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BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence

NCT04073303 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 377

Last updated 2025-05-06

Study results available
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Summary

This study is designed to evaluate the safety and effectiveness of administering BOTOX for the treatment of Masseter Muscle Prominence (MMP) in adults.

Conditions

  • Masseter Muscle Prominence

Interventions

BIOLOGICAL

Botulinum Toxin Type A

Day 1 Administration of bilateral intramuscular injections into the masseter

OTHER

Placebo

Day 1 Administration of bilateral intramuscular injections of placebo (normal saline) into the masseter

Sponsors & Collaborators

Principal Investigators

  • ALLERGAN INC. · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-29
Primary Completion
2022-11-10
Completion
2022-11-10
FDA Drug
Yes

Countries

  • Canada
  • China
  • Taiwan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04073303 on ClinicalTrials.gov