Efficacy and Safety of Botulinum Toxin at Moderate to Severe Glabellar Lines
Phase 3
Completed
- Conditions
- Glabellar Frown Lines
- Registration Number
- NCT04830345
- Lead Sponsor
- EuBiologics Co.,Ltd
- Brief Summary
Efficacy and safety of ATGC-100 are assessed in subjects with moderate to severe glabellar lines.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 290
Inclusion Criteria
- Healthy male and female aged 19 to 65 years old
- Participants with Facial Wrinkle Scale (FWS) score of > 2 at maximum frown at screening
- Participants willing to follow the study procedures and schedules
- Participants willing to give written informed consent to participate in the trial
Exclusion Criteria
- Participants with severe glabellar lines that cannot be improved physical method
- Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
- Participants with known hypersensitivity to any component of the study drug
- Participant who has skin disorder including infection and scar on injection site
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Nowon Eulji University Hospital
🇰🇷Seoul, Korea, Republic of
Nowon Eulji University Hospital🇰🇷Seoul, Korea, Republic of