Study Showed Sculptra(R) Aesthetic Effectively Corrects Nasolabial Folds and Other Facial Wrinkles

BRIDGEWATER, N.J., Feb. 23 /PRNewswire-FirstCall/ -- Results published in today's online issue of the Journal of American Academy of Dermatology showed that treatment with Sculptra®Aesthetic (injectable poly-L-lactic acid) was significantly more effective than a human-derived collagen treatment CosmoPlast®* in correcting shallow to deep nasolabial fold (NLF) wrinkles (smile lines). In addition, this study demonstrated that the effect in correcting the NLF wrinkles with SculptraAesthetic can last for up to 25 months.

A total of 233 patients of ages ranging from 26 to 73 years were randomized to receive injections of either SculptraAesthetic (n=116) or CosmoPlast (n=117) (standard of care at study initiation) into the left and right nasolabial folds at three-week intervals for up to a maximum of four treatments and followed for 13 months after the final treatment. Treatment with SculptraAesthetic resulted in significantly (P<0.001) higher scores than CosmoPlast on the Wrinkle Assessment Scale, a validated photographic measurement tool which is used to assess the NLF wrinkles at week three, and months three, six, nine and 13 during the follow up phase of the study. The SculptraAesthetic patients were followed for an additional 12 months. SculptraAesthetic treatment effects were maintained up to 25 months after the last treatment session, while the human derived collagen was effective up to three months.

"This study established that SculptraAesthetic offers significant improvements in correcting nasolabial folds, which are considered one of the signs of facial aging," said Dr. Gary Monheit, Associate Clinical Professor, Department of Dermatology, University of Alabama Medical Center, "We found that the treatment works gradually to replace lost collagen due to aging, resulting in a more natural-looking appearance that can last up to two years."

The majority of adverse events in both groups were mild or moderate in intensity; these included injection site reactions such as bleeding, tenderness or pain/discomfort, redness, bruising, itching or swelling. During the initial 13 month follow up, product-related application site nodules occurred in 8.6 percent of patients treated with SculptraAesthetic and 9.4 percent of those patients receiving CosmoPlast; papules occurred in 8.6 percent of patients in the SculptraAesthetic group versus 3.4 percent of patients treated with CosmoPlast.

In addition, after 25 months papules and nodules were reported in Sculptra Aesthetic treatment group in 1.9% and 0.9% of patients, respectively. Papules and nodules were typically palpable, asymptomatic and non-visible.  The majority of nodule and papule events were mild to moderate and most resolved without treatment. Overall, a higher incidence of adverse events was recorded among patients in the collagen group (63.2 percent) compared with patients treated with SculptraAesthetic (53.4 percent). No patient discontinued treatment with SculptraAesthetic due to a treatment-related adverse event.

Study Design

In the randomized, comparative, evaluator-blinded, parallel group, multi-center study, 233 patients received either SculptraAesthetic or an approved human derived collagen for the treatment of their nasolabial fold wrinkles. SculptraAesthetic was administered in a single treatment regimen, at three week intervals, for up to four treatment sessions for the correction of shallow to deep nasolabial fold contour deficiencies. The SculptraAesthetic patients were followed for an additional 12 months. In the comparative phase, the patients were followed for 13 months after the last treatment.

The study reports on the results of the primary efficacy and safety objectives. The primary efficacy objective evaluated the degree of correction of the nasolabial fold wrinkles attained by SculptraAesthetic compared with CosmoPlast based on Wrinkle Assessment Scale scores. Assessments were calculated at screening, three weeks after treatment and at three, six, nine and 13 months post-treatment. The primary safety endpoint was the overall incidence of adverse events reported during the 13-month follow-up period after treatment.

The study's secondary objectives included global investigator and subject evaluations of treatment, patient treatment satisfaction scores, time to peak correction and treatment success rates.

Following the comparative treatment phase of the trial, patients treated with SculptraAesthetic were evaluated for an additional 12 months during a long-term surveillance phase to collect further safety and efficacy data. These patients were scheduled to return for follow-up visits 19 and 25 months after their final treatment during the study.

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.

About Sculptra® Aesthetic

SculptraAesthetic was approved by the U.S. Food and Drug Administration July 28, 2009 for use in people with healthy immune systems as one-time treatment regimen of up to 4 injection sessions that are scheduled about 3 weeks apart for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate. Sculptra Aesthetic may provide cosmetic correction of facial wrinkles with a Wrinkle Assessment Score of 2, 3, or 4 as shown in the photos in Figure 1 of the full prescribing information for Sculptra Aesthetic.

For more information, including full Prescribing Information, please visit http://www.sculptraaesthetic.com or www.sanofi-aventis.us.

About sanofi-aventis

Sanofi-aventis U.S. is an affiliate of sanofi-aventis, a leading global pharmaceutical company, that discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York (NYSE: SNY). For more information, visit: www.sanofi-aventis.us or www.sanofi-aventis.com.

*Cosmoplast® is a registered trademark used for Injectable Bioengineered Human Collagen Implant Sold and Distributed Only To Licensed Physicians and owned by Allergan, Inc., Inamed Corporation.

US.POL.09.09.015

SOURCE sanofi-aventis