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

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: NCT00515944
Recruitment Status : Completed
First Posted : August 14, 2007
Last Update Posted : April 1, 2009
Information provided by:
Merz Pharmaceuticals GmbH

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: Botulinum neurotoxin type A, free of complexing proteins Phase 1

Detailed Description:
Conducted in Europe

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Study Start Date : August 2007
Primary Completion Date : February 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox
U.S. FDA Resources

Primary Outcome Measures :
  1. Measurement of area

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

Inclusion Criteria:

  • Healthy females, 18 to 65 years

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): NCT00515944

Merz Pharmaceuticals GmbH
Frankfurt am Main, Germany, 61273
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Study Chair: Merz Pharmaceuticals Merz Pharmaceuticals GmbH

Responsible Party: Clinical Pharmacology, Merz Pharmaceuticals Identifier: NCT00515944     History of Changes
Other Study ID Numbers: MRZ 60201-0709/1
First Posted: August 14, 2007    Key Record Dates
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
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