Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT00931268
First received: July 1, 2009
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Atrophy
Device: Macrolane VRF 30

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Stabilized Hyaluronic Acid of Non-animal Origin (Macrolane); a Baseline-controlled Single-centre Study.

Resource links provided by NLM:


Further study details as provided by Q-Med AB:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire [ Time Frame: Baseline and at 6 months after treatment ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Global Esthetic Improvement [ Time Frame: One month and up to 18 months after treatment ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Gel Displacement Evaluated by Magnetic Resonance Imaging (MRI) [ Time Frame: 12 months after treatment ] [ Designated as safety issue: No ]
    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.

  • Adverse Event Recording [ Time Frame: Up to 18 months after treatment ] [ Designated as safety issue: Yes ]
    Adverse events (AEs) were collected by open questioning, investigator findings, spontaneous reports and by direct questioning in the Case Report Form (CRF).

  • Time Until it Became Impossible to Stay Sitting [ Time Frame: Baseline and at 6 months after treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 10
Study Start Date: August 2009
Study Completion Date: May 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Macrolane VRF 30
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
One administration

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931268

Locations
France
Henri Mondor Hospital
Créteil, France
Sponsors and Collaborators
Q-Med AB
Investigators
Study Director: Head of Medical Affairs Q-Med AB
  More Information

No publications provided

Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT00931268     History of Changes
Other Study ID Numbers: 31GC0804, AFFSAPS: 2008-A01252-53
Study First Received: July 1, 2009
Results First Received: July 12, 2013
Last Updated: November 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Q-Med AB:
Lipoatrophy
Buttock treatment

Additional relevant MeSH terms:
Lipodystrophy
Atrophy
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 28, 2014