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


CONCLUSIONS
Ciclopirox 8% hydrolacquer is more active than reference ciclopirox nail lacquer in the treatment of onychomycosis.
Baran
R
R
Nail Disease Centre, Cannes, France. baran.r@wanadoo.fr
Tosti
A
A
Hartmane
I
I
Altmeyer
P
P
Hercogova
J
J
Koudelkova
V
V
Ruzicka
T
T
Combemale
P
P
Mikazans
I
I
D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D001704:Biopolymers / Q000008:administration & dosage*; D000077768:Ciclopirox; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D014009:Onychomycosis / Q000188:drug therapy*; D010919:Placebos; D011728:Pyridones / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D012995:Solubility; D016896:Treatment Outcome; D014867:Water
D000935:Antifungal Agents; D001704:Biopolymers; D010919:Placebos; D011728:Pyridones; D014867:Water; D000077768:Ciclopirox