BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence (NCT04073303) | Clinical Trial Compass
CompletedPhase 3
BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence
Canada377 participantsStarted 2019-08-29
Plain-language summary
This study is designed to evaluate the safety and effectiveness of administering BOTOX for the treatment of Masseter Muscle Prominence (MMP) in adults.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Inclusion Criteria:
* Masseter prominence at the Day 1 visit
* BMI ≤ 30 kg/m2 using the calculation: BMI = weight (kg)/\[height (m)\]2
* A female participant must be willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up periods
Exclusion Criteria:
* Any medical condition that may put the participant 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
* An anticipated need for surgery or overnight hospitalization during the study
* An anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention)
* History of dental or surgical procedure for lower facial shaping or masseter muscle reduction
* Prior mid-facial and/or lower facial treatment with nonpermanent soft tissue fillers, synthetic implantations, autologous fat transplantation, fat-reducing injectables, and/or skin-tightening laser treatments within 6 months prior to Day 1
* Prior exposure to botulinum toxin of any serotype to the masseter muscle or lower face at any time, or to any other part of the body within the 6 months prior to Day 1
* History of temporomandibular joint disorder (TMJD)
* Masseter prominence due to other etiologies (eg, parotid gland infection, parotiditis, malignancy)
* Known allergy or sensiti…
What they're measuring
1
Achievement of ≥ 2-Grade Improvement From Baseline on the Masseter Muscle Prominence Scale (MMPS) at Day 90