Sculptra™

Most doctors agree that injectable fillers may be the best option for patients with well-defined wrinkles, creases or soft tissue loss. Unfortunately, previous injectable fillers either required a skin test because they were made from animal proteins, or they didn’t last very long and required constant treatments to maintain their effect. We now have a synthetic filler material that lasts a long time, is not made from animals, and does not require a skin test.

Sculptra™

Sculptra is an injectable product that is intended to restore and correct the signs of facial fat loss. Sculptra is not made from human or animal sources and does not require a skin test. Sculptra is composed of poly-L-lactic acid, a synthetic product. Poly-L-lactic acid (PLLA) is biocompatible (does not harm the body) and biodegradable (able to be broken down by the body). PLLA has been widely used for many years in dissolvable stitches, soft tissue implants, and other types of implants.

Sculptra is effective when used to fill wrinkles and furrows. It makes the skin appear smoother and firmer, enabling it to resemble its previous elasticity. Sculptra provides an increase in the skin thickness of the areas where volume (fat) has been lost, helping to restore fullness to the face for a more natural appearance.

Will Sculptra stop the cause of my soft tissue loss?

Sculptra will not stop the cause of your soft tissue loss. But, Sculptra will improve your appearance by increasing the thickness of your skin and surrounding soft tissue in the treated areas.

What are the benefits of Sculptra?

Sculptra has been clinically proven to be long lasting and well-tolerated. Patients treated in these same clinical studies reported an improvement in quality of life. Decreases in the anxiety and depression often associated with lipoatrophy were also reported. Increases in skin thickness lasted up to 2 years.

What are the treatments like?

Treatments with Sculptra take 15-30 minutes and are performed in your doctor’s office. A local anesthetic cream or injection may be applied to the treatment area. Then, using a small needle, Sculptra is placed beneath the surface of the skin, in the area of your soft tissue loss.

How many treatments will I need?

During your consultation, the doctor will examine your areas of soft tissue deficiency and decide the appropriate number of treatment sessions and estimate the amount of Sculptra you will require at each session. Most patients require 1-3 treatment sessions every 2-4 weeks. Some patients may also do best with a combination of Sculptra and another filling substance. Severe soft tissue loss usually requires three to six treatment sessions.

How soon will I see results?

The results from Sculptra are not immediate. Sculptra provides a gradual increase in soft tissue and skin thickness. However, the effects of Sculptra are longlasting. Your doctor may want to see you again in a few weeks to decide if additional injections are needed. Touch-up treatments may be needed to maintain the desired effects.

What results can be expected?

Excellent results can be achieved with Sculptra when treating all parts of the face including the forehead, around the eyes and lips, between the mouth and nose, and the cheeks. Sculptra can add volume to the cheeks, to folds around the chin, and to rings around the eyes. It is equally effective on the neck and lower neckline. It can also be used to treat the hands, knees and ankles as well as certain types of scars.

What is recovery like?

Patients are up and around immediately after receiving their treatments with Sculptra. At first, there will be some swelling caused by the injections and the extra water used to dilute the Sculptra. This will go away in a day or two as the water is absorbed by your body. You could also experience some discomfort, tenderness, bleeding or bruising at the injection site. This too will disappear within a few days to a couple weeks. Occasionally, small bumps may form in the treated area. Local massage to the area usually can treat these should they occur.

Sculptra™ is approved by the US Food and Drug Administration (FDA) for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Until now, there were no products that had been approved by the FDA to treat facial lipoatrophy. However, that is all changing with the introduction of Sculptra™ in the United States, offering an effective option to treat the effects of lipoatrophy.

Facial fat loss, or lipoatrophy, is the loss of fat beneath the skin, which can result in sunken cheeks, indentations, and hollow eyes. Sculptra™ is a safe, synthetic, and biocompatible material that is injected below the surface of the skin in the area of fat loss. It provides a gradual and significant increase in skin thickness, improving the appearance of folds and sunken areas. No skin testing is required.

Sculptra™ (poly-L-lactic acid) has been safely used outside the United States since 1999 in over 150,000 patients under the trade name New-Fill™.

What It Does

Sculptra™ is an injectable product that restores and corrects the signs of facial fat loss by replacing lost volume. Sculptra™ provides an increase in skin thickness, helping to create a more natural facial appearance in those with facial lipoatrophy.

Sculptra™ is composed of poly-L-lactic acid, a synthetic material. Sculptra™ is not made from human or animal sources and does not require a skin test. Poly-L-lactic acid (PLLA) is a biocompatible (does not harm the body), biodegradable (able to be broken down by the body) material that has been widely used for many years in surgical products. The effects are long-lasting; they were shown in a clinical study to last for up to 2 years after the first treatment session.

What is Sculptra™?
Sculptra™ is a synthetic injectable material known as "poly-L-lactic acid." Poly-L-lactic acid is a biocompatible, biodegradable material that has been widely used for many years in dissolvable stitches, soft tissue implants, and other types of implants.

How does Sculptra™ work?
Sculptra™ is injected below the surface of the skin in the area of fat loss. Sculptra™ provides a gradual increase in skin thickness. Visible results appear within the first few treatment sessions.

Sculptra™ will not correct the underlying cause of the facial fat loss, but will help improve the appearance by increasing skin thickness in the treated area.

Are skin tests required before treatment with Sculptra™?
No, skin testing is not required prior to use.

Are the results from Sculptra™ immediate?
No. After the first treatment, it may appear that Sculptra™ worked immediately. Typically, patients will experience some degree of edema associated with the injection procedure, which will give the appearance of a full correction by the end of the injection session (within about 30 minutes). The patient should be informed that the injection-related edema typically resolves in several hours to a few days, resulting in the "reappearance" of the original contour deficiency. Sculptra™ takes time to gradually correct the depression in the skin.

How many treatments are required?
Each patient should be evaluated individually. More than one treatment session may be required. Patients with severe facial fat loss may require 3 to 6 treatment sessions.

How long do treatment effects last?
Treatment effects will differ for each person. In a clinical study, the treatment results lasted for up to 2 years after the first treatment session, in most patients. Touch-up treatments may be needed to maintain the desired effect.

How quickly can my patients return to their daily activities?
Most patients feel comfortable going back to their normal activities following treatment.

When will my patients be able to apply make-up after treatment?
Make-up may be applied a few hours after treatment if no complications are present (for example, open wounds or bleeding).

What are the possible side effects of treatment with Sculptra™?
The most commonly observed product-related adverse event was the delayed occurrence of subcutaneous papules (5 mm or less), which were typically palpable, asymptomatic, and non-visible, and confined to the injection site area. Other reported side effects of Sculptra™ include immediate and transient injection-related events such as bleeding from the injection site, discomfort, erythema or inflammation, ecchymosis, and edema.

Advise patients to report any side effects to their health care provider.

Who should not use Sculptra™?
Sculptra™ is contraindicated in those individuals who have shown a hypersensitivity to any of its components.

Lasting Results

The effects of Sculptra™ are enduring. In a clinical study, effects lasted for up to 2 years after the first treatment session in most patients. The results from Sculptra™ are not immediate; Sculptra™ provides a gradual increase in skin thickness. Your health care provider will see you again in a few weeks to decide if additional injections are needed. Touch-up treatments may be needed to maintain the desired effects.

People with mild lipoatrophy will require fewer treatments than those with severe lipoatrophy

Clinical Data - Results of the open-label study VEGA

Study Objectives
The goal of this open-label, single-arm pilot was to evaluate the efficacy and safety of facial injections of poly-L-lactic acid in patients with human immunodeficiency virus with severe facial lipoatrophy.

Study Design
Fifty patients received injections at day 0 and then every 2 weeks for 6 weeks. Patients were evaluated by clinical examination, facial ultrasonography to measure dermal thickness, and photography at screening and at weeks 6, 24, 48, 72, and 96.

Increases in dermal thickness are associated with visible improvements in the signs of facial lipoatrophy

• All of the patients markedly improved from baseline
• Sculptra™ provided a near 3-fold increase from baseline in mean dermal thickness
• Statistically significant increases in mean dermal thickness persisted throughout the 2-year study

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