Ongoing Clinical Trials for Muscle Hypertrophy
There is currently 1 ongoing clinical trial investigating treatments for muscle hypertrophy, specifically focusing on reducing the prominence of the masseter muscle (jaw muscle). This trial is being conducted across multiple European countries and is testing the effectiveness of Botulinum Toxin Type A (BOTOX) in reducing enlarged jaw muscles that can lead to a more prominent jawline.
Clinical trial locations
- Belgium
- Bulgaria
- France
- Germany
- Italy
- Netherlands
- Spain
Study on Botulinum Toxin Type A for Reducing Jaw Muscle Size in Adults with Prominent Masseter Muscle
This clinical trial is investigating whether BOTOX injections can effectively reduce the size of enlarged masseter muscles in adults. The masseter muscle is one of the main muscles used for chewing, located at the sides of the jaw. When this muscle becomes enlarged, it can create a more prominent, square-shaped jawline. This trial compares BOTOX treatment with a placebo to evaluate both effectiveness and safety.
Main inclusion criteria:
- Adults between 18 and 65 years of age
- Both male and female participants are eligible
- Must have enlarged masseter muscles on both sides of the face, confirmed by both the investigator and the participant
- Body Mass Index (BMI) will be calculated and recorded
Main exclusion criteria:
- Pregnancy or breastfeeding
- Any facial or jaw surgery within the past 6 months
- Previous treatment with BOTOX or similar products within the past 6 months
- Known allergy to BOTOX or any of its ingredients
- History of muscle or nerve disorders
- Current participation in another clinical trial
- History of drug or alcohol abuse
- Any other significant medical condition that might interfere with the study
- Unable to comply with study procedures
Focus and goal of the trial:
The study aims to determine whether BOTOX can effectively reduce the prominence of the masseter muscle and change the appearance of the jawline. Participants will receive either BOTOX or placebo injections directly into the masseter muscles. The trial follows a structured timeline with regular assessments to monitor changes in muscle size and facial appearance.
During the initial visit, the investigator will assess the prominence of the masseter muscles on both sides of the face. If eligible, participants will receive an intramuscular injection of either BOTOX or placebo. Follow-up visits will occur at specified intervals, with a key assessment at Day 90, to evaluate changes in muscle prominence, lower facial volume, and width. A final comprehensive assessment will be conducted at the end of the study period to determine treatment effectiveness and safety.
Investigational drug:
BOTOX (Botulinum Toxin Type A) is the investigational medication being tested in this trial. BOTOX contains botulinum toxin type A, a neurotoxin that works by blocking nerve signals to muscles, causing temporary muscle relaxation. In this trial, it is being used to reduce the size and prominence of enlarged masseter muscles. By temporarily relaxing these muscles, BOTOX may help create a slimmer, less prominent jawline. The medication is administered through injections directly into the masseter muscles.
Summary
Currently, there is one clinical trial available for individuals with enlarged masseter muscles, a form of muscle hypertrophy affecting the jaw area. This trial is being conducted across seven European countries: France, Belgium, Italy, Netherlands, Germany, Bulgaria, and Spain, providing broad access to participants across Europe.
The trial focuses specifically on testing BOTOX (Botulinum Toxin Type A) as a potential treatment for reducing muscle prominence. The study employs a placebo-controlled design to carefully evaluate both the effectiveness and safety of this approach. The trial is particularly relevant for adults aged 18 to 65 who have noticeable enlargement of the jaw muscles on both sides of the face.
The wide geographic distribution of this trial across multiple European countries suggests a significant interest in developing treatment options for this condition, which can affect both facial aesthetics and function, particularly in individuals who experience teeth grinding or jaw clenching.
