Safety and Efficacy Study of Botulinum Toxin Type A to Treat Glabellar Lines

A Randomised, Double-blind, Multi-centre, Phase II, Optimal Dose-finding Study to Determine the Safety and Efficacy of MT10109 (Clostridium Botulinum Toxin Type A) in Subjects With Moderate to Severe Glabellar Lines in Comparison to BOTOX®

The purpose of this study is to find an optimal dose to determine the safety and tolerability of a single dose of MT10109(clostridium botulinum type A) administered by intramuscular injection in subjects with glabellar lines compared with the standard dose of BOTOX®

Study Overview

• Status: Completed
• Conditions: Glabellar Frown Lines
• Intervention / Treatment: Biological: MT10109

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged between 18 and 75 years with glabellar facial lines of at least moderate severity at maximum frown by investigator's assessment.
• Women of childbearing potential must have a negative serum pregnancy test at screening

Exclusion Criteria:

• Patients with an inability to substantially lessen glabellar lines by physically spreading them apart.
• Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication
• Patients with an anaphylactic response history to botulinum toxin type A.
• Patients who have been administered botulinum toxin type A within the previous 6 months.
• Pregnant or lactating women.
• Participation in any research study involving drug administration within 90 days preceding enrollment.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MT10109; Clostridium botulinum toxin type A	Biological: MT10109; Single dose intramuscular injection MT10109 vs Botox®
Active Comparator: Botox (registered trade mark); Clostridium botulinum toxin type A	Biological: MT10109; Single dose intramuscular injection MT10109 vs Botox®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment.	Subjects included in the analysis had to have a baseline glabellar line (GL) severity rating at maximum frown of moderate (2) or severe (3). The GL severity were measured using a 4-point scale (0: none; 1: mild; 2: moderate; 3: Severe). A responder was defined as having a severity rating of none (0) or mild (1) at the corresponding post-baseline visit. Percentages are based on the number of subjects with an assessment at the relevant visit (Day 30).	at Day 30

Collaborators and Investigators

• Sponsor: Medy-Tox
• Investigators: Principal Investigator: Peter Foley, Doctor, Austrailia

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2011
• Primary Completion (Actual): March 30, 2012
• Study Completion (Actual): August 17, 2012

Study Registration Dates

• First Submitted: December 1, 2011
• First Submitted That Met QC Criteria: December 2, 2011
• First Posted (Estimated): December 5, 2011

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MT-GPRT-GL01