A comparison among four regimens of itraconazole treatment in onychomycosis.

The purpose of this study was to compare the efficacy of different dosage regimens in the management of onychomycosis with itraconazole and to determine the results of a further 1-week intermittent pulse treatment in non-cured patients. In this study, 153 patients were randomly allocated to four groups. Patients in group A were treated with daily doses of 100 mg for 3 months in the case of fingernail onychomycosis and for 4 months in the case of toenail onychomycosis. Patients in the other groups received a intermittent pulse therapy, in which the drug was taken for 1 week, then discontinued for 3 weeks, three cycles for fingernail and four cycles for toenail infection. The daily doses were 400 mg (group B), 300 mg (group C) and 200 mg (group D). After therapy, non-cured patients were treated further with one cycle in which the daily dose was 400 mg. Patients were subsequently observed for 9 months and efficacy was assessed by mycological examination and the growth of unaffected nails. At the end of the therapy, the cure rates in the four groups were 19.1% (A), 15.2% (B), 18.9% (C) and 17.9% (D), and no significant differences were found between each of B, C, D and A. At the end of the study, the cure rates were 76.2%, 91.3%, 78.4%, 28.6% respectively. The group that received further treatment had a cure rate of 55.6% at the end of the first month and of 83.3% in the second month. Drug tolerability was equally good in the four groups. Intermittent pulse therapy with a daily dose of 400 mg had the highest cure rate. Treatment of improved but non-cured patients with a dose of 400 mg intermittent pulse therapy markedly increased the cure rate. All treatment regimens were well tolerated.

RCT Entities:   Population Interventions Outcomes