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Sculptra® (New-Fill)

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Sculptra® (marketed as New-Fill™ in many countries) is a poly-L-lactic-acid-based injectable dermal filler. Sculptra® is very effective when used as a treatment for wrinkles and fine lines on the face, and it can also be used to improve facial volume and treat lipoatrophy, which is the facial wasting, or loss of facial fat, most often associated with HIV and AIDS.

What Is Sculptra®?

Used throughout Europe under the name of New-Fill™ since 1999, Sculptra® is an injectable treatment made from polylactic (also referred to as poly-L-lactic) acid that was FDA approved in August 2004 for the treatment of facial lipoatrophy (facial wasting), especially in patients with HIV/AIDS.

The main ingredient of Sculptra®, polylactic acid, has been used for more than 20 years in surgical products, including dissolvable stitches. Polylactic acid is a synthetic substance made to replicate a natural derivative created by the muscles during exercise. Since Sculptra® is comprised of synthetic materials, there is no need for allergy testing prior to treatment.

Candidates

Most people, including patients with HIV or AIDS, are suitable candidates for Sculptra® treatments. Since the polylactic acid in Sculptra® is biologically inert, there is no risk of patients developing an allergic reaction to treatments. Patients who have skin infections, who take aspirin or anti-inflammatory medications, or who have depleted immune systems should consult with a doctor before undergoing Sculptra® treatment.

General Sculptra® Treatment Requirements

Patients who wish to undergo Sculptra® treatments should be in good general health. Those with skin infections or rashes may not be suitable candidates for Sculptra®. In addition, the immune systems of some HIV or AIDS patients may be damaged to the point that Sculptra® treatments could have a negative effect on their health. If you are interested in using Sculptra® for restoring facial volume in your eyes or lips, or for the treatment of the facial lipoatrophy that is the result of HIV or AIDS, be sure to make your doctor fully aware of whatever health complications you have.

Facial Wasting ( Lipoatrophy) and Sculptra®

Lipoatrophy , or facial wasting, is common among HIV and AIDS patients. Sculptra® has been approved by the FDA to counteract facial lipoatrophy in these patients, as well as to improve the appearance of sunken eyes, temples, and cheeks. A study conducted by Dermik Aesthetics, the company that makes Sculptra®, found that patients who received three to six rounds of Sculptra® treatment showed roughly a 40 percent increase in facial volume for up to two years following their treatments. The collagen-building polylactic acid in Sculptra® injections helps to rebuild the structure of any area affected by facial wasting, and Sculptra® does not pose the threat of allergic reaction to patients with depleted immune systems.

Moderate facial wasting may require three to five Sculptra® treatment sessions for optimal results. Patients with a severe level of lipoatrophy may need as many as six or seven Sculptra® treatment sessions, which are typically spaced two weeks apart.

Sculptra® restores not only facial volume, but also the quality of life of many patients. The depression and anxiety frequently associated with facial lipoatrophy is often lessened as a result of Sculptra® treatment.

Sculptra® Injections for Facial Volume

Sculptra® injections can be used to increase facial volume. Loss of facial fat due to lipoatrophy can cause a hollow look under the eyes, a loss of lip definition, and a sunken appearance in the cheeks. The polylactic acid base of Sculptra® can restore definition to the face.

Another popular use of Sculptra®, especially in Europe (where it is marketed under the name New-FillTM), is to reduce the appearance of deep wrinkles and facial folds. Because of its longer lasting results, Sculptra® is often preferred to other cosmetic dermal fillers like Restylane®. Sculptra® is useful in rejuvenating eyes, lips, and all areas of the face that can show signs of aging. In fact, Sculptra® has earned the nickname of the "liquid facelift" because of its effectiveness in creating a fuller, more youthful appearance.

Medical and Health Considerations

Before undergoing any medical treatment, it is important that patients make their doctors fully aware of any medical conditions or allergies they may have. The polylactic acid of which Sculptra® is composed is biologically inert and does not pose a risk of allergic reaction for patients. Nonetheless, it is important for patients to inform their doctors of any immune deficiencies, skin infections or rashes, or medications (including aspirin and anti-inflammatory medications) that may affect the outcome of their Sculptra® treatment. Sculptra® is commonly used as a treatment for lipoatrophy, or facial wasting, and Sculptra® is suitable for use on many patients with HIV or AIDS.

Cost and Financing Information

As with all cosmetic treatments, the cost of Sculptra® varies by doctor. It also depends on the amount of Sculptra® needed to treat an individual patient’s facial lipoatrophy or to reach his or her cosmetic goals, as well as the number of visits required to complete the treatments . While the majority of cosmetic dermatology procedures are considered elective and are therefore not covered by most insurance plans, some insurance plans in the United States will cover the cost of Sculptra® treatments for patients who have HIV or AIDS. Dermik, the maker of Sculptra®, has also created a financial assistance program to help patients who have HIV or AIDS pay for treatments. To learn more about Sculptra® cost and the financing options that may be available to you, please visit the appropriate DocShop page.

The Sculptra® Treatment Process

Because Sculptra® is a synthetic, biocompatible substance made from lactic acid - a natural substance that is present in your body already - there's no need for allergy pretesting prior to Sculptra® treatment. However, be sure to disclose your complete medical history to your surgeon, including the use of any blood thinners such as aspirin. It is also necessary that you abstain from alcohol in the days leading up to treatment.

Sculptra ® treatment is administered on an outpatient basis at your doctor's office. Prior to treatment, your surgeon will determine the precise points of injection and mark them on your face. If desired, a topical anesthetic can be applied to minimize discomfort during treatment.

The Sculptra® Injection Procedure

Shortly before an injection of Sculptra® is administered, the Sculptra® suspension can be diluted with lidocaine to reduce discomfort from the injection. The suspension of Sculptra® is injected using a very fine-gauge syringe. It is injected under - not into - the skin, unlike some other dermal injectables.

Another difference between Sculptra® and other fillers is that Sculptra® is placed evenly under a facial defect, in contrast to the "spot" placement of other fillers under a wrinkle or line.

Starting immediately after treatment, the treated areas are massaged for a few minutes to distribute the Sculptra® suspension evenly. This massage helps to prevent the formation of bumps or nodules under the skin.

There is little or no downtime after receiving Sculptra® injections. Most patients are able to return immediately to their normal activities. There may be some redness and/or swelling at the injection sites, but these side effects fade quickly. A cold compress or icepack can be applied as needed.

How Does Sculptra® Work?

The microscopic Sculptra® crystals induce a mild inflammatory reaction under the skin where they were injected. This "triggers" the formation of new collagen - white blood cells surrounding the Sculptra® microcrystals recruit collagen-producing fibroblasts. Collagen production gradually increases, making the volume-enhancing results of the Sculptra® treatment apparent in about four to six weeks.

Are Results Immediate?

Immediately after Sculptra® treatment, the area of the face that was injected will appear to be filled out, but this is simply because of the water content in the Sculptra® injection (the Sculptra® microparticles are suspended in sterile water for injection). This temporary fullness will recede in a few days. The true and lasting effects of Sculptra® treatment take weeks or months to become evident.

Although the effects of Sculptra ® take some time to manifest themselves, they can last for up to two years. The results of treatment with other skin injectables such as Restylane® last only a few months.

Sculptra® Retreatment

Because it takes weeks or months for the effects of Sculptra® to become apparent, the treatment regimen for Sculptra® is usually "Treat, Wait, Assess, and Retreat As Necessary" - that is, your physician must wait and see whether enough Sculptra® was administered the first time before knowing whether additional injections are appropriate. In addition, the risk of overcorrection with Sculptra® is the formation of nodules under the skin; this can be avoided by allowing at least a few weeks to pass before assessing the effects of the first treatment.

Risks and Benefits

The positive effects of Sculptra® treatment include increased skin thickness and improved facial volume, which lead to a healthier, more youthful appearance. In fact, Sculptra® treatment has become known as the “liquid facelift,” so dramatic and impressive are its results. Sculptra® results can last for up to two years, while the results of other injectable dermal fillers, such as Restylane®, may only last for a few months.

Overall, Sculptra® is associated with fewer risks and side effects than Restylane® and other injectable treatments. Side effects may include tenderness, swelling, and redness at injection sites. Results of Sculptra® injections may take four to six weeks to become noticeable.

Sculptra® FAQs

The following questions include many of those asked by patients who are considering Sculptra® treatment. For answers of any further questions you have, consult with a qualified doctor in your area.

What is Sculptra® made of?

Sculptra® is synthetic and not derived from animal or human sources (such as cadaver material). The main ingredient of Sculptra® is poly-L-lactic acid (PLA), a substance that has been used for more than 30 years for medical applications such as absorbable sutures, in bone screws and plates, and as a medium for administering medication. PLA is made from lactic acid, a natural substance that is necessary for cellular metabolism. Lactic acid is already present in the human body.

Is Sculptra® treatment painful?

Some individuals find Sculptra® treatment painful while others feel no pain or discomfort whatsoever. It's an individual matter. If you are apprehensive about possible pain, ask your cosmetic surgeon or dermatologist whether lidocaine is added to the Sculptra® suspension, and whether a topical anesthetic could be used at the injection sites.

How is Sculptra® different from other injectables?

Sculptra® is different from other injectables in the following ways:

  • Its effects last for up to two years; the results of most other injectables last for a few months. 
  • Sculptra® is synthetic - not derived from human, animal, or plant sources. 
  • Sculptra® is completely biocompatible (it won't harm the body). 
  • Sculptra® is injected under the skin, rather than into the skin. 
  • Sculptra® is not placed in a "spot" injection; it is used in a pattern to evenly fill out the face in the problem area. The treated area is massaged to evenly distribute the Sculptra®. 
  • Sculptra® is supplied as a powder of microcrystals that are mixed with sterile water, unlike other fillers that are supplied in gel form. 
  • The effects of Sculptra® are not immediate; the results take weeks or months to become fully apparent. Is Sculptra® FDA-approved?

Sculptra® is FDA- approved in the United States for the treatment of human immunodeficiency virus (HIV)-associated lipodystrophy (fat loss). Sculptra® treatment for cosmetic purposes is considered "off-label" use.

When will I see results?

The true results of Sculptra® treatment take weeks or months to fully manifest themselves. A period of four to six weeks is a good estimate of how long the effects of Sculptra® treatment take to become apparent.

Is there downtime following Sculptra® treatment?

Sculptra® treatment involves minimal downtime. Patients are generally able to resume their normal daily activities as soon as their treatment is complete, though some choose to wait for any swelling or redness to fade.

How long will Sculptra® results last?

Sculptra® results are very long-lasting - up to two years or more - compared to the several months' duration of the effects of other fillers such as Restylane®, RadiesseTM, CosmoplastTM, and collagen.

Find a Cosmetic Dermatologist through DocShop

If you are suffering from lipoatrophy (facial wasting) and want to discuss Sculptra® treatments with a doctor, DocShop can help you find a qualified cosmetic dermatologist in your area. By learning more about the use of Sculptra® for facial volume enhancement, you will be taking the first step toward restoring your face to its natural fullness.

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