Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane

Atrophy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00931268
• Other study ID #: 31GC0804
• Secondary ID: AFFSAPS: 2008-A0
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Est. completion date: May 2012

Study information

• Verified date: November 2013
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Lipodystrophy

Intervention

Device:
• Macrolane VRF 30
One administration

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months after treatment compared to baseline
Secondary	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.	Baseline and up to 18 months after treatment
Secondary	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.	Baseline and at 6 months after treatment
Secondary	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.	One month and up to 18 months after treatment
Secondary	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.	12 months after treatment
Secondary	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).	Up to 18 months after treatment
Secondary	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.	Baseline and at 6 months after treatment