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August 1995

Treatment of Toenail Onychomycosis: A Randomized, Double-blind Study With Terbinafine and Griseofulvin

Author Affiliations

From the Departments of Dermatology, Technical University München (Germany) (Dr Hofmann) and University of the Saarland, Homburg, Germany (Dr Zaun), and the Department of Clinical Research, Sandoz AG, Nürnberg, Germany (Drs Bräutigam and Weidinger).

Arch Dermatol. 1995;131(8):919-922. doi:10.1001/archderm.1995.01690200057011

Background and Design:  The fungicidal mode of action of terbinafine should make it feasible to reduce treatment duration in onychomycosis. For 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 treatment 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 de- creased 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 81% with terbinafine and 62% with griseofulvin (two-tailed P=.02).

Conclusions:  This study has demonstrated the longterm therapeutic superiority of terbinafine to high-dose griseofulvin in the treatment of toenail mycosis. Furthermore, with the new antifungal terbinafine, treatment is no longer necessary until all affected nail material has grown out.(Arch Dermatol. 1995;131:919-922)

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