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.
Original language | English |
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Pages (from-to) | 134-40 |
Number of pages | 7 |
Journal | Skin Appendage Disorders |
Volume | 1 |
Issue number | 3 |
DOIs | |
Publication status | Published - Feb 2016 |
Externally published | Yes |
Keywords*
- Onychomycosis
- Topical treatment
- P-3051
- Hydroxypropyl chitosan
- Amorolfine
- Controlled clinical trial
Field of Science*
- 3.2 Clinical medicine
Publication Type*
- 1.3. Anonymously reviewed scientific article published in a journal with an international editorial board and is available in another indexed database