Clinical, cosmetic and investigational dermatology · 2026
Post-Market Observational Study of Injectable PLLA Microspheres for Facial Rejuvenation.
СтатьяНазвание и аннотация: Перевод в очереди
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Bertossi Dario, Camporese Alessandra, Kefalas Nicola, Massidda Enrico, Papagni Marco Francesco, Patalano Ii Mariagrazia, Quartucci Sandro, Renga Monica M R, Santorelli Adriano, Sciuto Chantal, Trocchi Gloria
Аннотация
PURPOSE: Facial aging and dermal conditions may negatively influence the quality of life, leading patients to seek aesthetic procedures to restore a more satisfying appearance. This post-market observational study investigates the efficacy and safety of PLLA microspheres (PLLA-LASYNPRO™) in patients affected by chrono-and photoaging and other facial skin conditions.
PATIENTS AND METHODS: Ninety-five adult patients affected by chronoaging, photoaging and skin conditions such as oily and acne-prone skin, rosacea, or scarring, were treated with PLLA-based injectable). The patients assessed treatment outcomes through a questionnaire during the sessions and after the end of the treatment. 2D and 3D images were taken for documentation. Physicians assessed the treatment efficacy through the Global Aesthetic Improvement Scale (GAIS) between sessions and at the 6 months follow-up. Adverse events (AEs) were evaluated immediately after the procedure and after 6 months.
RESULTS: All treated patients demonstrated visible improvement in facial appearance, with 100% showing GAIS enhancement as assessed by physicians and strong concordance from patient self-evaluations, where satisfaction was reported by 94.7% of respondents, although only 56 patients returned the follow-up questionnaire. Improvements were already present after the first session in 60% of the participants, noted in skin texture, firmness, and elasticity, with progressive enhancement over time. Only mild, transient AEs were reported, such as short-term swelling or localized discomfort, all resolving spontaneously without complications or nodular formation.
CONCLUSION: PLLA-LASYNPRO™ proved to be a safe, effective, and well-tolerated injectable bio-regenerator. The treatment achieved high levels of patient satisfaction and compliance, producing natural, gradual, and sustained aesthetic improvements in skin quality and facial contour, particularly in the middle and lower face.
PATIENTS AND METHODS: Ninety-five adult patients affected by chronoaging, photoaging and skin conditions such as oily and acne-prone skin, rosacea, or scarring, were treated with PLLA-based injectable). The patients assessed treatment outcomes through a questionnaire during the sessions and after the end of the treatment. 2D and 3D images were taken for documentation. Physicians assessed the treatment efficacy through the Global Aesthetic Improvement Scale (GAIS) between sessions and at the 6 months follow-up. Adverse events (AEs) were evaluated immediately after the procedure and after 6 months.
RESULTS: All treated patients demonstrated visible improvement in facial appearance, with 100% showing GAIS enhancement as assessed by physicians and strong concordance from patient self-evaluations, where satisfaction was reported by 94.7% of respondents, although only 56 patients returned the follow-up questionnaire. Improvements were already present after the first session in 60% of the participants, noted in skin texture, firmness, and elasticity, with progressive enhancement over time. Only mild, transient AEs were reported, such as short-term swelling or localized discomfort, all resolving spontaneously without complications or nodular formation.
CONCLUSION: PLLA-LASYNPRO™ proved to be a safe, effective, and well-tolerated injectable bio-regenerator. The treatment achieved high levels of patient satisfaction and compliance, producing natural, gradual, and sustained aesthetic improvements in skin quality and facial contour, particularly in the middle and lower face.