A Poly‐L‐Lactic Acid Formulation for Nasolabial Fold Correction: Handling, Tolerability and Effectiveness in a Prospective Observational Study

ABSTRACT Background Poly‐L‐lactic acid (PLLA) is a biostimulator used for nasolabial fold (NLF) correction. This study evaluated product handling, tolerability, and aesthetic outcomes. Objectives To assess handling and applicability of a PLLA formulation, tolerability, and pre‐specified effectiveness end points for NLF correction. Methods This prospective, open‐label, uncontrolled, single‐center observational study included adults with moderate‐to‐very severe NLFs receiving up to three treatment sessions, with follow‐up at 4, 12, and 26 weeks after the last injection. Handling was assessed using a 12‐item questionnaire. Effectiveness was assessed using MAS‐NLF, IGAIS, and SGAIS. Results Of 35 screened individuals, 33 were treated and 21 (63.6%) were assessed at Week 26. Handling was rated favorably. Four participants (12.1%) experienced adverse events, including treatment‐related slight bilateral swelling in two (6.1%). No serious adverse events, device deficiencies, papules, nodules or granulomas were documented through Week 26. At Week 26, improvement of at least one MAS‐NLF grade was recorded in 4/21 participants (19.0%), IGAIS of at least “improved” in 14/21 (66.7%) and SGAIS in 11/21 (52.4%). Conclusions Handling was rated favorably under the conditions studied, and descriptive improvements in NLF severity and global aesthetic ratings were observed. The uncontrolled design, sample size, and follow‐up limit conclusions regarding treatment‐specific effectiveness and uncommon or delayed adverse events. Trial Registration German Clinical Trials Register (DRKS00032634; registered 6 September 2023)