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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

July 1, 2009
November 22, 2013
August 2009
September 2011   (final data collection date for primary outcome measure)
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.
Assessment of pain in sitting position using visual analogue scale [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00931268 on ClinicalTrials.gov Archive Site
  • 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.
  • Assessment of pain in sitting position using visual analogue scale [ Time Frame: Up to 18 months after treatment ] [ Designated as safety issue: No ]
  • Quality of Life assessed by MOS-HIV questionnaire [ Time Frame: Up to 18 months after treatment ] [ Designated as safety issue: No ]
  • Global Esthetic Improvement [ Time Frame: Up to 18 months after treatment ] [ Designated as safety issue: No ]
  • Magnetic Resonance Imaging [ Time Frame: Up to 12 months after treatment ] [ Designated as safety issue: Yes ]
  • Adverse Event recording [ Time Frame: Up to 18 months after treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane
Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Stabilized Hyaluronic Acid of Non-animal Origin (Macrolane); a Baseline-controlled Single-centre Study.

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrophy
Device: Macrolane VRF 30
One administration
Macrolane VRF 30
Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
Intervention: Device: Macrolane VRF 30
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
May 2012
September 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00931268
31GC0804, AFFSAPS: 2008-A01252-53
No
Q-Med AB
Q-Med AB
Not Provided
Study Director: Head of Medical Affairs Q-Med AB
Q-Med AB
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP