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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030050 / PAS001 |
| Date Original Protocol Accepted |
08/17/2009
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| Date Current Protocol Accepted |
08/17/2009
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| Study Name |
Long Term Registry
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| Device Name |
SCULPTRA AND SCULPTRA AESTHETIC
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| General Study Protocol Parameters |
| Study Design |
Other Study Design
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This study is an five year, open-label, multi-center study to evaluate the long-term safety of Sculptra in HIV-infected patients with facial lipoatrophy by Fitzpatrick skin type and by gender, which will be assessed by the incidence and severity of concomitant illnesses (adverse events). Each subject will be enrolled into one of the four groups at baseline: (a) female with Fitzpatrick skin types I-III; (b) female with Fitzpatrick skin types IV-VI; (c) male with Fitzpatrick skin types I-III; and (d) male with Fitzpatrick skin types IV-VI. Patients will be treated with Sculptra (4-6 treatment sessions to reach optimal correction) at 4 to 6 week intervals.
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| Study Population |
This device is indicated for use in immune-competent subjects as a single regimen for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles. The study population includes patients with HIV-associated lipoatrophy.
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| Sample Size |
300 patients, 20 sites
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| Key Study Endpoints |
Effectiveness endpoints are the clinical presentation of lipoatrophy (James scale) and physician and subject satisfaction on the device based on questionnaire and photographic comparison before and after the previous visit. Safety endpoints include (1) Incidence and severity of concomitant illnesses and the usage and indications of concomitant medications at baseline, yearly follow-up visits, and unscheduled visits that are not mandated by protocol; (2) Incidence and severity of AEs, including hypertrophic scars or keloids at the yearly follow-up visits and unscheduled visits that are not mandated by protocol; (3) Information regarding any additional Sculptra administered at the yearly and unscheduled visits that are not mandated by protocol. In addition, subject-reported QOL/body image will be collected validated QOL and body image questionnaires.
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| Follow-up Visits and Length of Follow-up |
Subjects will have a follow-up visit at one year post baseline (approx 6 months post last treatment), and then yearly office visits for a total of 5 years
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| Interim or Final Data Summary |
| Interim Results |
Preliminary data has shown Sculptra to have a reasonable effectiveness and safety profile at approximately two year after initial treatment.
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| Actual Number of Patients Enrolled |
296
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| Actual Number of Sites Enrolled |
18
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| Patient Follow-up Rate |
81.4%
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| Final Safety Findings |
87.2% of subjects reported treatment emergent adverse events (TEAEs) during the 5쳌]year study. The majority of TEAEs were mild or moderate in severity (19.0% and 42.1% respectively). The most frequently reported SOC categories were: Infections and Infestations (60.0%), General Disorders and Administrative Site Conditions (43.1%), and Gastrointestinal Disorders (34.1%). One subject reported a TEAE of hypertophic scar or keloid.
Seventy six subjects (26.2%) reported serious TEAEs and 17 subjects (5.9%) died during study. None of the SAEs or deaths was related to either the injection procedure or study medication.
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| Final Effect Findings |
There was statistically significant improvement in clinical presentation of facial lipoatrophy at all follow쳌up time쳌points (all p<0.001). Significant reductions in mean James scale scores at 1 Year (쳌-1.4) was either maintained or slightly reduced for the remainder of follow쳌]up (쳌-1.4, 쳌-1.1, 쳌-1.1, and 쳌-1.1 at 2, 3, 4, and 5 Years, respectively). Overall, the proportion of subjects with Grade 1 facial lipoatrophy (almost normal) increased from baseline (11.5%) to Year 1 (81.3%) and was maintained or slightly reduced for the remainder of follow쳌up (79.2%, 61.1%, 58.3%, and 60.1% for the 2, 3, 4, and 5 Year time쳌points, respectively). Mean change in James Scale scores from baseline by gender and Fitzpatrick skin type were consistent with the overall results.
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| Recommendations for Labeling Changes |
Update labeling to include 5 year data from the post approval study
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