Sculptra: PRODUCT DESCRIPTION AND PHARMACOKINETICS

2 May
2010

Sculptra™ is an injectable implant that contains microparticles of poly-L-lactic acid (PLLA). It is a biodegradable, biocompatible, and immunologically inert synthetic polymer derived from the alpha-hydroxy acid family.

Sculptra™ is available as alyophilized, sterile, freeze-dried preparation for injection in a clear glass vial. The preparation is reconstituted with 3 to 5 ml of Sterile Water for Injection (USP) and is then injected by a trained health care professional into the deep dermis layer or the subcutaneous layer of the skin only. The final composition consists of PLLA, sodium carboxymethylcellulose (USP), nonpyrogenic mannitol (USP), and the Sterile Water.
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These injections gradually improve the appearance of skin folds and sunken areas by significantly increasing skin thickness. In clinical trials, the results of Sculptra™ use lasted for up to two years after the first treatment session.

ADMINISTRATION

Only health care providers who are fully trained and familiar with Sculptra™ should administer it. These professionals should be aware of the correction of volume deficiencies needed for each individual patient with HIV infection, and they must also be registered with Der-mik Laboratories to be able to order and give the injections.

The number of injection sessions needed differs for each patient, depending on the degree of severity of the lipoatrophy. Previous studies have noted three to five injection sessions per patient, given at two-week intervals.

CLINICAL TRIALS

The efficacy and safety of Sculptra™ have been demonstrated in two clinical trials.

The VEGA Study

The VEGA Study was a 96-week, open-label, non-control, single-center study in Paris, France, that evaluated the efficacy, safety, and durability of facial injections of New-Fill® in HIV-infected patients with lipoatrophy. Of the 50 patients who were enrolled in this study, 49 (98%) were men and 42 (84%) were white.
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To be included in the trial, patients had to be at least 18 years of age and had to have severe lipoatrophy, defined as thickness of fat tissue in the nasogenian area less than 2 mm, as measured by ultrasonography. The study participants also had to have received at least three years of antiretroviral therapy, with stable plasma HIV-1 RNA levels below 5,000 copies/ml within the three months of their enrollment into the study.

Patients were excluded from the study if they had any facial skin disease, if they had received a facial implant within the previous six months, or if they were currently receiving interferon or cytokine therapy. The average age of the participants was 45.9 years.

The participants received four to five sets of New-Fill® injections every two weeks into and around the deep dermis of the atrophied area in each cheek. At weeks 0, 6, 24, 48, 72, and 96, they were evaluated by clinical examination, facial ultrasonography, and photographs. The Visual Analogue Scale (VAS) was used to assess the patients’ quality of life, and data were collected at weeks 0, 12, 24, 48, 72, and 96. The fifth set of injections was given only to patients whose facial total cutaneous thickness (TCT) was less than 8 mm at the sixth week.

The primary endpoint evaluated in this study was the proportion of responders, defined as patients with a TCT greater than 10 mm, measured at the nasogenian fold, at week 24. The proportion of patients with a TCT of at least 10 mm at week 24 was 41% (95% confidence interval [CI], 27-56 mm; P < .001). The median increases of TCT from baseline were also statistically significant at all time points from baseline. These values are shown in Table 2.

Table 2 Total Cutaneous Thickness (TCT) in the VEGA Study

No. of WeeksProportion of Patients with a TCT >10 mm*Median Changes in TCT from Baselinef

6

19% (9-33 mm)+5.1 (2.2-8.6)
41% (27-56 mm)+6.4 (3.1-9.1)

48

61% (46-75 mm)+7.2 (4.2-9.6)

72

52% (37-67 mm)+7.2 (3.5-9.6)

96

43% (28-59 mm)+6.8 (3.9-10.1)
* 95% confidence interval for all time points. f P < .001 at all time points. ф Study’s primary endpoint.

Quality-of-life measurements were obtained from 44 patients. These figures progressively increased from the baseline evaluation up until week 48 (+0.8, -3.9 to +10.0; P = .021).

Figure 1 Treatment effects seen with SculptraFigure 1 Treatment effects seen with Sculptra™.

No serious adverse drug events (ADEs) were reported during the trial, and no patients withdrew from the study because of side effects. The most common side effects noted were minimal, localized edema at the injection site; ecchymosis; and palpable, invisible subcutaneous micronodules, which resolved spontaneously.
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The viral load and CD4+ cell count remained stable throughout the study period. No AIDS-defining event occurred during the trial.

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