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, Alfons 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 journalArticle

88 Citations (Scopus)

Abstract

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
Volume37
Issue number5 I
StatePublished - 1997
Externally publishedYes

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terbinafine
Onychomycosis
Nails
Multicenter Studies
Therapeutics
Withholding Treatment
Placebos

ASJC Scopus subject areas

  • Dermatology

Cite this

Drake, L. A., Shear, N. H., Arlette, J. P., Cloutier, R., Danby, F. W., Elewski, B. E., ... Birnbaum, J. E. (1997). Oral terbinafine in the treatment of toenail onychomycosis: North American multicenter trial. Journal of the American Academy of Dermatology, 37(5 I), 740-745.

Oral terbinafine in the treatment of toenail onychomycosis : North American multicenter trial. / Drake, L. A.; Shear, N. H.; Arlette, J. P.; Cloutier, R.; Danby, F. W.; Elewski, B. E.; Garnis-Jones, S.; Giroux, J. M.; Gratton, D.; Gulliver, W.; Hull, P.; Jones, H. E.; Journet, M.; Krol, Alfons; Leyden, J. J.; Maddin, S. C.; Ross, J. B.; Savin, R. C.; Scher, R. K.; Sibbald, G. R.; Tawfik, N. H.; Zaias, N.; Tolpin, M.; Evans, S.; Marsolais, C.; Chin, T.; Lin, T. H.; Maher, T.; Birnbaum, J. E.

In: Journal of the American Academy of Dermatology, Vol. 37, No. 5 I, 1997, p. 740-745.

Research output: Contribution to journalArticle

Drake, LA, Shear, NH, Arlette, JP, Cloutier, R, Danby, FW, Elewski, BE, Garnis-Jones, S, Giroux, JM, Gratton, D, Gulliver, W, Hull, P, Jones, HE, Journet, M, Krol, A, Leyden, JJ, Maddin, SC, Ross, JB, Savin, RC, Scher, RK, Sibbald, GR, Tawfik, NH, Zaias, N, Tolpin, M, Evans, S, Marsolais, C, Chin, T, Lin, TH, Maher, T & Birnbaum, JE 1997, 'Oral terbinafine in the treatment of toenail onychomycosis: North American multicenter trial', Journal of the American Academy of Dermatology, vol. 37, no. 5 I, pp. 740-745.
Drake LA, Shear NH, Arlette JP, Cloutier R, Danby FW, Elewski BE et al. Oral terbinafine in the treatment of toenail onychomycosis: North American multicenter trial. Journal of the American Academy of Dermatology. 1997;37(5 I):740-745.
Drake, L. A. ; Shear, N. H. ; Arlette, J. P. ; Cloutier, R. ; Danby, F. W. ; Elewski, B. E. ; Garnis-Jones, S. ; Giroux, J. M. ; Gratton, D. ; Gulliver, W. ; Hull, P. ; Jones, H. E. ; Journet, M. ; Krol, Alfons ; Leyden, J. J. ; Maddin, S. C. ; Ross, J. B. ; Savin, R. C. ; Scher, R. K. ; Sibbald, G. R. ; Tawfik, N. H. ; Zaias, N. ; Tolpin, M. ; Evans, S. ; Marsolais, C. ; Chin, T. ; Lin, T. H. ; Maher, T. ; Birnbaum, J. E. / Oral terbinafine in the treatment of toenail onychomycosis : North American multicenter trial. In: Journal of the American Academy of Dermatology. 1997 ; Vol. 37, No. 5 I. pp. 740-745.
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abstract = "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.",
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T1 - Oral terbinafine in the treatment of toenail onychomycosis

T2 - North American multicenter trial

AU - Drake, L. A.

AU - Shear, N. H.

AU - Arlette, J. P.

AU - Cloutier, R.

AU - Danby, F. W.

AU - Elewski, B. E.

AU - Garnis-Jones, S.

AU - Giroux, J. M.

AU - Gratton, D.

AU - Gulliver, W.

AU - Hull, P.

AU - Jones, H. E.

AU - Journet, M.

AU - Krol, Alfons

AU - Leyden, J. J.

AU - Maddin, S. C.

AU - Ross, J. B.

AU - Savin, R. C.

AU - Scher, R. K.

AU - Sibbald, G. R.

AU - Tawfik, N. H.

AU - Zaias, N.

AU - Tolpin, M.

AU - Evans, S.

AU - Marsolais, C.

AU - Chin, T.

AU - Lin, T. H.

AU - Maher, T.

AU - Birnbaum, J. E.

PY - 1997

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N2 - 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.

AB - 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.

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