BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence
- Conditions
- Masseter Muscle Prominence
- Interventions
- Other: Placebo
- Registration Number
- NCT04073303
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 377
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo (normal saline) will be administered on Day 1 as bilateral intramuscular injections into the masseter Botulinum Toxin Type A (BOTOX®) Botulinum Toxin Type A Botulinum Toxin Type A (BOTOX ®) will be administered on Day 1 as bilateral intramuscular injections into the masseter with the possibility of 2 additional treatments
- Primary Outcome Measures
Name Time Method Achievement of ≥ 2-Grade Improvement From Baseline on the Masseter Muscle Prominence Scale (MMPS) at Day 90 Day 90 Proportion of participants who achieve ≥ 2-grade improvement from baseline at Day 90, per investigator assessments of MMP using the Masseter Muscle Prominence Scale (MMPS).
MMPS ranges from 1 = minimal to 5 = very marked.
- Secondary Outcome Measures
Name Time Method Median Duration of Effect for MMPS Responders Up to Day 360 Median duration of effect for BOTOX-treated MMPS responders.
Achievement of MMPS Grade ≤ 3 at Day 90 Day 90 Proportion of participants who achieve MMPS Grade of ≤ 3 at Day 90, per investigator assessments of MMP using the Masseter Muscle Prominence Scale (MMPS).
MMPS ranges from 1 = minimal to 5 = very marked.Achievement of MMPS-P Grade ≤ 3 on Day 90 Day 90 Proportion of participants who achieve MMPS-P Grade ≤ 3 at Day 90, according to participant, per Masseter Muscle Prominence Scale-Participant (MMPS-P)
MMPS-P ranges from 1 = not at all pronounced to 5 = very pronounced.Achievement of MMPS-P ≥ 2-Grade Improvement From Baseline at Day 90 Day 90 Proportion of participants who achieve ≥ 2-grade improvement from baseline at Day 90, per Masseter Muscle Prominence Scale-Participant (MMPS-P)
MMPS-P ranges from 1 = not at all pronounced to 5 = very pronounced.Achievement of PSAC Grade ≥ 1 (at Least Minimally Improved From Baseline) on Day 90 Day 90 Proportion of participants who achieve Grade ≥ 1 on Participant Self-Assessment of Change (PSAC) (at least minimally improved from baseline) at Day 90
PSAC ranges from 3 = much improved to -3 = much worse.Change From Baseline in Lower Facial Width (mm) at Day 90 Day 90 Calculated from standardized images, measured in millimeters (mm)
Trial Locations
- Locations (21)
Tri-Service General Hospital /ID# 233080
🇨🇳Taipei City, Taiwan
Duplicate_Beacon Dermatology Inc /ID# 233018
🇨🇦Calgary, Alberta, Canada
Duplicate_Humphrey Cosmetic Dermatology /ID# 232764
🇨🇦Vancouver, British Columbia, Canada
Duplicate_Peking Union Medical College Hospital /ID# 233072
🇨🇳Beijing, Beijing, China
Project Skin MD LTD /ID# 232763
🇨🇦Vancouver, British Columbia, Canada
Pacific Derm /ID# 233156
🇨🇦Vancouver, British Columbia, Canada
The Center For Dermatology /ID# 233001
🇨🇦Richmond Hill, Ontario, Canada
Peking University Third Hospital /ID# 233148
🇨🇳Beijing, Beijing, China
Chinese PLA General Hospital /ID# 233158
🇨🇳Beijing, Beijing, China
Peking University First Hospital /ID# 232973
🇨🇳Xicheng District, Beijing, China
Tianjin Medical University General Hospital /ID# 232961
🇨🇳Tianjin, Guizhou, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 233008
🇨🇳Wuhan, Hubei, China
Xiangya Hospital Central South University /ID# 233027
🇨🇳Changsha, Hunan, China
Nanjing Drum Tower Hospital /ID# 233016
🇨🇳Nanjing, Jiangsu, China
Zhongda Hospital Southeast University /ID# 232836
🇨🇳Nanjing, Jiangsu, China
Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 232656
🇨🇳Shanghai, Shanghai, China
Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 233087
🇨🇳Xi'an, Shanxi, China
West China Hospital, Sichuan University /ID# 233107
🇨🇳Chengdu, Sichuan, China
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 233033
🇨🇳Kaohsiung, Keelung, Taiwan
National Taiwan University Hospital /ID# 233133
🇨🇳Taipei City, Taipei, Taiwan
Taipei Medical University Hospital /ID# 233009
🇨🇳Taipei City, Taiwan