BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence

Masseter Muscle Prominence Clinical Trial

Official title:

BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04073303
• Other study ID #: 1789-301-008
• Status: Completed
• Phase: Phase 3
• Start date: August 29, 2019
• Est. completion date: November 10, 2022

Study information

• Verified date: October 2023
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the safety and effectiveness of administering BOTOX for the treatment of Masseter Muscle Prominence (MMP) in adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: November 10, 2022
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Masseter Muscle Prominence

Intervention

Biological:
• Botulinum Toxin Type A
Day 1 Administration of bilateral intramuscular injections into the masseter

Other:
• Placebo
Day 1 Administration of bilateral intramuscular injections of placebo (normal saline) into the masseter

Locations

Country	Name	City	State
Canada	Beacon Dermatology Inc /ID# 233018	Calgary	Alberta
Canada	The Center For Dermatology /ID# 233001	Richmond Hill	Ontario
Canada	Humphrey Cosmetic Dermatology /ID# 232764	Vancouver	British Columbia
Canada	Pacific Derm /ID# 233156	Vancouver	British Columbia
Canada	Project Skin MD LTD /ID# 232763	Vancouver	British Columbia
China	Chinese PLA General Hospital /ID# 233158	Beijing	Beijing
China	Peking Union Medical College Hospital /ID# 233072	Beijing	Beijing
China	Peking University Third Hospital /ID# 233148	Beijing	Beijing
China	Xiangya Hospital Central South University /ID# 233027	Changsha	Hunan
China	West China Hospital, Sichuan University /ID# 233107	Chengdu	Sichuan
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
China	Tianjin Medical University General Hospital /ID# 232961	Tianjin
China	Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 233008	Wuhan	Hubei
China	Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 233087	Xi'an	Shaanxi
China	Peking University First Hospital /ID# 232973	Xicheng District	Beijing
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 233033	Kaohsiung
Taiwan	National Taiwan University Hospital /ID# 233133	Taipei City
Taiwan	Taipei Medical University Hospital /ID# 233009	Taipei City
Taiwan	Tri-Service General Hospital /ID# 233080	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

Canada,  China,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of responders that show change in masseter muscle prominence (MMP)	Investigator assessment of severity of MMP using the Masseter Muscle Prominence Scale (MMPS). Score ranges from 1 = minimal to 5 = very marked	Baseline, Day 90
Primary	Incidence of Adverse Events (AEs)	The number of patients who experienced one or more AEs during the study	Up to 18 Months
Primary	Change from baseline in vital sign values (blood pressure, respiratory rate, and pulse rate)	Summary statistics of change from baseline vital sign values	Up to 18 Months
Secondary	Proportion of responders who achieve a clinical target on a MMP scale	Investigator assessment of MMP using a scale ranging from minimal to very marked	Baseline, Day 90
Secondary	Proportion of responders who achieve improvement using a self-assessment scale	Improvement of MMP is self-assessed by the participant using a scale ranging from not at all pronounced to very pronounced.	Baseline, Day 90
Secondary	Proportion of responders that show improvement in MMP	Improvement of MMP is self-assessed by the participant using a scale for change in MMP ranging from much improved to much worse	Baseline, Day 90
Secondary	Change from baseline in lower facial width	Calculated from standardized images, measured in millimeters (mm)	Baseline, Day 90
Secondary	Duration of treatment effect	Improvement from baseline of MMP	Baseline, Day 90