A Study to Assess Adverse Events and Change of Masseter Muscle Prominence Using BOTOX Injections in Adult Participants

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

The masseter muscle is one of the muscles in the lower face used for chewing. Prominence of the masseter muscle can appear as a widened and square lower face shape, which is an aesthetic concern for individuals who prefer a narrower and more ovoid lower face shape. Treatments are available for masseter muscle prominence (MMP), but researchers are looking for new non-surgical treatments. This study will assess adverse events and effectiveness of BOTOX in adult participants with MMP.

BOTOX is being investigated for the treatment of MMP. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is 1 in 5 chance that participants will be assigned to placebo. Around 250 adult participants with MMP will be enrolled in the study at approximately 20 sites in Japan.

Participants will receive either BOTOX or Placebo administered as 6 intramuscular injections to each masseter muscle on Day 1. Participants who are eligible for retreatment will be given BOTOX on either Day 180, 210, 240, or 270 and will be followed until approximately Day 360.

There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, facial photography, checking for side effects and completing questionnaires.

Study Overview

• Status: Recruiting
• Conditions: Masseter Muscle Prominence
• Intervention / Treatment: Drug: BOTOX; Drug: Placebo for BOTOX

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AbbVie GK Clinical Trial Registration Desk; Phone Number: +81-3-4577-1111; Email: abbvie_jpn_info_clingov@abbvie.com

Study Locations

• Japan
  • Nagano, Japan, 380-0826
    • Recruiting
    • Jun Clinic /Id# 254870
  • Sapporo-shi, Japan, 063-0812
    • Recruiting
    • Kotoni tower Skin and Cosmetic Surgery Clinic /ID# 260668
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 810-0022
      • Recruiting
      • Jyosui Dermatology Clinic /ID# 254300
  • Kanagawa
    • Isehara-shi, Kanagawa, Japan, 259-1193
      • Recruiting
      • Tokai University Hospital /ID# 254204
  • Kyoto
    • Kyoto-shi, Kyoto, Japan, 604-8035
      • Recruiting
      • Ecru Clinic /ID# 256505
  • Okinawa
    • Naha-shi, Okinawa, Japan, 900-0015
      • Recruiting
      • Touyama Plastic Surgery Clinic /ID# 254831
  • Osaka
    • Sakai-shi, Osaka, Japan, 5938324
      • Recruiting
      • Dermatology and Ophthalmology Kume Clinic /ID# 254632
  • Saitama
    • Saitama-shi, Saitama, Japan, 330-0055
      • Recruiting
      • Chiharu Dermatology Clinic /ID# 254778
  • Shizuoka
    • Fujieda-shi, Shizuoka, Japan, 426-0067
      • Recruiting
      • Skin Clinic Fujieda /ID# 254214
  • Tokyo
    • Central District, Tokyo, Japan, 103-0028
      • Recruiting
      • Tokyo Center Clinic /ID# 254775
    • Chuo-ku, Tokyo, Japan, 104-0061
      • Recruiting
      • Ginza Skin Clinic /ID# 254666
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Recruiting
      • Tokyo Asbo Clinic /ID# 257728
    • Minato-ku, Tokyo, Japan, 106-0032
      • Recruiting
      • Roppongi Imaizumi Skin Clinic /ID# 254573
    • Minato-ku, Tokyo, Japan, 106-0045
      • Recruiting
      • Azabu Beauty Clinic ANNEX /ID# 254519
    • Minato-ku, Tokyo, Japan, 108-8642
      • Recruiting
      • Kitasato University Kitasato Institute Hospital /ID# 255369
    • Tachikawa-shi, Tokyo, Japan, 190-0023
      • Recruiting
      • Greenwood skin clinic Tachikawa /ID# 254830
    • Toshima-ku, Tokyo, Japan, 171-0021
      • Recruiting
      • Ikebukuronishiguchi Fukurou Dermatology Clinic /ID# 254639

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult Japanese individuals.
• Participant with marked or very marked masseter muscle prominence (MMP).

Exclusion Criteria:

• Asymmetry of left and right sides of the face that could prevent identical Masseter Muscle Prominence Scale (MMPS) or MMPS-P grading on both sides of the face, as determined by the investigator.
• History of permanent soft tissue fillers in the jawline.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; In Period 1, participant will receive 6 injections of BOTOX VISTA Dose A on Day 1. In Period 2, participants who meet the retreatment criteria will receive 6 injections of BOTOX VISTA Dose A on either Day 180, 210, 240, or 270.	Drug: BOTOX; Intramuscular Injection; Other Names: OnabotulinumtoxinA; BOTOX VISTA
Experimental: Group 2; In Period 1, participant will receive 6 injections of BOTOX VISTA Dose B on Day 1. In Period 2, participants who meet the retreatment criteria will receive 6 injections of BOTOX VISTA Dose B on either Day 180, 210, 240, or 270.	Drug: BOTOX; Intramuscular Injection; Other Names: OnabotulinumtoxinA; BOTOX VISTA
Experimental: Group 3; In Period 1, participant will receive 6 injections of BOTOX VISTA placebo on Day 1. In Period 2, participants who meet the retreatment criteria will receive 6 injections of BOTOX VISTA Dose A on either Day 180, 210, 240, or 270.	Drug: BOTOX; Intramuscular Injection; Other Names: OnabotulinumtoxinA; BOTOX VISTA; Drug: Placebo for BOTOX; Intramuscular Injection
Experimental: Group 4; In Period 1, participant will receive 6 injections of BOTOX VISTA placebo on Day 1. In Period 2, participants who meet the retreatment criteria will receive 6 injections of BOTOX VISTA Dose B on either Day 180, 210, 240, or 270.	Drug: BOTOX; Intramuscular Injection; Other Names: OnabotulinumtoxinA; BOTOX VISTA; Drug: Placebo for BOTOX; Intramuscular Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants who Achieve >= 2-Grade Improvement on Investigator-Rated Masseter Muscle Prominence Scale (MMPS)	The MMPS is a photonumeric scale encompassing visual inspection of the masseter muscles as performed by the investigator, where the masseter muscle prominence (MMP) is rated at rest, by separately evaluating the left and right side of the participant's face. The evaluation is on a 5-grade scale where 1 = the masseter muscle prominence is minimal and 5 = the masseter muscle prominence is very marked.	Baseline to Day 90
Number of Participants with Adverse Events (AEs)	An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment	Up to approximately 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Lower Facial Volume (cm^3)	Photographic technologies developed to provide 3D quantitative analysis of facial morphology include image subtraction technique, moire topography, liquid crystal scanning, light luminance scanning, laser scanning, stereo-lithography, and passive stereophotogrammetry, which all measure change to the lower facial contour.	Baseline to Day 90
Change from Baseline in Lower Facial Width (mm)	Photographic technologies developed to provide 3D quantitative analysis of facial morphology include image subtraction technique, moire topography, liquid crystal scanning, light luminance scanning, laser scanning, stereo-lithography, and passive stereophotogrammetry, which all measure change to the lower facial contour.	Baseline to Day 90
Percentage of Participants with Responses of Very Satisfied or Satisfied on the Lower Facial Shape Questionnaire - Treatment Satisfaction (LFSQ-TXSAT) Follow-Up Version	The LFSQ-TXSAT at follow-up measures the participant's satisfaction with the effect of treatment on the appearance of their lower face based on a 5-point scale where 2 = very satisfied and -2 = very dissatisfied.	Day 90
Responses of Not at All Bothered or A Little Bothered on the Bother Impact Assessment for Masseter Muscle Prominence (BIA-MMP) (for Subjects Somewhat Bothered, A Lot Bothered, or Extremely Bothered at Baseline)	The BIA-MMP is a single item evaluation of how bothered the participant is by the appearance of their lower face using a 5-point scale where 0 = not at all bothered and 4 = extremely bothered.	Day 90
Percentage of Participants who Achieve >= 2-Grade Improvement on Masseter Muscle Prominence Scale - Participant (MMPS-P)	The MMPS-P is a patient reported outcomes (PRO) measure with an accompanying photo guide used to assess MMP severity from the participant perspective using a 5-grade scale where 1 = the muscle is not at all noticeable and 5 = the muscle is extremely noticeable.	Baseline to Day 90
Change from Baseline in Lower Facial Shape Questionnaire - Impact Assessment (LFSQ-IA) Summary Score	The LFSQ-IA is a 6-item assessment that measures psychosocial impact of the appearance of the lower face using a 5-point scale where 0 = not at all and 4 = extremely.	Baseline to Day 90

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2023
• Primary Completion (Estimated): January 10, 2026
• Study Completion (Estimated): January 10, 2026

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: OnabotulinumtoxinA; BOTOX; Masseter Muscle Prominence; BOTOX VISTA
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: M22-080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No