Once-weekly fluconazole (450 mg) for 4, 6, or 9 months of treatment for distal subungual onychomycosis of the toenail

M. R. Ling, L. J. Swinyer, M. T. Jarrat, L. Falo, E. W. Monroe, M. Tharp, J. Kalivas, G. D. Weinstein, R. G. Asarch, L. Drake, A. G. Martin, J. J. Leyden, J. Cook, D. M. Pariser, R. Pariser, B. H. Thiers, M. G. Lebwohl, D. Babel, D. M. Stewart, W. H. EaglsteinV. Falanga, H. I. Katz, W. F. Bergfeld, Jon Hanifin, S. Kang, C. J. McDonald, J. Muglia, B. S. Goffe, M. R. Young

Research output: Contribution to journalArticle

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Abstract

Background: Fluconazole is a bis-triazole antifungal agent approved for the treatment of oropharyngeal, esophageal, and vaginal candidiasis, serious systemic candidal infections, and cryptococcal meningitis. Objective: The purpose of this study was to evaluate three different durations of once- weekly fluconazole for the treatment of onychomycosis of the toenail caused by dermatophytes. Methods: In a multicenter, randomized, double-blind, parallel, placebo-controlled trial, 384 patients with distal subungual onychomycosis of the toenail received fluconazole, 450 mg once weekly, or placebo for 4, 6, or 9 months. For inclusion, patients were required to have mycologically confirmed distal subungual onychomycosis of the toenail with a large toenail at least 25% clinically affected but having at least 2 mm of healthy nail between the nail fold and the proximal onychomycotic border. Efficacy was assessed by clinical and mycologic (microscopic and microbiologic) measures at screening, at every treatment visit starting at month 3, and at months 2, 4, and 6 after therapy. Observed or volunteered adverse events were recorded and classified at all visits. Results: At the end of treatment, very significantly superior clinical and mycologic results were achieved in all fluconazole groups compared with placebo (p = 0.0001). This superiority was largely maintained over 6 months of follow-up. The clinical and mycologic responses of the 9-month treatment duration were significantly superior to the 4- and 6-month durations. Similar percentages of patients in the fluconazole and placebo groups reported adverse experiences for all three durations of the study. Conclusion: Results of this study support the efficacy and safety of fluconazole in the treatment of distal subungual onychomycosis of the toenail.

Original languageEnglish (US)
JournalJournal of the American Academy of Dermatology
Volume38
Issue number6 II
StatePublished - 1998
Externally publishedYes

Fingerprint

Onychomycosis
Fluconazole
Nails
Placebos
Therapeutics
Cryptococcal Meningitis
Arthrodermataceae
Triazoles
Antifungal Agents
Safety
Infection

ASJC Scopus subject areas

  • Dermatology

Cite this

Ling, M. R., Swinyer, L. J., Jarrat, M. T., Falo, L., Monroe, E. W., Tharp, M., ... Young, M. R. (1998). Once-weekly fluconazole (450 mg) for 4, 6, or 9 months of treatment for distal subungual onychomycosis of the toenail. Journal of the American Academy of Dermatology, 38(6 II).

Once-weekly fluconazole (450 mg) for 4, 6, or 9 months of treatment for distal subungual onychomycosis of the toenail. / Ling, M. R.; Swinyer, L. J.; Jarrat, M. T.; Falo, L.; Monroe, E. W.; Tharp, M.; Kalivas, J.; Weinstein, G. D.; Asarch, R. G.; Drake, L.; Martin, A. G.; Leyden, J. J.; Cook, J.; Pariser, D. M.; Pariser, R.; Thiers, B. H.; Lebwohl, M. G.; Babel, D.; Stewart, D. M.; Eaglstein, W. H.; Falanga, V.; Katz, H. I.; Bergfeld, W. F.; Hanifin, Jon; Kang, S.; McDonald, C. J.; Muglia, J.; Goffe, B. S.; Young, M. R.

In: Journal of the American Academy of Dermatology, Vol. 38, No. 6 II, 1998.

Research output: Contribution to journalArticle

Ling, MR, Swinyer, LJ, Jarrat, MT, Falo, L, Monroe, EW, Tharp, M, Kalivas, J, Weinstein, GD, Asarch, RG, Drake, L, Martin, AG, Leyden, JJ, Cook, J, Pariser, DM, Pariser, R, Thiers, BH, Lebwohl, MG, Babel, D, Stewart, DM, Eaglstein, WH, Falanga, V, Katz, HI, Bergfeld, WF, Hanifin, J, Kang, S, McDonald, CJ, Muglia, J, Goffe, BS & Young, MR 1998, 'Once-weekly fluconazole (450 mg) for 4, 6, or 9 months of treatment for distal subungual onychomycosis of the toenail', Journal of the American Academy of Dermatology, vol. 38, no. 6 II.
Ling, M. R. ; Swinyer, L. J. ; Jarrat, M. T. ; Falo, L. ; Monroe, E. W. ; Tharp, M. ; Kalivas, J. ; Weinstein, G. D. ; Asarch, R. G. ; Drake, L. ; Martin, A. G. ; Leyden, J. J. ; Cook, J. ; Pariser, D. M. ; Pariser, R. ; Thiers, B. H. ; Lebwohl, M. G. ; Babel, D. ; Stewart, D. M. ; Eaglstein, W. H. ; Falanga, V. ; Katz, H. I. ; Bergfeld, W. F. ; Hanifin, Jon ; Kang, S. ; McDonald, C. J. ; Muglia, J. ; Goffe, B. S. ; Young, M. R. / Once-weekly fluconazole (450 mg) for 4, 6, or 9 months of treatment for distal subungual onychomycosis of the toenail. In: Journal of the American Academy of Dermatology. 1998 ; Vol. 38, No. 6 II.
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abstract = "Background: Fluconazole is a bis-triazole antifungal agent approved for the treatment of oropharyngeal, esophageal, and vaginal candidiasis, serious systemic candidal infections, and cryptococcal meningitis. Objective: The purpose of this study was to evaluate three different durations of once- weekly fluconazole for the treatment of onychomycosis of the toenail caused by dermatophytes. Methods: In a multicenter, randomized, double-blind, parallel, placebo-controlled trial, 384 patients with distal subungual onychomycosis of the toenail received fluconazole, 450 mg once weekly, or placebo for 4, 6, or 9 months. For inclusion, patients were required to have mycologically confirmed distal subungual onychomycosis of the toenail with a large toenail at least 25{\%} clinically affected but having at least 2 mm of healthy nail between the nail fold and the proximal onychomycotic border. Efficacy was assessed by clinical and mycologic (microscopic and microbiologic) measures at screening, at every treatment visit starting at month 3, and at months 2, 4, and 6 after therapy. Observed or volunteered adverse events were recorded and classified at all visits. Results: At the end of treatment, very significantly superior clinical and mycologic results were achieved in all fluconazole groups compared with placebo (p = 0.0001). This superiority was largely maintained over 6 months of follow-up. The clinical and mycologic responses of the 9-month treatment duration were significantly superior to the 4- and 6-month durations. Similar percentages of patients in the fluconazole and placebo groups reported adverse experiences for all three durations of the study. Conclusion: Results of this study support the efficacy and safety of fluconazole in the treatment of distal subungual onychomycosis of the toenail.",
author = "Ling, {M. R.} and Swinyer, {L. J.} and Jarrat, {M. T.} and L. Falo and Monroe, {E. W.} and M. Tharp and J. Kalivas and Weinstein, {G. D.} and Asarch, {R. G.} and L. Drake and Martin, {A. G.} and Leyden, {J. J.} and J. Cook and Pariser, {D. M.} and R. Pariser and Thiers, {B. H.} and Lebwohl, {M. G.} and D. Babel and Stewart, {D. M.} and Eaglstein, {W. H.} and V. Falanga and Katz, {H. I.} and Bergfeld, {W. F.} and Jon Hanifin and S. Kang and McDonald, {C. J.} and J. Muglia and Goffe, {B. S.} and Young, {M. R.}",
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TY - JOUR

T1 - Once-weekly fluconazole (450 mg) for 4, 6, or 9 months of treatment for distal subungual onychomycosis of the toenail

AU - Ling, M. R.

AU - Swinyer, L. J.

AU - Jarrat, M. T.

AU - Falo, L.

AU - Monroe, E. W.

AU - Tharp, M.

AU - Kalivas, J.

AU - Weinstein, G. D.

AU - Asarch, R. G.

AU - Drake, L.

AU - Martin, A. G.

AU - Leyden, J. J.

AU - Cook, J.

AU - Pariser, D. M.

AU - Pariser, R.

AU - Thiers, B. H.

AU - Lebwohl, M. G.

AU - Babel, D.

AU - Stewart, D. M.

AU - Eaglstein, W. H.

AU - Falanga, V.

AU - Katz, H. I.

AU - Bergfeld, W. F.

AU - Hanifin, Jon

AU - Kang, S.

AU - McDonald, C. J.

AU - Muglia, J.

AU - Goffe, B. S.

AU - Young, M. R.

PY - 1998

Y1 - 1998

N2 - Background: Fluconazole is a bis-triazole antifungal agent approved for the treatment of oropharyngeal, esophageal, and vaginal candidiasis, serious systemic candidal infections, and cryptococcal meningitis. Objective: The purpose of this study was to evaluate three different durations of once- weekly fluconazole for the treatment of onychomycosis of the toenail caused by dermatophytes. Methods: In a multicenter, randomized, double-blind, parallel, placebo-controlled trial, 384 patients with distal subungual onychomycosis of the toenail received fluconazole, 450 mg once weekly, or placebo for 4, 6, or 9 months. For inclusion, patients were required to have mycologically confirmed distal subungual onychomycosis of the toenail with a large toenail at least 25% clinically affected but having at least 2 mm of healthy nail between the nail fold and the proximal onychomycotic border. Efficacy was assessed by clinical and mycologic (microscopic and microbiologic) measures at screening, at every treatment visit starting at month 3, and at months 2, 4, and 6 after therapy. Observed or volunteered adverse events were recorded and classified at all visits. Results: At the end of treatment, very significantly superior clinical and mycologic results were achieved in all fluconazole groups compared with placebo (p = 0.0001). This superiority was largely maintained over 6 months of follow-up. The clinical and mycologic responses of the 9-month treatment duration were significantly superior to the 4- and 6-month durations. Similar percentages of patients in the fluconazole and placebo groups reported adverse experiences for all three durations of the study. Conclusion: Results of this study support the efficacy and safety of fluconazole in the treatment of distal subungual onychomycosis of the toenail.

AB - Background: Fluconazole is a bis-triazole antifungal agent approved for the treatment of oropharyngeal, esophageal, and vaginal candidiasis, serious systemic candidal infections, and cryptococcal meningitis. Objective: The purpose of this study was to evaluate three different durations of once- weekly fluconazole for the treatment of onychomycosis of the toenail caused by dermatophytes. Methods: In a multicenter, randomized, double-blind, parallel, placebo-controlled trial, 384 patients with distal subungual onychomycosis of the toenail received fluconazole, 450 mg once weekly, or placebo for 4, 6, or 9 months. For inclusion, patients were required to have mycologically confirmed distal subungual onychomycosis of the toenail with a large toenail at least 25% clinically affected but having at least 2 mm of healthy nail between the nail fold and the proximal onychomycotic border. Efficacy was assessed by clinical and mycologic (microscopic and microbiologic) measures at screening, at every treatment visit starting at month 3, and at months 2, 4, and 6 after therapy. Observed or volunteered adverse events were recorded and classified at all visits. Results: At the end of treatment, very significantly superior clinical and mycologic results were achieved in all fluconazole groups compared with placebo (p = 0.0001). This superiority was largely maintained over 6 months of follow-up. The clinical and mycologic responses of the 9-month treatment duration were significantly superior to the 4- and 6-month durations. Similar percentages of patients in the fluconazole and placebo groups reported adverse experiences for all three durations of the study. Conclusion: Results of this study support the efficacy and safety of fluconazole in the treatment of distal subungual onychomycosis of the toenail.

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