Atrophy
Conditions
Keywords
Lipoatrophy, Buttock treatment
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.
Interventions
DEVICEMacrolane VRF 30
One administration
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire | Baseline and at 6 months after treatment | 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. |
| Number of Participants With Global Esthetic Improvement | One month and up to 18 months after treatment | 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. |
| 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 | 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. |
| Adverse Event Recording | Up to 18 months after treatment | Adverse events (AEs) were collected by open questioning, investigator findings, spontaneous reports and by direct questioning in the Case Report Form (CRF). |
| Time Until it Became Impossible to Stay Sitting | Baseline and at 6 months after treatment | 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. |
| Number of Participants With Gel Displacement Evaluated by Magnetic Resonance Imaging (MRI) | 12 months after treatment | 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. |
Countries
France
Participant flow
Recruitment details
First subject enrolled (screened) and treated: 11 August 2009. Last subject completed study: 2 September 2011.
Participants by arm
| Arm | Count |
|---|---|
| Macrolane VRF 30 Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
Baseline characteristics
| Characteristic | Macrolane VRF 30 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 44.6 years STANDARD_DEVIATION 3.7 |
| Region of Enrollment France | 10 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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.
Time frame: 6 months after treatment compared to baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Macrolane VRF 30 | Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting | -28.1 mm | Standard Deviation 22.2 |
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).
Time frame: Up to 18 months after treatment
Population: Reported AEs, Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Macrolane VRF 30 | Adverse Event Recording | 3 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.
Time frame: Baseline and up to 18 months after treatment
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Macrolane VRF 30 | Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting | VAS pain; change from 1 month to baseline | -14.3 mm | Standard Deviation 15.3 |
| Macrolane VRF 30 | Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting | VAS pain; change from 3 months to baseline | -40.3 mm | Standard Deviation 8.9 |
| Macrolane VRF 30 | Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting | VAS pain; change from 9 months to baseline | -29.4 mm | Standard Deviation 22.3 |
| Macrolane VRF 30 | Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting | VAS pain; change from 12 months to baseline | -22.4 mm | Standard Deviation 25.2 |
| Macrolane VRF 30 | Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting | VAS pain; change from 18 months to baseline | -15.8 mm | Standard Deviation 12.7 |
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.
Time frame: 12 months after treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macrolane VRF 30 | Number of Participants With Gel Displacement Evaluated by Magnetic Resonance Imaging (MRI) | Gel displacement right buttock | 0 participants |
| Macrolane VRF 30 | Number of Participants With Gel Displacement Evaluated by Magnetic Resonance Imaging (MRI) | Gel displacement left buttock | 0 participants |
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.
Time frame: One month and up to 18 months after treatment
Population: The ITT population at 6 months comprised all 10 treated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macrolane VRF 30 | Number of Participants With Global Esthetic Improvement | Subject assessed improvement at 6 months | 10 participants |
| Macrolane VRF 30 | Number of Participants With Global Esthetic Improvement | Physician assessed improvement at 6 months | 10 participants |
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.
Time frame: Baseline and at 6 months after treatment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Macrolane VRF 30 | Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire | Physical health; change from 6 months to baseline | 9.0 units on a scale | Standard Deviation 6.2 |
| Macrolane VRF 30 | Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire | Mental health; change from 6 months to baseline | 5.1 units on a scale | Standard Deviation 15.6 |
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.
Time frame: Baseline and at 6 months after treatment
Population: The ITT population at 6 months comprised all 10 treated subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Macrolane VRF 30 | Time Until it Became Impossible to Stay Sitting | Mean value at baseline | 23.8 minutes | Standard Deviation 4.1 |
| Macrolane VRF 30 | Time Until it Became Impossible to Stay Sitting | Mean value at 6 months | 59.0 minutes | Standard Deviation 3.2 |