BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence

NCT ID: NCT03861936

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-16
• Study Completion Date: 2020-07-02

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BOTOX® 72U

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

Group Type: EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type: BIOLOGICAL

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

BOTOX® 48U

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

Group Type: EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type: BIOLOGICAL

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

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

Interventions

OnabotulinumtoxinA

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

Intervention Type: BIOLOGICAL

Normal saline

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

Intervention Type: DRUG

Other Intervention Names

BOTOX®; botulinum toxin Type A

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tanya Brandstetter

Role: STUDY_DIRECTOR

Allergan

Locations

Total Skin & Beauty Dermatology Center, PC

Birmingham, Alabama, United States

Westside Aesthetics

Los Angeles, California, United States

Skin Care and Laser Physicians of Beverly Hills

Los Angeles, California, United States

Cosmetic Laser Dermatology

San Diego, California, United States

Baumann Cosmetic and Research Institute

Miami, Florida, United States

DeNova Research

Chicago, Illinois, United States

Etre, Cosmetic Dermatology and Laser Center

New Orleans, Louisiana, United States

Saint Louis University Dermatology

St Louis, Missouri, United States

Skin Specialists, PC

Omaha, Nebraska, United States

Nashville Centre for Laser and Facial Surgery

Nashville, Tennessee, United States

DermResearch, Inc.

Austin, Texas, United States

Bellaire Dermatology Associates

Bellaire, Texas, United States

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, United States

Advanced Clinical Research Gateway Aesthetic Institute & Laser Center

Salt Lake City, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1789-202-008

Identifier Type: -

Identifier Source: org_study_id