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Trial details imported from ClinicalTrials.gov
Ethics application status
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®
Universal Trial Number (UTN)
Glabellar Frown Lines
Description of intervention(s) / exposure
Other interventions - MT10109
Experimental: MT10109 - Clostridium botulinum toxin type A
Active Comparator: Botox (registered trade mark) - Clostridium botulinum toxin type A
Other interventions: MT10109
Single dose intramuscular injection MT10109 vs Botox®
Intervention code 
Comparator / control treatment
Primary outcome 
Investigator's rating of glabellar line severity at maximum frown by live assessment.
Key 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
Both males and females
Can healthy volunteers participate?
Key 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
- Pregnant or lactating women.
- Participation in any research study involving drug administration within 90 days
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
Recruitment postcode(s) 
Primary sponsor type
Ethics application status
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®
Trial related presentations / publications
Peter Foley, Doctor