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We undertook a prospective, randomised, double-blind, double-dummy, multicentre, parallel-group study to compare the efficacy and tolerability of continuous terbinafine (Lamisil) with intermittent itraconazole (Sporanox) in the treatment of toenail onychomycosis. A total of 496 patients (age range 18-75 years) with a clinical diagnosis of dermatophyte toenail onychomycosis, confirmed by positive mycological culture and microscopy (KOH), were recruited from 35 centres in six European countries. They were randomly divided into four parallel groups to receive either terbinafine 250 mg/day for 12 or 16 weeks (groups T12 and T16), or itraconazole 400 mg/day for 1 week in every 4 weeks for 12 or 16 weeks (groups I3 and I4). The primary efficacy measurement at week 72 was mycological cure, defined as negative microscopy and negative culture of samples from the target toenail. At week 72, the mycological cure rates were 75.5% (81/107) in the T12 group and 80.8% (80/99) in the T16 group, compared with 38.3% (41/107) in the I3 group and 49.1% (53/108) in the I4 group. All comparisons (T12 vs. I3, T12 vs. I4, T16 vs. I3, T16 vs. I4) showed significantly higher cure rates in the terbinafine groups (all P<0.0001). In addition, all secondary clinical outcome measures were significantly in favour of terbinafine at week 72. Both treatments were well tolerated, with no significant differences in the number or type of adverse events reported. We conclude that continuous terbinafine is significantly more effective than intermittent itraconazole in the treatment of toenail dermatophyte onychomycosis.