Status:
COMPLETED
BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence
Lead Sponsor:
AbbVie
Conditions:
Masseter Muscle Prominence
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is designed to evaluate the safety and effectiveness of administering BOTOX for the treatment of Masseter Muscle Prominence (MMP) in adults.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2022
Estimated Enrollment :
377 Patients enrolled
Trial Details
Trial ID
NCT04073303
Start Date
August 29 2019
End Date
November 10 2022
Last Update
May 6 2025
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
Duplicate_Beacon Dermatology Inc /ID# 233018
Calgary, Alberta, Canada, T3E 0B2
2
Duplicate_Humphrey Cosmetic Dermatology /ID# 232764
Vancouver, British Columbia, Canada, V5Z 4E1
3
Project Skin MD LTD /ID# 232763
Vancouver, British Columbia, Canada, V6H 1K9
4
Pacific Derm /ID# 233156
Vancouver, British Columbia, Canada, V6H 4E1