Please use this identifier to cite or link to this item:
10.1159/000441569
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 |
Authors: | Iorizzo, Matilde Hartmane, Ilona Derveniece, Andra Mikazans, Ingmars |
Keywords: | 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 |
Issue Date: | Feb-2016 |
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 |
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. |
DOI: | 10.1159/000441569 |
ISSN: | 2296-9195 |
Appears in Collections: | Research outputs from Pure / Zinātniskās darbības rezultāti no ZDIS Pure |
Files in This Item:
File | Size | Format | |
---|---|---|---|
Ciclopirox_8_HPCH_Nail_Lacquer_in_the.pdf | 662.86 kB | Adobe PDF | View/Open |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.