Back to resultsMorphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane
Primary Purpose
Atrophy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Macrolane VRF 30
Sponsored by
About this trial
This is an interventional treatment trial for Atrophy focused on measuring Lipoatrophy, Buttock treatment
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.
Sites / Locations
- Henri Mondor Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Macrolane VRF 30
Arm Description
Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
Outcomes
Primary Outcome Measures
Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting
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
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
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
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)
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00931268
Brief Title
Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophy
Keywords
Lipoatrophy, Buttock treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Macrolane VRF 30
Arm Type
Other
Arm Description
Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
Intervention Type
Device
Intervention Name(s)
Macrolane VRF 30
Intervention Description
One administration
Primary Outcome Measure Information:
Title
Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting
Description
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.
Time Frame
6 months after treatment compared to baseline
Secondary Outcome Measure Information:
Title
Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting
Description
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.
Time Frame
Baseline and up to 18 months after treatment
Title
Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire
Description
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.
Time Frame
Baseline and at 6 months after treatment
Title
Number of Participants With Global Esthetic Improvement
Description
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.
Time Frame
One month and up to 18 months after treatment
Title
Number of Participants With Gel Displacement Evaluated by Magnetic Resonance Imaging (MRI)
Description
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.
Time Frame
12 months after treatment
Title
Adverse Event Recording
Description
Adverse events (AEs) were collected by open questioning, investigator findings, spontaneous reports and by direct questioning in the Case Report Form (CRF).
Time Frame
Up to 18 months after treatment
Title
Time Until it Became Impossible to Stay Sitting
Description
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.
Time Frame
Baseline and at 6 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Head of Medical Affairs
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
Henri Mondor Hospital
City
Créteil
Country
France
12. IPD Sharing Statement
Learn more about this trial
Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane
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