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OpenTrials
Completed

NCT Number: NCT06212960

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

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

Completed

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Key information

Conditions

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chung-Ang University Hosptial

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

DWP712

Biological

Clostridium botulinum Toxin

BOTOX®

Biological

Clostridium botulinum Toxin

Primary outcomes

  1. Number of occurrences for grade 3 or higher adverse drug reactions (ADRs) according to CTCAE 5.0

    Time frame: At 4, 8, 12 week after the injection

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 19, 2024
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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