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Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT00931268
First received: July 1, 2009
Last updated: November 22, 2013
Last verified: November 2013
History of Changes
Results First Received: July 12, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Atrophy
Intervention: Device: Macrolane VRF 30

  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
First subject enrolled (screened) and treated: 11 August 2009. Last subject completed study: 2 September 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Macrolane VRF 30 Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.

Participant Flow:   Overall Study
    Macrolane VRF 30  
STARTED     10  
COMPLETED     4  
NOT COMPLETED     6  
Lost to Follow-up                 6  



  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
Macrolane VRF 30 Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.

Baseline Measures
    Macrolane VRF 30  
Number of Participants  
[units: participants]
 		  10  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation) 		  44.6  (3.7)  
Gender  
[units: participants]
 		 
Female     5  
Male     5  
Region of Enrollment  
[units: participants]
 		 
France     10  



  Outcome Measures
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1.  Primary:   Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting   [ Time Frame: 6 months after treatment compared to baseline ]
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2.  Secondary:   Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting   [ Time Frame: Baseline and up to 18 months after treatment ]
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3.  Secondary:   Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire   [ Time Frame: Baseline and at 6 months after treatment ]
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4.  Secondary:   Number of Participants With Global Esthetic Improvement   [ Time Frame: One month and up to 18 months after treatment ]
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Measure Type Secondary
Measure Title Number of Participants With Global Esthetic Improvement
Measure Description Number of participants maintaining an improvement compared to baseline using the Global Esthetic Improvement Scale (GEIS) consisting of 5 grades (worse/no change/improved/much improved/very much improved), where the three latter indicates improvement. GEIS was assessed at the time points 1, 3, 6, 9, 12 and 18 months compared to pre-treatment photos.
Time Frame One month and up to 18 months after treatment  
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.
The ITT population at 6 months comprised all 10 treated subjects.

Reporting Groups
  Description
Macrolane VRF 30 Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.

Measured Values
    Macrolane VRF 30  
Number of Participants Analyzed  
[units: participants]
 		  10  
Number of Participants With Global Esthetic Improvement  
[units: participants]
 		 
Subject assessed improvement at 6 months     10  
Physician assessed improvement at 6 months     10  

No statistical analysis provided for Number of Participants With Global Esthetic Improvement



5.  Secondary:   Number of Participants With Gel Displacement Evaluated by Magnetic Resonance Imaging (MRI)   [ Time Frame: 12 months after treatment ]
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6.  Secondary:   Adverse Event Recording   [ Time Frame: Up to 18 months after treatment ]
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7.  Secondary:   Time Until it Became Impossible to Stay Sitting   [ Time Frame: Baseline and at 6 months after treatment ]
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  Serious Adverse Events
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  Other Adverse Events
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  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Head of Clinical Development
Organization: Q-Med AB
phone: +46 (0)18 4749000
e-mail: reception.SEUPP@galderma.com



Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT00931268     History of Changes
Other Study ID Numbers: 31GC0804
AFFSAPS: 2008-A01252-53
Study First Received: July 1, 2009
Results First Received: July 12, 2013
Last Updated: November 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)