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Study of Restylane and Perlane in the Correction of Peri-Oral Wrinkles

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medicis Global Service Corporation
ClinicalTrials.gov Identifier:
NCT00977704
First received: September 14, 2009
Last updated: May 7, 2013
Last verified: May 2013
Results First Received: December 22, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Peri-oral Wrinkles
Intervention: Device: Restylane and Perlane

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Perlane and Restylane Perlane and Restylane used open label to correct peri-oral wrinkles

Participant Flow:   Overall Study
    Perlane and Restylane  
STARTED     20  
COMPLETED     20  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Perlane and Restylane Perlane and Restylane used open label to correct peri-oral wrinkles

Baseline Measures
    Perlane and Restylane  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     20  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  59.6  ± 4.04  
Gender  
[units: participants]
 
Female     20  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures

1.  Primary:   Local and Systemic Adverse Events   [ Time Frame: 2-weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
None.


  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.


Results Point of Contact:  
Name/Title: Head of Clinical Trials
Organization: Medicis R&D Clinical Research Department
e-mail: ClinicalTrialsQuery@Medicis.com


No publications provided


Responsible Party: Medicis Global Service Corporation
ClinicalTrials.gov Identifier: NCT00977704     History of Changes
Other Study ID Numbers: MA-1900-01
Study First Received: September 14, 2009
Results First Received: December 22, 2011
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board