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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
History of Changes
  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:

MedlinePlus related topics: Botox
U.S. FDA Resources

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

ClinicalTrials.gov processed this record on May 16, 2013