AtrophyNCT00931268

Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane

A study testing Macrolane VRF 30 in people with Atrophy, run by Galderma R&D at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Atrophy
What is being tested?: Macrolane VRF 30
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteFrance
Study dates: Aug 2009to May 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 14Show fewer

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.

Trial locations and contacts

1 site in 1 country.

France1 site

Henri Mondor Hospital
Créteil

Other trials in France

About this study

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.

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
Being tested: Macrolane VRF 30
Keywords: Lipoatrophy, Buttock treatment
Medical subject headings: Atrophy, Lipodystrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Macrolane VRF 30Device
One administration

Study groups in NCT00931268
Study group	Role	What they receive
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. Receives: Device: Macrolane VRF 30

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: Baseline and up to 18 months after treatment
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.
Measured: Baseline and at 6 months after treatment
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.
Measured: One month and up to 18 months after treatment
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.
Measured: 12 months after treatment
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).
Measured: Up to 18 months after treatment
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.
Measured: Baseline and at 6 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009May 2012

First posted2 Jul 2009 (estimated)
Study startAug 2009
Primary completionSep 2011
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AtrophyStudies of the same condition, open and under way.
More trials run by Galderma R&DThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00931268
Sponsor's protocol ID: 31GC0804
Other IDs: AFFSAPS: 2008-A01252-53
Status last verified: Nov 2013
First submitted: 1 Jul 2009
Last updated: 28 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Atrophy trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00931268
Acronym / sponsor ID: 31GC0804
Conditions: Atrophy
Keywords: Lipoatrophy, Buttock treatment
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Sep 2011 (actual)
Study completion: May 2012 (actual)
First posted: 2 Jul 2009 (estimated)
Results: Posted 19 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Macrolane VRF 30	Other	Device: Macrolane VRF 30Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (14 listed)

Active infections.
Active skin disease, inflammation or related conditions.
Perineal pathology.
Condition that may affect pain assessment.
Skin with underlying fibrous tissue.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Macrolane VRF 30One administration	Device	Macrolane VRF 30

Primary outcome

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
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 secondary outcomes

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
Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire
Time frame: Baseline and at 6 months after treatment
Number of Participants With Global Esthetic Improvement
Time frame: One month and up to 18 months after treatment
Number of Participants With Gel Displacement Evaluated by Magnetic Resonance Imaging (MRI)
Time frame: 12 months after treatment
Adverse Event Recording
Time frame: Up to 18 months after treatment
Time Until it Became Impossible to Stay Sitting
Time frame: Baseline and at 6 months after treatment

Results and safety

Results posted to the registry on 19 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Macrolane VRF 30	10	4

Primary outcome: 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. Mean (Standard Deviation). Unit: mm

Measure	Macrolane VRF 30 n = 10
Value	-28.1 (22.2)

Population analysed: All efficacy analyses were performed using the intention to treat (ITT) population. The ITT population at baseline and 6 months comprised all 10 treated subjects.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From treatment up to 18 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Macrolane VRF 30	0 of 10 (0%)	3 of 10 (30%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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A Study of Bimagrumab in Participants With HFpEF
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Head of Medical Affairs study director

Galderma R&D

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Macrolane VRF 30 in people with Atrophy, run by Galderma R&D at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00931268.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.