Safety/Efficacy Study of Restylane® in Lip Augmentation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medicis Global Service Corporation
ClinicalTrials.gov Identifier:
NCT00935272
First received: July 7, 2009
Last updated: December 22, 2011
Last verified: December 2011
Results First Received: November 2, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Lip Augmentation
Interventions: Device: Restylane®
Device: Non-Treatment

  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
Date of first enrollment: July 20, 2009 Date last subject completed: June 1, 2010 180 subjects enrolled from 12 investigational centers

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Subjects with Fitzpatrick Skin Types I, II or III (lighter skin types) needed both lips to be assessed as very thin or thin to meet enrollment criteria.

Subjects with Fitzpatrick Skin Types IV, V or VI (darker skin types) need at least one lip to be assessed as very thin or thin to meet enrollment criteria.


Reporting Groups
  Description
Treatment With Restylane Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.
No Treatment Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis

Participant Flow:   Overall Study
    Treatment With Restylane     No Treatment  
STARTED     135     45  
COMPLETED     116     39  
NOT COMPLETED     19     6  
Lost to Follow-up                 10                 3  
Withdrawal by Subject                 8                 2  
Physician Decision                 1                 0  
Protocol Violation                 0                 1  



  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 With Restylane Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.
No Treatment Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
Total Total of all reporting groups

Baseline Measures
    Treatment With Restylane     No Treatment     Total  
Number of Participants  
[units: participants]
  135     45     180  
Age  
[units: participants]
     
<=18 years     1     0     1  
Between 18 and 65 years     133     44     177  
>=65 years     1     1     2  
Age  
[units: years]
Mean ± Standard Deviation
  47.8  ± 10.5     47.2  ± 10.9     47.6  ± 10.6  
Gender  
[units: participants]
     
Female     134     45     179  
Male     1     0     1  
Region of Enrollment  
[units: participants]
     
United States     135     45     180  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Response   [ Time Frame: Baseline and at 8 weeks ]

2.  Secondary:   Percentage of Participants With a Response   [ Time Frame: Baseline and at weeks 12, 16, 20 and 24 ]


  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: Heather M Corey
Organization: Medicis Global Services
phone: 480-291-5981
e-mail: hcorey@medicis.com


No publications provided


Responsible Party: Medicis Global Service Corporation
ClinicalTrials.gov Identifier: NCT00935272     History of Changes
Other Study ID Numbers: MA-1300-15
Study First Received: July 7, 2009
Results First Received: November 2, 2011
Last Updated: December 22, 2011
Health Authority: United States: Food and Drug Administration