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Trial record 1 of 1 for:    MT14-AU18LCL209
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Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Lateral Canthal Lines

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ClinicalTrials.gov Identifier: NCT04143854
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 phase 2 study includes two treatment period; 1)Dose- ranging period, Day 0 to 16 weeks, which will assess dose-related safety/tolerance, and the potential to improve the appearance of lateral canthal lines and 2) open-label extension period, 16 weeks to 52 weeks, which will evaluate the long term-safety of MBA-P01

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase II, 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 Lateral Canthal Lines
Actual Study Start Date : May 21, 2019
Actual Primary Completion Date : August 19, 2020
Actual Study Completion Date : August 19, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: MBA-P01 24U
Experimental group; Dose: 24U
 Drug: MBA-P01(Botulinum toxin A)
Intramuscular injection; Dose varies by group
Experimental: MBA-P01 12U
Experimental group; Dose: 12U
 Drug: MBA-P01(Botulinum toxin A)
Intramuscular injection; Dose varies by group
Placebo Comparator: Placebo
Placebo group; normal saline
 Drug: Placebo
Intramuscular injection; normal saline


Outcome Measures
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Primary Outcome Measures :
  1. Facial wrinkle scale(FWS) change of lateral canthal line at maximum smile [ Time Frame: 4 weeks ]
    Proportion of subjects achieving at least a 2 grade decrease from baseline and a grade 0 or 1 in Facial Wrinkle Scale (0: none to 3: severe) of LCL at maximum smile, as assessed by the investigator and subject


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged 18 to 65
  • Bilaterally symmetrical moderate to severe lateral canthal lines(LCLs) at maximum smile 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): NCT04143854


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: NCT04143854    
Other Study ID Numbers: MT14-AU18LCL209
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