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

This study has been completed.
Sponsor:
Information provided by:
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00515944
First received: August 13, 2007
Last updated: March 31, 2009
Last verified: March 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy females, 18 to 65 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Clinical Pharmacology, Merz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00515944     History of Changes
Other Study ID Numbers: MRZ 60201-0709/1
Study First Received: August 13, 2007
Last Updated: March 31, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014