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
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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


  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 ]

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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