BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence

NCT03861936 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 1789-202-008
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 14

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.

Conditions

Masseter Muscle Prominence

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants Who Achieved Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 at Day 90 as Assessed by the Investigator

  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.

  Day 90

• Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)

  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.

  First dose (Day 1) to the End of Study (Up to Day 180)

• 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 Respiratory Rate

  Respiratory rate is calculated as number of breaths (inhalation and exhalation) in one minute.

  Baseline (Day 1) to the End of Study (Up to Day 180)

• Change From Baseline in Pulse Rate

  Pulse rate measures the number of times your heart beats per minute.

  Baseline (Day 1) to the End of Study (Up to Day 180) ]

Secondary Outcomes (6)

• 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

• 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

• 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

• 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

• Change From Baseline in Lower Facial Volume at Day 90 Using Landmark Area of Interest (AOI) Analysis

  Baseline (Day 1) to Day 90

Study Arms (3)

BOTOX® 72U

EXPERIMENTAL

OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72 units (U) total dose administered intramuscularly to the bilateral masseter muscles on Day 1.

Biological: OnabotulinumtoxinA

BOTOX® 48U

EXPERIMENTAL

OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.

Biological: OnabotulinumtoxinA

Placebo

PLACEBO COMPARATOR

Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.

Drug: Normal saline

Interventions

OnabotulinumtoxinA BIOLOGICAL

OnabotulinumtoxinA (botulinum toxin Type A;BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1.

Also known as: BOTOX®, botulinum toxin Type A

BOTOX® 48U; BOTOX® 72U

Normal saline DRUG

Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles on Day 1.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Not a woman of childbearing potential (WOCBP) OR
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (14)

Total Skin & Beauty Dermatology Center, PC

Birmingham, Alabama, 35205, United States

Location

Westside Aesthetics

Los Angeles, California, 90025, United States

Location

Skin Care and Laser Physicians of Beverly Hills

Los Angeles, California, 90069, United States

Location

Cosmetic Laser Dermatology

San Diego, California, 92121, United States

Location

Baumann Cosmetic and Research Institute

Miami, Florida, 33137, United States

Location

DeNova Research

Chicago, Illinois, 60611, United States

Location

Etre, Cosmetic Dermatology and Laser Center

New Orleans, Louisiana, 70130, United States

Location

Saint Louis University Dermatology

St Louis, Missouri, 63122, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

Nashville Centre for Laser and Facial Surgery

Nashville, Tennessee, 37203, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

Bellaire Dermatology Associates

Bellaire, Texas, 77401, United States

Location

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, 78660, United States

Location

Advanced Clinical Research Gateway Aesthetic Institute & Laser Center

Salt Lake City, Utah, 84101, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; Saline Solution

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Tanya Brandstetter

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: March 5, 2019
• Study Start: May 16, 2019
• Primary Completion: April 3, 2020
• Study Completion: July 2, 2020
• Last Updated: April 28, 2021
• Results First Posted: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
• Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.

Locations

US (14)