Safety and Efficacy Study of Botulinum Toxin Type A to Treat Glabellar Lines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01485601
Recruitment Status : Completed
First Posted : December 5, 2011
Last Update Posted : September 20, 2012
Information provided by (Responsible Party):

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 subjects with glabellar lines compared with the standard dose of BOTOX®

Condition or disease Intervention/treatment Phase
Glabellar Frown Lines Biological: MT10109 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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®
Study Start Date : November 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: MT10109
Clostridium botulinum toxin type A
Biological: MT10109
Single dose intramuscular injection MT10109 vs Botox®

Active Comparator: Botox (registered trade mark)
Clostridium botulinum toxin type A
Biological: MT10109
Single dose intramuscular injection MT10109 vs Botox®

Primary Outcome Measures :
  1. Investigator's rating of glabellar line severity at maximum frown by live assessment. [ Time Frame: at Day 30 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01485601

Melbourne, Australia
Sponsors and Collaborators
Principal Investigator: Peter Foley, Doctor Austrailia

Responsible Party: Medy-Tox Identifier: NCT01485601     History of Changes
Other Study ID Numbers: MT-GPRT-GL01
First Posted: December 5, 2011    Key Record Dates
Last Update Posted: September 20, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents