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OpenTrials
Completed

NCT Number: NCT04830345

Efficacy and Safety of Botulinum Toxin at Moderate to Severe Glabellar Lines

Efficacy and safety of ATGC-100 are assessed in subjects with moderate to severe glabellar lines.

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Key information

Conditions

Glabellar Frown Lines

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nowon Eulji University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and female aged 19 to 65 years old
  • Participants with Facial Wrinkle Scale (FWS) score of > 2 at maximum frown at screening
  • Participants willing to follow the study procedures and schedules
  • Participants willing to give written informed consent to participate in the trial

Exclusion criteria

  • Participants with severe glabellar lines that cannot be improved physical method
  • Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
  • Participants with known hypersensitivity to any component of the study drug
  • Participant who has skin disorder including infection and scar on injection site

Treatment and study plan

ATGC-100 100U

Biological

Clostridium botulinum toxin type A

Botox 100U

Biological

Clostridium botulinum toxin type A

Primary outcomes

  1. Proportion of patients with improvement of glabellar lines at maximum frown

    Time frame: 4 weeks post injection compared to baseline

    Improvement rate of glabellar lines at maximum frown with Physician's Facial wrinkle scale (FWS)

Sponsors and collaborators

Lead sponsor

EuBiologics Co.,Ltd

Industry

Registry information

Official study title

A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase 3 Clinical Trial to Compare the Efficacy and Safety of ATGC-100 Versus Botox in Subjects With Moderate to Severe Glabellar Lines

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 5, 2021
Registry last updated
Apr 4, 2022

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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