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Botulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy

NCT02010775 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2019-05-28

Study results available
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Summary

This study will evaluate the safety and efficacy of a range of doses of botulinum toxin Type A (BOTOX®) for the treatment of patients with bilateral Masseter Muscle Hypertrophy (MMH).

Conditions

  • Masseter Muscle Hypertrophy

Interventions

BIOLOGICAL

botulinum toxin Type A

Botulinum toxin Type A (BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.

DRUG

Normal saline

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

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Beta Bowen · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-20
Primary Completion
2017-03-07
Completion
2017-11-29

Countries

  • Australia
  • Canada
  • Taiwan

Study Locations

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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 NCT02010775 on ClinicalTrials.gov