Status:
COMPLETED
Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane
Lead Sponsor:
Galderma R&D
Conditions:
Atrophy
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00931268
Start Date
August 1 2009
End Date
May 1 2012
Last Update
September 28 2022
Active Locations (1)
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1
Henri Mondor Hospital
Créteil, France