Medytoxin® Treatment in Patients With Benign Masseteric Hypertrophy

March 25, 2019 updated by: Medy-Tox

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 2

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

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Normal Saline
Drug: Placebos
Inject intramuscularly once in visit 2
Other Names:
  • Normal saline
Experimental: Medytoxin®
Botulinum toxin type A
Drug: Botulinum Toxin Type A
Inject intramuscularly once in visit 2
Other Names:
  • Medytoxin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction amount of masseter muscle thickness
Time Frame: after the injection
after the injection

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction amount of masseter muscle thickness and lower face volume
Time Frame: after the injection
after the injection
Overall satisfaction of subject
Time Frame: after the injection
after the injection

Collaborators and Investigators

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

Sponsor

Medy-Tox

Investigators

  • Principal Investigator: Beom Joon Kim, Ph D, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

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)

October 6, 2014

Primary Completion (Actual)

May 24, 2015

Study Completion (Actual)

August 24, 2015

Study Registration Dates

First Submitted

November 12, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (Estimate)

November 17, 2014

Study Record Updates

Last Update Posted (Actual)

March 27, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT_PRT_BMH01

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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