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Phase I/II clinical trial will be integrated and conducted. In phase I clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled and safety is assessed after 12 weeks of administration of 20U of ATGC-100. In phase II clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled, and efficacy and safety are assessed by comparing with Botox (Allergan).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATGC-100 (Phase I/II) | Experimental | ATGC-100 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 |
|---|---|---|---|---|
| ATGC-100 | Biological | Clostridium Botulinum Type A |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I) | Up tp 12 weeks | |
| Glabellar line improvement rate at maximum frown confirmed with investigator's assessment (Phase II) | 4 weeks after the injection |
| Measure | Description | Time Frame |
|---|---|---|
| Glabella line improvement rate at maximum frown confirmed with investigator's assessment (Phase II) | 8, 12 weeks after the injection | |
| Glabellar line improvement rate at rest confirmed with investigator's assessment (Phase II) | 4, 8, 12 weeks after the injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nowon Eulji Medical Center, Eulji University | Seoul | South Korea |
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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 |
Clostridium Botulinum Type A |
|
| Glabellar line improvement rate at rest confirmed with subject's assessment (Phase II) | 4, 8, 12 weeks after the injection |
| Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase II) | Up tp 12 weeks |
| 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 |