Itraconazole in onychomycosis: intermittent dose schedule.

Fifty (13 men and 37 women) consecutive patients, attending the Dermatology. Department of the General Hospital of Mexico, with mycologically proven onychomycosis of the finger and toenails were included in an open clinical trial. These patients received a pulse regimen of itraconazole (200 mg twice daily) given after meals during the first week of each month, for 3 consecutive months. After the last dose, the drug was discontinued, and patients were followed-up for 9 months. Initially, the patients underwent a clinical and fungal evaluation. The study included those with positive potassium hydroxide (KOH) preparation and mycologic cultures, who had not been treated either with a systemic antifungal agent for a period of 3 months prior to the study or with a topical agent for a 1-month period prior to the study. Complete blood count and liver test functions that included transaminase, total bilirubin, alkaline phosphatase, and lactic dehydrogenase were carried out at the beginning of the study, after the first half of the study (second pulse), and 2 weeks after completion of treatment. Exclusion criteria were pregnant or lactating women, patients receiving antimycotic treatment during the 3 previous months or patients under treatment for gastric hyperacidity. Three mycologic examinations were carried out: before starting treatment in order to identify the fungal species; after the third pulse; and 3, 6, and 9 months after the last drug administration. The effectiveness of the drug was evaluated based on Zaias' method to estimate the reduction of the affected area. A 400 mg/day dose of oral itraconazole was administered in two takes: 200 mg after breakfast and 200 mg after dinner for 1 week (first pulse). The drug was discontinued for a 3-week period and this regimen was applied twice. This meant that only three treatment periods or pulses were carried out. Follow-up visits were scheduled at 6 months after completion of treatment for handnails and 9 months for toenails. At the end of the study, a correlation between clinical-mycologic outcome and liver function tests were carried out to assess the effectiveness and safety of the proposed treatment regimen.