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.

The Diagnosis and Treatment of Nail Disorders

“…The decision on the optimal type of treatment is also based on the number of affected fingernails or toenails, the extent of nail involvement, multimorbidity, drug interactions, and the identified pathogen (Table 4). For topical use, water-soluble ciclopiroxol amine nail varnish is more effective than amorolfin (36).…”

Ciclopirox Hydroxypropyl Chitosan: Efficacy in Mild-to-Moderate Onychomycosis

“…The same approach was adopted with topical antifungal drugs [3, 4, 8-11]. The adoption of the most stringent criterion of efficacy, namely complete cure (mycological and clinical), reduced the interstudy variability of the results, giving a more reliable measure of the treatment’s efficacy.…”

“…P-3051 (Polichem SA, Lugano, Switzerland), currently marketed in 35 countries worldwide, is an 8% CPX water-soluble nail lacquer based on hydroxypropyl chitosan technology, which has shown superior activity to both reference insoluble CPX [8] and amorolfine [11] commercial nail lacquers in the management of onychomycosis. In the overall evaluation of the pivotal study, 20% of the patients included in the efficacy analysis had severe onychomycosis (proximal involvement, yellow spikes, and/or > 65% nail involvement) [8].…”

Kombinationstherapie von schweren Onychomykosen – Empfehlungen eines Expertengremiums

“…Grundsätzlich sind die Wirkstoffe Amorolfin und Ciclopirox für die Therapie von Onychomykosen mit Dermatophyten geeignet. Aussagefähige direkte Vergleichsstudien zur relativen Wirksamkeit liegen nicht vor [2,3].…”