Double-blind, Randomized, Parallel Design, Active-controlled Phase 1 Clinical Trial to Evaluate the Efficacy and Safety of DWP712 and Botox® in Adult Patients in Need of Moderate to Severe Glabellar Lines
| Registry | NCT06212960 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 20 (Actual) |
| Sponsor | Daewoong Pharmaceutical Co. LTD. (Industry) |
| Conditions | Glabellar Lines |
| Interventions | DWP712, BOTOX® (Biological) |
| Dates | start 2023-11-28, primary completion 2024-02-26, completion 2024-03-21, first posted 2024-01-19, last updated 2024-04-04 |
| Locations | 1 site in South Korea |
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To evaluate the safety of 12-week administration of DWP712 inj. in subjects with moderate to severe glabellar lines.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| DWP712 | Experimental | Biological: DWP712 | Patients were intramuscularly injected (IM) with a total of 20U of DWP712 in 5 places of 0.1 mL (4 U/0.1 mL) each on the glabellar line. |
| Botox® | Active comparator | Biological: BOTOX® | Patients were intramuscularly injected (IM) with a total of 20U of BOTOX® in 5 places of 0.1 mL (4 U/0.1 mL) each on the glabellar line. |
Sex: All, ages: 19 Years to 65 Years, accepts healthy volunteers
Inclusion Criteria: * Subjects with facial wrinkle scale (FWS) score of visual appearance of glabellar lines ≥2 (moderate) at maximum frown as assessed by the investigator at screening Exclusion Criteria: \-
| Facility | City | Country | Status |
|---|---|---|---|
| Chung-Ang University Hosptial | Seoul | South Korea |