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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 October 2022 |
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Main ID: |
NCT00931268 |
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Date of registration:
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01/07/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane
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Scientific 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. |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00931268 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Head of Medical Affairs |
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Address:
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Telephone:
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Email:
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Affiliation:
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Galderma R&D |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Atrophy
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Intervention(s)
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Device: Macrolane VRF 30
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Primary Outcome(s)
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Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting
[Time Frame: 6 months after treatment compared to baseline]
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Secondary Outcome(s)
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Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire
[Time Frame: Baseline and at 6 months after treatment]
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Adverse Event Recording
[Time Frame: Up to 18 months after treatment]
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Number of Participants With Global Esthetic Improvement
[Time Frame: One month and up to 18 months after treatment]
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Number of Participants With Gel Displacement Evaluated by Magnetic Resonance Imaging (MRI)
[Time Frame: 12 months after treatment]
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Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting
[Time Frame: Baseline and up to 18 months after treatment]
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Time Until it Became Impossible to Stay Sitting
[Time Frame: Baseline and at 6 months after treatment]
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Secondary ID(s)
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AFFSAPS: 2008-A01252-53
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31GC0804
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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