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®

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.