Topical treatment of onychomycosis with amorolfine 5% nail lacquer: comparative efficacy and tolerability of once and twice weekly use.

456 patients with onychomycosis were treated once or twice weekly for up to 6 months with amorolfine 5% nail lacquer in an open, randomized study. The patients were examined at monthly intervals during treatment and followed-up 1 and 3 months after completion of treatment. Slightly better cure rates were achieved with twice weekly use than with once weekly use (overall cure rates 54.2 vs. 46.0%, p = 0.4). An overall cure or improvement was achieved in 74 and 68% of patients receiving twice- and once-weekly treatment, respectively. The mycological cure rate was 76.1% for twice-weekly treatment and 70.6% for once-weekly treatment. The nail lacquer was extremely well tolerated; 4 out of 456 patients reported mild local irritation. Plasma levels of amorolfine were determined in 19 patients and found to be below the detection limit of 0.5 ng/ml in all cases.