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Safety and Effectiveness of Juvederm(R) Ultra XC Injectable Gel for Lip Augmentation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01197495
First received: September 8, 2010
Last updated: April 29, 2016
Last verified: April 2016
Results First Received: December 1, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Outcomes Assessor)
Condition: Lip Augmentation
Intervention: Device: hyaluronic acid gel

  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
The modified intent-to-treat (mITT) population is presented and includes all treated subjects.

Reporting Groups
  Description
Treatment Juvederm(R) Ultra XC Injectable Gel
Control No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.

Participant Flow:   Overall Study
    Treatment     Control  
STARTED     157     56  
COMPLETED     144     49  
NOT COMPLETED     13     7  



  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
Treatment Juvederm(R) Ultra XC Injectable Gel
Control No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
Total Total of all reporting groups

Baseline Measures
    Treatment     Control     Total  
Number of Participants  
[units: participants]
  157     56     213  
Age  
[units: Years]
Mean (Standard Deviation)
  48.6  (11.46)     49.2  (9.72)     48.8  (11.01)  
Gender  
[units: Participants]
     
Female     150     54     204  
Male     7     2     9  



  Outcome Measures
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1.  Primary:   Percentage of Subjects With ≥1-Point Improvement on the Investigator Assessed 5-point Lip Fullness Scale 2 (LFS2)   [ Time Frame: Baseline, Month 3 ]

2.  Secondary:   Percentage of Subjects With ≥1-Point Improvement on the Perioral Line (POL) Severity Scale   [ Time Frame: Baseline, Month 3 ]

3.  Secondary:   Percentage of Oral Commissures With ≥1-Point Improvement on the Oral Commissures Severity (OCS) Scale   [ Time Frame: Baseline, Month 3 ]

4.  Secondary:   Percentage of Subjects Achieving Their Personal Treatment Goal of Overall Lip Fullness   [ Time Frame: Baseline, Month 3 ]

5.  Secondary:   Duration Effect of Treatment on Lip Fullness   [ Time Frame: Month 1, Month 3, Month 6, Month 7.5, Month 9, Month 10.5, Month 12 ]


  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: Allergan Inc.,
Organization: Allergan, Inc
e-mail: clinicaltrials@allergan.com



Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01197495     History of Changes
Other Study ID Numbers: JULIDO-002
Study First Received: September 8, 2010
Results First Received: December 1, 2015
Last Updated: April 29, 2016
Health Authority: United States: Food and Drug Administration