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

R. Baran, Antonella Tosti, I. Hartmane, P. Altmeyer, J. Hercogova, V. Koudelkova, T. Ruzicka, P. Combemale, I. Mikazans

Research output: Contribution to journalArticle

68 Citations (Scopus)

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. Conflicts of interest None declared.

Original languageEnglish
Pages (from-to)773-781
Number of pages9
JournalJournal of the European Academy of Dermatology and Venereology
Volume23
Issue number7
DOIs
StatePublished - Jul 1 2009
Externally publishedYes

Fingerprint

ciclopirox
Lacquer
Onychomycosis
Biopolymers
Nails
Water
Placebos
Nail Diseases
Conflict of Interest
Keratins
Therapeutics
Technology
Safety

Keywords

  • Ciclopirox
  • Hydroxypropyl chitosan
  • Onychomycosis
  • Water-soluble nail lacquer

ASJC Scopus subject areas

  • Dermatology
  • Infectious Diseases

Cite this

An innovative water-soluble biopolymer improves efficacy of ciclopirox nail lacquer in the management of onychomycosis. / Baran, R.; Tosti, Antonella; Hartmane, I.; Altmeyer, P.; Hercogova, J.; Koudelkova, V.; Ruzicka, T.; Combemale, P.; Mikazans, I.

In: Journal of the European Academy of Dermatology and Venereology, Vol. 23, No. 7, 01.07.2009, p. 773-781.

Research output: Contribution to journalArticle

Baran, R. ; Tosti, Antonella ; Hartmane, I. ; Altmeyer, P. ; Hercogova, J. ; Koudelkova, V. ; Ruzicka, T. ; Combemale, P. ; Mikazans, I. / An innovative water-soluble biopolymer improves efficacy of ciclopirox nail lacquer in the management of onychomycosis. In: Journal of the European Academy of Dermatology and Venereology. 2009 ; Vol. 23, No. 7. pp. 773-781.
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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. Conflicts of interest None declared.",
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AU - Baran, R.

AU - Tosti, Antonella

AU - Hartmane, I.

AU - Altmeyer, P.

AU - Hercogova, J.

AU - Koudelkova, V.

AU - Ruzicka, T.

AU - Combemale, P.

AU - Mikazans, I.

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N2 - 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. Conflicts of interest None declared.

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