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Evaluate the Migration Potential of Xeomin® Compared to Two Other Botulinum Toxin Type A Products

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00515944
First Posted: August 14, 2007
Last Update Posted: April 1, 2009
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.
Information provided by:
Merz Pharmaceuticals GmbH
  Purpose
Xeomin® is a Botulinum neurotoxin type A preparation free of complexing proteins, i.e. free of bacterial proteins other than the active toxin. Injected into the muscle, Xeomin® causes local weakening. Botulinum toxin type A is used for certain neurological and aesthetic treatments. This study will investigate the migration potential of Xeomin®.

Condition Intervention Phase
Healthy Drug: Botulinum neurotoxin type A, free of complexing proteins Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • Measurement of area

Estimated Enrollment: 30
Study Start Date: August 2007
Study Completion Date: June 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:
Conducted in Europe
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy females, 18 to 65 years
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00515944


Locations
Germany
Merz Pharmaceuticals GmbH
Frankfurt am Main, Germany, 61273
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
Study Chair: Merz Pharmaceuticals Merz Pharmaceuticals GmbH
  More Information

Responsible Party: Clinical Pharmacology, Merz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00515944     History of Changes
Other Study ID Numbers: MRZ 60201-0709/1
First Submitted: August 13, 2007
First Posted: August 14, 2007
Last Update Posted: April 1, 2009
Last Verified: March 2009

Keywords provided by Merz Pharmaceuticals GmbH:
No condition
healthy volunteers

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