Oral terbinafine in the treatment of toenail onychomycosis: North American multicenter trial

L. A. Drake, N. H. Shear, J. P. Arlette, R. Cloutier, F. W. Danby, B. E. Elewski, S. Garnis-Jones, J. M. Giroux, D. Gratton, W. Gulliver, P. Hull, H. E. Jones, M. Journet, A. L. Krol, J. J. Leyden, S. C. Maddin, J. B. Ross, R. C. Savin, R. K. Scher, G. R. SibbaldN. H. Tawfik, N. Zaias, M. Tolpin, S. Evans, C. Marsolais, T. Chin, T. H. Lin, T. Maher, J. E. Birnbaum

Research output: Contribution to journalArticlepeer-review

102 Scopus citations


Background: Onychomycosis is an increasing problem with limited therapeutic options. Objective: We evaluated the safety and efficacy of oral terbinafine, a new fungicidal antimycotic, in patients with toenail onychomycosis. Methods: A North American multicenter, double-blind, placebo- controlled study evaluated the mycologic and clinical efficacy of oral terbinafine 250 mg/day for 12 or 24 weeks in 358 patients with toenail onychomycosis. Results: A total of 74% of patients treated with 12 or 24 weeks of terbinafine achieved a successful clinical outcome. Approximately 11% of terbinafine responders showed evidence of relapse 18 to 21 months after cessation of treatment. Terbinafine was well tolerated; most adverse events were transient and mild to moderate in severity. Conclusion: The results of this study confirm that oral terbinafine is a safe and effective therapy for the treatment of onychomycosis.

Original languageEnglish (US)
Pages (from-to)740-745
Number of pages6
JournalJournal of the American Academy of Dermatology
Issue number5 I
StatePublished - 1997
Externally publishedYes

ASJC Scopus subject areas

  • Dermatology


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