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Phase 3 Study to Compare the Efficacy and Safety of Botulinum Toxin at Moderate to Severe Glabellar Lines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04830345
Recruitment Status : Active, not recruiting
First Posted : April 5, 2021
Last Update Posted : April 5, 2021
Sponsor:
Information provided by (Responsible Party):
EuBiologics Co.,Ltd

Study Description
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Brief Summary:
Efficacy and safety of ATGC-100 are assessed in subjects with moderate to severe glabellar lines.

Condition or disease Intervention/treatment Phase
Glabellar Frown Lines Biological: ATGC-100 100U Biological: Botox 100U Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 29, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arms and Interventions
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Arm Intervention/treatment
Experimental: ATGC-100 100U
ATGC-100 will be injected to 5 glabellar lines (each 4U/0.1mL; total 20U) at Day 0
 Biological: ATGC-100 100U
Clostridium botulinum toxin type A
Active Comparator: Botox 100U
Botox inj. will be injected to 5 glabellar lines (each 4U/0.1mL; total 20U) at Day 0
 Biological: Botox 100U
Clostridium botulinum toxin type A


Outcome Measures
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Primary Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04830345


Locations
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Korea, Republic of
Nowon Eulji University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
EuBiologics Co.,Ltd
More Information
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Responsible Party: EuBiologics Co.,Ltd
ClinicalTrials.gov Identifier: NCT04830345    
Other Study ID Numbers: CBA-PLN-002
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No