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Completed

NCT Number: NCT02010775

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

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).

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Key information

Conditions

Masseter Muscle Hypertrophy Masticatory Muscles, Hypertrophy of

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shape Clinic, Darlinghurst, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Participants with Masseter Muscle Hypertrophy

Exclusion criteria

  • Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
  • Prior botulinum toxin treatment of any serotype to the masseter muscle or lower face
  • History of dental or surgical procedure for lower facial shaping or masseter muscle reduction
  • History of or current temporomandibular joint disorder (TMJD)

Treatment and study plan

Botulinum toxin type A

Biological

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

Other names: BOTOX®, onabotulinumtoxinA

normal saline

Drug

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

Primary outcomes

  1. Change From Baseline in Lower Facial Volume Using VECTRA 3D Images

    Time frame: Baseline (Day 1) to Day 90 of Treatment Cycle 1

    Lower facial volume was calculated from 3-dimensional (3D) images captured with the VECTRA M3 3D Stereophotogrammetry imaging system and was analyzed using computer assisted systems and predetermined facial landmarks. The difference in volume was measured between the select region of the baseline surface 3D model and the select region of the posttreatment surface 3D model. A negative change from Baseline (decrease in volume) indicates improvement.

Secondary outcomes

  1. Percentage of Participants Who Achieved a Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 as Assessed by the Investigator

    Time frame: Day 90 of Treatment Cycle 1

    The investigator used visual inspection and palpation to grade the prominence of the participant's masseter muscle on the left and right sides of the face using the MMPS where: 1=minimal prominence (best), 2=mild prominence, 3=moderate prominence, 4=marked prominence, 5=very marked prominence (worst). The percentage of participants with grade 3 or less is reported.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

BOTOX® Treatment of Masseter Muscle Hypertrophy

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 13, 2013
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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