A Study to Assess the Effectiveness of BOTOX (Botulinum Toxin Type A) Injections for the Change of Masseter Muscle Prominence in Adult Participants
- Conditions
- Masseter Muscle ProminenceTherapeutic area: Not possible to specify
- Registration Number
- CTIS2022-500568-37-00
- Lead Sponsor
- Abbvie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 248
Subject reports that he/she is A lot or Extremely bothered by the appearance of their MMP as measured by the BIA-MMP and attains a total score of >= 15 on the LFSQ-IA, determined at the Day 1 visit., Body mass index = 30 kg/m2 using the calculation: BMI = weight (kg)/height (m)2, rounded to the nearest whole number., • Bilateral Grade 4 or Grade 5 MMP (identical grades for left and right sides of the face), as determined at screening and at the Day 1 visit by the investigator using the MMPS. • Bilateral Grade 4 or Grade 5 MMP (identical grades for left and right sides of the face), as determined at the Day 1 visit by the subject using the MMPS-P. • MMP grades, as assessed by investigator and subject, do not need to be identical but have to be a minimum of Grade 4 with bilateral symmetry at Day 1.
Subject has current intraoral infection, including infection of the mouth or gums, or facial skin infection requiring medical treatment in the opinion of the investigator., Prior exposure to botulinum toxin of any serotype to any part of the body (not including masseter muscle) within the 3 months prior to Day 1., History of or current TMJD, or presence of signs/symptoms of possible TMJD in the opinion of the investigator., Subject has weakness of the masseter, pterygoid, or temporalis muscles due to trauma, facial nerve injury, or other condition that could interfere with normal chewing and jaw clenching, as determined by the investigator., Excess lower facial fat, jowling, loose or lax skin in lower face, or parotid gland prominence that could interfere with MMPS or MMPS-P grading, as determined by the investigator., Medical condition that may put the subject at increased medical risk with exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function., History of dental or surgical procedure for lower facial shaping or masseter muscle reduction., No history of any permanent soft tissue fillers in the jawline., No history of any semi-permanent soft tissue fillers, HA fillers, or autologous fat in the jawline within 24 months prior to Day 1.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method