Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

BOTOX® (Botulinum toxin type A) for the Reduction of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

This research study is investigating BOTOX® (a type of botulinum toxin) to see if it can help reduce the prominence of the masseter muscles – these are the chewing muscles at the back of your jaw. If these muscles are large, they can make the lower part of the face appear wider. The study is particularly interested in whether BOTOX® can effectively change the facial shape and reduce the muscle size. This is a Phase 3 study, meaning it’s a big step before BOTOX® might be considered for this specific use. We will be looking at how people feel about their facial appearance and what the doctors observe over about 90 days.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Abbvie Deutschland GmbH & Co. KG

Enrolment target

199

Start

06 Feb 2023

Masseter Muscle Prominence

What is this study about?

This study is about a treatment called BOTOX® which contains a substance called botulinum toxin type A. We're looking at its use for a condition called 'Masseter Muscle Prominence'. This simply means that the chewing muscles, located at the back of your jaw (they're called masseter muscles), are larger than usual. For some people, this can make the lower part of their face look wider or more square, and they might prefer a different facial shape.

The main goal of this study is to see if BOTOX® injections can reduce the size of these muscles and improve the overall shape of the lower face. Researchers want to understand how well BOTOX® works compared to a 'placebo' (which looks like the actual treatment but doesn't contain the active medicine). They'll be watching to see if there's a noticeable improvement in how the face looks and feels after about 90 days.

This is a 'Phase 3' study, which means it’s one of the final stages of research before a treatment might be considered for wider use. It involves many people and several treatment centers to make sure the results are reliable. It's also a 'double-blind' study, meaning neither the patient nor the doctor knows whether the patient is receiving BOTOX® or the placebo. This helps ensure the results are as fair and unbiased as possible.

Key takeaways

This study investigates BOTOX® for reducing jaw muscle size.
It aims to see if BOTOX® can improve lower facial shape.
Participation involves injections and follow-up visits over 3 months.
You might receive BOTOX® or a placebo (inactive treatment).
It's a 'double-blind' study, meaning neither you nor your doctor will know which you receive.
The study is for adults aged 18 and over.

Who may be eligible?

To take part in this study, you need to be an adult, at least 18 years old or older. The study is open to both men and women.

Beyond age and sex, there will be other important criteria that determine if this study is right for you. For example, your current health, any other medical conditions you have, and medicines you might be taking will all be carefully considered.

Each study has specific requirements to ensure it's safe for participants and that the results are clear. Your doctor will discuss all the details with you to see if you're a good fit for this research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you feel your masseter muscles are prominent?
Are you able to attend study visits for about 3 months?
Are you willing to potentially receive a placebo?
Are you comfortable with injections into your jaw muscles?

Answer every question to see your result.

What does participation involve?

If you decide to participate in this study, you would first have a screening visit to check if you meet all the requirements. If you do, you would then be randomly assigned (like flipping a coin) to receive either the BOTOX® treatment or a placebo injection. You wouldn't know which one you received, and neither would your study doctor.

The treatment involves injections into the masseter muscles in your jaw. Following the injection, you would have several follow-up visits over approximately 90 days. During these visits, doctors would assess your facial appearance, take measurements, and ask you to complete questionnaires about how you feel about your face. They will use special tools to measure changes in your facial width and volume. The total duration of your active participation in the study would be around three months.

Potential risks and benefits

Taking part in a study like this could potentially lead to benefits, such as a reduction in the size of your masseter muscles, which might improve your facial shape if the BOTOX® treatment is effective. However, there's also a chance you might receive the placebo and experience no benefit from the study treatment. As with any medical procedure involving injections, there are potential risks, such as temporary pain, bruising, or swelling at the injection site. More serious side effects, though rare with BOTOX®, are always a possibility and would be explained in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium
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Unverified
Italy
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Unverified
Bulgaria
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Unverified
France
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Unverified
Germany
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Unverified
Netherlands
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Unverified
Spain

Common questions

What are 'masseter muscles'?

These are the strong chewing muscles located at the back of your jaw. When they are prominent, they can make the lower face look wider.

What is BOTOX®?

BOTOX® is a well-known medicine that uses a substance called botulinum toxin type A. It works by temporarily relaxing certain muscles.

What is a 'placebo'?

A placebo is a substance or treatment that looks exactly like the real treatment but does not contain the active medicine. It helps compare the actual effects of the drug.

Why is this called a 'double-blind' study?

Double-blind means neither you nor your study doctor will know if you're getting the BOTOX® or the placebo. This helps keep the study fair and unbiased.

How long will I be in the study?

If you join, your active participation in the study, including treatments and follow-up visits, will last for about 90 days, which is roughly three months.