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
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: 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 September 18, 2014