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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum Toxin Type A(Botulax®) 24Units | Experimental | Botulinum Toxin Type A (Botulax®) 24Units total dose administered intramuscularly to the bilateral masseter muscles. |
|
| Botulinum Toxin Type A(Botulax®) 48Units | Experimental | Botulinum Toxin Type A (Botulax®) 48Units total dose administered intramuscularly to the bilateral masseter muscles. |
|
| Botulinum Toxin Type A(Botulax®) 72Units | Experimental | Botulinum Toxin Type A (Botulax®) 72Units total dose administered intramuscularly to the bilateral masseter muscles. |
|
| Botulinum Toxin Type A(Botulax®) 96Units | Experimental | Botulinum Toxin Type A (Botulax®) 96Units total dose administered intramuscularly to the bilateral masseter muscles. |
|
| Placebo(Normal Saline) | Placebo Comparator | Placebo(Normal saline) administered intramuscularly to the bilateral masseter muscles. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A Injection (Botulax®) 24Units | Drug | Experimental: Botulax® 24Units |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hugel | Seoul | South Korea |
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|
| Botulinum Toxin Type A Injection (Botulax®) 48Units | Drug | Experimental: Botulax® 48Units |
|
|
| Botulinum Toxin Type A Injection (Botulax®) 72Units | Drug | Experimental: Botulax® 72Units |
|
|
| Botulinum Toxin Type A Injection (Botulax®) 96Units | Drug | Experimental: Botulax® 96Units |
|
|
| Normal Saline | Other | Placebo Comparator: Normal Saline |
|
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 |
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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