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

EuBiologics

Status and phase: Completed; Phase 3

Conditions: Glabellar Frown Lines

Treatments: Biological: Botox 100U; Biological: ATGC-100 100U

Study type: Interventional

Funder types: Industry

Identifiers

NCT04830345

CBA-PLN-002

Details and patient eligibility

About

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

Enrollment: 290 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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290 participants in 2 patient groups

ATGC-100 100U

Experimental group

Description:

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

Treatment:

Biological: ATGC-100 100U

Botox 100U

Active Comparator group

Description:

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

Treatment:

Biological: Botox 100U