Open randomized comparison of different itraconazole regimens for the treatment of onychomycosis

Abstract

Aims: This study aimed to compare the efficacy of four different itraconazole regimens in the treatment of toenail onychomycosis caused by dermatophytes.

Methods: The four treatment regimens were: 3 months and 4 months of continuous treatment (200 mg/day of itraconazole) vs 3 months and 4 months of pulse therapy (400 mg/day of itraconazole for 1 week every month). The follow-up period was for 48 weeks after the end of treatment.

Results: A total of 66 patients completed the study. Only three patients (4.5%) had reversible abnormal liver function tests. No significant difference in cure rates was noted between the pulse and the continuous treatment regimens during the follow-up period. At 12 and 24 weeks after the end of treatment, more patients in the 4-month treatment groups were cured compared with the 3-month treatment groups. However, at the end of the follow-up period the cure rates levelled among the four different regimens.

Conclusion: Itraconazole, in each of the regimens tested, proved to be efficient and safe for the long-term treatment of onychomycosis. Because no difference was noted between the four regimens, the shorter and more tolerable 3-month pulse treatment is preferable.

Key Words:

• Continuous treatment
• Itraconazole
• Onychomycosis
• Pulse therapy