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
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
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.

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 ]

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 ]

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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Measure Type Secondary
Measure Title Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire
Measure Description A physical health summary score and a mental health summary score was generated on a rating scale of 0 to 100 where higher scores indicate better health. The change in health summary scores were assessed at the time points 3, 6, 9, 12 and 18 months compared to baseline.
Time Frame Baseline and at 6 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 physical and mental health summary scores at 6 months after treatment were compared to baseline. The ITT population comprised 8 of 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]
  8  
Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire  
[units: units on a scale]
Mean ± Standard Deviation
 
Physical health; change from 6 months to baseline     9.0  ± 6.2  
Mental health; change from 6 months to baseline     5.1  ± 15.6  

No statistical analysis provided for Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire



4.  Secondary:   Number of Participants With Global Esthetic Improvement   [ Time Frame: One month and up to 18 months after treatment ]

5.  Secondary:   Number of Participants With Gel Displacement Evaluated by Magnetic Resonance Imaging (MRI)   [ Time Frame: 12 months after treatment ]

6.  Secondary:   Adverse Event Recording   [ Time Frame: Up to 18 months after treatment ]

7.  Secondary:   Time Until it Became Impossible to Stay Sitting   [ Time Frame: Baseline and at 6 months after treatment ]


  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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