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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:
ClinicalTrials.gov Identifier:
NCT00823069
First Posted: January 15, 2009
Last Update Posted: November 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Q-Med Scandinavia, Inc.
Information provided by:
Medicis Global Service Corporation
Results First Submitted: August 25, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, 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
No text entered.

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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


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


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



Responsible Party: Mary Sanstead, Clinical Study Manager, Medicis Global Services
ClinicalTrials.gov Identifier: NCT00823069     History of Changes
Other Study ID Numbers: MA-1400-03
First Submitted: January 14, 2009
First Posted: January 15, 2009
Results First Submitted: August 25, 2010
Results First Posted: November 30, 2010
Last Update Posted: November 30, 2010