Skip to main content
OpenTrials
Completed

NCT Number: NCT03970876

Safety and Efficacy Study of ATGC-100 for the Treatment of Moderate to Severe Glabellar Lines in Adult Subjects

Phase I/II clinical trial will be integrated and conducted. In phase I clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled and safety is assessed after 12 weeks of administration of 20U of ATGC-100. In phase II clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled, and efficacy and safety are assessed by comparing with Botox (Allergan).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Moderate to Severe Glabellar Lines

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Nowon Eulji Medical Center, Eulji University

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy males and females aged between 19 to 65 years old
  • Subjects attaining ≥ grade 2 in the investigator's rating of the severity of glabellar line at maximum frown
  • Subjects who voluntarily signed the informed consent

Exclusion criteria

  • Subjects with general neuromuscular synaptic disorders
  • Presence or history of eyelid and/or ptosis
  • Subjects with noticeable facial asymmetry
  • Inability to substantially lessen glabellar frown lines even by physically spreading apart
  • Subjects who have administered the following drugs within 4 weeks prior to screening: Muscle relaxants, Anti-cholinergic agents, Benzodiazepine and similar drugs, Benzamide drugs, Tetracycline antibiotics, Lincomycin antibiotics, Aminoglycoside antibiotics
  • Subjects who are taking Anti-Coagulant and Anti-Platelet agent
  • Subjects who have taken Aspirin and NSAIDs within 7 days prior to administration of investigational drug
  • Subjects with skin disorders at the injection site
  • Subjects with previous treatment of Face Lifting, Permanent Implant, and/or Filler in glabellar region
  • Subjects with prior filler treatments which would have interfered with the evaluation of the efficacy of the study treatment
  • Any other planned facial aesthetic procedure in the glabellar area during the trial period
  • Previous treatment with botulinum toxin in the forehead within the last 5 months or any planned treatment during the study period
  • A history of drug or alcohol abuse
  • Condition including anxiety disorder, or any other significant psychiatric disorder (e.g. depression), in the investigator's opinion

Treatment and study plan

ATGC-100

Biological

Clostridium Botulinum Type A

BOTOX®

Biological

Clostridium Botulinum Type A

Primary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I)

    Time frame: Up tp 12 weeks

  2. Glabellar line improvement rate at maximum frown confirmed with investigator's assessment (Phase II)

    Time frame: 4 weeks after the injection

Secondary outcomes

  1. Glabella line improvement rate at maximum frown confirmed with investigator's assessment (Phase II)

    Time frame: 8, 12 weeks after the injection

  2. Glabellar line improvement rate at rest confirmed with investigator's assessment (Phase II)

    Time frame: 4, 8, 12 weeks after the injection

  3. Glabellar line improvement rate at rest confirmed with subject's assessment (Phase II)

    Time frame: 4, 8, 12 weeks after the injection

  4. Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase II)

    Time frame: Up tp 12 weeks

Sponsors and collaborators

Lead sponsor

EuBiologics Co.,Ltd

Industry

Registry information

Official study title

A Single Center, Randomized, Double-Blind, Active-controlled, Single-Dose, Phase I/II, Non-Inferiority Study Comparing ATGC-100 and Botox for the Treatment of Moderate to Severe Glabellar Lines in Adult Subjects

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 3, 2019
Registry last updated
Mar 23, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.