Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Macrolane VRF 30

Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.

Group Type OTHER

Macrolane VRF 30

Intervention Type DEVICE

One administration

Interventions

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Macrolane VRF 30

One administration

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No