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CompletedNCT04143854Updated Mar 19, 2021

Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Lateral Canthal Lines

A Phase 2 interventional study of MBA-P01(Botulinum toxin A) and Placebo in Lateral Canthal Lines, sponsored by Medy-Tox. Completed at 1 site in Australia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-03-19.

Sponsored by Medy-Tox · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled May 2019, registered Oct 2019).
Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Lateral Canthal Lines
03

In context

Lead sponsor

Medy-Tox is the lead sponsor of 48 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • History of facial nerve paralysis
  • Any eyebrow or eyelied ptosis as determined by the investigator
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    MBA-P01 24U

    Experimental group; Dose: 24U

    Drug: MBA-P01(Botulinum toxin A)

  • Experimental
    MBA-P01 12U

    Experimental group; Dose: 12U

    Drug: MBA-P01(Botulinum toxin A)

  • Placebo comparator
    Placebo

    Placebo group; normal saline

    Drug: Placebo

Interventions

  • DrugMBA-P01(Botulinum toxin A)

    Intramuscular injection; Dose varies by group

  • DrugPlacebo

    Intramuscular injection; normal saline

06

What researchers measure

Primary outcomes

  1. Facial wrinkle scale(FWS) change of lateral canthal line at maximum smile

    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

    Time frame: 4 weeks

07

Study locations

1 site
  • Maroubra Medical Centre
    Maroubra, New South Wales 2035, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04143854
Lead sponsor
Medy-Tox
Responsible party
Sponsor
First posted
Oct 29, 2019
Start date
May 21, 2019
Primary completion
Aug 19, 2020
Completion
Aug 19, 2020
Last update
Mar 19, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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