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Sculptra

Sculptra® has been safely used outside the United States since 1999 in over 150,000 patients under the trade names New-Fill™ and Sculptra. Sculptra® is an enduring treatment approved by the FDA for restoration and/or correction of the signs of facial fat loss, or lipoatrophy, in people with human immunodeficiency virus. It is the first FDA-approved product of its kind for this condition. 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 Q & A

What is Sculptra?

Sculptra® is an enduring treatment approved by the FDA for restoration and/or correction of the signs of facial fat loss, or lipoatrophy, in people with human immunodeficiency virus.

Sculptra is a new and unique non-invasive cosmetic dermatology option designed to restore volume of depressed areas such as skin creases, wrinkles and folds resulting from natural aging. It results in a fuller, more smoother natural-looking face with minimal touch-up treatments.

Sculptra is a synthetic injectable material known as poly-L-lactic acid. This synthetic polymer is derived from the alpha-hydroxy family (fruits acids) and is biocompatible and biodegradable.

Who makes Sculptra?

Dermik Laboratories conducts the U.S. dermatology business of sanofi-aventis U.S.

What is the background of Dermik®?

Dermik is the dermatology division of sanofi-aventis Canada Inc. part of the sanofi-aventis Group, one of the world’s leading pharmaceutical companies with over 55 years of experience in the development, marketing and distribution of prescription pharmaceutical products. Backed by a world-class research and development organization, sanofi-aventis is developing leading positions in 7 major therapeutic areas. Sanofi-Aventis Canada Inc. is headquartered in Laval, Quebec.

What are the benefits of Sculptra?

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.

What is the clinical experience behind Sculptra?

Sculptra® has been safely used outside the United States since 1999 in over 150,000 patients under the trade names New-Fill™ and Sculptra.

What does Sculptra treatment involve?

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.

Unlike other products that use fillers to temporarily correct skin imperfections, Sculptra naturally stimulates the body to produce its own collagen, resulting in a more natural-looking, youthful appearance that can last up to 2 years.1

Sculptra is injected into the dermis of the skin in the area of fat and volume loss. Sculptra helps lift, smooth and firm-up your skin gradually because it stimulates the production of your own collagen*. Visible results appear naturally and progressively after each treatment session. While Sculptra will not correct the underlying cause of the facial fat loss, it will help improve the appearance by increasing skin firmness in the treated area.

Are the results of Sculptra seen immediately?

No, Sculptra works progressively by naturally stimulating the body to produce its own collagen*, thereby firming-up the skin and creating long-lasting results. An assessment must be made after 4 to 6 weeks to determine if more treatments are needed.

How many treatments are required?

Generally, 3 treatment sessions over a 3-to 4-month period may be necessary to obtain the desired results.

How much does a Sculptra treatment cost?

Cost will depend on your age, level of skin damage and desired treatment areas. A complete treatment will typically cost $2,000 for localized treatment (e.g., for nasolabial folds) and $5,000 for global volumetric treatment (e.g., all areas where Sculptra can be injected). Various cosmetic procedures may be considered medical expenses if they are done by a licensed medical professional. Talk to your tax consultant to find out if your treatment can be tax deductible.

How long does Sculptra treatment effect 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. Dermik® is studying the long-term effects beyond two years.

Your health care provider will decide with you the number of treatment sessions and the amount of SCULPTRA you will need at each treatment session. Patients with severe facial fat loss may require three to six treatment sessions. Touch-up treatments may be needed to maintain the desired effect. Your health care provider will see you two or more weeks after each treatment to assess whether you need additional treatments.

Does Sculptra treatment hurt?

As with any injection, injections with SCULPTRA may hurt. SCULPTRA is injected in small amounts using a very fine needle. Your health care provider may apply a topical or local anesthetic.

Is there any downtime with Sculptra?

Most patients feel comfortable going back to their normal activities following treatment.

Are there any risks with Sculptra?

Immediately following a treatment session with SCULPTRA, redness, swelling, pain, bruising or all of these signs can happen in the treatment area. These signs usually go away in a few hours to a few days. Some have been known to last up to 17 days. Your health care provider will give you specific post-treatment care instructions. You should massage the treated area (a few times each day) for several days after the treatment session. Within the first 24 hours after treatment, an ice pack should be applied for a few minutes at a time to the treatment area to help reduce swelling. Wrap the ice in a cloth and avoid putting ice directly on your skin. Avoid excessive sun and UV lamp exposure until any initial swelling and redness has resolved.

Report any worsening or longer-lasting symptoms or signs to your health care provider.

Are there any side effects with Sculptra?

The most common side effects with the use of SCULPTRA include injection-related side effects at the site of the injection, such as bleeding, tenderness or pain, redness, bruising, or swelling. These side effects generally last, on average, 3 to 17 days.

One possible delayed side effect with SCULPTRA can be small bumps under the skin in the treated area. These small bumps may not be visible, and you may notice them only when you press on the treated skin. These bumps tend to happen within the first six to twelve months after the first treatment. Occasionally, these bumps go away on their own. Visible bumps, sometimes with redness or color change to the treated area, have also been reported. As with all procedures that involve an injection through the skin, there is a risk of infection.

Report any side effects to your health care provider.

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