Poly-L-lactic acid affords safe, durable treatment

June 1, 2005

New Orleans — Poly-L-lactic acid (Sculptra, Dermik) appears to provide safe and long-lasting volume correction in patients with moderate-to-severe HIV-related facial lipoatrophy, said Graeme Moyle, M.D., at the 63rd Annual Meeting of the American Academy of Dermatology here.

New Orleans - Poly-L-lactic acid (Sculptra, Dermik) appears to provide safe and long-lasting volume correction in patients with moderate-to-severe HIV-related facial lipoatrophy, said Graeme Moyle, M.D., at the 63rd Annual Meeting of the American Academy of Dermatology here.

He reports follow-up data from a series of 27 patients seen approximately 21 to 24 months after initial treatment. The patients were originally enrolled in an open-label, single-center study at his institution where they were randomized to receive poly-L-lactic acid (PLLA) injections immediately or after a 12-week delay.

At the last recall visit, the patients overall and those individuals treated only with the series of three PLLA injections continued to maintain their original cosmetic benefits with significant increases from baseline in self-assessed facial thinness. Those changes were accompanied by persistent psychological improvements measured using the Hospital Anxiety and Depression Scale.

No serious acute or delayed adverse events were reported. Nine cases of small, palpable, subcutaneous nodules were seen at the last visit, although the lumps were not considered clinically significant as they were asymptomatic, generally not visible and had caused no patient to seek corrective treatment.

"PLLA is a biodegradable substance and so can only be viewed as a semi-permanent filler. Nevertheless, its cosmetic benefits for the treatment of HIV-associated facial lipoatrophy appear to be very durable, and other studies confirm that the volume restorative effects of PLLA in cosmetic and HIV patients persist from 30 to 40 months," Dr. Moyle says.

Optimizing results Dr. Moyle notes that many of the persons enrolled in the trial had some of the most severe facial lipoatrophy among patients being seen in the HIV clinic.

"While the study protocol restricted the number of treatments to three injections on each side of the face, the reality is that depending on the magnitude of the physical change and the level of correction sought by the patient, a series of four to six injections is usually necessary," he says.

Dr. Moyle notes that the frequency of subcutaneous papule formation in this patient series is higher than what has been reported in other studies. He attributes that phenomenon at least in part to injection of over-concentrated PLLA.

"The nurse in our HIV clinic who is currently responsible for the PLLA injections, has worked closely with the manufacturer to refine the treatment technique in order to reduce the risk of post-treatment papules. A gentle injection technique is probably important as is product dilution, and the PLLA is now being reconstituted with a larger diluent volume," he explains.

"The less concentrated solution likely distributes more readily in the deep dermal layer, and, anecdotally at least, this change in technique has been associated with fewer papules," Dr. Moyle reports.

Otherwise, the safety review revealed the injections were well-tolerated. Post-treatment bruising was relatively common (38 percent) while a few patients noted discomfort (10 percent) or erythema (10 percent). However, there were no cases of severe, acute inflammation or late development of tissue reactivity in areas distant from the injection site.

Disclosure: Dr. Moyle reports no financial interest in Dermik or PLLA.