Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy

Study Overview
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Brief Summary
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This Study is A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DWP450 in Subjects With Benign Masseteric 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 NABOTA® in Subjects With Benign Masseteric Hypertrophy

Conditions
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Benign Masseteric Hypertrophy

Intervention / Treatment
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* Drug: DWP450
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subject over 18 years of age and written informed consent is obtained. Subject with Benign Masseter Hypertrophy. Subject who has Bisymmetry of masseter at visual assessment. Subjects who meets thickness of Masseter muscle by ultrasonography. Subjects who can and will comply with the requirements of the protocol. Exclusion Criteria: Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function. Subject who got any facial aesthetic procedure (e.g. surgery, laser, thread treatment etc.) in lower facial area within 52 weeks prior to the study entry. Subject who had previously received botulinum toxin within 12 weeks prior to the study entry. 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 period. Subjects who are not eligible for this study at the discretion of the investigator.

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWP450<br> | Drug: DWP450<br>* Botulinum toxin type A(DWP450) will be administered intramuscularly to the bilateral masseter muscles on Day 1.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo(Normal Saline) will be administered intramuscularly to the bilateral masseter muscles on Day 1.<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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in masseter muscle thickness | Change from baseline in masseter muscle thickness by Ultrasonography | 24 weeks | 
| Change from baseline in lower face volume | Change from baseline in lower face volume by 3D digital imaging | 24 weeks | 
| Overall satisfaction of subject: questionnaire | Subject satisfaction assessment using a scale ranging from very dissatisfied to very satisfied by questionnaire | 24 weeks |