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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
  Purpose

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.


Condition Intervention
Atrophy
 Device: Macrolane VRF 30

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Stabilized Hyaluronic Acid of Non-animal Origin (Macrolane); a Baseline-controlled Single-centre Study.

Further study details as provided by Q-Med AB:

Primary Outcome Measures:
  • Assessment of pain in sitting position using visual analogue scale [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: August 2009
Study Completion Date: May 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Macrolane VRF 30
Open label
 Device: Macrolane VRF 30
One administartion

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931268

Locations
France
Henri Mondor Hospital
Créteil, France
Sponsors and Collaborators
Q-Med AB
Investigators
Study Director: Head of Medical Affairs Q-Med AB
  More Information

No publications provided

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
Last Updated: November 6, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Q-Med AB:
Lipoatrophy
Buttock treatment

Additional relevant MeSH terms:
Lipodystrophy
Atrophy
Skin Diseases, Metabolic
Skin Diseases
 Lipid Metabolism Disorders
Metabolic Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013