N/A
N=10
Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane
Atrophy
Bottom Line
View on ClinicalTrials.gov: NCT00931268 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting — -28.1 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Macrolane VRF 30 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting |
-28.1 | — |
| SECONDARY Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting |
-14.3; -40.3; -29.4; -22.4; -15.8 | — |
| SECONDARY Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire |
9.0; 5.1 | — |
| SECONDARY Number of Participants With Global Esthetic Improvement |
10; 10 | — |
| SECONDARY Number of Participants With Gel Displacement Evaluated by Magnetic Resonance Imaging (MRI) |
0; 0 | — |
| SECONDARY Adverse Event Recording |
3 | — |
| SECONDARY Time Until it Became Impossible to Stay Sitting |
23.8; 59.0 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT00931268). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.