Study to Compare the Efficacy and Safety of ATGC-110 (Botulinum Toxin) With Xeomin® for the Treatment of Moderate to Severe Glabellar Frown Lines
- Sponsor
- ATGC Co., Ltd.
- Study ID
- NCT05623410
- Phase
- PHASE3
- Status
- Unknown
Conditions
- Glabellar Frown Lines
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- ATGC-110 — BIOLOGICALATGC-110 is a prescription medicine that is injected into muscles and used to improve the moderate to severe glabellar lines. It should be reconstituted with sterile, preservative-free 0.9% saline before use.
- Xeomin® — BIOLOGICALXeomin® is a prescription medicine that is injected into muscles and used to improve the moderate to severe glabellar lines. It should be reconstituted with sterile, preservative-free 0.9% saline before use.
Study Details
Efficacy and safety of the investigational product, ATGC-110, was evaluated in comparison with Xeomin for a total of 16 weeks after the administration in treatment of glabellar frown lines.
Key Dates
- Start date
- Oct 11, 2022
- Status verified
- Feb 2023
- Primary completion
- Feb 10, 2023
- Completion
- Jun 10, 2023
Study Design
- Enrollment
- 300 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Botulinum toxin type A(ATGC-110)ATGC-110 will be injected to 5 glabellar lines (Each 4U/0.1ml, Total 20U/0.5ml)
- Active Comparator: Incobotulinumtoxin A (Xeomin®)Xeomin® will be injected to 5 glabellar lines (Each 4U/0.1ml, Total 20U/0.5ml)
Primary Outcome Measure
Improvement rate (%) of glabellar lines at maximum frown according to the investigator's on-site evaluation at week 4 compared to the baseline [ Time Frame: 4 weeks after the administration ]