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

Phase 3CompletedNCT04830345

EuBiologics Co.,Ltd290 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

290

Conditions

Glabellar Frown Lines

Interventions

ATGC-100 100UBIOLOGICAL

Clostridium botulinum toxin type A

Botox 100UBIOLOGICAL

Clostridium botulinum toxin type A

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Nowon Eulji University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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)

Time frame: 4 weeks post injection compared to baseline

Data from ClinicalTrials.gov

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