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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medy-Tox
ClinicalTrials.gov Identifier:
NCT01485601
First received: December 1, 2011
Last updated: September 19, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Glabellar Frown Lines
Biological: MT10109
Phase 2

Study Type: 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
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®

Resource links provided by NLM:


Further study details as provided by Medy-Tox:

Primary Outcome Measures:
  • Investigator's rating of glabellar line severity at maximum frown by live assessment. [ Time Frame: at Day 30 ] [ Designated as safety issue: No ]

Enrollment: 121
Study Start Date: November 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485601

Locations
Australia
Melbourne, Australia
Sponsors and Collaborators
Medy-Tox
Investigators
Principal Investigator: Peter Foley, Doctor Austrailia
  More Information

No publications provided

Responsible Party: Medy-Tox
ClinicalTrials.gov Identifier: NCT01485601     History of Changes
Other Study ID Numbers: MT-GPRT-GL01
Study First Received: December 1, 2011
Last Updated: September 19, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014