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Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers (FRESH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01151436
First received: June 24, 2010
Last updated: May 29, 2012
Last verified: May 2012
History of Changes
Results First Received: April 10, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Facial Wrinkles
Intervention: Device: hyaluronic acid dermal fillers

  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
Hyaluronic Acid No text entered.

Participant Flow:   Overall Study
    Hyaluronic Acid  
STARTED     77  
COMPLETED     76  
NOT COMPLETED     1  



  Baseline Characteristics
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Reporting Groups
  Description
Hyaluronic Acid No text entered.

Baseline Measures
    Hyaluronic Acid  
Number of Participants  
[units: participants]
 		  77  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     66  
>=65 years     11  
Age  
[units: years]
Mean ± Standard Deviation 		  54.5  ± 8.2  
Gender  
[units: participants]
 		 
Female     73  
Male     4  
Region of Enrollment  
[units: participants]
 		 
France     47  
Germany     30  



  Outcome Measures
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1.  Primary:   Full Face Global Aesthetic Improvement   [ Time Frame: 3 weeks after last injection ]
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2.  Primary:   Full Face Global Aesthetic Improvement   [ Time Frame: 3 months after last injection ]
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3.  Primary:   Full Face Global Aesthetic Improvement   [ Time Frame: 6 months after last injection ]
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4.  Secondary:   NASOLABIAL FOLDS SEVERITY ASSESSMENT   [ Time Frame: baseline ]
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5.  Secondary:   NASOLABIAL FOLDS SEVERITY ASSESSMENT   [ Time Frame: 3 weeks after last injection ]
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6.  Secondary:   NASOLABIAL FOLDS SEVERITY ASSESSMENT   [ Time Frame: 3 months after last injection ]
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7.  Secondary:   NASOLABIAL FOLDS SEVERITY ASSESSMENT   [ Time Frame: 6 months after last injection ]
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8.  Secondary:   PERIORBITAL LINES SEVERITY ASSESSMENT   [ Time Frame: baseline ]
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9.  Secondary:   PERIORBITAL LINES SEVERITY ASSESSMENT   [ Time Frame: 3 weeks after last injection ]
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10.  Secondary:   PERIORBITAL LINES SEVERITY ASSESSMENT   [ Time Frame: 3 MONTHS AFTER LAST INJECTION ]
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11.  Secondary:   PERIORBITAL LINES SEVERITY ASSESSMENT   [ Time Frame: 6 MONTHS AFTER LAST INJECTION ]
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12.  Secondary:   MARIONETTE LINES SEVERITY ASSESSMENT   [ Time Frame: BASELINE ]
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13.  Secondary:   MARIONETTE LINES SEVERITY ASSESSMENT   [ Time Frame: 3 WEEKS AFTER LAST INJECTION ]
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14.  Secondary:   MARIONETTE LINES SEVERITY ASSESSMENT   [ Time Frame: 3 MONTHS AFTER LAST INJECTION ]
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15.  Secondary:   MARIONETTE LINES SEVERITY ASSESSMENT   [ Time Frame: 6 MONTHS AFTER LAST INJECTION ]
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16.  Secondary:   UPPER LIP LINES SEVERITY ASSESSMENT   [ Time Frame: BASELINE ]
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17.  Secondary:   UPPER LIP LINES SEVERITY ASSESSMENT   [ Time Frame: 3 WEEKS AFTER LAST INJECTION ]
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18.  Secondary:   UPPER LIP LINES SEVERITY ASSESSMENT   [ Time Frame: 3 MONTHS AFTER LAST INJECTION ]
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19.  Secondary:   UPPER LIP LINES SEVERITY ASSESSMENT   [ Time Frame: 6 MONTHS AFTER LAST INJECTION ]
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20.  Secondary:   CHEEK FOLDS SEVERITY ASSESSMENT   [ Time Frame: BASELINE ]
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21.  Secondary:   CHEEK FOLDS SEVERITY ASSESSMENT   [ Time Frame: 3 WEEKS AFTER LAST INJECTION ]
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22.  Secondary:   CHEEK FOLDS SEVERITY ASSESSMENT   [ Time Frame: 3 MONTHS AFTER LAST INJECTION ]
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23.  Secondary:   CHEEK FOLDS SEVERITY ASSESSMENT   [ Time Frame: 6 MONTHS AFTER LAST INJECTION ]
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24.  Secondary:   LIP ENHANCEMENT ASSESSMENT   [ Time Frame: baseline ]
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25.  Secondary:   LIP ENHANCEMENT ASSESSMENT   [ Time Frame: 3 WEEKS AFTER LAST INJECTION ]
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26.  Secondary:   LIP ENHANCEMENT ASSESSMENT   [ Time Frame: 3 MONTHS AFTER LAST INJECTION ]
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27.  Secondary:   LIP ENHANCEMENT ASSESSMENT   [ Time Frame: 6 MONTHS AFTER LAST INJECTION ]
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Measure Type Secondary
Measure Title LIP ENHANCEMENT ASSESSMENT
Measure Description

Lip fullness grading scale score:

0: very thin lip

  1. thin lip
  2. moderately thick lip
  3. thick lip
  4. full lip
Time Frame 6 MONTHS AFTER LAST INJECTION  
Safety Issue No  

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.
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

Reporting Groups
  Description
Hyaluronic Acid No text entered.

Measured Values
    Hyaluronic Acid  
Number of Participants Analyzed  
[units: participants]
 		  43  
Number of number of lips (upper or lower) Analyzed  
[units: number of lips (upper or lower)]
 		  70  
LIP ENHANCEMENT ASSESSMENT  
[units: units on a scale]
Mean ± Standard Deviation 		  2  ± 0.9  

No statistical analysis provided for LIP ENHANCEMENT ASSESSMENT




  Serious Adverse Events
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  Other Adverse Events
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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.


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: Ma May
Organization: Galderma
phone: +33 4 92 38 67 33
e-mail: may.ma@galderma.com


No publications provided


Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01151436     History of Changes
Other Study ID Numbers: RD.03.CIP.29089, 2009-018163-28
Study First Received: June 24, 2010
Results First Received: April 10, 2012
Last Updated: May 29, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)