Open randomized comparison of itraconazole versus terbinafine in onychomycosis

Int J Dermatol. 1995 Feb;34(2):138-43. doi: 10.1111/j.1365-4362.1995.tb03600.x.


Background: Onychomycoses are among the most frequent nail diseases. The principal agents are dermatophytes. Itraconazole and terbinafine are two effective and systemic antimycotics. Previous trials have shown, that treatment schedules with effective concentrations for 3 months cause drug deposits in nail plates that persist 6 months after the end of the treatment.

Methods: A comparative, open, prospective study was carried out with random assignment of patients. The first group included 27 patients under treatment with 200 mg of itraconazole once daily for 3 months. The second group included 26 patients treated with 250 mg of terbinafine for 3 months. Both series of patients were followed for 6 additional months.

Results: Both groups were similar in age, sex, and history of onychomycosis. Trichophyton rubrum was the main isolated agent in all patients. The percentage of diseased nails was similar in both groups affecting predominantly the first toenail. Treatment was highly effective and differences between groups were not significant. The rate of adverse events was 21% in the itraconazole group and 47% in the terbinafine group.

Conclusions: Itraconazole and terbinafine are two drugs of choice in dermatophytic onychomycosis.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Antifungal Agents / administration & dosage
  • Antifungal Agents / therapeutic use*
  • Drug Administration Schedule
  • Female
  • Foot Dermatoses / drug therapy
  • Foot Dermatoses / physiopathology
  • Humans
  • Itraconazole / administration & dosage
  • Itraconazole / therapeutic use*
  • Male
  • Middle Aged
  • Naphthalenes / administration & dosage
  • Naphthalenes / therapeutic use*
  • Onychomycosis / drug therapy*
  • Onychomycosis / physiopathology
  • Prospective Studies
  • Terbinafine
  • Treatment Outcome


  • Antifungal Agents
  • Naphthalenes
  • Itraconazole
  • Terbinafine