A DOUBLE-BLIND, RANDOMIZED STUDY COMPARING ITRACONAZOLE PULSE THERAPYWITH CONTINUOUS DOSING FOR THE TREATMENT OF TOE-NAIL ONYCHOMYCOSIS

In this multicentre, double-blind parallel group study, we evaluated t he efficacy and safety of continuous treatment with itraconazole, 200 mg daily for 3 months, in comparison with itraconazole pulse therapy, 400 mg daily 1 week per month for 3 months, in the treatment of toe-na il onychomycosis. The study included 129 patients with distal subungua l onychomycosis of the toenails, confirmed by microscopy and positive for dermatophyte culture; 65 received continuous treatment and 64 rece ived pulse therapy. Patients were followed up for 9 months after treat ment. After 12 months, there were 62 evaluable patients in the continu ous group and 59 evaluable patients in the pulse group. The clinical r esponse (i.e. the size of the affected area and the progress of the in fection) and mycological cure (i.e. negative results on microscopy and culture) were the main outcome measures. A clinical response was defi ned as a cure or a marked improvement. Clinical response rates were 69 %, in the continuous group, and 81% in the pulse group at month 12; th e corresponding mycological cure rates were 66 and 69%. A better impro vement in signs and symptoms was noted in the pulse group. Six patient s were withdrawn from treatment because of adverse events, not all of which were thought to be drug-related There were no clinically relevan t laboratory abnormalities. We conclude that both regimens are effecti ve, safe and well tolerated. The superiority of one treatment over the other was not established, but the results tended to favour pulse the rapy. Equivalence testing confirmed that pulse therapy was at least eq uivalent to continuous treatment.