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OpenTrials
Completed

NCT Number: NCT02292472

Medytoxin® Treatment in Patients With Benign Masseteric Hypertrophy

This study design is A Randomized, Double-blind, Multi-center, Phase II Optimal Dose-finding Study to Determine the Safety and Efficacy of Meditoxin® in Subjects in Benign Masseteric Hypertrophy.

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Key information

Conditions

Hypertrophy of Masseter Muscle Masticatory Muscles, Hypertrophy of

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chungang university hospital

Seoul, South Korea

About this study

Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intramuscularly injected with the study drug or the placebo to find appropreate dose for the treatment of Benign Masseteric Hypertrophy. Thereafter, follow-up visits will be made and efficacy and safety assessment will be conducted.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject who shows benign masseteric hypertrophy
  • Male or female subject over 19 years of age and written informed consent is obtained from the patient or LAR.
  • Subject who has bisymmetry of masster at visual assessment.
  • Subejects who qualifies the standard meets on ultrasonics wave value.
  • Subjects who can and will comply with the requirements of the protocol.

Exclusion criteria

  • Diagnosis of myasthenia, facial palsy or severe facial asymmetry
  • Subject who got any treatment, including double jaw surgery, laser, thread treatment etc. in 1 year.
  • Subject who had previously received botulinum toxin within 3 months prior to the study entry
  • Subject who is participating in other investigational study at present or 30 prior to the screening date.
  • Subject with known hypersensitivity to botulinum toxin
  • Subject who are pregnant or lactating or found pregnancy though the urine or sebum test or disagreed to avoid pregnancy during study preiod.
  • Subjects who are not eligible for this study at the discretion of the investigator.

Treatment and study plan

Botulinum Toxin Type A

Drug

Inject intramuscularly once in visit 2

Other names: Medytoxin®

Placebos

Drug

Inject intramuscularly once in visit 2

Other names: Normal saline

Primary outcomes

  1. Reduction amount of masseter muscle thickness

    Time frame: after the injection

Secondary outcomes

  1. Reduction amount of masseter muscle thickness and lower face volume

    Time frame: after the injection

  2. Overall satisfaction of subject

    Time frame: after the injection

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

A Randomized, Double-blind, Multi-center, Phase II Optimal Dose-finding Study to Determine Safety and Efficacy of Medytoxin® in Subjects in Benign Masseteric Hypertrophy

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 17, 2014
Registry last updated
Mar 27, 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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