An Injectable Biopolymer Hydrogel Complex (PN/HA/B3) for Facial Skin Redensification and General Rejuvenation: Clinical Report on Device Safety and Efficacy.

1. J Funct Biomater. 2026 May 20;17(5):254. doi: 10.3390/jfb17050254. An Injectable Biopolymer Hydrogel Complex (PN/HA/B3) for Facial Skin Redensification and General Rejuvenation: Clinical Report on Device Safety and Efficacy. Porcello A(1), Lourenço K(1), Marques C(1), Raffoul W(2), Cerrano M(3), Applegate LA(4)(5)(6), Laurent AE(7)(8). Author information: (1)Development Department, LOUNA REGENERATIVE SA, CH-1228 Plan-les-Ouates, Switzerland. (2)Plastic and Reconstructive Surgery, Ensemble Hospitalier de la Côte, CH-1110 Morges, Switzerland. (3)Entourage Aesthetic Clinic, CH-1003 Lausanne, Switzerland. (4)Regenerative Therapy Unit, Lausanne University Hospital, University of Lausanne, CH-1066 Epalinges, Switzerland. (5)Center for Applied Biotechnology and Molecular Medicine, University of Zurich, CH-8057 Zurich, Switzerland. (6)Oxford OSCAR Suzhou Center, Oxford University, Suzhou 215123, China. (7)Manufacturing Department, LAM Biotechnologies SA, CH-1066 Epalinges, Switzerland. (8)Manufacturing Department, TEC-PHARMA SA, CH-1038 Bercher, Switzerland. This study evaluated the safety and effectiveness of HYDRAGEL A2, an injectable medical device containing hyaluronic acid (HA), polynucleotides (PN), and niacinamide, for improving facial skin quality. These ingredients are increasingly recognized for their synergistic effects in aesthetic medicine, with HA and PN providing hydration and skin support, and niacinamide offering anti-inflammatory and antioxidant properties. A prospective, open-label clinical investigation was conducted on 42 female subjects (mean age 45 ± 1 years, Fitzpatrick skin phototypes II-V) to assess skin elasticity, hydration, and mild skin depression correction following cheek area injections. Efficacy was measured using the Global Aesthetic Improvement Scale (GAIS), Antera 3D® (texture), Cutometer® (elasticity/firmness), Corneometer® (hydration), and Dermascan® (density/thickness) devices at baseline (D0), week 2 (W2/D14), and week 6 (W6/D42). GAIS values showed significant overall facial improvement (p < 0.001) by both investigators and subjects, where 100% of subjects rated their appearance as improved immediately post-injection (D0), with sustained improvements at D42. Objective measurements revealed significant improvements in skin texture (reduced roughness), elasticity, firmness, hydration (p < 0.001), density, and thickness, demonstrating the combined benefits of the HA, PN, and niacinamide blend. Injection site reactions, primarily mild and transient, were reported immediately post-injection. Investigators and subjects reported high satisfaction with the product's ease of use and aesthetic outcomes. Globally, HYDRAGEL A2, leveraging the established benefits of HA, PN, and niacinamide, was well-tolerated and effectively enhanced facial skin quality, demonstrating significant and sustained improvements in monitored skin parameters. The study concludes that this combination of ingredients, formulated in HYDRAGEL A2, provides a well-tolerated approach associated with improvements in skin quality. DOI: 10.3390/jfb17050254 PMCID: PMC13208250 PMID: 42188421 Conflict of interest statement: Authors A.P., K.L., and C.M., were employed by LOUNA REGENERATIVE SA (Plan-les-Ouates, Switzerland) during the course of this study. Author A.E.L. was employed by LAM Biotechnologies SA (Epalinges, Switzerland) and by TEC-PHARMA SA (Bercher, Switzerland) during the course of this study. While these industry-affiliated authors contributed to the initial clinical study conceptualization/design and the provision of clinical study materials, the employing companies had no role in patient recruitment, clinical data collection as well as interpretation of outcomes reported by the injectors and patients. All data are presented transparently without censorship, concealing drafting interference, or publication restrictions from the employing entities. The remaining authors declare no conflicts of interest for this study.