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Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]

Single-arm study for the characterization of human tissue response to injectable poly-L-lactic acid.


PMID 23464798

Abstract

Injectable poly-L-lactic acid (PLLA) is a synthetic polymer indicated for the correction of facial wrinkles and folds. Animal studies have shown that implantation of PLLA stimulates collagen synthesis; human studies have been limited. To investigate human tissue response to injectable PLLA. In this exploratory single-arm, open-label study, 14 healthy subjects were administered injectable PLLA; punch biopsies at 3, 6, and 12xa0months were analyzed for qualitative and quantitative changes from baseline in collagen types I and III and assessed for inflammatory responses. Quantitative and qualitative increases were observed for collagen types I and III at 3 and 6xa0months and were statistically significant for collagen type I at 3 and 6xa0months. Post hoc analyses at 12xa0months showed nominal collagen increases but were hindered by technical difficulties. The degree of inflammatory response was similar to baseline at 3, 6, and 12xa0months; all subjects were found to have no or mild inflammation after baseline. Adverse events were mild and among those reported previously. Results of this study in humans found statistically significant stimulation of collagen type I with no or mild inflammatory response after administration of injectable PLLA.