Study on Botulinum Toxin Type A for Reducing Jaw Muscle Size in Adults with Prominent Masseter Muscle

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What is this study about?

This clinical trial is focused on studying the effects of BOTOX (Botulinum Toxin Type A) on reducing the prominence of the masseter muscle in adults. The masseter muscle is one of the muscles in the jaw that can become enlarged, leading to a more prominent jawline. The study will compare the effectiveness and safety of BOTOX injections with a placebo in treating this condition.

The purpose of the study is to assess whether BOTOX can effectively reduce the size of the masseter muscle, thereby altering the appearance of the jawline. Participants in the study will receive either BOTOX or a placebo through injections into the muscle. The study will be conducted over a period of time, with regular assessments to monitor changes in the muscle’s size and the overall appearance of the lower face.

Throughout the study, participants will be evaluated to determine any improvements in the prominence of the masseter muscle. These evaluations will include both the investigator’s and the participant’s assessments of changes in the muscle’s size. The study aims to provide valuable information on the potential benefits of BOTOX for individuals with prominent masseter muscles.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, the investigator will assess the prominence of your masseter muscles on both sides of your face. This assessment will help determine your eligibility for the study.

You will also be asked to confirm your own assessment of your masseter muscle prominence. This ensures that both you and the investigator agree on the condition being studied.

2 treatment administration

If eligible, you will receive an injection. This injection will either be BOTOX (botulinum toxin type A) or a placebo. The injection is administered directly into the masseter muscles through an intramuscular injection.

The dosage and frequency of the injection will be determined by the study protocol, and you will be informed of these details during the visit.

3 follow-up visits

You will be required to attend follow-up visits to monitor the effects of the treatment. These visits will occur at specified intervals, with a key assessment at Day 90.

During these visits, the investigator will evaluate any changes in your masseter muscle prominence and other related measurements, such as lower facial volume and width.

4 final assessment

At the end of the study period, a final assessment will be conducted. This will include a comprehensive evaluation of the changes in your masseter muscle prominence and any other relevant outcomes.

The results of this assessment will help determine the effectiveness and safety of the treatment you received.

Who Can Join the Study?

Participants must have a Body Mass Index (BMI) calculated using the formula: weight in kilograms divided by height in meters squared (BMI = weight (kg)/height (m)²), rounded to the nearest whole number.
Participants must have bilateral masseter muscle prominence (MMP), meaning the muscle prominence is the same on both the left and right sides of the face. This will be checked by the investigator during the screening and on the first day of the study.
Participants must also agree that their masseter muscle prominence (MMP) is the same on both sides of the face on the first day of the study.
Participants must be within the age range of 18 to 65 years old.
Both male and female participants are eligible to join the study.

Who Cannot Join the Study?

Patients with any other significant medical condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had any surgery on the face or jaw in the past 6 months.
Patients who have received any treatment with BOTOX or similar products in the past 6 months.
Patients with a known allergy to BOTOX or any of its ingredients.
Patients with a history of muscle or nerve disorders.
Patients who are currently participating in another clinical trial.
Patients who have a history of drug or alcohol abuse.
Patients who are unable to comply with the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Privatpraxis Dr. Hilton & Partner	Duesseldorf	Germany
ICMR (International Center for Medical Research)	Madrid	Spain

Other Sites

Site Name	City	Country
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Vrije Universiteit Brussel	Jette	Belgium
Hamburg University	Hamburg	Germany
Bodokh Isaac	Cannes	France
Doctors at Soap B.V.	Amsterdam	The Netherlands
Dermatologie Kempenland	Beerse	Belgium
Aesthics	Melle	Belgium
ESTHETICARE	Schilde	Belgium
Dermavist Group Practice For Specialized Medical Aid For Skin Diseases Ltd.	Plovdiv	Bulgaria
Medical Center Derma Vita EOOD	Sofia	Bulgaria
Medical Center Dermatologia D-R Denkova EOOD	Sofia	Bulgaria
Docteur Belhaouari	Toulouse	France
Selarl Du Dr Laurence Benouaiche	Paris	France
Clinica Alejandria	Valencia	Spain
Gavin Dermatologos Vigo S.L.P.	Vigo	Spain
Clinica Robega	Madrid	Spain
Ajd Ds Loumvk	Latina	Italy
Mcrkaj Sfgdog	Antibes	France
Gblduc Eapvxwwp	Paris	France
Hhtztridtqa Kboq	Cologne	Germany
Suonvqrkdzqxci Tbbnijppehz	Munich	Germany
Hpifqp ans Htswgzaymdogliso	Munich	Germany

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	02.10.2023
Bulgaria	Not recruiting	02.10.2023
France	Not recruiting	02.10.2023
Germany	Not recruiting	02.10.2023
Italy	Not recruiting	02.10.2023
Spain	Not recruiting	02.10.2023
The Netherlands	Not recruiting	02.10.2023

Trial locations

Investigated drugs:

Botulinum Toxin Type A

BOTOX is a medication that contains a substance called botulinum toxin type A. It is used in this clinical trial to help reduce the size and prominence of the masseter muscles, which are the muscles located at the sides of your jaw. These muscles can sometimes become enlarged, leading to a more prominent jawline. BOTOX works by temporarily relaxing these muscles, which can help make the jawline appear slimmer and less pronounced. This trial is designed to test how effective and safe BOTOX is for people who have noticeable masseter muscle prominence.

Masseter Muscle Prominence – Masseter Muscle Prominence is a condition characterized by the enlargement or hypertrophy of the masseter muscles, which are located at the angle of the jaw. This condition can lead to a more square-shaped jawline and may be associated with functional issues such as bruxism or teeth grinding. The progression of masseter muscle prominence can vary, with some individuals experiencing gradual enlargement over time. Factors such as genetics, habitual behaviors, and certain medical conditions can influence the development and progression of this condition. It is often more noticeable in individuals who frequently clench or grind their teeth. The prominence of the masseter muscle can affect facial aesthetics and may lead to concerns about facial symmetry.

Trial ID:

2022-500568-37-00

Protocol code:

M23-123

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Botulinum Toxin Type A for Reducing Jaw Muscle Size in Adults with Prominent Masseter Muscle

What is this study about?

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