BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence

Phase 2

Completed

• Conditions: Masseter Muscle Prominence
• Interventions: Biological: OnabotulinumtoxinA; Drug: Normal saline

• Registration Number: NCT03861936
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-05
• Study Start: 2019-05-16
• Primary Completion: 2020-04-03
• Study Completion: 2020-07-02
• Status Verified: 2021-04
• Results First Submitted: 2021-04-02
• Results First Submitted QC: 2021-04-02
• Last Update Submitted: 2021-04-02
• Results First Posted: 2021-04-28
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BOTOX® 72U	OnabotulinumtoxinA	OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72 units (U) total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
BOTOX® 48U	OnabotulinumtoxinA	OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
Placebo	Normal saline	Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 at Day 90 as Assessed by the Investigator	Day 90	The investigator assessed the severity of the participant's masseter muscle prominence (MMP) using the MMPS 5-point scale where: 1=minimal (best), 2=mild, 3=moderate, 4=marked, and 5=very marked (worst). The percentage of participants where the investigator selected 1=minimal, 2=mild, or 3=moderate are reported.
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)	First dose (Day 1) to the End of Study (Up to Day 180)	An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE is an AE that occurs or worsens after receiving study drug.
Change From Baseline in Systolic Blood Pressure	Baseline (Day 1) to the End of Study (Up to Day 180)
Change From Baseline in Diastolic Blood Pressure	Baseline (Day 1) to the End of Study (Up to Day 180)
Change From Baseline in Pulse Rate	Baseline (Day 1) to the End of Study (Up to Day 180) ]	Pulse rate measures the number of times your heart beats per minute.
Change From Baseline in Respiratory Rate	Baseline (Day 1) to the End of Study (Up to Day 180)	Respiratory rate is calculated as number of breaths (inhalation and exhalation) in one minute.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved ≥ 2-grade MMPS Improvement From Baseline at Day 90 as Assessed by the Investigator	Baseline (Day 1) to Day 90	The investigator assessed the severity of the participant's MMP using the MMPS 5-point scale where: 1=minimal (best), 2=mild, 3=moderate, 4=marked, and 5=very marked (worst). The percentage of participants who achieved a ≥ 2-grade improvement (decrease) from Baseline as assessed by the investigator are reported.
Percentage of Participants Who Achieved Participant Self-Assessment of Change (PSAC) in MMP Grade ≥ 2 (at Least Moderately Improved From Baseline) at Day 90	Baseline (Day 1) to Day 90	The participants assessed the degree of change of their MMP using a single item composed of 7 grades (3 to -3) where: 3=much improved, 2=moderately improved, 1=minimally improved, 0=no change, -1=minimally worse, -2=moderately worse, and -3=much worse. The percentage of participants where the participant selected 2=moderately improved, or 3=much improved as compared to Baseline are reported.
Change From Baseline in Lower Facial Volume at Day 90 Using Statistical MMP AOI Analysis	Baseline (Day 1) to Day 90	Lower facial volume was calculated from 3D surface models of the full area of the lower face captured at Baseline and Day 90. The statistical MMP AOI method is based on a statistical shape averaging of the area of change post masseter treatment from multiple facial models. The difference in volume is calculated between the two 3D surface models at Baseline and Day 90. An ANCOVA model was used for analyses.
Percentage of Participants Who Achieved ≥ 2-grade MMPS-P Improvement From Baseline at Day 90 as Assessed by the Participant	Baseline (Day 1) to Day 90	The participant assessed the severity of their MMP using the MMPS-P 5-point scale where: 1=not at all pronounced (best), 2=mildly pronounced, 3=moderately pronounced, 4=pronounced, and 5=very pronounced (worst). The percentage of participants who achieved a ≥ 2-grade improvement (decrease) from Baseline as assessed by the participant are reported.
Percentage of Participants Who Achieved Participant Masseter Muscle Prominence Scale-Participant (MMPS-P) Grade ≤ 3 at Day 90 as Assessed by the Participant	Day 90	The participant assessed the severity of their MMP using the MMPS-P 5-point scale where: 1=not at all pronounced (best), 2=mildly pronounced, 3=moderately pronounced, 4=pronounced, and 5=very pronounced (worst). The percentage of participants who selected 1=not at all pronounced, 2=mildly pronounced, or 3=moderately pronounced are reported.
Change From Baseline in Lower Facial Volume at Day 90 Using Landmark Area of Interest (AOI) Analysis	Baseline (Day 1) to Day 90	Lower facial volume was calculated from 3-dimensional (3D) surface images captured at Baseline and Day 90. The analysis region is defined using a series of anatomical landmarks placed on the baseline surface that are then projected mathematically to the posttreatment surface and verified by a technician. The difference in volume is measured between the select region of the baseline surface to the posttreatment surface. The lower facial volume is summed for both the left side and the right side of the face. An analysis of covariance (ANCOVA) model was used for analyses.

Trial Locations

Locations (14)

Cosmetic Laser Dermatology; 🇺🇸 San Diego, California, United States

DeNova Research; 🇺🇸 Chicago, Illinois, United States

Baumann Cosmetic and Research Institute; 🇺🇸 Miami, Florida, United States

Westside Aesthetics; 🇺🇸 Los Angeles, California, United States

DermResearch, Inc.; 🇺🇸 Austin, Texas, United States

Etre, Cosmetic Dermatology and Laser Center; 🇺🇸 New Orleans, Louisiana, United States

Skin Specialists, PC; 🇺🇸 Omaha, Nebraska, United States

Bellaire Dermatology Associates; 🇺🇸 Bellaire, Texas, United States

Total Skin & Beauty Dermatology Center, PC; 🇺🇸 Birmingham, Alabama, United States

Skin Care and Laser Physicians of Beverly Hills; 🇺🇸 Los Angeles, California, United States

Advanced Clinical Research Gateway Aesthetic Institute & Laser Center; 🇺🇸 Salt Lake City, Utah, United States

Austin Institute for Clinical Research, Inc.; 🇺🇸 Pflugerville, Texas, United States

Nashville Centre for Laser and Facial Surgery; 🇺🇸 Nashville, Tennessee, United States

Saint Louis University Dermatology; 🇺🇸 Saint Louis, Missouri, United States