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Completed

NCT Number: NCT04143854

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

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

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Key information

Conditions

Lateral Canthal Lines

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Maroubra Medical Centre

Maroubra, New South Wales, 2035, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBA-P01(Botulinum toxin A)

Drug

Intramuscular injection; Dose varies by group

Placebo

Drug

Intramuscular injection; normal saline

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 29, 2019
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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