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Completed

NCT Number: NCT00931268

Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane

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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Key information

Conditions

Atrophy Lipid Metabolism Disorders Lipodystrophy Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Metabolic Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henri Mondor Hospital

Créteil, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Macrolane VRF 30

Device

One administration

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. 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

    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.

  2. Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire

    Time frame: Baseline and at 6 months after treatment

    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.

  3. Number of Participants With Global Esthetic Improvement

    Time frame: One month and up to 18 months after treatment

    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.

  4. Number of Participants With Gel Displacement Evaluated by Magnetic Resonance Imaging (MRI)

    Time frame: 12 months after treatment

    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.

  5. Adverse Event Recording

    Time frame: Up to 18 months after treatment

    Adverse events (AEs) were collected by open questioning, investigator findings, spontaneous reports and by direct questioning in the Case Report Form (CRF).

  6. Time Until it Became Impossible to Stay Sitting

    Time frame: Baseline and at 6 months after treatment

    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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jul 2, 2009
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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