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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 6, 2012
Last verified: December 2009
History of Changes

July 1, 2009
November 6, 2012
August 2009
September 2011   (final data collection date for primary outcome measure)
Assessment of pain in sitting position using visual analogue scale [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00931268 on ClinicalTrials.gov Archive Site
  • Assessment of pain in sitting position using visual analogue scale [ Time Frame: Up to 18 months after treatment ] [ Designated as safety issue: No ]
  • Quality of Life assessed by MOS-HIV questionnaire [ Time Frame: Up to 18 months after treatment ] [ Designated as safety issue: No ]
  • Global Esthetic Improvement [ Time Frame: Up to 18 months after treatment ] [ Designated as safety issue: No ]
  • Magnetic Resonance Imaging [ Time Frame: Up to 12 months after treatment ] [ Designated as safety issue: Yes ]
  • Adverse Event recording [ Time Frame: Up to 18 months after treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane
Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Stabilized Hyaluronic Acid of Non-animal Origin (Macrolane); a Baseline-controlled Single-centre Study.

The study is being undertaken to establish the effectiveness and safety of Macrolane volume restoration factor 30 (VRF30) when used for treatment of HIV-infected subjects with buttocks lipoatrophy.
Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrophy
Device: Macrolane VRF 30
One administartion
Macrolane VRF 30
Open label
Intervention: Device: Macrolane VRF 30
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
May 2012
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have buttocks lipoatrophy and is unable to remain seated for more than 30 minutes due to pain.
  • Have undergone HIV treatment for more than 2 years.
  • Have RNA copies less than 50/ml.
  • Have CD4 more than 200 cell/mm3.

Exclusion Criteria:

  • Active infections.
  • Active skin disease, inflammation or related conditions.
  • Perineal pathology.
  • Condition that may affect pain assessment.
  • Skin with underlying fibrous tissue.
  • BMI less than 19.
  • Insufficient tissue cover in the area to be treated.
  • Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation within 14 days prior to treatment, or a history of bleeding disorders.
  • Permanent implant placed in the treatment area.
  • Other injectable implant, liposuction or other surgical therapy in the treatment area.
  • Presence or history of connective tissue diseases.
  • Tumors or pre-malign tissue disorder near or on the area to be treated.
  • Contraindications for MRI
  • Previous hypersensitivity to hyaluronic acid, or to the local anesthetic or antibiotic used in the study.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00931268
31GC0804, AFFSAPS: 2008-A01252-53
No
Q-Med AB
Q-Med AB
Not Provided
Study Director: Head of Medical Affairs Q-Med AB
Q-Med AB
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP