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Completed

NCT Number: NCT05804656

Efficacy and Safety of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines in Phase 3 Trial

A Randomized, Double-blind, Active-controlled, Multi-center Phase 3 Trial to Investigate the Efficacy and Safety of CKDB-501A in Subjects with Moderated-to-severe Glabella Lines

Completed

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Key information

Conditions

Glabellar Lines

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chung-Ang University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with at least moderate glabellar lines at maximum frown as determined by severity score of at least 2-point (moderate) on the Facial Wrinkle Scale (4-point FWS) as assessed by investigator.

Exclusion criteria

  • Any medical condition that can affect the neuromuscular function
  • History of facial nerve paralysis or ptosis
  • Significant facial asymmetry
  • Subjects whose glabellar lines cannot be sufficiently improved by physical method
  • Subjects who have a previous surgical history that could result in any anatomical changes related to corrugator muscle, procerus muscle, or any relevant nerves
  • Subjects with skin abnormalities at potential injection sites

Treatment and study plan

CKDB-501A

Drug

Intramuscular injection CKDB-501A

Botox®

Drug

Intramuscular injection Botox®

Primary outcomes

  1. Proportion of subjects with a ≥ 2-point improvement on the FWS score at maximum frown from baseline, as assessed by the investigator post-administration of the investigational product

    Time frame: Week 4

Sponsors and collaborators

Lead sponsor

CKD Bio Corporation

Industry

Registry information

Official study title

A Randomized, Double-blind, Active-controlled, Multi-center Phase 3 Trial to Investigate the Efficacy and Safety of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 7, 2023
Registry last updated
Dec 12, 2023

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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