Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT04073303
Eligibility Criteria:
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 sensitivity to any of the components of the study treatments or any materials used in the study procedures
* History of alcohol or drug abuse within 12 months of Day 1
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04073303
Study Brief:
Protocol Section:
NCT04073303