Medytoxin® Treatment in Patients With Benign Masseteric Hypertrophy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hypertrophy of Masseter Muscle

Intervention / Treatment
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* Drug: Botulinum Toxin Type A
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medytoxin®<br>Botulinum toxin type A | Drug: Botulinum Toxin Type A<br>* Inject intramuscularly once in visit 2<br>* Other names: Medytoxin®;|
| Placebo Comparator: Normal Saline<br>Normal Saline | Drug: Placebos<br>* Inject intramuscularly once in visit 2<br>* Other names: Normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction amount of masseter muscle thickness |  | after the injection | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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masticatory muscles