Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer: A Review of Its Use in Onychomycosis

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Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer: A Review of Its Use in Onychomycosis Bianca Maria Piraccini . Matilde Iorizzo . Andre´ Lencastre . Pietro Nenoff . Dimitris Rigopoulos

Received: May 25, 2020 Ó The Author(s) 2020

ABSTRACT Ciclopirox 8% hydroxypropyl chitosan (HPCH) [Marketed in different countries as the following registered (Ò) brands: Ciclopoli, Fulcare, Kitonail, Myconail, Niogermos, Niogermox, Onytec, Ony-Tec, Polinail, Privex, Rejuvenail] is Digital Features To view digital features for this article go to https://doi.org/10.6084/m9.figshare.12555215. B. M. Piraccini (&) Dermatology Unit, Department of Experimental, Diagnostic and Specialty Medicine, Alma Mater Studiorum, University of Bologna, Bologna, Italy e-mail: [email protected] M. Iorizzo Private Dermatology Practice, Bellinzona, Switzerland A. Lencastre Servic¸o de Dermatologia, Hospital de Santo Anto´nio dos Capuchos, Centro Hospitalar Universita´rio de Lisboa Central, Lisbon, Portugal P. Nenoff Allergology, Andrology, Tropical and Travel Dermatology (DDA), Laboratory for Medical Microbiology, Partnership Prof. Dr. med. Pietro ¨ ger, Ro ¨ tha OT Nenoff & Dr. med. Constanze Kru ¨ lbis, Germany Mo D. Rigopoulos Dermatology-Venereology, Department of Medicine, School of Health Sciences, National and Kapodistrian University of Athens–A. Sygros Hospital, Athens, Greece

the first topical nail lacquer developed using innovative drug formulation technology. It is indicated for the treatment of mild-to-moderate fungal infections of the nails that are caused by dermatophytes and/or other ciclopirox-sensitive fungi, without nail matrix involvement. HPCH is a patented drug formulation technology for the delivery of active principles into the nails based on a hydrosoluble semisynthetic amino-polysaccharide biopolymer derivative of chitosan. The lacquer acts as a protective barrier against microbiological attack, physical damage and/or aggressive chemicals. Results from in vitro studies suggest that the application of ciclopirox 8% HPCH nail lacquer improves drug permeation into and/or drug penetration through the nail, relative to the water-insoluble ciclopirox 8%, amorolfine 5% and efinaconazole 10% reference lacquers. In addition, in vitro and clinical studies in healthy subjects found that the concentration of ciclopirox reached in subungual fluids after application of ciclopirox 8% HPCH was sufficient for inhibiting fungal growth. In clinical studies in patients with mild-to-moderate onychomycosis, ciclopirox 8% HPCH was found to be more effective than the commercial water-insoluble ciclopirox 8% and amorolfine 5% lacquers, as indicated by higher complete cure, response and mycological cure rates at 48 weeks after treatment initiation. Ciclopirox 8% HPCH has been found to be generally well tolerated, with no treatmentrelated adverse events reported in patients using

Dermatol Ther (Heidelb)

this nail lacquer. Thus, current evidence indicates that ciclopirox 8% HPCH represents a valuable treatment option for the tre