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To evaluate the efficacy and safety of DWP712 Inj. in Subjects with Moderate to Severe Glabellar Lines
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWP712 inj. | Experimental | The investigational product will be administered by a single intramuscular injection, and 4 U/0.1 mL of the IP will be injected into a total of 5 sites, totaling 20 U/0.5 mL. |
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| Botox® 100 Units | Active Comparator | The investigational product will be administered by a single intramuscular injection, and 4 U/0.1 mL of the IP will be injected into a total of 5 sites, totaling 20 U/0.5 mL. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP712 inj. | Biological | Clostridium botulinum Toxin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with glabellar line improvement* rate at maximum frown based on the investigator's on-site assessment at 4 weeks after IP administration | Improvement means FWS grade of "0" or "1" with a ≥2-point improvement from baseline | At 4 weeks after IP administration |
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Inclusion Criteria:
- Subjects with a facial wrinkle scale (FWS) score of ≥2 (moderate) for glabellar lines at maximum frown in the investigator's on-site assessment at screening
Exclusion Criteria:
- Subjects with glabellar lines that cannot sufficiently be improved by physical attempts, e.g., glabellar lines not flattened by hand, in the judgment of the investigator
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang University Hosptial | Seoul | South Korea |
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| Botox® 100 Units |
| Biological |
Clostridium botulinum Toxin |
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