Evaluate the Migration Potential of Xeomin® Compared to Two Other Botulinum Toxin Type A Products
March 31, 2009 updated by: Merz Pharmaceuticals GmbH
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®.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Conducted in Europe
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Frankfurt am Main, Germany, 61273
- Merz Pharmaceuticals GmbH
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Healthy females, 18 to 65 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Measurement of area
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Merz Pharmaceuticals, Merz Pharmaceuticals GmbH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
February 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
August 13, 2007
First Submitted That Met QC Criteria
August 13, 2007
First Posted (Estimate)
August 14, 2007
Study Record Updates
Last Update Posted (Estimate)
April 1, 2009
Last Update Submitted That Met QC Criteria
March 31, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRZ 60201-0709/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.