TREATMENT OF TOENAIL ONYCHOMYCOSIS - A RANDOMIZED, DOUBLE-BLIND-STUDYWITH TERBINAFINE AND GRISEOFULVIN

Background and Design: The fungicidal mode of action of terbinafine sh ould make it feasible to reduce treatment duration in onychomycosis. F or this reason, a randomized, double-blind study in 195 patients with severe dermatophyte infections of the toenails was performed comparing a 24-week treatment with terbinafine (250 mg/d) with a 48-week treatm ent with micronized griseofulvin (1000 mg/d). Results: After 48 weeks, effective treatment was achieved in 67% of the patients treated with terbinafine and in 56% of those treated with griseofulvin (two-tailed P=.120). At a follow-up visit 24 weeks later, cure rates had decreased to 60% in the terbinafine group and to 39% in the griseofulvin group (two-tailed P=.006). At the same time, the mycological cure rate was 8 1% with terbinafine and 62% with griseofulvin (two-tailed P=.02). Conc lusions: This study has demonstrated the longterm therapeutic superior ity of terbinafine to high-dose griseofulvin in the treatment of toena il mycosis. Furthermore, with the new antifungal terbinafine, treatmen t is no longer necessary until all affected nail material has grown ou t.