Sanofi-aventis has received FDA approval for Sculptra Aesthetic (injectable poly-L-lactic acid), for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles.
Reportedly, the FDA approval is based on results from a randomized, comparative, evaluator-blinded, parallel group, multi-center study of 233 patients. These 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 four treatment sessions. It was done for the correction of shallow to deep nasolabial fold contour deficiencies using a deep dermal grid pattern (cross-hatch) injection technique.
Moreover, Sculptra Aesthetic patients were followed for an additional 12 months. The treatment effects were maintained up to 25 months after the last treatment session, while the human derived collagen was effective up to three months.
Doris Day, clinical assistant professor of Dermatology at New York University, said: 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, Sculptra Aesthetic allows for a natural correction.