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| ID | Type | Description | Link |
|---|---|---|---|
| AFFSAPS: 2008-A01252-53 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macrolane VRF 30 | Device | One administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Head of Medical Affairs | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henri Mondor Hospital | Créteil | France |
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First subject enrolled (screened) and treated: 11 August 2009. Last subject completed study: 2 September 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Macrolane VRF 30 | Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Macrolane VRF 30 | Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | mm | 6 months after treatment compared to baseline |
|
From treatment up to 18 months.
Adverse events (AEs) were collected by open questioning, investigator findings, spontaneous reports and by direct questioning in the Case Report Form (CRF).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Macrolane VRF 30 | Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site effusion | General disorders | MedDRA 15.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Development | Q-Med AB | +46 (0)18 4749000 | reception.SEUPP@galderma.com |
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| ID | Term |
|---|---|
| D001284 | Atrophy |
| D008060 | Lipodystrophy |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
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| 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. | 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. | 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. | 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). | 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. | Baseline and at 6 months after treatment |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | The VAS pain at 1, 3, 9, 12 and 18 months after treatment was compared to baseline. Of 10 treated subjects the ITT populations at each time point was: 9 (1 month), 8 (3 months), 7 (9 months), 5 (12 months) and 4 (18 months). | Posted | Mean | Standard Deviation | mm | 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. | The physical and mental health summary scores at 6 months after treatment were compared to baseline. The ITT population comprised 8 of 10 treated subjects. | Posted | Mean | Standard Deviation | units on a scale | 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. | The ITT population at 6 months comprised all 10 treated subjects. | Posted | Number | participants | 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. | Posted | Number | participants | 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). | Reported AEs, Safety population | Posted | Number | participants | 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. | The ITT population at 6 months comprised all 10 treated subjects. | Posted | Mean | Standard Deviation | minutes | Baseline and at 6 months after treatment |
|
|
|
| 0 |
| 10 |
| 3 |
| 10 |
| Injection site inflammation | General disorders | MedDRA 15.0 |
|
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| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
|
| VAS pain; change from 12 months to baseline |
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| VAS pain; change from 18 months to baseline |
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