Clinical trial NCT04073303: BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence
Official title: BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Masseter Muscle Prominence
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-08-29
Enrollment: 377
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Achievement of ≥ 2-Grade Improvement From Baseline on the Masseter Muscle Prominence Scale (MMPS) at Day 90
timeFrame: Day 90
Secondary outcomes:
measure: Achievement of MMPS Grade ≤ 3 at Day 90
timeFrame: Day 90
measure: Achievement of MMPS-P Grade ≤ 3 on Day 90
timeFrame: Day 90
measure: Achievement of MMPS-P ≥ 2-Grade Improvement From Baseline at Day 90
timeFrame: Day 90
measure: Achievement of PSAC Grade ≥ 1 (at Least Minimally Improved From Baseline) on Day 90
timeFrame: Day 90
measure: Change From Baseline in Lower Facial Width (mm) at Day 90
timeFrame: Day 90
measure: Median Duration of Effect for MMPS Responders
timeFrame: Up to Day 360
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Duplicate_Beacon Dermatology Inc /ID# 233018
state: Alberta
city: Vancouver
country: Canada
facility: Duplicate_Humphrey Cosmetic Dermatology /ID# 232764
state: British Columbia
city: Vancouver
country: Canada
facility: Project Skin MD LTD /ID# 232763
state: British Columbia
city: Vancouver
country: Canada
facility: Pacific Derm /ID# 233156
state: British Columbia
city: Richmond Hill
country: Canada
facility: The Center For Dermatology /ID# 233001
state: Ontario
city: Beijing
country: China
facility: Peking University Third Hospital /ID# 233148
state: Beijing
city: Beijing
country: China
facility: Duplicate_Peking Union Medical College Hospital /ID# 233072
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital /ID# 233158
state: Beijing
city: Xicheng District
country: China
facility: Peking University First Hospital /ID# 232973
state: Beijing
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital /ID# 232961
state: Guizhou
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 233008
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University /ID# 233027
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital /ID# 233016
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University /ID# 232836
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 232656
state: Shanghai
city: Xi'an
country: China
facility: Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 233087
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University /ID# 233107
state: Sichuan
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 233033
state: Keelung
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 233133
state: Taipei
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital /ID# 233009
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital /ID# 233080
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: