Evaluate the Safety and Efficacy of Botulax® in Subjects With Benign Masseteric Hypertrophy

Study Overview
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Brief Summary
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This study is A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects with Benign Masseteric Hypertrophy

Detailed Description
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A Randomized, Double-blind, Placebo-controlled, Multi-center Phase Ⅱ Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects with Benign Masseteric Hypertrophy

Official Title
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A Randomized, Double-blind, Placebo-controlled, Multi-center Phase Ⅱ Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® 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 Injection (Botulax®) 24Units
* Drug: Botulinum Toxin Type A Injection (Botulax®) 48Units
* Drug: Botulinum Toxin Type A Injection (Botulax®) 72Units
* Drug: Botulinum Toxin Type A Injection (Botulax®) 96Units
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and Female adults aged 19 or older. Sighting, facilitation measurement are judged by the investigator to be the ratio of Benign Masseteric Hypertrophy. Subject who understand and willing to perform with the procedures and visiting schedules of clinical trial. Subject who voluntarily agree to participate in this clinical trial. Exclusion Criteria: Subject who is clinically significant facial asymmetry in visual measurement by the investigator. Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception. Subject who is deemed unable to participate in a clinical trial under the judgement of a 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum Toxin Type A(Botulax®) 24Units<br>Botulinum Toxin Type A (Botulax®) 24Units total dose administered intramuscularly to the bilateral masseter muscles. | Drug: Botulinum Toxin Type A Injection (Botulax®) 24Units<br>* Experimental: Botulax® 24Units<br>* Other names: Botulax®;|
| Experimental: Botulinum Toxin Type A(Botulax®) 48Units<br>Botulinum Toxin Type A (Botulax®) 48Units total dose administered intramuscularly to the bilateral masseter muscles. | Drug: Botulinum Toxin Type A Injection (Botulax®) 48Units<br>* Experimental: Botulax® 48Units<br>* Other names: Botulax®;|
| Experimental: Botulinum Toxin Type A(Botulax®) 72Units<br>Botulinum Toxin Type A (Botulax®) 72Units total dose administered intramuscularly to the bilateral masseter muscles. | Drug: Botulinum Toxin Type A Injection (Botulax®) 72Units<br>* Experimental: Botulax® 72Units<br>* Other names: Botulax®;|
| Experimental: Botulinum Toxin Type A(Botulax®) 96Units<br>Botulinum Toxin Type A (Botulax®) 96Units total dose administered intramuscularly to the bilateral masseter muscles. | Drug: Botulinum Toxin Type A Injection (Botulax®) 96Units<br>* Experimental: Botulax® 96Units<br>* Other names: Botulax®;|
| Placebo Comparator: Placebo(Normal Saline)<br>Placebo(Normal saline) administered intramuscularly to the bilateral masseter muscles. | Other: Normal Saline<br>* Placebo Comparator: Normal Saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of change from baseline in masseter muscle thickness during maximum clenching | Amount of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography | Baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of change from baseline in masseter muscle thickness during maximum clenching | Amount of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography | Baseline to week 4, 8, 16 | 
| Rate of change from baseline in masseter muscle thickness during maximum clenching | Rate of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography | Baseline to week 4, 8, 12, 16 | 
| Amount of change from baseline in masseter muscle thickness during resting | Amount of change from baseline in masseter muscle thickness during resting by Ultrasonography | Baseline to week 4, 8, 12, 16 | 
| Rate of change from baseline in masseter muscle thickness during resting | Rate of change from baseline in masseter muscle thickness during resting by Ultrasonography | Baseline to week 4, 8, 12, 16 | 
| Amount and rate of change from baseline in lower face volume during maximum clenching | Amount and rate of change from baseline in lower face volume during maximum clenching by 3D imaging | Baseline to week 4, 8, 12, 16 | 
| Overall improvement of Investigator | Overall improvement of Investigator by assessment scale | Baseline to week 4, 8, 12, 16 | 
| Overall satisfaction of subject | Subject satisfaction assessment using a scale ranging from Extremely dissatisfied to Extremely satisfied by questionnaire | Baseline to week 4, 8, 12, 16 |