Clinical trial NCT03861936: BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence
Official title: BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 2b, Multicenter, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Masseter Muscle Prominence
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2019-03-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Based on the results of the Phase 2 Study 191622-130 \[NCT02010775\], the current Phase 2b study is designed to further evaluate the safety and efficacy of BOTOX® for the treatment of Masseter Muscle Prominence (MMP) in adults.


Eligibility criteria: Inclusion Criteria

* Participant has bilateral MMP (identical grades for left and right masseter), as determined at the Day 1 visit by the investigator using the MMPS
* Participant has bilateral MMP, as determined at the Day 1 visit by the participant using the Masseter Muscle Prominence Scale-Participant (MMPS-P)
* Body mass index (BMI) ≤ 30 kilogram/square meter (kg/m\^2) using the calculation: BMI = weight (kg) \[height (m\^2)\]
* Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization), not breastfeeding, and at least one of the following conditions applies:

  1. Not a woman of childbearing potential (WOCBP) OR
  2. A WOCBP who agrees to follow the contraceptive guidance during the treatment and follow-up period
* Able, as assessed by the investigator, and willing to follow study instructions and likely to complete all required study visits.

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
* Any uncontrolled medical condition
* 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 of entry into the study
* Current or planned dental or facial procedures during the study period (eg, braces, dental implants, and reconstructive or aesthetic surgery) that could interfere with MMPS, as determined by the investigator
* Facial hair or scarring (eg, acne) significant enough to interfere with the 3D clinical photography assessment
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
* 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
* Current intraoral infection, including infection of the mouth or gums, or facial skin infection requiring medical treatment in the opinion of the investigator
* History of or current Temporomandibular Joint Dysfunction (TMJD), or presence of signs/symptoms of possible TMJD, in the opinion of the investigator
* Weakness of the masseter, pterygoid, or temporalis muscles due to trauma, facial nerve injury, or other condition that could interfere with normal chewing and jaw clenching, as determined by the investigator
* Excess lower facial fat, loose or lax skin in lower face, or parotid gland prominence that could interfere with MMPS, as determined by the investigator
* Significant asymmetry of left and right sides of the face that could prevent identical MMPS grading on both sides of the face, as determined by the investigator
* Masseter prominence due to other etiologies (eg, parotid gland infection, parotiditis, malignancy) based upon findings from the oral examination.

Primary outcomes:
measure: Percentage of Participants Who Achieved Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 at Day 90 as Assessed by the Investigator
timeFrame: Day 90
measure: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
timeFrame: First dose (Day 1) to the End of Study (Up to Day 180)
measure: Change From Baseline in Systolic Blood Pressure
timeFrame: Baseline (Day 1) to the End of Study (Up to Day 180)
measure: Change From Baseline in Diastolic Blood Pressure
timeFrame: Baseline (Day 1) to the End of Study (Up to Day 180)
measure: Change From Baseline in Respiratory Rate
timeFrame: Baseline (Day 1) to the End of Study (Up to Day 180)
measure: Change From Baseline in Pulse Rate
timeFrame: Baseline (Day 1) to the End of Study (Up to Day 180) ]
Secondary outcomes:
measure: Percentage of Participants Who Achieved Participant Masseter Muscle Prominence Scale-Participant (MMPS-P) Grade ≤ 3 at Day 90 as Assessed by the Participant
timeFrame: Day 90
measure: Percentage of Participants Who Achieved ≥ 2-grade MMPS Improvement From Baseline at Day 90 as Assessed by the Investigator
timeFrame: Baseline (Day 1) to Day 90
measure: Percentage of Participants Who Achieved ≥ 2-grade MMPS-P Improvement From Baseline at Day 90 as Assessed by the Participant
timeFrame: Baseline (Day 1) to Day 90
measure: Percentage of Participants Who Achieved Participant Self-Assessment of Change (PSAC) in MMP Grade ≥ 2 (at Least Moderately Improved From Baseline) at Day 90
timeFrame: Baseline (Day 1) to Day 90
measure: Change From Baseline in Lower Facial Volume at Day 90 Using Landmark Area of Interest (AOI) Analysis
timeFrame: Baseline (Day 1) to Day 90
measure: Change From Baseline in Lower Facial Volume at Day 90 Using Statistical MMP AOI Analysis
timeFrame: Baseline (Day 1) to Day 90
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin & Beauty Dermatology Center, PC
state: Alabama
city: Los Angeles
country: United States
facility: Westside Aesthetics
state: California
city: Los Angeles
country: United States
facility: Skin Care and Laser Physicians of Beverly Hills
state: California
city: San Diego
country: United States
facility: Cosmetic Laser Dermatology
state: California
city: Miami
country: United States
facility: Baumann Cosmetic and Research Institute
state: Florida
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
city: New Orleans
country: United States
facility: Etre, Cosmetic Dermatology and Laser Center
state: Louisiana
city: Saint Louis
country: United States
facility: Saint Louis University Dermatology
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Nashville
country: United States
facility: Nashville Centre for Laser and Facial Surgery
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Advanced Clinical Research Gateway Aesthetic Institute & Laser Center
state: Utah
Study officials:
affiliation: Allergan
name: Tanya Brandstetter
role: STUDY_DIRECTOR
References: