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

NCT ID: NCT07013279

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2026-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Glabellar Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DWP712 inj.

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.

Group Type EXPERIMENTAL

DWP712 inj.

Intervention Type BIOLOGICAL

Clostridium botulinum Toxin

Botox® 100 Units

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.

Group Type ACTIVE_COMPARATOR

Botox® 100 Units

Intervention Type BIOLOGICAL

Clostridium botulinum Toxin

Interventions

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DWP712 inj.

Clostridium botulinum Toxin

Intervention Type BIOLOGICAL

Botox® 100 Units

Clostridium botulinum Toxin

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chung-Ang University Hosptial

Seoul, , South Korea

Site Status

Countries

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South Korea

Facility Contacts

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Beom Joon Kim, MD, phD

Role: primary

[email protected]
+82262991525

Other Identifiers

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DW_DWP712301

Identifier Type: -

Identifier Source: org_study_id

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