Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Glabellar Lines
NCT ID: NCT05059587
Last Updated: 2022-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
318 participants
INTERVENTIONAL
2021-08-30
2022-03-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MBA-P01
MBA-P01 will be injected into the GL: initial double-blind treatment on Day 1.
MBA-P01
MBA-P01 will be injected into the Glabellar line.
BOTOX®
BOTOX® will be injected into the GL: initial double-blind treatment on Day 1.
BOTOX
Botox will be injected into the Glabellar line.
Interventions
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MBA-P01
MBA-P01 will be injected into the Glabellar line.
BOTOX
Botox will be injected into the Glabellar line.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
* Patients who can comply with the study procedures and visit schedule
* Patients who voluntarily sign the informed consent
Exclusion Criteria
* Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
* Patients who have received other procedures which may affect glabellar lines within 6 months
* Patients who were injected with botulinum toxin within the past 6 months
* Patients with allergy or hypersensitivity to the investigational drugs or their components
* Patients who have bleeding tendency or taking anti-coagulant
* Female subjects who are pregnant or lactating. Female subjects of childbearing age who have a plan to get pregnant during the study period, or 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 with skin disorders or infection at the injection site
* Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
* Patients who are unable to communicate or follow the instructions
* Patients who are not eligible for this study based on the judgment of an investigator
19 Years
65 Years
ALL
No
Sponsors
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Medytox Korea
INDUSTRY
Responsible Party
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Locations
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Chung-Ang Univ. Hospital
Seoul, Dongjak-gu, South Korea
Countries
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Other Identifiers
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MT14-KR20GBL309
Identifier Type: -
Identifier Source: org_study_id
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