An Injectable Biopolymer Hydrogel Complex (PN/HA/B3) for Facial Skin Redensification and General Rejuvenation: Clinical Report on Device Safety and Efficacy
Source abstract
Abstract
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.
Source: crossref · Quality: baseline
Research context
OpenAlex topics: Facial Rejuvenation and Surgery Techniques · Dermatologic Treatments and Research · Botulinum Toxin and Related Neurological Disorders
SciVX discovery tags are terminology-based. OpenAlex topics are source-provided classifications.
Affiliations
Development Department, LOUNA REGENERATIVE SA, CH-1228 Plan-les-Ouates, Switzerland
Plastic and Reconstructive Surgery, Ensemble Hospitalier de la Côte, CH-1110 Morges, Switzerland
Entourage Aesthetic Clinic, CH-1003 Lausanne, Switzerland
Regenerative Therapy Unit, Lausanne University Hospital, University of Lausanne, CH-1066 Epalinges, Switzerland
Center for Applied Biotechnology and Molecular Medicine, University of Zurich, CH-8057 Zurich, Switzerland
Oxford OSCAR Suzhou Center, Oxford University, Suzhou 215123, China
Manufacturing Department, LAM Biotechnologies SA, CH-1066 Epalinges, Switzerland
Manufacturing Department, TEC-PHARMA SA, CH-1038 Bercher, Switzerland
References (59)
Show source-provided references
1. Characteristics of the aging skin10.1089/wound.2011.0356 ↗
2. Advanced glycation end products: Key players in skin aging?10.4161/derm.22028 ↗
3. IsHak, W.W. (2020). The Role of Aesthetics in Wellness. The Handbook of Wellness Medicine, Cambridge University Press.10.1017/9781108650182 ↗
4. Dermatology: How to manage facial hyperpigmentation in skin of colour10.7573/dic.2021-11-2 ↗
5. The skin barrier and moisturization: Function, disruption, and mechanisms of repair10.1159/000534136 ↗
6. Age-related evolutions of the dermis: Clinical signs, fibroblast and extracellular matrix dynamics10.1016/j.mad.2018.03.006 ↗
7. Chen, D., Yin, S., Lu, X., Fu, H., Gao, H., and Zhang, S. (2024). Research on the Correlation Between Skin Elasticity Evaluation Parameters and Age. Cosmetics, 11.10.3390/cosmetics11060205 ↗
8. Skin ageing and topical rejuvenation strategies10.1093/bjd/ljad282 ↗
9. Facial Rejuvenation: A Global Trend of Dermatological Procedures in the Last Decade10.1097/GOX.0000000000005801 ↗
10. Benefits of topical hyaluronic acid for skin quality and signs of skin aging: From literature review to clinical evidence10.1111/dth.15903 ↗
11. The Effectiveness of Injectable Hyaluronic Acid in the Improvement of the Facial Skin Quality: A Systematic Review10.2147/CCID.S404248 ↗
12. Evaluation of Safety and Efficacy of Booster Injections of Hyaluronic Acid in Improving the Facial Skin Quality10.1111/jocd.13493 ↗
13. Injectable “Skin Boosters” in Aging Skin Rejuvenation: A Current Overview10.1055/a-2366-3436 ↗
14. Injectable non-animal stabilized hyaluronic acid as a skin quality booster: An expert panel consensus
15. The Effect of Local Hyaluronic Acid Injection on Skin Aging: A Systematic Review and Meta-Analysis10.1111/jocd.16760 ↗
16. Skin health and biological aging10.1038/s43587-025-00901-6 ↗
17. Žádníková, P., Šínová, R., Pavlík, V., Šimek, M., Šafránková, B., Hermannová, M., Nešporová, K., and Velebný, V. (2022). The degradation of hyaluronan in the skin. Biomolecules, 12.10.3390/biom12020251 ↗
18. Siquier-Dameto, G., Boadas-Vaello, P., and Verdú, E. (2024). Intradermal treatment with a hyaluronic acid complex supplemented with amino acids and antioxidant vitamins improves cutaneous hydration and viscoelasticity in healthy subjects. Antioxidants, 13.10.3390/antiox13070770 ↗
19. Clinical efficacy and safety of non-cross-linked hyaluronic acid combined with l-carnosine for horizontal neck wrinkles treatment10.1007/s00266-021-02307-2 ↗
20. Lee, K.W.A., Chan, K.W.L., Lee, A., Lee, C.H., Wan, J., Wong, S., and Yi, K.H. (2024). Polynucleotides in Aesthetic Medicine: A Review of Current Practices and Perceived Effectiveness. Int. J. Mol. Sci., 25.10.3390/ijms25158224 ↗
21. Hsin, S., Lourenço, K., Porcello, A., Chemali, M., Marques, C., Raffoul, W., Cerrano, M., Applegate, L.A., and Laurent, A.E. (2025). Clinical Safety and Efficacy of Hyaluronic Acid–Niacinamide–Tranexamic Acid Injectable Hydrogel for Multifactorial Facial Skin Quality Enhancement with Dark Skin Lightening. Gels, 11.10.3390/gels11070495 ↗
22. Marques, C., Porcello, A., Cerrano, M., Hadjab, F., Chemali, M., Lourenço, K., Hadjab, B., Raffoul, W., Applegate, L.A., and Laurent, A.E. (2025). From Polydeoxyribonucleotides (PDRNs) to Polynucleotides (PNs): Bridging the Gap Between Scientific Definitions, Molecular Insights, and Clinical Applications of Multifunctional Biomolecules. Biomolecules, 15.10.3390/biom15010148 ↗
23. Marques, C., Hadjab, F., Porcello, A., Lourenço, K., Scaletta, C., Abdel-Sayed, P., Hirt-Burri, N., Applegate, L.A., and Laurent, A. (2024). Mechanistic Insights into the Multiple Functions of Niacinamide: Therapeutic Implications and Cosmeceutical Applications in Functional Skincare Products. Antioxidants, 13.10.3390/antiox13040425 ↗
24. Evaluation of the Biological Effect of a Nicotinamide-Containing Broad-Spectrum Sunscreen on Photo-Damaged Skin10.1007/s13555-024-01298-7 ↗
25. Effects and mechanism of nicotinamide against UVA- and/or UVB-mediated DNA damages in normal melanocytes10.1111/php.12994 ↗
26. As Members of The Polynucleotides HPT™ Priming Board, Collegio Italiano delle Società Scientifiche di Medicina Estetica (Italian College of the Aesthetic Medicine Scientific Societies)—SIME, AGORÀ, SIES. Consensus Report on the Use of PN-HPT™ (Polynucleotides Highly Purified Technology) in Aesthetic Medicine10.1111/jocd.13679 ↗
27. Polydeoxyribonucleotide Exerts Opposing Effects on ERK Activity in Human Skin Keratinocytes and Fibroblasts10.3892/mmr.2023.13035 ↗
28. Chang, T.-M., Yang, T.-Y., and Huang, H.-C. (2022). Nicotinamide mononucleotide and coenzyme Q10 protects fibroblast senescence induced by particulate matter preconditioned mast cells. Int. J. Mol. Sci., 23.10.3390/ijms23147539 ↗
29. World Medical Association (2013). World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA, 310, 2191–2194.10.1001/jama.2013.281053 ↗
30. Combined and Hybrid Treatments of Hyaluronic Acid (HA) and Calcium Hydroxylapatite (CaHA): A Systematic Review of Mechanisms of Action, Aesthetic Effectiveness, Satisfaction, and Safety Profile10.1007/s00266-025-04904-x ↗
31. Hyaluronic acid basics and rheology10.1016/j.fsc.2022.03.004 ↗
32. Effects of Hyaluronic Acid on Skin at the Cellular Level: A Systematic Review10.1590/1806-9282.20250208 ↗
33. Niacinamide and Its Impact on Stratum Corneum Hydration and Structure10.1038/s41598-025-88899-0 ↗
34. Niacinamide Protects Skin Cells from Oxidative Stress Induced by Particulate Matter10.4062/biomolther.2019.061 ↗
35. Abuyousif, H.S., Porcello, A., Cerrano, M., Marques, C., Scaletta, C., Lourenço, K., Abdel-Sayed, P., Chemali, M., Raffoul, W., and Hirt-Burri, N. (2025). In vitro evaluation and clinical effects of a regenerative complex with non-cross-linked hyaluronic acid and a high-molecular-weight polynucleotide for periorbital treatment. Polymers, 17.10.3390/polym17050638 ↗
36. Porcello, A., Chemali, M., Marques, C., Scaletta, C., Lourenço, K., Abdel-Sayed, P., Raffoul, W., Hirt-Burri, N., Applegate, L.A., and Laurent, A. (2024). Dual Functionalization of Hyaluronan Dermal Fillers with Vitamin B3: Efficient Combination of Bio-Stimulation Properties with Hydrogel System Resilience Enhancement. Gels, 10.10.3390/gels10060361 ↗
37. Polydeoxyribonucleotide Exerts Therapeutic Effect by Increasing VEGF and Inhibiting Inflammatory Cytokines in Ischemic Colitis Rats10.1155/2020/2169083 ↗
38. The Effect of Polynucleotide–Hyaluronic Acid Hydrogel in the Recovery After Mechanical Skin Barrier Disruption10.1111/srt.70068 ↗
39. Comparative Evaluation of the Effectiveness of Novel Hyaluronic Acid-Polynucleotide Complex Dermal Filler10.1038/s41598-020-61952-w ↗
40. Human Skin Penetration of Hyaluronic Acid of Different Molecular Weights as Probed by Raman Spectroscopy10.1111/srt.12228 ↗
41. Efficacy and Tolerability of Profhilo® Structura Intended to Restore the Lateral Cheek Fat Compartment: An Observational Pilot Study10.1002/hsr2.1743 ↗
42. Rheologic and Physicochemical Characteristics of Hyaluronic Acid Fillers: Overview and Relationship to Product Performance10.1055/s-0041-1741560 ↗
43. Radical Scavenging Activities of Niacin-Related Compounds10.1271/bbb.66.641 ↗
44. Colangelo, M.T., Belletti, S., Guizzardi, S., and Galli, C. (2025). Polynucleotide HPT™-Based Hydrogels Exhibit Scavenging Activity Against Reactive Oxygen Species. Antioxidants, 14.10.20944/preprints202505.2207.v1 ↗
45. Hadjab, F., Antoine, S., Hamel, B., Benderdour, M., Fahmi, H., Porcello, A., Philippe, V., Martin, R., Marques, C., and Lourenço, K. (2025). Preclinical Mechanistic Evaluation of Hyaluronan/Niacinamide (Vitamin B3) Hydrogels: Toward an Enhanced Viscosupplement System with Ancillary Anti-Arthritic Attributes. Bioengineering, 12.10.3390/bioengineering12111246 ↗
46. Kuppa, S.S., Kim, H.K., Kang, J.Y., Lee, S.C., Yang, H.Y., Sankaranarayanan, J., and Seon, J.K. (2023). Polynucleotides Suppress Inflammation and Stimulate Matrix Synthesis in an In Vitro Cell-Based Osteoarthritis Model. Int. J. Mol. Sci., 24.10.3390/ijms241512282 ↗
47. Hadjab, B., Gavard Molliard, S., Bon Bétemps, J., Cerrano, M., de Boccard, F., and Finke, A. (2025). Efficacy and Safety of a Stabilized Composition of 26 mg/mL of High Molecular Weight Hyaluronic Acid for Aesthetic Applications. J. Clin. Med., 14.10.3390/jcm14176015 ↗
48. Wrinkle and roughness measurement by the Antera 3D and its application for evaluation of cosmetic products10.1111/srt.12436 ↗
49. Comparison of the Effects of Polynucleotide and Hyaluronic Acid Fillers on Periocular Rejuvenation: A Randomized, Double-Blind, Split-Face Trial10.1080/09546634.2020.1748857 ↗
50. The Effectiveness of Polynucleotides in Esthetic Medicine: A Systematic Review10.1111/jocd.16721 ↗
51. A prospective multicenter clinical trial evaluating the efficacy and safety of a hyaluronic acid-based filler with Tri-Hyal technology in the treatment of lips and the perioral area10.1111/jocd.15169 ↗
52. Dermal thickness and echogenicity using DermaScan C high frequency ultrasound: Methodology and reliability testing in people with and without primary lymphoedema10.1111/srt.12880 ↗
53. A hyaluronic acid-based micro-filler improves superficial wrinkles and skin quality: A randomized prospective controlled multicenter study10.1080/09546634.2023.2216323 ↗
54. Age-related changes in skin mechanical properties: A quantitative evaluation of 120 female subjects10.1111/j.1600-0846.2010.00486.x ↗
55. Skin hydration measurement: Comparison between devices and clinical evaluations10.5021/ad.23.103 ↗
56. Efficacy and tolerability of hybrid complexes of high- and low-molecular-weight hyaluronan intradermal injections for the treatment of skin roughness and laxity of the neck10.1155/2022/4497176 ↗
57. Postinflammatory hyperpigmentation: A review of the epidemiology, clinical features, and treatment options in skin of color
58. (2020). Clinical Investigation of Medical Devices for Human Subjects—Good Clinical Practice (Standard No. ISO 14155:2020).
59. (2011). Clinical Investigation of Medical Devices for Human Subjects—Good Clinical Practice (Standard No. ISO 14155:2011).