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FDA approves Sculptra Aesthetic a facial injectable “filler”

PRESS RELEASE: Sculptra Aesthetic FDA Approves Sculptra®Aesthetic, A Facial Injectable for Correction of Nasolabial Folds and other Facial Wrinkles Bridgewater, N.J., July 29, 2009 – Sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) approved Sculptra®Aesthetic (injectable poly-L-lactic acid) 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 patients. Sculptra®Aesthetic works gradually to offer natural-looking results that can last up to two years. “We are excited by the FDA approval of Sculptra®Aesthetic because it changes the landscape of what physicians can offer patients seeking natural and gradual looking results from an aesthetic injectable that is long-lasting,” said Doris Day, M.D., Clinical Assistant Professor of Dermatology at New York University and in private practice in New York City. “Sculptra®Aesthetic allows for a natural correction.” The FDA approval of Sculptra®Aesthetic is based on results from a randomized, comparative, evaluator-blinded, parallel group, multi-center study of 233 patients. Patients received Sculptra®Aesthetic or an approved human derived collagen for the treatment of their nasolabial fold wrinkles. Sculptra®Aesthetic was administered in a single treatment regimen, at three week intervals, for up to 4 treatment sessions for the correction of shallow to deep nasolabial fold contour deficiencies using a deep dermal grid pattern (cross-hatch) injection technique. The Sculptra®Aesthetic patients were followed for an additional 12 months. Sculptra®Aesthetic treatment effects were maintained up to 25 months after the last treatment session, while the human derived collagen was effective up to 3 months. “Sculptra®Aesthetic showed effective correction of the nasolabial folds, which are considered to be the hallmark signs of facial aging,” said Paul Chew, M.D., Chief Science Officer/Chief Medical Officer, sanofi-aventis U.S. No serious adverse events were reported in this study for either treatment. Commonly occurring short-term injection site reactions were bleeding, tenderness or pain/discomfort, redness, bruising, itching or swelling and were reported in both treatment groups. Other adverse events reported during the 25 month trial included small bumps and lumps, some with a delayed onset and were mild or moderate in intensity. Most side effects resolved on their own; one small lump required treatment by the healthcare provider For more information, please visit www.SculptraAesthetic.com

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About the Author

Dima Ali, M.D. is an internationally recognized Aesthetic and Anti-Aging Medicine expert. Her areas of expertise include aesthetic laser surgery, minimally invasive face lifts, lipofilling, botox, soft tissue fillers, chemical peels, sclerotherapy, mesotherapy/lipo-dissolve and bio-identical hormone replacement therapy. Dr. Ali received her undergraduate degree at Southern Methodist University in Dallas, TX. After receiving her Doctorate of Medicine and completing a general residency training at The George Washington University School of Medicine, Dr. Ali devoted all of her postgraduate work on her passion of Cosmetic Dermatology, Cutaneous Laser Surgery, Anti-Aging Medicine and cosmetic formulations. “Dr. Dima,” as her patients and colleagues affectionately call her, founded one of the East Coasts first medical spas, WellMedica Aesthetic & Anti-Aging Medicine in Reston, VA.

Dr. Dima’s Cosminology (clinical skincare & clinical mineral make up) was created by Dr. Dima Ali, and inspired by her personal sensitivity to harsh, over the counter and prescription strength topical treatments. As a long-time acne sufferer with a propensity for hyperpigmentation, Dr. Dima began to combine varying strengths of potent, rejuvenating ingredients with natural, anti-inflammatory botanical extracts and essential oils to treat her own skin conditions and those of her patients.

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