Sculptra® Aesthetic Customer Communications Fact Sheet
- Sculptra®Aesthetic (injectable poly-L-lactic acid) was approved by the U.S. Food and Drug Administration as a treatment indicated for the correction of shallow to deep nasolabial fold (smile lines) contour deficiencies and other facial wrinkles which are treated with the appropriate injection technique in healthy people.
- SculptraAesthetic is the only facial injectable that works gradually with results that can last up to two years.
- SculptraAesthetic works gradually, resulting in a more youthful looking appearance without making it look like you’ve had work done.
- As we age, facial wrinkles and folds begin to show in part because collagen beneath the skin’s surface starts to break down. SculptraAesthetic helps to replace lost collagen.
- Results from a recent study conducted by the American Society for Dermatologic Surgery (ASDS) and sanofi-aventis U.S. showed that both injectable users and women considering a medical anti-aging treatment prefer gradual results that last two years (75 percent) as opposed to immediate results that last one year (25 percent).
- A treatment regimen of SculptraAesthetic requires an average of three injection sessions over a few months.
- SculptraAesthetic is made from poly-L-lactic acid, which has been safely used for the past 25 years in resorbable stitches. It is biocompatible (a material that does not harm the body) and biodegradable (able to be broken down by the body).
- Injectable poly-L-lactic acid has also been widely used in Europe for close to a decade for cosmetic treatment.
Safe and Well-tolerated
In the pivotal clinical trial, SculptraAesthetic (injectable poly-L-lactic acid) demonstrated a comparable safety profile to CosmoPlast® (human collagen). As with most injections, commonly occurring short-term injection site reactions were bleeding, tenderness or pain/discomfort, redness, bruising and/or swelling and were reported in both treatment groups. Other adverse events included bumps and lumps which were mild or moderate in intensity. The majority of these adverse events resolved without treatment.
No patients discontinued treatment with SculptraAesthetic due to an adverse event.
Important Safety Information:
You should not use Sculptra Aesthetic if you are allergic to any ingredient of the product or have a history of keloid formation or hypertrophic scarring. Sculptra Aesthetic should not be injected while you have an active skin infection or inflammation in the treatment area and should not be injected into the red area of the lip. Use in the skin near the eyes is not recommended.
Side effects of Sculptra Aesthetic may include injection site discomfort, redness, bruising, bleeding, itching and swelling. Other side effects may include small lumps under the skin that are sometimes noticeable when pressing on the treated area. Larger lumps, some with delayed onset with or without inflammation or skin discoloration, have also been reported. In a key clinical study the numbers of small and larger lumps were low and most resolved without treatment.
Please see full prescribing information at www.SculptraAesthetic.com