Ciclopirox 8% HPCH Nail Lacquer in the Treatment of Mild-to-Moderate Onychomycosis : A Randomized, Double-Blind Amorolfine Controlled Study Using a Blinded Evaluator
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Date
2016-02
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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.
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Onychomycosis, Topical treatment, P-3051, Hydroxypropyl chitosan, Amorolfine, Controlled clinical trial, 3.2 Clinical medicine, 1.3. Anonymously reviewed scientific article published in a journal with an international editorial board and is available in another indexed database
Citation
Iorizzo, M, Hartmane, I, Derveniece, A & Mikazans, I 2016, 'Ciclopirox 8% HPCH Nail Lacquer in the Treatment of Mild-to-Moderate Onychomycosis : A Randomized, Double-Blind Amorolfine Controlled Study Using a Blinded Evaluator', Skin Appendage Disorders, vol. 1, no. 3, pp. 134-40. https://doi.org/10.1159/000441569