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OpenTrials
Completed

NCT Number: NCT03452345

MEDITOXIN® Treatment in Subject With Benign Masseteric Hypertrophy

To evaluate the efficacy and safety of MEDITOXIN in subjects with benign masseteric hypertrophy compared with placebo

Completed

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Key information

Conditions

Masseter Muscle Hypertrophy Masticatory Muscles, Hypertrophy of

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • subject who aged 20 to less than 65 years
  • subject with benign masseteric hypertrophy

Exclusion criteria

  • subject not appropriate for participating in this study according to the investigator's opinion
  • subject with known an anaphylactic response to BoNT/A and other involved ingredients of Investigational product

Treatment and study plan

Meditoxin

Drug

Meditoxin (Botulinum toxin type A)

Placebo

Drug

Placebo (Normal saline)

Primary outcomes

  1. changes in the thickness of the masseter muscle during maximum clenching measured using ultrasound at week 12 from baseline

    Time frame: 12 week follow-up visit

Secondary outcomes

  1. changes in the thickness of the masseter muscle as usual measured using ultrasound at week 12 from baseline

    Time frame: 12 week follow-up visit

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of MEDOTIXN® in Subject With Benign Masseteric Hypertrophy

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 2, 2018
Registry last updated
Jul 28, 2020

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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