Safety Study That Compares Perlane to Perlane With Lidocaine (Perlane-L) While Correcting Wrinkles in the Area Around Your Nose

This study has been completed.
Sponsor:
Collaborator:
Q-Med Scandinavia, Inc.
Information provided by:
Medicis Global Service Corporation
ClinicalTrials.gov Identifier:
NCT00823069
First received: January 14, 2009
Last updated: November 1, 2010
Last verified: November 2010
Results First Received: August 25, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Nasolabial Folds
Intervention: Device: Perlane and Perlane-L

  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
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Reporting Groups
  Description
Perlane-L and Perlane Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.

Participant Flow:   Overall Study
    Perlane-L and Perlane  
STARTED     60  
COMPLETED     60  
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 Perlane-L Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.

Baseline Measures
    Perlane and Perlane-L  
Number of Participants  
[units: participants]
  60  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     60  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  53.4  ± 8.0  
Gender  
[units: participants]
 
Female     56  
Male     4  
Region of Enrollment  
[units: participants]
 
United States     60  



  Outcome Measures
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1.  Primary:   Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm   [ Time Frame: After Injection on Day of Treatment ]

2.  Secondary:   Number of Subjects Showing Wrinkle Improvement at Day 14   [ Time Frame: 14 days after treatment when compared to baseline ]


  Serious Adverse Events


  Other Adverse Events


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
No text entered.  


Results Point of Contact:  
Name/Title: Mary Sanstead
Organization: Medicis
phone: 480-291-5926
e-mail: msanstead@medicis.com


No publications provided


Responsible Party: Mary Sanstead, Clinical Study Manager, Medicis Global Services
ClinicalTrials.gov Identifier: NCT00823069     History of Changes
Other Study ID Numbers: MA-1400-03
Study First Received: January 14, 2009
Results First Received: August 25, 2010
Last Updated: November 1, 2010
Health Authority: United States: Food and Drug Administration