Status:
COMPLETED
Long-term Extension Study to Evaluate MBA-P01 in Subjects With Moderate to Severe Glabellar Lines
Lead Sponsor:
Medytox Korea
Conditions:
Glabellar Frown Lines
Eligibility:
All Genders
19-65 years
Phase:
PHASE3
Brief Summary
This study is intended to evaluate long-term safety and efficacy of MBA-P01 in treatment of glabellar lines.
Eligibility Criteria
Inclusion
- Patients who completed the phase III trial (MT14-KR20GBL309)
- Patients who were capable of understanding and complying with the protocol and have signed the informed consent form voluntarily
Exclusion
- Patients who have received other procedures which may affect glabellar lines within 6 months (except of MBA-P01 or BOTOX® treated in phase III trial, MT14-KR20GBL309)
- Female patients who are pregnant or lactating. Female patients of childbearing age who have a plan to get pregnant during the study period.
- Patient who do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.)
- Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
- Patients who are not eligible for this study based on the judgment of an investigator
Key Trial Info
Start Date :
February 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2023
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT05321979
Start Date
February 7 2022
End Date
May 30 2023
Last Update
January 16 2024
Active Locations (1)
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1
Chung-Ang Univ. Hospital
Seoul, Dongjak-gu, South Korea, 06973