Terbinafine is an antimycotic drug which has a much higher in vitro ac
tivity against dermatophytes than against yeasts. To investigate the c
linical relevance of these in vitro data, 118 patients with cutaneous
candidosis were enrolled in a randomized, double-blind study and alloc
ated to a 4-week treatment with a daily dose of either 250 mg b.i.d. t
erbinafine or 200 mg once-daily ketoconazole. At the final assessment,
3 weeks after cessation of therapy, mycological cure rates (negative
culture and negative microscopy) were 82% in the terbinafine group and
73% in the ketoconazole group. Effective treatment with negative myco
logy and no or minimal signs or symptoms could be achieved in 65% of t
hose who received terbinafine and in 57% of those randomized to ketoco
nazole. Five per cent and 7% of the patients taking terbinafine and ke
toconazole, respectively, complained about adverse events, which were
usually mild and did not lead to discontinuation of treatment. In one
patient in the ketoconazole group, abnormal liver enzymes were noted a
t the final laboratory assessment. The results of this study indicate
that terbinafine 500 mg daily can be an alternative to ketoconazole wh
en systemic treatment of skin candidosis is required.