FDA Approves Injectable Poly-L-Lactic Acid to
Correct Smile Wrinkles (Sculptra)

July 30, 2009 — The US Food and Drug Administration (FDA) has approved injectable
poly-L-lactic acid (Sculptra Aesthetic, sanofi-aventis US) for use in immune-competent
people to correct shallow to deep nasolabial fold contour deficiencies ("smile
wrinkles") and other facial wrinkles in which deep dermal grid pattern (cross-hatch)
injection technique is appropriate.

The approval was based on data from a randomized, comparative, evaluator-blinded,
parallel-group, multicenter study (n = 233) showing that use of the product yielded
greater improvements in wrinkle correction at 13 months compared with human-
derived collagen, as determined by wrinkle assessment scores.

"Sculptra Aesthetic showed effective correction of the nasolabial folds, which are
considered to be the hallmark signs of facial aging," said Paul Chew, MD, chief science
officer/chief medical officer, sanofi-aventis US, in a company news release.
During the extension-phase study, patients initially treated with injectable poly-L-
lactic acid continued to demonstrate gradual improvements in wrinkle assessment
scores; benefits were maintained for up to 25 months after completion of therapy
compared with 3 months for patients treated with human-derived collagen.
Injectable poly-L-lactic acid is administered as a single treatment regimen of up to 4
sessions at 3-week intervals. It should not be used in patients with hypersensitivity
to product components or in those with known history of or susceptibility to keloid
formation or hypertrophic scarring.

Because poly-L-lactic acid is not a true filler, but relies on neocollagenesis to achieve
clinical improvement, the clinical results from this agent are less predictable than the
true dermal fillers. Patients should be properly educated that results take 4-6 weeks
to be appreciated. Dermal nodules have been reported after treatment and often
take 7 months or much longer to develop.  When treating the face, these nodules can
often be felt, but not seen.  Use of this product on the hands reveals an incidence of
nodules of 10%, and the nodules are often visible.

Commonly reported short-term injection site reactions included bleeding, tenderness
or pain/discomfort, erythema, bruising, pruritis, or inflammation.

Injectable poly-L-lactic acid previously was approved by the FDA for the restoration
and/or correction of lipoatrophy in patients with HIV-1 infection.
Aesthetic Medicine Today