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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®


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Glabellar Frown Lines

Thank you

Trial Information

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®


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Investigator's rating of glabellar line severity at maximum frown by live assessment.

Outcome Time Frame:

at Day 30

Safety Issue:

No

Principal Investigator

Peter Foley, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Austrailia

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

MT-GPRT-GL01

NCT ID:

NCT01485601

Start Date:

November 2011

Completion Date:

December 2012

Related Keywords:

  • Glabellar Frown Lines

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