← Back to Search

Neuromodulator

Open-Label 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 testing the use of BOTOX injections to reduce the size of the masseter muscle in the lower face, which can sometimes look too wide. Participants will be divided into two groups,

Who is the study for?

Adults with Masseter Muscle Prominence, which causes a widened lower face, can join this study. They'll be randomly assigned to receive either BOTOX or a placebo injection. Participants must be willing to attend monthly visits and may have the option for additional BOTOX treatment.Check my eligibility

What is being tested?

The trial is testing if BOTOX injections are safe and effective in reducing the size of masseter muscles compared to a placebo. It involves two periods: initial random assignment to BOTOX or placebo, followed by an optional phase where eligible participants can get more BOTOX treatments.See study design

What are the potential side effects?

Possible side effects from BOTOX could include pain at the injection site, muscle weakness, bruising, headache, neck pain, eye problems like dryness or tearing up, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

I have severe jaw muscle prominence as I rated myself on the MMPS-P.

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

503,356 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

404 Previous Clinical Trials

147,890 Total Patients Enrolled

Frequently Asked Questions

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

Is the enrollment for this research study still ongoing?

"As per clinicaltrials.gov, the ongoing recruitment of participants for this trial has been confirmed. Originally shared on 4/22/2024, the study was last modified on 4/24/2024."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical research study?

"Indeed, information on clinicaltrials.gov reveals that this medical investigation is actively seeking participants. The study was initially shared on April 22nd, 2024 and last amended on April 24th, 2024. Enrollment of approximately 200 volunteers will take place at two designated sites."

Answered by AI

Has the Open-Label Period for BOTOX been endorsed by the FDA?

"Based on our team's assessment at Power, the safety rating for Open-Label Period: BOTOX is graded as 3. This score reflects the trial being in Phase 3 and having a solid foundation of efficacy data along with substantial evidence supporting its safety profile."

Answered by AI

What is the primary objective of this medical study?

"The primary objective of this investigation at around Day 90 is to document the occurrence of Adverse Events (AEs) among participants. Secondary endpoints encompass the proportion of individuals expressing "Very satisfied" or "Satisfied" feedback on the Lower Facial Shape Questionnaire - Treatment Satisfaction Assessment (LFSQ-TXSAT), where satisfaction levels are gauged on a scale from 'Very satisfied' to 'Very dissatisfied.' Additionally, secondary measures include evaluating the percentage of respondents indicating "Much improved" or "Moderately improved" outcomes using the MMP Participant Self-Assessment of Change (MMP-PSAC). This assessment determines changes in"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Assess BOTOX Injections in Adult Participants for the Change of Masseter Muscle Prominence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06387394.

All > Pflugerville Tx > Nashville