Status:
COMPLETED
Safety and Efficacy Study of Botulinum Toxin Type A to Treat Glabellar Lines
Lead Sponsor:
Medy-Tox
Conditions:
Glabellar Frown Lines
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 subje...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 7 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2012
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01485601
Start Date
December 7 2011
End Date
August 17 2012
Last Update
February 22 2024
Active Locations (1)
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1
Melbourne, Australia