Ciclopirox HPCH Nail Lacquer after Failure of Topical Treatment with Amorolfine

According to a recent controlled study, about 85% of patients with onychomycosis fail to respond to a standard treatment with amorolfine 5%. An 8% ciclopirox nail hydrolacquer, based on hydroxypropyl chitosan technology (P-3051), has been shown to improve efficacy in topical treatment of onychomycosis. No comparative studies between P-3051 and amorolfine were hitherto published. It has been investigated the efficacy of P-3051 in patients with onychomycosis who did not respond to amorolfine. This was a non-interventional, multicentre study. Patients with mild-to-moderate onychomycosis, who had failed to respond to a previous 6-month treatment course with amorolfine twice weekly, were treated daily for 24 weeks with P-3051. The primary endpoint was the success rate of treatment, defined as conversion to negative of KOH of the target nail. Secondary endpoints included clinical effectiveness, defined as negative mycology (culture and KOH) and ≥ 90% clear nail. Overall, 70 patients were included in the Full Analysis Set (FAS) and 66 completed the study. Success at primary endpoint was achieved by 41 patients (58.6% of FAS, 95% CI 46.17%; 70.23%). The null hypothesis that success rate is ≤ 15.7% taken from literature was rejected (P<0.0001). Clinical effectiveness was obtained in 21.4% of patients. The study showed that treatment failures to amorolfine, subsequently treated with P-3051 for 24 weeks, resulted in a high statistically and clinically significant success rate. The high response rate observed suggested that P-3051 may be efficacious in amorolfine treatment failures as an alternative prior to oral therapy.