MEDITOXIN® Treatment in Subject With Benign Masseteric Hypertrophy

July 27, 2020 updated by: Medy-Tox

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo (Normal saline)
Experimental: MEDITOXIN
Drug: Meditoxin
Meditoxin (Botulinum toxin type A)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 week follow-up visit

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 week follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medy-Tox

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2018

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

April 16, 2019

Study Registration Dates

First Submitted

February 26, 2018

First Submitted That Met QC Criteria

February 26, 2018

First Posted (Actual)

March 2, 2018

Study Record Updates

Last Update Posted (Actual)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT01-KR17BMH305

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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