German randomized double-blind multicentre comparison of terbinafine and itraconazole for the treatment of toenail tinea infection.
One-hundred and ninety-five patients with toenail tinea unguium were recruited to a multicentre double-blind clinical trial. Patients were given 250 mg terbinafine or 200 mg itraconazole daily for 12 weeks, with follow-up for a further 40 weeks. At the end of the study, mycological cure rates were 81% (70/86 assessed) for terbinafine and 63% (53/84 assessed) for itraconazole (two-tailed, P < 0.01). The length of unaffected nail was 9.44 mm in the terbinafine group and 7.85 mm in the itraconazole group (two-tailed, P < 0.05). Patient self-assessment also favoured terbinafine, with 65% evaluating it as good to very good, compared with 58% for itraconazole. Before treatment the terbinafine group had a mean of 6.7 and the itraconazole group 6.3 affected nails per patient. Total cure was achieved in 69% of terbinafine and 61% of itraconazole affected nails. We conclude that terbinafine is more effective than itraconazole in the treatment of toenail tinea infection.
Bräutigam
M
M
Department of Clinical Research, Sandoz AG, Germany.
Nolting
S
S
Schopf
R E
RE
Weidinger
G
G
D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D017964:Itraconazole / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000627:therapeutic use*; D014009:Onychomycosis / Q000188:drug therapy*; D017060:Patient Satisfaction; D000077291:Terbinafine; D014008:Tinea Pedis / Q000188:drug therapy*
D000935:Antifungal Agents; D009281:Naphthalenes; D017964:Itraconazole; D000077291:Terbinafine