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

NCT ID: NCT04830345

Last Updated: 2022-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-29

Study Completion Date

2021-10-01

Brief Summary

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

Detailed Description

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Conditions

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Glabellar Frown Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ATGC-100 100U

ATGC-100 will be injected to 5 glabellar lines (each 4U/0.1mL; total 20U) at Day 0

Group Type EXPERIMENTAL

ATGC-100 100U

Intervention Type BIOLOGICAL

Clostridium botulinum toxin type A

Botox 100U

Botox inj. will be injected to 5 glabellar lines (each 4U/0.1mL; total 20U) at Day 0

Group Type ACTIVE_COMPARATOR

Botox 100U

Intervention Type BIOLOGICAL

Clostridium botulinum toxin type A

Interventions

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ATGC-100 100U

Clostridium botulinum toxin type A

Intervention Type BIOLOGICAL

Botox 100U

Clostridium botulinum toxin type A

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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EuBiologics Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nowon Eulji University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CBA-PLN-002

Identifier Type: -

Identifier Source: org_study_id

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