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

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

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.

Study Overview

• Status: Completed
• Conditions: Glabellar Frown Lines
• Intervention / Treatment: Drug: Placebo; Drug: MBA-P01 (Botulinum toxin A)

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Maroubra, New South Wales, Australia, 2035
      • Maroubra MEdical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MBA-P01 30U; Experimental group, Dose: 30U	Drug: MBA-P01 (Botulinum toxin A); Intramuscular injection, dose varies by groups
Experimental: MBA-P01 20U; Experimental group, Dose: 20U	Drug: MBA-P01 (Botulinum toxin A); Intramuscular injection, dose varies by groups
Experimental: MBA-P01 10U; Experimental group, Dose: 10U	Drug: MBA-P01 (Botulinum toxin A); Intramuscular injection, dose varies by groups
Placebo Comparator: Placebo; Placebo group, Normal saline	Drug: Placebo; Intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial Wrinkle Scale(FWS) change	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	4 weeks

Collaborators and Investigators

• Sponsor: Medy-Tox

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: MT14-AU18GBL208

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No