Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane

Galderma

Status

Completed

Conditions

Atrophy

Treatments

Device: Macrolane VRF 30

Study type

Interventional

Funder types

Industry

Identifiers

NCT00931268

31GC0804

AFFSAPS: 2008-A01252-53

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.