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

NCT ID: NCT06212960

Last Updated: 2024-04-04

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-28

Study Completion Date

2024-03-21

Brief Summary

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To evaluate the safety of 12-week administration of DWP712 inj. in subjects with moderate to severe glabellar lines.

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

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.

Group Type EXPERIMENTAL

DWP712

Intervention Type BIOLOGICAL

Clostridium botulinum Toxin

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.

Group Type ACTIVE_COMPARATOR

BOTOX®

Intervention Type BIOLOGICAL

Clostridium botulinum Toxin

Interventions

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DWP712

Clostridium botulinum Toxin

Intervention Type BIOLOGICAL

BOTOX®

Clostridium botulinum Toxin

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

\-
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

Principal Investigators

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Beom Joon Kim, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Locations

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Chung-Ang University Hosptial

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DW_DWP712101

Identifier Type: -

Identifier Source: org_study_id

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