An innovative water-soluble biopolymer improves efficacy of ciclopirox nail lacquer in the management of onychomycosis.

Abstract

BACKGROUND:

A new 8% ciclopirox-medicated nail lacquer (P-3051), based on a new technology, revealed superior properties in terms of affinity to keratin, nail permeation, and ease of use.

OBJECTIVE:

This study aims to assess the efficacy and safety of P-3051 vs. the market 8% ciclopirox nail lacquer.

METHODS:

This is a multicentre, randomized, three-arm, placebo-controlled, parallel groups, evaluator-blinded study. Overall, 467 patients with onychomycosis of at least one big toenail were randomized to receive P-3051, the reference drug or placebo in a 2 : 2 : 1 ratio for a 48-week treatment by daily application, followed by a 12-week follow-up.

RESULTS:

The study satisfied its objective by demonstrating that P-3051 was both superior to placebo and non-inferior to reference in the complete cure rate after a 48-week active treatment period. Switching the non-inferiority to superiority hypothesis, the superiority of P-3051 vs. reference was nearly significant at week 48 (confirmed at week 52), and it was significant at week 60 (cure rate for P-3051 is 119% higher than reference; P < 0.05). Altogether, the results on primary endpoint exceed expectations; superiority test was performed also on secondary endpoints to confirm the superiority trend of the study. At the end of follow-up, percentages of patients who achieved the endpoint 'responder' in the P-3051 group were 66% higher than reference (P < 0.05), and those who achieved the endpoint 'decrease of diseased nail' were 40% higher (P < 0.05).

CONCLUSION:

Ciclopirox 8% hydrolacquer is more active than reference ciclopirox nail lacquer in the treatment of onychomycosis.

• Authors: R Baran, A Tosti, I Hartmane, P Altmeyer, J Hercogova, V Koudelkova, T Ruzicka, P Combemale, I Mikazans
• Journal: Journal of the European Academy of Dermatology and Venereology : JEADV (J Eur Acad Dermatol Venereol) Vol. 23 Issue 7 Pg. 773-81 (Jul 2009) ISSN: 1468-3083 [Electronic] England
• PMID: 19453778 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antifungal Agents
• Biopolymers
• Placebos
• Pyridones
• Water
• Ciclopirox

Topics

• Adult
• Antifungal Agents (administration & dosage, adverse effects, therapeutic use)
• Biopolymers (administration & dosage)
• Ciclopirox
• Female
• Humans
• Male
• Middle Aged
• Onychomycosis (drug therapy)
• Placebos
• Pyridones (administration & dosage, adverse effects, therapeutic use)
• Solubility
• Treatment Outcome
• Water