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®
- 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
- 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
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Investigator's rating of glabellar line severity at maximum frown by live assessment.
Outcome Time Frame:
at Day 30
Peter Foley, Doctor
Australia: Department of Health and Ageing Therapeutic Goods Administration