A Comparative Study to Evaluate the Effectiveness between Synergic Activities of 0.1% Polyhexanide and Rigenase® (Fitostimoline® Plus spray) versus a Hydrating Formulation for the Topical Management of Rubbing Injuries Secondary to Atopic Dermatitis

A Comparative Study to Evaluate the Effectiveness between Synergic Activities of 0.1% Polyhexanide and Rigenase® (Fitostimoline® Plus spray) versus a Hydrating Formulation for the Topical Management of Rubbing Injuries Secondary to Atopic Dermatitis

Authors

  • Eugenia Veronica Di Brizzi Dermatology Unit, University of Campania "L. Vanvitelli"
  • Anna Balato Dermatology Unit, University of Campania, Naples, Italy
  • Stefano Caccavale Dermatology Unit, University of Campania, Naples, Italy
  • Amalia Lupoli Dermatology Unit, University of Campania, Naples, Italy
  • Carlo Panetti Dermatology Unit, University of Campania, Naples, Italy
  • Giuseppe Argenziano Dermatology Unit, University of Campania, Naples, Italy

Keywords:

Atopic dermatitis, Rubbing injuries, Fitostimoline® Plus, Rigenase®, Wound healing

Abstract

Introduction: Managing rubbing injuries in atopic dermatitis is challenging and has a significant impact on patients' quality of life. Polyhexamethylene biguanide (PHMB) and Rigenase® (a patented Triticum vulgare extract) show promise in tissue repair and antimicrobial activity.

Objective: The aim of this study was to compare the effectiveness of two topical treatments, Fitostimoline® Plus spray and a hydrating formulation with hyaluronic acid, in rubbing injuries secondary to atopic dermatitis.

Materials and Methods: This comparative study enrolled 68 patients with atopic dermatitis and rubbing injuries, randomly assigned to Group A (N=38) receiving Fitostimoline® Plus spray (0.1% PHMB and Rigenase®) or Group B (N=30) receiving a hyaluronic acid spray. The primary endpoint was the clinical lesion response at 10 days post-treatment. Secondary endpoints included pain reduction (Visual Analogue Scale, VAS) and patient satisfaction (Dermatology Life Quality Index,DLQI).

Results: Group A had a significantly higher complete response rate (81.3% vs. 64.3%, P <0.001). Partial response rates were also higher in Group A (P = 0.045). Pain reduction was greater in Group A (VAS: 6.8 ± 1.2 to 2.4 ± 0.8) compared to Group B (7.1 ± 1.3 to 3.9 ± 1.0) (P <0.001). DLQI scores improved more in Group A (12.5 ± 3.5 to 3.2 ± 1.1) than in Group B (13.0 ± 3.2 to 6.5 ± 1.4) (P <0.001). Dermoscopic examinations showed significant skin barrier improvement in Group A (P <0.001).

Conclusion: Fitostimoline® Plus spray, with 0.1% PHMB and Rigenase®, offers superior treatment for chronic lesions in atopic dermatitis, enhancing wound healing and patient quality of life.

References

Kim J, Kim BE, Leung DYM. Pathophysiology of atopic dermatitis: Clinical implications. Allergy Asthma Proc. 2019 Mar 1;40(2):84-92. doi: 10.2500/aap.2019.40.4202. PMID: 30819278; PMCID: PMC6399565.

Ali F, Vyas J, Finlay AY. Counting the Burden: Atopic Dermatitis and Health-related Quality of Life. Acta Derm Venereol. 2020 Jun 9;100(12):adv00161. doi: 10.2340/00015555-3511. PMID: 32412644; PMCID: PMC9189752.

Koszorú K, Borza J, Gulácsi L, Sárdy M. Quality of life in patients with atopic dermatitis. Cutis. 2019 Sep;104(3):174-177. PMID: 31675393.

Rippon MG, Rogers AA, Ousey K. Polyhexamethylene biguanide and its antimicrobial role in wound healing: a narrative review. J Wound Care. 2023 Jan 2;32(1):5-20. doi: 10.12968/jowc.2023.32.1.5. PMID: 36630111.

Johnson W Jr, Boyer I, Zhu J, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Heldreth B. Safety Assessment of Polyaminopropyl Biguanide (Polyhexamethylene Biguanide Hydrochloride) as Used in Cosmetics. Int J Toxicol. 2020 Nov/Dec;39(3_suppl):26S-73S. doi: 10.1177/1091581820958683. PMID: 33203268.

Antonucci I, Fiorentino G, Contursi P, Minale M, Riccio R, Riccio S, Limauro D. Antioxidant Capacity of Rigenase®, a Specific Aqueous Extract of Triticum vulgare. Antioxidants (Basel). 2018 May 17;7(5):67. doi: 10.3390/antiox7050067. PMID: 29772758; PMCID: PMC5981253.

Kramer A, Dissemond J, Kim S, Willy C, Mayer D, Papke R, Tuchmann F, Assadian O. Consensus on Wound Antisepsis: Update 2018. Skin Pharmacol Physiol. 2018;31(1):28-58. doi: 10.1159/000481545. Epub 2017 Dec 21. PMID: 29262416.

Falciglia MD, Palladino R, Maglione B, Schiavo G. In Vitro Antimicrobial Activity Evaluation of a Novel Fitostimoline® Plus Spray Formulation. Int J Microbiol. 2021 Sep 2;2021:1114853. doi: 10.1155/2021/1114853. PMID: 34567124; PMCID: PMC8457973.

Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet. 2020 Aug 1;396(10247):345-360. doi: 10.1016/S0140-6736(20)31286-1. Erratum in: Lancet. 2020 Sep 12;396(10253):758. doi: 10.1016/S0140-6736(20)31825-0. PMID: 32738956.

Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016 Mar 12;387(10023):1109-1122. doi: 10.1016/S0140-6736(15)00149-X. Epub 2015 Sep 13. PMID: 26377142.

Boguniewicz M, Leung DY. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011 Jul;242(1):233-46. doi: 10.1111/j.1600-065X.2011.01027.x. PMID: 21682749; PMCID: PMC3122139.

Leung DY. Infection in atopic dermatitis. Curr Opin Pediatr. 2003 Aug;15(4):399-404. doi: 10.1097/00008480-200308000-00008. PMID: 12891053.

Langan SM, Abuabara K, Henrickson SE, Hoffstad O, Margolis DJ. Increased Risk of Cutaneous and Systemic Infections in Atopic Dermatitis-A Cohort Study. J Invest Dermatol. 2017 Jun;137(6):1375-1377. doi: 10.1016/j.jid.2017.01.030. Epub 2017 Feb 12. PMID: 28202403; PMCID: PMC5660507.

Tito A, Minale M, Riccio S, Grieco F, Colucci MG, Apone F. A Triticum vulgare Extract Exhibits Regenerating Activity During the Wound Healing Process. Clin Cosmet Investig Dermatol. 2020 Jan 14;13:21-30. doi: 10.2147/CCID.S216391. PMID: 32021367; PMCID: PMC6969697.

Fiore, L.; Scapagnini, U.; Riccio, R.; Canonico, P.L. Differential activities of Triticum vulgare extract and its fractions in mouse fibroblasts. Acta Ther. 1993, 19, 151–162.

Morretta E, D'Agostino A, Cassese E, Maglione B, Petrella A, Schiraldi C, Monti MC. Label-Free Quantitative Proteomics to Explore the Action Mechanism of the Pharmaceutical-Grade Triticum vulgare Extract in Speeding Up Keratinocyte Healing. Molecules. 2022 Feb 7;27(3):1108. doi: 10.3390/molecules27031108. PMID: 35164377; PMCID: PMC8839156.

Kaehn K. Polihexanide: a safe and highly effective biocide. Skin Pharmacol Physiol. 2010;23 Suppl:7-16. doi: 10.1159/000318237. Epub 2010 Sep 8. PMID: 20829657.

Russo R, Carrizzo A, Barbato A, Rasile BR, Pentangelo P, Ceccaroni A, Marra C, Alfano C, Losco L. Clinical Evaluation of the Efficacy and Tolerability of Rigenase® and Polyhexanide (Fitostimoline® Plus) vs. Hyaluronic Acid and Silver Sulfadiazine (Connettivina® Bio Plus) for the Treatment of Acute Skin Wounds: A Randomized Trial. J Clin Med. 2022 Apr 29;11(9):2518. doi: 10.3390/jcm11092518. PMID: 35566643; PMCID: PMC9105357.

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Published

2025-01-29

How to Cite

1.
Di Brizzi EV, Balato A, Caccavale S, Lupoli A, Panetti C, Argenziano G. A Comparative Study to Evaluate the Effectiveness between Synergic Activities of 0.1% Polyhexanide and Rigenase® (Fitostimoline® Plus spray) versus a Hydrating Formulation for the Topical Management of Rubbing Injuries Secondary to Atopic Dermatitis. Dermatol Pract Concept. 2025;15(1):4906 . doi:10.5826/dpc.1501a4906

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