Short-duration therapy with terbinafine for dermatophyte onychomycosis: a multicentre trial.

Terbinafine, an orally active antifungal agent, is effective in the treatment of dermatophyte onychomycosis when given for 12 months in the case of toenail infection (TN) and 6 months for fingernail infection (FN). The rapid response and short mycological cure time indicate a potential for a reduced treatment duration. In this multicentre double-blind placebo-controlled trial, 112 patients with mycologically proven dermatophyte onychomycosis were given 250 mg/day of terbinafine for 3 months. Twenty-seven patients were excluded, leaving 85 fully evaluable [average age 44 (range 19-78) years; 55 men; 75 TN, 10 FN]. Forty-nine of the TN patients and seven of the FN patients received terbinafine. At the end of the follow-up period, the TN mycological cure rate with active treatment was 82% (37/45), but no patient taking placebo maintained mycological cure (P less than 0.001). Of the FN patients treated with active drug, 71% (5/7) achieved mycological cure at the end of follow-up. Minor side-effects occurred in 41% of the placebo-treated group compared with 33% of those taking terbinafine. These adverse events were mainly gastrointestinal. Two patients taking terbinafine discontinued treatment--one with tonsillitis and another with diarrhoea. In conclusion, 3-month treatment with terbinafine is effective, well tolerated and safe in dermatophyte onychomycosis. Short-duration therapy for this indication represents a major therapeutic advance.