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

Journal article

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.

Authors: Porcello, A; Lourenço, K; Marques, C; Raffoul, W; Cerrano, M

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: MDPI
• Journal: Journal of Functional Biomaterials
• Volume: 17
• Issue: 5
• Pages: 254
• Publication date: 2026-05-20
• DOI: 10.3390/jfb17050254
• EISSN: 2079-4983
• ISSN: 2079-4983
• Pmid: 42188421
• Language: English
• Keywords: Gais (Global Aesthetic Improvement Scale); Skin Texture; Skin Hydration; Skin quality; Hyaluronic acid; Skin Elasticity; Polynucleotides; Cutometer; Niacinamide; Dermascan