Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane

NCT00931268 | Completed Results

• 2 other identifiers: 31GC0804AFFSAPS: 2008-A01252-53
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrophy

Keywords

Lipoatrophy; Buttock treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting

  Baseline and up to 18 months after treatment

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

  Baseline and at 6 months after treatment

• Number of Participants With Global Esthetic Improvement

  One month and up to 18 months after treatment

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

  12 months after treatment

• Adverse Event Recording

  Up to 18 months after treatment

Study Arms (1)

Macrolane VRF 30

OTHER

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

Interventions

Macrolane VRF 30 DEVICE

One administration

Macrolane VRF 30

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Henri Mondor Hospital

Créteil, France

Location

MeSH Terms

Conditions

Atrophy; Lipodystrophy

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Head of Clinical Development
• Organization: Q-Med AB

reception.SEUPP@galderma.com

+46 (0)18 4749000

Study Officials

• Head of Medical Affairs

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: July 2, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: May 1, 2012
• Last Updated: September 28, 2022
• Results First Posted: December 19, 2013

Record last verified: 2013-11

Locations

FR (1)