Sculptra for the treatment of acne scars: efficacy and safety

Sculptra (injectable poly-L-lactic acid) is approved by the United States Food and Drug Administration. It is a safe, synthetic, and biocompatible material that is injected below the surface of the skin. and it has been safely used outside the United States since 1999 in over 150,000 patients under the trade names New-Fill™ and Sculptra®.

This product is is composed of poly-L-lactic acid, a synthetic material and it is not made from human or animal sources and does not require a skin test.

Poly-L-lactic acid (PLLA) is a biocompatible (does not harm the body), biodegradable (able to be broken down by the body) material that has been widely used for many years in surgical products.

The effects are long-lasting; they were shown in a clinical study to last for up to 2 years after the first treatment session.

A new study has collect preliminary data on the efficacy and safety of injectable poly-L-lactic acid (PLLA, Sculptra, Dermik Laboratories) for the treatment of acne scars.

METHODS: Twenty subjects aged 42.4+/-10.7 years (10 men, 10 women) with facial scars resulting from moderate to severe acne or varicella participated in this single-center, open-label prospective study. The primary end point was the resolution of the acne or varicella scars. Secondary end points were the physician and subject assessments of scar improvement.

PLLA reconstituted with 5 mL of sterile water was injected serially at or near the sites of the acne scars without topical anesthesia. RESULTS: Investigator-assessed reductions in acne scar size and severity were significant (p<.0001) during the course of seven treatments.

Subject-rated reduction in scar severity was also significant (p=.0078). Subject satisfaction with treatment trended toward an increase with each treatment session and approached significance (p=.0899). Adverse events were limited to depression (n=1) not related to the treatment. CONCLUSION: Injectable PLLA as used in this investigation appears to correct the types of acne scars treated in this study without serious adverse effects.

(Source: Dermatol Surg. 2007 Dec;33 Suppl 2:S159-67.)

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