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NCT04830345 Clinical Trial

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

Glabellar Frown Lines Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04830345
Other study ID # CBA-PLN-002
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 29, 2020
Est. completion date October 1, 2021

Study information
Verified date March 2021
Source EuBiologics Co.,Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 290
Est. completion date October 1, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 65 Years
Eligibility Inclusion Criteria: 1. Healthy male and female aged 19 to 65 years old 2. Participants with Facial Wrinkle Scale (FWS) score of > 2 at maximum frown at screening 3. Participants willing to follow the study procedures and schedules 4. Participants willing to give written informed consent to participate in the trial Exclusion Criteria: 1. Participants with severe glabellar lines that cannot be improved physical method 2. Pregnant, lactating women or women of childbearing age not using a reliable method of contraception 3. Participants with known hypersensitivity to any component of the study drug 4. Participant who has skin disorder including infection and scar on injection site

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• ATGC-100 100U
Clostridium botulinum toxin type A
• Botox 100U
Clostridium botulinum toxin type A

Locations
Country Name City State
Korea, Republic of Nowon Eulji University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
EuBiologics Co.,Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients with improvement of glabellar lines at maximum frown Improvement rate of glabellar lines at maximum frown with Physician's Facial wrinkle scale (FWS) 4 weeks post injection compared to baseline
See also
  Status Clinical Trial Phase
Completed NCT02236312 - Safety and Efficacy Study of Botulinum Toxin for the Treatment of Glabellar Frown Lines Phase 2
Active, not recruiting NCT05565950 - AI-09 In Subjects With Glabellar Lines, GL-101 Phase 1/Phase 2
Completed NCT00430963 - IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines Phase 3
Recruiting NCT05083286 - Duration of Botox Using OLD Versus COLD for Treatment of Glabellar Lines Early Phase 1
Completed NCT03687736 - Subject Satisfaction With AbobutulinumtoxinA Treatment Phase 4
Active, not recruiting NCT04281745 - Long-term Open-label Treatment of Moderate to Severe Glabellar Lines With CORETOX® Phase 4
Active, not recruiting NCT05623410 - Study to Compare the Efficacy and Safety of ATGC-110 (Botulinum Toxin) With Xeomin® for the Treatment of Moderate to Severe Glabellar Frown Lines Phase 3
Active, not recruiting NCT03440671 - The Safety and Efficacy Study of Hutox Versus Botox® in Subject With Moderate to Severe Glabellar Lines Phase 3
Completed NCT03736928 - Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines Phase 2
Completed NCT01808742 - Study Evaluating the Treatment of Forehead and/or Glabellar Lines With the CRYO-TOUCH III Device N/A
Completed NCT00777803 - NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines Phase 3
Completed NCT00430586 - Finding of Optimal Dose for NT 201 in the Treatment of Glabellar Frown Lines Phase 2
Completed NCT04281095 - A Comparative Study of Botulinum Neurotoxin Type A in Treatment of Moderate to Severe Glabellar Frown Lines Phase 1/Phase 2
Active, not recruiting NCT05146999 - Assess Aesthetic Improvement and Onset of QM1114-DP in Subjects With Moderate to Severe Glabellar Lines Phase 3
Completed NCT02428608 - Safety Study of DWP-450 (Botulinum Toxin, Type a) to Treat Glabellar Lines - EV-006 Phase 2
Completed NCT04143815 - Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Glabellar Lines Phase 2
Not yet recruiting NCT05305768 - Xeomin Treatment of Glabellar Lines Using OLD Versus COLD Early Phase 1
Completed NCT05364580 - The Efficacy and Safety Study of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines Phase 3
Completed NCT05320393 - Study to Demonstrate Safety and Duration of Effect of 40 Units of PrabotulinumtoxinA-xvfs to Treat Glabellar Lines Phase 2
Completed NCT02677805 - Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study II Phase 3