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Open randomized comparison of itraconazole versus terbinafine in onychomycosis

R Arenas1, J Domínguez-Cherit, L M Fernández

  • 1Department of Dermatology, General Hospital Dr. Manuel Gea González, Tlalpan, Mexico.

Abstract

Insights

Itraconazole and terbinafine are effective treatments for fungal nail infections (onychomycoses). Both drugs showed similar efficacy, though terbinafine had a higher rate of adverse events in this comparative study.

Area of Science:

  • Dermatology
  • Mycology
  • Pharmacology

Background:

  • Onychomycoses are common nail diseases primarily caused by dermatophytes.
  • Itraconazole and terbinafine are established systemic antifungal medications for onychomycosis.
  • Prior research indicates that effective drug concentrations persist in nail plates for months post-treatment.

Purpose of the Study:

  • To compare the efficacy and safety of itraconazole versus terbinafine in treating dermatophytic onychomycosis.
  • To evaluate treatment outcomes and adverse events in patients receiving either itraconazole or terbinafine.

Main Methods:

  • A prospective, randomized, open-label study involving 53 patients.
  • Group 1: 27 patients received itraconazole 200 mg daily for 3 months.
  • Group 2: 26 patients received terbinafine 250 mg daily for 3 months. Both groups were followed for 6 months post-treatment.

Main Results:

  • Trichophyton rubrum was the predominant fungal agent identified.
  • Both treatments demonstrated high effectiveness with no significant differences in clinical outcomes.
  • Adverse event rates were 21% for itraconazole and 47% for terbinafine.

Conclusions:

  • Itraconazole and terbinafine are both suitable first-line treatments for dermatophytic onychomycosis.
  • While effective, terbinafine was associated with a higher incidence of adverse events compared to itraconazole.

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