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Completed

NCT Number: NCT04143815

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

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.

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Key information

Conditions

Glabellar Frown Lines

Age range

18 year and older

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 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

Treatment and study plan

MBA-P01 (Botulinum toxin A)

Drug

Intramuscular injection, dose varies by groups

Placebo

Drug

Intramuscular injection

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study 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

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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