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Safety and Effectiveness of Belotero® in Subjects With Fitzpatrick Phototypes IV Through VI

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00922623
First received: June 3, 2009
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
Results First Received: December 22, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Facial Wrinkles
Intervention: Device: Belotero®

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Belotero® Belotero® injection into both nasolabial folds of Fitzpatrick IV, V, VI subjects.

Participant Flow:   Overall Study
    Belotero®  
STARTED     93  
COMPLETED     88  
NOT COMPLETED     5  
Other                 4  
Lost to Follow-up                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Belotero® Belotero® injection into both nasolabial folds of Fitzpatrick IV, V, VI subjects.

Baseline Measures
    Belotero®  
Number of Participants  
[units: participants]
 		  93  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     81  
>=65 years     12  
Age  
[units: years]
Mean ± Standard Deviation 		  51.5  ± 10.1  
Gender  
[units: participants]
 		 
Female     80  
Male     13  
Race/Ethnicity, Customized  
[units: participants]
 		 
Hispanic or Latino     3  
Not Hispanic or Latino     90  
Unknown or Not Reported     0  



  Outcome Measures

1.  Primary:   Percentage of Subjects With Product-related Adverse Events.   [ Time Frame: 24 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Merz Aesthetics, Inc.
Organization: Merz Aesthetics, Inc.
phone: 650-286-4000
e-mail: clinicaltrials@merzaesthetics.com


No publications provided


Responsible Party: Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT00922623     History of Changes
Other Study ID Numbers: MUS 90028-0622/1 Supplement
Study First Received: June 3, 2009
Results First Received: December 22, 2011
Last Updated: April 19, 2013
Health Authority: United States: Food and Drug Administration