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Neuromodulator

Double-Blind Period: BOTOX for Masseter Muscle Hypertrophy

Phase 3

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must have bilateral Grade 4 or Grade 5 Masseter Muscle Prominence (MMP) as determined by the investigator using the Masseter Muscle Prominence Scale (MMPS)

Participant must have bilateral Grade 4 or Grade 5 MMP as determined by the participant using the Masseter Muscle Prominence Scale - Participant (MMPS-P)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 360

Awards & highlights

Study Summary

This trial is looking at using BOTOX injections to treat the prominence of the masseter muscle in the lower face. The study will involve approximately 200 adult participants who will receive injections of either B

Who is the study for?

Adults with Masseter Muscle Prominence, which causes a widened lower face, can join this study. They must be willing to receive injections and attend monthly visits at the clinic or hospital. People who don't meet these requirements or have conditions that could interfere with the trial may not participate.Check my eligibility

What is being tested?

The trial is testing BOTOX injections against a placebo to see if they can safely reduce the size of masseter muscles in adults. Participants are randomly assigned to get either BOTOX or a placebo, with a follow-up period where eligible participants might receive additional BOTOX treatments.See study design

What are the potential side effects?

Possible side effects from BOTOX may include pain at the injection site, muscle weakness, bruising, headache, and rarely more serious effects like spread of toxin effects away from the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My jaw muscles are very prominent, rated as the highest on a specific scale.

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I have severe jaw muscle prominence as I rated myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 360

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 360

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 360 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite Achievement of MMP Severity Improvement and at Least a 2-Grade Improvement from Baseline by Both Investigator-Rated MMPS and Participant-Rated MMPS-P

Number of Participants with Adverse Events (AEs)

Secondary outcome measures

Change from Baseline in Lower Facial Shape Questionnaire-Impact Assessment (LFSQ-IA) Summary Score

Percentage of Participants Achieving Investigator-Rated MMPS Improvement Over Time

Percentage of Participants Achieving Participant-Rated MMPS-P Improvement Over Time

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Open-Label Period: BOTOXExperimental Treatment1 Intervention

Participants who are eligible for re-treatment will receive BOTOX injections on either the Day 180, 210, 240, or 270 visit and will be followed for up to 6 months.

Group II: Double-Blind Period: BOTOXExperimental Treatment1 Intervention

Participants will receive BOTOX injections across both the right and left masseter muscle on Day 1.

Group III: Double-Blind Period: PlaceboPlacebo Group1 Intervention

Participants will receive placebo injections across both the right and left masseter muscle on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BOTOX

2013

Completed Phase 4

~1200

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

967 Previous Clinical Trials

503,198 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

404 Previous Clinical Trials

147,732 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being enrolled in this ongoing medical trial?

"Yes, information available on clinicaltrials.gov shows that this trial is currently in search of participants. The trial was initially posted on April 30th, 2024 and most recently revised on May 1st, 2024. Recruitment aims to enroll 200 patients at a single site."

Answered by AI

What is the overall count of participants involved in this clinical investigation?

"Affirmative. Records from clinicaltrials.gov indicate that recruitment for this trial is ongoing. The original posting date was 30th April 2024 with the most recent update on 1st May 2024. This research endeavor aims to enroll 200 participants at a single designated site."

Answered by AI

Are there any risks associated with the administration of Double-Blind Period: BOTOX to patients?

"In this Phase 3 trial, the safety rating for the Double-Blind Period treatment with BOTOX is set at 3 by our experts at Power. This score indicates that there exists a body of evidence supporting both its effectiveness and safety profiles."

Answered by AI

What are the main goals that this clinical trial aims to achieve?

"The primary endpoint of this trial, assessed around Day 90, is the incidence of Adverse Events (AEs) among participants. Secondary objectives encompass assessing improvements over time in Participant-Rated Masseter Muscle Prominence Severity using a 5-point scale and evaluating responses on the MMP Participant Self-Assessment of Change with ratings from "Much improved" to "Much worse." Additionally, the study aims to gauge participant bother levels regarding lower face appearance through the Bother Impact Assessment for Masseter Muscle Prominence using a 5-point scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess BOTOX Injections for the Change of Masseter Muscle Prominence in Adult Participants

2024. "A Study to Assess BOTOX Injections for the Change of Masseter Muscle Prominence in Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06399718.

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