Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan Medical
ClinicalTrials.gov Identifier:
NCT00850889
First received: February 23, 2009
Last updated: December 3, 2013
Last verified: December 2013
Results First Received: February 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator)
Condition: Nasolabial Folds
Interventions: Device: Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine
Device: A gel of hyaluronic acid (concentration of 20 mg/mL)

  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
Enrollment:32 Study Start Date: November 2008 Study Completion Date: February 2009 Primary Completion Date: November 2008

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
Total Participants Each participant received Juvederm on one side of the face and Restylane on the other side.

Participant Flow:   Overall Study
    Total Participants  
STARTED     32  
COMPLETED     32  
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
Total Participants Each participant received Juvederm on one side of the face and Restylane on the other side.

Baseline Measures
    Total Participants  
Number of Participants  
[units: participants]
  32  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     30  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation
  51.8  ± 7.82  
Gender  
[units: participants]
 
Female     31  
Male     1  
Region of Enrollment  
[units: participants]
 
Canada     32  



  Outcome Measures
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1.  Primary:   Procedural Pain Score   [ Time Frame: 1 day ]

2.  Secondary:   Comparative Pain   [ Time Frame: 1 day ]

3.  Secondary:   Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity   [ Time Frame: Day 0, Day 14 ]

4.  Secondary:   Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity   [ Time Frame: Day 0, Day 14 ]


  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 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: Steven P. James, MD, VP, Global Medical Affairs
Organization: Allergan, Inc.
phone: 714-246-4500
e-mail: james_steven@allergan.com


No publications provided


Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT00850889     History of Changes
Other Study ID Numbers: MA-JULIDO-0801
Study First Received: February 23, 2009
Results First Received: February 24, 2011
Last Updated: December 3, 2013
Health Authority: Canada: IRB