Medytoxin® Treatment in Patients With Benign Masseteric Hypertrophy

NCT02292472 | Completed Phase 2

• 1 other identifier: MT_PRT_BMH01
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertrophy of Masseter Muscle

Keywords

masticatory muscles

Outcome Measures

Primary Outcomes (1)

• Reduction amount of masseter muscle thickness

  after the injection

Secondary Outcomes (2)

• Reduction amount of masseter muscle thickness and lower face volume

  after the injection

• Overall satisfaction of subject

  after the injection

Study Arms (2)

Medytoxin®

EXPERIMENTAL

Botulinum toxin type A

Drug: Botulinum Toxin Type A

Normal Saline

PLACEBO COMPARATOR

Normal Saline

Drug: Placebos

Interventions

Botulinum Toxin Type A DRUG

Inject intramuscularly once in visit 2

Also known as: Medytoxin®

Medytoxin®

Placebos DRUG

Inject intramuscularly once in visit 2

Also known as: Normal saline

Normal Saline

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medy-Tox: lead

Study Sites (1)

Chungang university hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Masticatory Muscles, Hypertrophy of

Interventions

Botulinum Toxins, Type A; Saline Solution

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Beom Joon Kim, Ph D

  Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: November 17, 2014
• Study Start: October 6, 2014
• Primary Completion: May 24, 2015
• Study Completion: August 24, 2015
• Last Updated: March 27, 2019

Record last verified: 2019-03

Locations

KR (1)