BRIDGEWATER, N.J., Oct. 30 /PRNewswire/ -- Dermik Laboratories, the dermatology business of sanofi-aventis U.S. LLC, announced today that results from a pivotal trial show that Sculptra(R) (injectable poly-L-lactic acid) demonstrated significantly greater improvement and longer-lasting effects compared to CosmoPlast(TM)(1) Collagen Implant, human-based collagen, in the treatment of nasolabial fold wrinkles. Sculptra belongs to a unique class of injectables that work to stimulate a progressive increase in dermal thickness. Sculptra is currently under investigation for the treatment of nasolabial fold wrinkles. These data were presented at the 2006 American Society of Dermatologic Surgery (ASDS) Annual Meeting in Palm Springs, CA.
Sculptra(R) demonstrated consistent, progressive and significant improvements over baseline using wrinkle assessment scores beginning three weeks after last treatment and continuing through 13 months of follow-up. Forty-nine percent (49%) of the Sculptra(R) patients had wrinkle assessment scores that were less than 2 (no wrinkle or just barely perceptible wrinkle) at the 13-month post-treatment compared to four percent of the CosmoPlast(TM) subjects. The Sculptra(R) treatment effect was maintained for up to 13 months whereas the CosmoPlast(TM) treatment outcome was maintained for three months.
The study was a randomized, evaluator-blinded, parallel group, multi-center study of 233 patients who sought correction of nasolabial fold wrinkles. Eligible patients received between one and four treatment sessions of either Sculptra(R) or collagen at three-week intervals, until optimal cosmetic correction was achieved. Follow-up visits were scheduled at three weeks and at three, six, nine and 13 months after the last treatment session. "The 13-month duration seen with Sculptra(R) was significantly longer than Cosmoplast(TM)," said William Philip Werschler, M.D., Assistant Clinical Professor of Medicine/Dermatology at the University of Washington School of Medicine in Seattle and study investigator. "These data build on what is already known about the effect of Sculptra(R) for its approved use."
In the trial, both treatments had acceptable safety profiles. There were no serious product-related adverse events (AE's) and the majority of AE's were characterized as mild to moderate in intensity.
The most common adverse events for Sculptra(R) were localized injection- site events. A significantly higher incidence (p<0.05) of overall product related AEs and administrative site condition events was observed in the CosmoPlast(TM) group when compared to the Sculptra(R) group. This was attributed to a greater incidence of product related injection site erythema in the CosmoPlast(TM) group (26.5%) compared to the Sculptra group (2.6%). Additionally, higher rates of product related injection site pruritus were observed with CosmoPlast(TM) compared to Sculptra(R) (7.7% vs. 0.9%; p<0.05). Product related papules that are confined to the injection site and are defined as palpable elevations less than 5 mm in diameter, were reported more frequently in the Sculptra(R) group (8.6%) compared with the CosmoPlast(TM) group (3.4%). Rates of product related application site nodules (greater than or equal to 5 mm in diameter) were comparable between the CosmoPlast(TM) group (6.0%) and the Sculptra(R) group (6.9%).
Sculptra(R) is a synthetic, biocompatible, bioabsorbable material that is naturally broken down by the body over time. It was approved in the U.S. in 2004 for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. It should not be used in anyone who is allergic to any ingredient of Sculptra(R). Sculptra(R) should not be injected if there is an active skin infection or inflammation in the treatment area. Side effects of Sculptra(R) may include the delayed formation of small papules under the skin in the treated area. Generally these papules are not visible and may only be noticed when pressing on the treated area. Other side effects may include injection-related events at the site of injection, such as bleeding, tenderness or discomfort, redness, bruising or swelling.
About Dermik Laboratories
Dermik, the dermatology business of sanofi-aventis U.S. LLC, has pioneered the development of new pharmaceutical products for skin and nails for nearly 60 years. With a strong commitment to dermatology, Dermik continues to expand its support of cutting-edge research.
Sanofi-aventis is the world's third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE:SNY)
(1) CosmoPlast is a trademark of INAMED Corporation.
Contact: Terri Pedone, 908-243-6578, Terri.Pedone@sanofi-aventis.com
Source: Dermik Laboratories
CONTACT: Terri Pedone, +1-908-243-6578, Terri.Pedone@sanofi-aventis.com,
for Dermik Laboratories