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

J Eur Acad Dermatol Venereol. 2009 Jul;23(7):773-81. doi: 10.1111/j.1468-3083.2009.03164.x. Epub 2009 May 4.


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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

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


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