Poly-L-Lactic Acid for Nasolabial Folds

Injectable poly-L-lactic acid (Sculptra) is a filler that volumizes by stimulating fibrous capsule formation around individual particles over several months. In an industry-sponsored, multicenter, randomized, evaluator-blinded, parallel-group study, 233 subjects with mild to deep nasolabial folds were randomized to receive a series of human collagen (CosmoPlast) or Sculptra injections at 3-week intervals until optimal correction was achieved (up to 4 sessions). All patients were followed for 13 months after the last injection, and the Sculptra patients were followed for an additional year. An independent panel of blinded evaluators examined randomly presented photographs and scored each nasolabial fold on a 6-point wrinkle assessment scale.

The mean number of treatment sessions required for optimal correction was 3.2 in the Sculptra group and 2.6 in the CosmoPlast group. The mean time from first injection to peak correction was 6.5 months in the Sculptra group and 3.5 months in the CosmoPlast group. All correction was lost by 3 months after the last injection in the CosmoPlast group, while a correction of about 75% persisted throughout the 25-month follow-up period in the Sculptra group. Temporary injection site adverse effects were seen in 34% of CosmoPlast recipients and 21% of Sculptra subjects. Injection site papules lasting more than 1 month were seen in 4.3% of the Sculptra recipients and 0.9% of the CosmoPlast recipients. Nodules enduring more than 1 month were seen in 6.6% of Sculptra recipients and in 5.1% of CosmoPlast recipients. No granulomas were reported in any patient. During the second year of follow-up of the Sculptra group, 0.9% had nodules, 1.9% had papules, and 1.9% had injection site pain. These complications resolved without treatment, except in one patient who required a corticosteroid injection into a nodule, with subsequent resolution.