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Trial record 1 of 1 for:    MT14-AU18GBL208
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Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Glabellar Lines

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ClinicalTrials.gov Identifier: NCT04143815
Recruitment Status : Completed
First Posted : October 29, 2019
Last Update Posted : March 19, 2021
Sponsor:
Information provided by (Responsible Party):
Medy-Tox

Study Description
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Brief Summary:

This study will determine the effect of MBA-P01 in subjects with glabellar lines at a range of doses compared with placebo.

This study includes two treatment period; 1) Dose-ranging period, Day0 to 16weeks and 2) Open-label extension period, 16 weeks to 52.


Condition or disease Intervention/treatment Phase
Glabellar Frown Lines Drug: MBA-P01 (Botulinum toxin A) Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: PhaseII, Randomized, Double-blind, Placebo Controlled, Multi-center, Dose-ranging and Open Label Extension Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Moderate to Severe Glabellar Lines
Actual Study Start Date : May 20, 2019
Actual Primary Completion Date : September 1, 2020
Actual Study Completion Date : September 1, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: MBA-P01 30U
Experimental group, Dose: 30U
 Drug: MBA-P01 (Botulinum toxin A)
Intramuscular injection, dose varies by groups
Experimental: MBA-P01 20U
Experimental group, Dose: 20U
 Drug: MBA-P01 (Botulinum toxin A)
Intramuscular injection, dose varies by groups
Experimental: MBA-P01 10U
Experimental group, Dose: 10U
 Drug: MBA-P01 (Botulinum toxin A)
Intramuscular injection, dose varies by groups
Placebo Comparator: Placebo
Placebo group, Normal saline
 Drug: Placebo
Intramuscular injection


Outcome Measures
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Primary Outcome Measures :
  1. Facial Wrinkle Scale(FWS) change [ Time Frame: 4 weeks ]
    Proportion of subjects achieving at least a 2-grade decrease from baseline in score of Facial Wrinkle Scale (FWS) (0:none to 3: severe) of Glabellar line at maximum frown


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female over 18 years of age
  • Bilaterally symmetrical moderate to severe GL at maximum frown as assessed by both investigator and subject using FWS

Exclusion Criteria:

  • History of facial nerve paralysis
  • Any eyebrow or eyelied ptosis as determined by the investigator
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04143815


Locations
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Australia, New South Wales
Maroubra MEdical Centre
Maroubra, New South Wales, Australia, 2035
Sponsors and Collaborators
Medy-Tox
More Information
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Responsible Party: Medy-Tox
ClinicalTrials.gov Identifier: NCT04143815    
Other Study ID Numbers: MT14-AU18GBL208
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents