A Poly‐L‐Lactic Acid Formulation for Nasolabial Fold Correction: Handling, Tolerability and Effectiveness in a Prospective Observational Study
- 1CentroDerm Clinic Wuppertal Germany
- 2Faculty of Health University of Witten‐Herdecke Witten Germany
- 3Department of Dermatology, Venereology and Allergology Ruhr‐University Bochum Germany
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)
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BibTeX
@article{dirschka2026polyllactic,
title = {{A Poly‐L‐Lactic Acid Formulation for Nasolabial Fold Correction: Handling, Tolerability and Effectiveness in a Prospective Observational Study}},
author = {Thomas Dirschka and Marcus Kuchner and Lutz Schmitz},
journal = {Journal of cosmetic dermatology},
year = {2026},
month = nov,
doi = {10.1111/jocd.71251},
url = {https://europepmc.org/article/PMC/PMC13724798},
note = {CC BY},
}
RIS
TY - JOUR
TI - A Poly‐L‐Lactic Acid Formulation for Nasolabial Fold Correction: Handling, Tolerability and Effectiveness in a Prospective Observational Study
AU - Thomas Dirschka
AU - Marcus Kuchner
AU - Lutz Schmitz
PY - 2026
DA - 2026/11/01
JO - Journal of cosmetic dermatology
DO - 10.1111/jocd.71251
UR - https://europepmc.org/article/PMC/PMC13724798
AB - 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)
SN - 1473-2130
SN - 1473-2165
ER -