A 12-week treatment for dermatophyte toe onychomycosis: terbinafine 250 mg/day vs. itraconazole 200 mg/day - a double-blind comparative trial

Lamisil® (terbinafine) 250 mg daily and itraconazole 200 mg daily were compared in the treatment of dermalophyte toe onychomycosis over 12 weeks in a double‐blind randomized clinical trial. At the end of follow‐up (week 48) treatment with Lamisil® led to negative mycology in 7 3% of patients compared with 45–8% in the itraconazole group (P < 00001), Globally the clinical symptoms of the target nail improved, a response which was in favour of Lamisil® (P=0·001), The percentages of patients who were clinically totally cured or who presented with only minimal symptoms were 76′3')() for the Lamisil®‐treated group compared with 58–1% in the itraconazole group. The unaffected nail length for big toes was significantly higher in the Lamisil®‐treated group (9·1 mm vs, 7·7mm; P= 0·0298). Onycholysis was also less in the Lamisil® group (P = 0·001). We conclude that 12 weeks” conlinitous oral therapy leads to higher cure rates with Lamisil® than with itraconazole and that both drugs are equally well tolerated.