A comparison among four regimens of itraconazole treatment in onychomycosis

The purpose of this study was to compare the efficacy of different dosage r egimens in the management of onychomycosis with itraconazole and to determi ne the results of a further 1-week intermittent pulse treatment in non-cure d patients. In this study, 153 patients were randomly allocated to four gro ups. Patients in group A were treated with daily doses of 100 mg for 3 mont hs 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 f or 3 weeks, three cycles for fingernail and four cycles for toenail infecti on. The daily doses were 400 mg (group B), 300 mg (group C) and 200 mg (gro up D). After therapy, non-cured patients were treated further with one cycl e in which the daily dose was 400 mg. Patients were subsequently observed f or 9 months and efficacy was assessed by mycological examination and the gr owth 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 sign ificant 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. Th e 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 tolcrability was equally good in the four groups. Intermittent pulse therapy with a daily d ose of 400 mg had the highest cure rate. Treatment of improved but non-cure d patients with a dose of 400 mg intermittent pulse therapy markedly increa sed the cure rate. All treatment regimens were well tolerated.