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Published on: June 10, 2018
Single-arm study for the characterization of human tissue response to injectable poly-L-lactic acid
David Goldberg1, Adriana Guana, Andrea Volk
1Skin Laser and Surgery Specialists of NY/NJ, New York, New York 10016, USA. drdavidgoldberg@skinandlasers.com
Background:
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.
Objective:
To investigate human tissue response to injectable PLLA.
Methods And Materials:
In this exploratory single-arm, open-label study, 14 healthy subjects were administered injectable PLLA; punch biopsies at 3, 6, and 12 months were analyzed for qualitative and quantitative changes from baseline in collagen types I and III and assessed for inflammatory responses.
Results:
Quantitative and qualitative increases were observed for collagen types I and III at 3 and 6 months and were statistically significant for collagen type I at 3 and 6 months. Post hoc analyses at 12 months showed nominal collagen increases but were hindered by technical difficulties. The degree of inflammatory response was similar to baseline at 3, 6, and 12 months; all subjects were found to have no or mild inflammation after baseline. Adverse events were mild and among those reported previously.
Conclusion:
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.
