Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Glabellar Lines
NCT ID: NCT04143815
Last Updated: 2021-03-19
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
PHASE2
200 participants
INTERVENTIONAL
2019-05-20
2020-09-01
Brief Summary
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This study includes two treatment period; 1) Dose-ranging period, Day0 to 16weeks and 2) Open-label extension period, 16 weeks to 52.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MBA-P01 30U
Experimental group, Dose: 30U
MBA-P01 (Botulinum toxin A)
Intramuscular injection, dose varies by groups
MBA-P01 20U
Experimental group, Dose: 20U
MBA-P01 (Botulinum toxin A)
Intramuscular injection, dose varies by groups
MBA-P01 10U
Experimental group, Dose: 10U
MBA-P01 (Botulinum toxin A)
Intramuscular injection, dose varies by groups
Placebo
Placebo group, Normal saline
Placebo
Intramuscular injection
Interventions
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MBA-P01 (Botulinum toxin A)
Intramuscular injection, dose varies by groups
Placebo
Intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* Bilaterally symmetrical moderate to severe GL at maximum frown as assessed by both investigator and subject using FWS
Exclusion Criteria
* Any eyebrow or eyelied ptosis as determined by the investigator
18 Years
ALL
No
Sponsors
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Medy-Tox
INDUSTRY
Responsible Party
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Locations
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Maroubra MEdical Centre
Maroubra, New South Wales, Australia
Countries
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Other Identifiers
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MT14-AU18GBL208
Identifier Type: -
Identifier Source: org_study_id
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