An intermittent itraconazole 1‐week dosing regimen for the treatment of toenail onychomycosis in dermatological practice

Abstract

The efficacy and safety of an intermittent itraconazole dosing regimen was investigated in 354 patients with toenail onychomycosis, from 98 dermatology centres. Patients received itraconazole 400 mg daily for 1 week per month for 3 months. If the nail of the big toe was completely involved, a fourth treatment cycle was administered. Because of the short-term nature of the dosing regimen, renal and liver function tests were not compulsory. Cure rates were influenced by proximal nail involvement, particularly in the big toenails. At the end of month 10, clinical cure (complete clearance or clearance with a few small residual lesions) was achieved in 64% of patients with proximal nail involvement in the big toenails, in 77% of patients with proximal nail involvement in other toenails and in 87% of patients without proximal nail involvement; mycological cure was achieved in 77% of 197 patients examined. Fifty-nine patients (17%) reported adverse events: mainly headache, fatigue or minor gastrointestinal problems; only nine patients (3%) stopped treatment because of adverse events. Response rates were similar to those achieved with 3 months of continuous therapy with itraconazole or terbinafine but intermittent therapy is probably safer and is considerably cheaper than continuous itraconazole treatment.