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Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01012388
First received: November 11, 2009
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
Results First Received: November 19, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Nasolabial Folds
Intervention: Device: Radiesse® Injectable Dermal Filler

  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
Radiesse Injectable Dermal Filler Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds

Participant Flow:   Overall Study
    Radiesse Injectable Dermal Filler  
STARTED     100  
COMPLETED     100  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Radiesse Injectable Dermal Filler Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds

Baseline Measures
    Radiesse Injectable Dermal Filler  
Number of Participants  
[units: participants]
 		  100  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     88  
>=65 years     12  
Age  
[units: years]
Mean ± Standard Deviation 		  52  ± 11.1  
Gender  
[units: participants]
 		 
Female     94  
Male     6  
Region of Enrollment  
[units: participants]
 		 
United States     100  



  Outcome Measures
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1.  Primary:   Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment   [ Time Frame: 3 months ]
  Show Outcome Measure 1

2.  Primary:   Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment   [ Time Frame: 6 months ]
  Show Outcome Measure 2


  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: 650-286-4041
e-mail: clinicaltrials@merzaesthetics.com


Publications of Results:


Responsible Party: Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01012388     History of Changes
Other Study ID Numbers: P1206248
Study First Received: November 11, 2009
Results First Received: November 19, 2009
Last Updated: April 19, 2013
Health Authority: United States: Institutional Review Board