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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 28, 2019
First Posted Date  ICMJE October 29, 2019
Last Update Posted Date March 19, 2021
Actual Study Start Date  ICMJE May 21, 2019
Actual Primary Completion Date August 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2019)
Facial wrinkle scale(FWS) improvement of lateral canthal line at maximum smile [ Time Frame: 4 weeks ]
Proportion of subjects achieving at least a 2 grade improvement from baseline in FWS of LCL at maximum smile, as assessed by the investigator and subject
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Lateral Canthal Lines
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Lateral Canthal Lines
Intervention  ICMJE
  • Drug: MBA-P01(Botulinum toxin A)
    Intramuscular injection; Dose varies by group
  • Drug: Placebo
    Intramuscular injection; normal saline
Study Arms  ICMJE
  • Experimental: MBA-P01 24U
    Experimental group; Dose: 24U
    Intervention: Drug: MBA-P01(Botulinum toxin A)
  • Experimental: MBA-P01 12U
    Experimental group; Dose: 12U
    Intervention: Drug: MBA-P01(Botulinum toxin A)
  • Placebo Comparator: Placebo
    Placebo group; normal saline
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 19, 2020
Actual Primary Completion Date August 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04143854
Other Study ID Numbers  ICMJE MT14-AU18LCL209
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medy-Tox
Study Sponsor  ICMJE Medy-Tox
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medy-Tox
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP