Evaluate the Efficacy and Safety of DWP712 With Moderate to Severe Glabellar Lines

Daewoong Pharmaceutical

Status and phase: Not yet enrolling; Phase 3

Conditions: Glabellar Lines

Treatments: Biological: DWP712 inj.; Biological: Botox® 100 Units

Study type: Interventional

Funder types: Industry

Identifiers

NCT07013279

DW_DWP712301

Details and patient eligibility

About

To evaluate the efficacy and safety of DWP712 Inj. in Subjects with Moderate to Severe Glabellar Lines

Enrollment: 324 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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324 participants in 2 patient groups

DWP712 inj.

Experimental group

Description:

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.

Treatment:

Biological: DWP712 inj.

Botox® 100 Units

Active Comparator group

Description:

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.

Treatment:

Biological: Botox® 100 Units