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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04830345

Enrollment

290

Registered

2021-04-05

Start date

2020-06-29

Completion date

2021-10-01

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glabellar Frown Lines

Brief summary

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

Interventions

BIOLOGICALATGC-100 100U

Clostridium botulinum toxin type A

BIOLOGICALBotox 100U

Clostridium botulinum toxin type A

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients with improvement of glabellar lines at maximum frown	4 weeks post injection compared to baseline	Improvement rate of glabellar lines at maximum frown with Physician's Facial wrinkle scale (FWS)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026