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This study will be conducted in Phase I/II clinical trials. In Phase I, subjects with moderate to severe glabellar lines are enrolled and those who are judged to be eligible for this study will be injected with the "PROTOXIN" at a total of 20U(4U/0.1mL each) in five sites of the glabellar lines. Safety is assessed after 12 weeks. In Phase II, subjects with moderate to severe glabellar lines are enrolled and will be injected the "PROTOXIN" or the "BOTOX®" at a total of 20U(4U/0.1mL each)in five sites of the glabellar lines. Thereafter, efficacy and safety are assessed by comparing with BOTOX®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROTOXIN (Phase I/II) | Experimental | PROTOXIN will be injected to 5 glabellar lines (Each 4U/0.1mL, Total 20U/0.5mL). |
|
| Botox® (Phase II) | Active Comparator | Botox® will be injected to 5 glabellar lines (Each 4U/0.1mL, Total 20U/0.5mL). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROTOXIN | Biological | Botulinum toxin Type A |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I) | 12 weeks after the injection | |
| Glabellar line improvement rate confirmed with investigator's assessment (Phase II) | 4 weeks after the injection |
| Measure | Description | Time Frame |
|---|---|---|
| Glabellar line improvement rate confirmed with investigator's assessment (Phase II) | 4, 8, 12 weeks after the injection | |
| Glabellar line improvement rate confirmed by subject' satisfaction assessment (Phase II) | 4, 8, 12 weeks after the injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beomjoon Kim | Chung-Ang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang University Hospital | Seoul | South Korea | ||||
| Nowon Eulji Medical Center |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Botox® |
| Biological |
Botulinum toxin Type A |
|
| Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase II) | 12 weeks after the injection |
| Seoul |
| South Korea |
| 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 |