A multicenter, open-label study of the efficacy and safety of ciclopirox nail lacquer solution 8% for the treatment of onychomycosis in patients with diabetes.

This multicenter, open-label, uncontrolled, noncomparative, observational, postmarketing study assessed the efficacy and safety of ciclopirox nail lacquer solution 8% in 3666 patients for the treatment of onychomycosis. Results of an analysis in a subset of 215 (5.9%) patients with diabetes are summarized here. Patients applied ciclopirox nail lacquer once daily to affected toenails and fingernails for 6 months. Efficacy parameters included the decrease from baseline of the affected area of the nail. Physicians rated the level of onychomycosis at 3 months and the efficacy of ciclopirox nail lacquer at 6 months. Treatment with ciclopirox nail lacquer reduced the mean affected nail area from 64.3% at baseline to 41.2% at 3 months and 25.7% at 6 months. At 3 months, physicians rated onychomycosis as improved in 88.7% of patients. unchanged in 9.8%, and worse in 1.5%. The efficacy of ciclopirox nail lacquer was good in 62.0% of patients, satisfactory in 23.9%, and unsatisfactory in 14.1%. Adverse events were mild to moderate, with no serious events reported. Ciclopirox nail lacquer is safe and effective for the topical treatment of onychomycosis in patients with diabetes and produced results similar to those observed in the general population.