Efficacy of Pegylated Hyaluronic Acid Filler Enriched with Calcium Hydroxyapatite: A 24-Week Post-Market, Observational, Prospective, Open-Label, Single-Center Study

Author:

Zerbinati Nicola1,D’Este Edoardo2,De Silvestri Annalisa3ORCID,Zullino Marco4,Rabbiosi Giulio2,Guida Stefania56,Kubik Paweł7,Stabile Giorgio56,Mocchi Roberto8,Barlusconi Chiara9,Sommatis Sabrina7,Cipolla Giovanna2

Affiliation:

1. Dermatologic Unit, Department of Medicine and Surgery, University of Insubria, 21100 Varese, Italy

2. Dermatologic Unit, Centro Medico Polispecialistico, 27100 Pavia, Italy

3. Unit of Clinic Epidemiology and Biometric Scientific Direction, Foundation IRCCS Policlinic San Matteo, 27100 Pavia, Italy

4. Department of Mathematics and Applications, University of Milan Bicocca, 20125 Milano, Italy

5. Meidicine and Surgery Department, Università Vita-Salute San Raffaele, 20132 Milan, Italy

6. Dermatology Clinic, IRCCS San Raffaele Scientific Institute, 20158 Milan, Italy

7. Centrum Medyczne dr Kubik, Skwer Kościuszki 15/17, 81-370 Gdynia, Poland

8. UB-CARE S.r.l.-Spin-Off, University of Pavia, 27100 Pavia, Italy

9. Department of Biomedical Sciences and Human Oncology, Section of Dermatology, University of Bari, 70121 Bari, Italy

Abstract

Recently, thanks to the greater discovery of the mechanisms of facial aging, an alternative to invasive plastic surgery has found space with less invasive aesthetic procedures, also based on an increasingly pressing request. We are specifically referring to dermal filler injection into or under the skin which leads to immediate rejuvenation and aesthetic improvements. In this study, we wanted to analyze the results obtained through the use of NEAUVIA Organic Stimulate, particularly with regard to its effectiveness, which is a cross-linked polymeric hydrogel, containing stabilized sodium hyaluronate 26 mg/mL and calcium hydroxyapatite (1%), glycine and L-proline in buffer pyrogen-free water, in its main indication, namely, the temporary correction of congenital and acquired deficiencies of the soft tissues of the face by intradermal injection. Initially, 70 patients were enrolled, but 10 did not complete the study due to non-observance of the investigation rules, so they were excluded from the protocol. The collected data demonstrate an efficient mechanical effect of the pegylated polymeric acid matrix enriched with low concertation of calcium hydroxyapatite and in accordance with other evidence in vitro and in vivo, and the mechanical support of the interstitial connective space improves the homestays of the anatomical layer rebalancing the physiological activity of the dermis cells.

Publisher

MDPI AG

Subject

Biomedical Engineering,Biomaterials

Reference36 articles.

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3. Dermal fillers in aesthetics: An overview of adverse events and treatment approaches;Funt;Clin. Cosmet. Investig. Dermatol.,2013

4. Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: A 24 month study;Callan;Clin. Cosmet. Investig. Dermatol.,2013

5. A new hyaluronic acid polymer in the augmentation & restoration of labia majora;Zerbinati;J. Biol. Regul. Homeost. Agents,2017

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