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Efficacy and safety of the investigational product, ATGC-110, was evaluated in comparison with Xeomin for a total of 16 weeks after the administration in treatment of glabellar frown lines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin type A(ATGC-110) | Experimental | ATGC-110 will be injected to 5 glabellar lines (Each 4U/0.1ml, Total 20U/0.5ml) |
|
| Incobotulinumtoxin A (Xeomin®) | Active Comparator | Xeomin® will be injected to 5 glabellar lines (Each 4U/0.1ml, Total 20U/0.5ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATGC-110 | Biological | ATGC-110 is a prescription medicine that is injected into muscles and used to improve the moderate to severe glabellar lines. It should be reconstituted with sterile, preservative-free 0.9% saline before use. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement rate (%) of glabellar lines at maximum frown according to the investigator's on-site evaluation at week 4 compared to the baseline | Investigators will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe. Only the subjects whose FWS score is 0- or 1-grade when it's assessed and ≥ 2-grade improvement from baseline will be defined as their glabellar lines are improved. | 4 weeks after the administration |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement rate (%) of glabellar lines at maximum frown according to the investigator's on-site evaluation at weeks 8, 12, and 16 compared to the baseline | Investigators will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe. Only the subjects whose FWS score is 0- or 1-grade when it's assessed and ≥ 2-grade improvement from baseline will be defined as their glabellar lines are improved. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nowon Eulji Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C545476 | incobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| Xeomin® | Biological | Xeomin® is a prescription medicine that is injected into muscles and used to improve the moderate to severe glabellar lines. It should be reconstituted with sterile, preservative-free 0.9% saline before use. |
|
|
| 8, 12 and 16 weeks after the administration |
| Improvement rate (%) of glabellar lines at rest according to the investigator's on-site evaluation at weeks 4, 8, 12, and 16 compared to the baseline | Investigators will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe. Only the subjects whose FWS score is 0- or 1-grade when it's assessed and ≥ 2-grade improvement from baseline will be defined as their glabellar lines are improved. | 4, 8, 12 and 16 weeks after the administration |
| Improvement rate (%) of glabellar lines at maximum frown evaluated through photographs by the independent evaluator at weeks 4, 8, 12, and 16 compared to the baseline | Independent evaluator will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe. Only the subjects whose FWS score is 0- or 1-grade when it's assessed and ≥ 2-grade improvement from baseline will be defined as their glabellar lines are improved. | 4, 8, 12 and 16 weeks after the administration |
| Improvement rate (%) of glabellar lines at rest evaluated through photographs by the independent evaluator at weeks 4, 8, 12, and 16 compared to the baseline | Independent evaluator will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe. Only the subjects whose FWS score is 0- or 1-grade when it's assessed and ≥ 2-grade improvement from baseline will be defined as their glabellar lines are improved. | 4, 8, 12 and 16 weeks after the administration |
| The percentage of subjects whose FWS score is 0- or 1-grade at maximal frown according to the investigator's on-site evaluation at week 4, 8, 12, and 16 | Investigators will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe. | 4, 8, 12 and 16 weeks after the administration |
| The percentage of subjects whose FWS score is 0- or 1-grade at rest according to the investigator's on-site evaluation at week 4, 8, 12, and 16 | Investigators will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe. | 4, 8, 12 and 16 weeks after the administration |
| The percentage of subjects whose FWS score is 0- or 1-grade at maximal frown evaluated through photographs by the independent evaluator at week 4, 8, 12, and 16 | Independent evaluator will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe. | 4, 8, 12 and 16 weeks after the administration |
| The percentage of subjects whose FWS score is 0- or 1-grade at rest evaluated through photographs by the independent evaluator at week 4, 8, 12, and 16 | Independent evaluator will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe. | 4, 8, 12 and 16 weeks after the administration |
| The percentage of subjects whose FWS score is improved ≥ 2 grade improvement according to the subject's evaluation at week 4, 8, 12, and 16 | Subjects will assess their glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe. | 4, 8, 12 and 16 weeks after the administration |
| Evaluation of subjects' satisfaction at weeks 4, 8, 12, and 16 | If the subject's satisfaction evaluation score is 6 points or higher, it is evaluated as satisfactory. | 4, 8, 12 and 16 weeks after the administration |
| The percentage of subjects whose FWS score is imporved ≥ 2 grade improvement at maximal frown according to the investigator's on-site and subject's evaluation at weeks 4, 8, 12, and 16 | If the glabellar line score evaluated by the subject is +2 points or higher, it is evaluated as improved | 4, 8, 12 and 16 weeks after the administration |
| 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 |