Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane

Study Overview
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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.

Official Title
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Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Stabilized Hyaluronic Acid of Non-animal Origin (Macrolane); a Baseline-controlled Single-centre Study.

Conditions
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Atrophy

Intervention / Treatment
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* Device: Macrolane VRF 30


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Macrolane VRF 30<br>Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject. | Device: Macrolane VRF 30<br>* One administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting | Pain at sitting was evaluated using a 100 mm VAS with the descriptors 0 = no pain to the left and 100 = worst possible pain to the right. Pain was assessed by the subject after sitting 15 minutes on a standardized chair. The VAS pain at 6 months was compared to baseline and the change was calculated. | 6 months after treatment compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting | Pain at sitting was evaluated using a 100 mm VAS with the descriptors 0 = no pain to the left and 100 = worst possible pain to the right. Pain was assessed by the subject after sitting 15 minutes on a standardized chair. The change in VAS pain was assessed at the time points 1, 3, 9, 12 and 18 months compared to baseline. | Baseline and up to 18 months after treatment | 
| Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire | A physical health summary score and a mental health summary score was generated on a rating scale of 0 to 100 where higher scores indicate better health. The change in health summary scores were assessed at the time points 3, 6, 9, 12 and 18 months compared to baseline. | Baseline and at 6 months after treatment | 
| Number of Participants With Global Esthetic Improvement | Number of participants maintaining an improvement compared to baseline using the Global Esthetic Improvement Scale (GEIS) consisting of 5 grades (worse/no change/improved/much improved/very much improved), where the three latter indicates improvement. GEIS was assessed at the time points 1, 3, 6, 9, 12 and 18 months compared to pre-treatment photos. | One month and up to 18 months after treatment | 
| Number of Participants With Gel Displacement Evaluated by Magnetic Resonance Imaging (MRI) | MRI was performed at baseline and at 1, 6, 9, and 12 months to determine the implant volume, thickness, localization and the possible local displacement of the implant. At the 6, 9 and 12 month visits any displacement was evaluated with MRI by comparison to the 1-month position of the gel. The number of participants with gel displacement are shown below. | 12 months after treatment | 
| Adverse Event Recording | Adverse events (AEs) were collected by open questioning, investigator findings, spontaneous reports and by direct questioning in the Case Report Form (CRF). | Up to 18 months after treatment | 
| Time Until it Became Impossible to Stay Sitting | Evaluation of when (in minutes) it became impossible for the subject to stay in the sitting position on a standardized chair, at the time points 1, 3, 6, 9, 12 and 18 months compared to baseline. In this analysis more than 60 minutes was handled as 60 minutes. | Baseline and at 6 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipoatrophy, Buttock treatment