To Evaluate the Efficacy and Safety of LIZTOX in Subjects With Benign Masseteric Hypertrophy

Study Overview
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Brief Summary
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A double-blind, randomized, placebo-controlled, multi-center, phase III study to evaluate the efficacy and safety of LIZTOX in subjects with benign massesric hypertrophy

Official Title
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A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of LIZTOX in Subjects With Benign Masseteric Hypertrophy.

Conditions
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Benign Masseteric Hypertrophy

Intervention / Treatment
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* Drug: Botulinum toxin type A
* Drug: normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subject over 19 years of age and written informed consent is obtained. Subject who has bisymmetry of masseter at visual and palpable assessment. Subject who meets thickness of masseter muscle by ultrasonography. Subject who has a scale of benign masseter hypertrophy of 4 or more as determined by investigator. Subject who fully understands this clinical trial and voluntarily writes ICF in the clinical trial. Exclusion Criteria: Subject who had previously received botulinum toxin within 12 weeks prior to the study entry. Subject who got any facial aesthetic procedure (e.g. surgery, laser, thread treatment etc.) in lower facial area within 48 weeks prior to the study entry. Subject who has a disease(e.g. Temporo mandibular joint disorder, etc.) Subject who were diagnosed Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might influence with neuromuscular function. Subject who had taken medication(e.g. muscle relaxant, polypeptide antibiotics, aminoglycoside antibiotics, etc.) within 4 weeks prior to the study entry. Subject with known hypersensitivity to botulinum toxin. Subject who are pregnant or lactating or planing pregnancy or disagreed to avoid pregnancy during study period. Subject who participate other clinical trials within 4 weeks prior to the study entry. Subject 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: HU-014<br> | Drug: Botulinum toxin type A<br>* Botulinum toxin type A(HU-014) will be administered intramuscularly to the bilateral masseter muscles on Visit 2.<br>|
| Placebo Comparator: Placebo<br> | Drug: normal Saline<br>* Normal Saline will be administered intramuscularly to the bilateral masseter muscles on Visit 2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in masseter muscle thickness | Change from baseline in masseter muscle thickness by Ultrasonography | 12week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMH