinal cord damage, and movement disorders caused by overactive muscles."

Answered by AI

How many people are being enrolled to test this new medication?

"This study is not currently enrolling patients. However, it is important to note that this study was posted on 2019-08-29 and was edited as recently as 2022-06-07. Additionally, there are 1 other study involving muscle tissue and 69 trials involving Botulinum Toxin Type A (BOTOX®) that are actively recruiting participants."

Answered by AI

What are the historical results of using Botulinum Toxin Type A (BOTOX®)?

"BOTOX® was first studied in 2012 at Rothman Institute. Up to this point, there have been a total of 18623 completed trials. Right now, 69 trials are actively recruiting, with many of them taking place in Richmond Hill, Ontario."

Answered by AI

What are the potential risks associated with BOTOX® treatments?

"There is pre-existing clinical evidence supporting the safety of Botulinum Toxin Type A (BOTOX), thus it received a score of 3."

Answered by AI

Can patients currently enroll in this research project?

"According to the clinicaltrials.gov website, this trial is not presently looking for candidates. The trial was initially posted on 2019-08-29 and was last updated on 2022-06-07. Even though this study is not recruiting right now, there are 70 other trials that are."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence

2019. "BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04073303.