An interventional study of Macrolane VRF 30 in Atrophy, sponsored by Galderma R&D. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-09-28.
Sponsored by Galderma R&D (part of Galderma Group AG) · Not applicable, Interventional, and Treatment
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.
125 studies on the registry are indexed under Atrophy; 21 are open to participants now.
This study's enrollment of 10 is below the median of 36 across 104 interventional studies indexed under Atrophy.
Browse Atrophy studies →Galderma R&D is the lead sponsor of 284 studies on the registry; 11 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 55 (92%) have results posted.
Compared within Atrophy, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
One administration
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.
Time frame: 6 months after treatment compared to baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Baseline and at 6 months after treatment
First subject enrolled (screened) and treated: 11 August 2009. Last subject completed study: 2 September 2011.
| Milestone | Macrolane VRF 30 |
|---|---|
| Started | 10 |
| Completed | 4 |
| Not completed | 6 |
| Withdrew: Lost to follow-up | 6 |
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.
| mm | Macrolane VRF 30 |
|---|---|
| Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting | -28.1 ± 22.2 |
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.
| mm | Macrolane VRF 30 |
|---|---|
| VAS pain; change from 1 month to baseline | -14.3 ± 15.3 |
| VAS pain; change from 3 months to baseline | -40.3 ± 8.9 |
| VAS pain; change from 9 months to baseline | -29.4 ± 22.3 |
| VAS pain; change from 12 months to baseline | -22.4 ± 25.2 |
| VAS pain; change from 18 months to baseline | -15.8 ± 12.7 |
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.
| units on a scale | Macrolane VRF 30 |
|---|---|
| Physical health; change from 6 months to baseline | 9.0 ± 6.2 |
| Mental health; change from 6 months to baseline | 5.1 ± 15.6 |
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.
| participants | Macrolane VRF 30 |
|---|---|
| Subject assessed improvement at 6 months | 10 |
| Physician assessed improvement at 6 months | 10 |
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.
| participants | Macrolane VRF 30 |
|---|---|
| Gel displacement right buttock | 0 |
| Gel displacement left buttock | 0 |
Adverse events (AEs) were collected by open questioning, investigator findings, spontaneous reports and by direct questioning in the Case Report Form (CRF).
| participants | Macrolane VRF 30 |
|---|---|
| Adverse Event Recording | 3 |
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.
| minutes | Macrolane VRF 30 |
|---|---|
| Mean value at baseline | 23.8 ± 4.1 |
| Mean value at 6 months | 59.0 ± 3.2 |
Collected over From treatment up to 18 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Macrolane VRF 30 | — | 0/10 (0%) | 3/10 (30%) |
| Event | Macrolane VRF 30 |
|---|---|
| Injection site inflammationGeneral disorders | 3/10 |
| Implant site effusionGeneral disorders | 2/10 |
| Age, Categorical(Participants) | Macrolane VRF 30 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 0 |
| Age, Continuous(years) | Macrolane VRF 30 |
|---|---|
| Mean | 44.6 ± 3.7 |
| Sex: Female, Male(Participants) | Macrolane VRF 30 |
|---|---|
| Female | 5 |
| Male | 5 |
| Region of Enrollment(participants) | Macrolane VRF 30 |
|---|---|
| France | 10 |
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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