Safety and Effectiveness of Juvéderm® Volbella With Lidocaine Versus Restylane-L® for Lip Volume Enhancement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan ( Allergan Medical )
ClinicalTrials.gov Identifier:
NCT01579305
First received: April 16, 2012
Last updated: October 6, 2014
Last verified: August 2014
Results First Received: June 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Lip Volume Enhancement
Interventions: Device: Juvéderm® Volbella with Lidocaine
Device: Restylane-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
Enrollment was defined as having signed the IRB-approved Informed Consent Form. Prior to randomization, 4 subjects were excluded as screen fails, leaving an “Intent-to-Treat” population of 281 subjects.

Reporting Groups
  Description
Subject Randomized to Receive VOLBELLA® No text entered.
Subjects Randomized to Receive Restylane-L® No text entered.

Participant Flow:   Overall Study
    Subject Randomized to Receive VOLBELLA®     Subjects Randomized to Receive Restylane-L®  
STARTED     139 [1]   142 [1]
Discontinued Before Treatment     0     1  
Continued After Treatment     139     141  
COMPLETED     118     115  
NOT COMPLETED     21     27  
[1] Subjects that signed Informed Consent, passed screening criteria, and were randomized.



  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.
Baseline characteristics are based on the “modified Intent-to-Treat” population: subjects randomized to receive treatment and treated.

Reporting Groups
  Description
Subjects Randomized to Receive VOLBELLA® No text entered.
Subjects Randomized to Receive Restylane-L® No text entered.
Total Total of all reporting groups

Baseline Measures
    Subjects Randomized to Receive VOLBELLA®     Subjects Randomized to Receive Restylane-L®     Total  
Number of Participants  
[units: participants]
  139     141     280  
Age  
[units: years]
Mean ± Standard Deviation
  47.1  ± 11.94     48.3  ± 12.61     47.7  ± 12.28  
Gender  
[units: participants]
     
Female     135     139     274  
Male     4     2     6  
Region of Enrollment  
[units: participants]
     
France     48     49     97  
United Kingdom     91     92     183  



  Outcome Measures

1.  Primary:   Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer’s Assessment   [ Time Frame: 3 months ]


  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
No text entered.


  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: Medical Monitor
Organization: Allergan, Inc.
phone: 805 961 5000
e-mail: devicetrials@allergan.com


No publications provided


Responsible Party: Allergan ( Allergan Medical )
ClinicalTrials.gov Identifier: NCT01579305     History of Changes
Other Study ID Numbers: S15L-003
Study First Received: April 16, 2012
Results First Received: June 27, 2014
Last Updated: October 6, 2014
Health Authority: France: Committee for the Protection of Personnes
United Kingdom: National Research Ethics Services