Back to resultsMedytoxin® Treatment in Patients With Benign Masseteric Hypertrophy
Primary Purpose
Hypertrophy of Masseter Muscle
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Hypertrophy of Masseter Muscle focused on measuring masticatory muscles
Eligibility Criteria
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.
Sites / Locations
- Chungang university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Medytoxin®
Normal Saline
Arm Description
Botulinum toxin type A
Normal Saline
Outcomes
Primary Outcome Measures
Reduction amount of masseter muscle thickness
Secondary Outcome Measures
Reduction amount of masseter muscle thickness and lower face volume
Overall satisfaction of subject
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02292472
Brief Title
Medytoxin® Treatment in Patients With Benign Masseteric Hypertrophy
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 6, 2014 (Actual)
Primary Completion Date
May 24, 2015 (Actual)
Study Completion Date
August 24, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medy-Tox
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophy of Masseter Muscle
Keywords
masticatory muscles
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medytoxin®
Arm Type
Experimental
Arm Description
Botulinum toxin type A
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Normal Saline
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
Medytoxin®
Intervention Description
Inject intramuscularly once in visit 2
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
Normal saline
Intervention Description
Inject intramuscularly once in visit 2
Primary Outcome Measure Information:
Title
Reduction amount of masseter muscle thickness
Time Frame
after the injection
Secondary Outcome Measure Information:
Title
Reduction amount of masseter muscle thickness and lower face volume
Time Frame
after the injection
Title
Overall satisfaction of subject
Time Frame
after the injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beom Joon Kim, Ph D
Organizational Affiliation
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungang university hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Medytoxin® Treatment in Patients With Benign Masseteric Hypertrophy
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