title: Ciclopirox 8% HPCH Nail Lacquer in the Treatment of Mild-to-Moderate Onychomycosis: A Randomized, Double-Blind Amorolfine Controlled Study Using a Blinded Evaluator.
abstract: This was a randomized, controlled, parallel-group clinical trial with a blinded evaluator, designed to compare the efficacy and safety of the nail lacquer P-3051 with amorolfine 5% in the treatment of mild-to-moderate toenail onychomycosis. Patients were treated for 48 weeks with P-3051 daily, or twice weekly with amorolfine 5%. Out of 120 evaluable patients, 60 (50.0%) received P-3051 and 60 (50.0%) amorolfine 5%. At baseline, the two groups were homogeneous in terms of race, pathogens, number of affected toenails and severity of the infected target nail area. The statistical superiority of P-3051 versus amorolfine was achieved after 48 weeks (treatment success: 58.3% for P-3051 vs. 26.7% for amorolfine, p < 0.001; complete cure: 35.0% for P-3051 vs. 11.7% for amorolfine, p < 0.001). Mycological cure at week 48 was achieved in all patients treated with P-3051 compared to 81.7% of patients treated with amorolfine (p < 0.001). Moreover, fungal eradication by P-3051 was statistically superior at week 24. The results of this study, and of a previous pivotal study versus the insoluble formulation of ciclopirox 8%, led to consider P-3051 as the gold standard for the topical treatment of mild-to-moderate onychomycosis.
authors.affiliation: Private Dermatology Practice, Bellinzona, Switzerland.
authors.forename: Matilde
authors.initials: M
authors.lastname: Iorizzo
authors.affiliation: Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre, Riga, Latvia.
authors.forename: Ilona
authors.initials: I
authors.lastname: Hartmane
authors.affiliation: Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre, Riga, Latvia.
authors.forename: Andra
authors.initials: A
authors.lastname: Derveniece
authors.affiliation: Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre, Riga, Latvia.
authors.forename: Ingmars
authors.initials: I
authors.lastname: Mikazans
keywords: Amorolfine; Controlled clinical trial; Hydroxypropyl chitosan; Onychomycosis; P-3051; Topical treatment