2-WEEK ORAL TREATMENT OF TINEA-PEDIS, COMPARING TERBINAFINE (250 MG DAY) WITH ITRACONAZOLE (100 MG/DAY) - A DOUBLE-BLIND, MULTICENTER STUDY/

In this randomized double-blind trial, two new antifungal compounds we re compared in patients with interdigital or more extensive forms of t inea pedis. Two weeks of oral treatment with either terbinafine, an al lylamine and new chemical entity, 250 mg daily, or itraconazole 100 mg daily, was given to 366 patients (184 terbinafine, 182 itraconazole). Of 13 patients who did not return after the first visit, 11 were lost to follow-up (five on terbinafine, six on itraconazole) and two repor ted adverse events. Another nine patients (three on terbinafine and si x on itraconazole) were excluded because it was uncertain to which gro up they were randomized. A central laboratory performed both the mycol ogy and safety tests. In 355 patients who received the study medicatio ns and were available for analysis of side-effects, 18 out of 179 (10. 0%) in the terbinafine group and 10 out of 176 (5.7%) in the itraconaz ole group reported adverse events. No new clinically significant labor atory abnormalities were seen after treatment. At week 8 the efficacy analysis in 117 patients with mycologically confirmed dermatophyte inf ections (51 on terbinafine, 66 on itraconazole) showed that clinical s ymptoms were absent or minimal in 94.1% of the terbinafine and 72.7% o f the itraconazole group (P=0.0095); mycology was negative in 86.3% of the terbinafine and 54.5% of the itraconazole group (P=0.0002). With terbinafine, negative mycology at week 8 was 81.3% in the interdigital and 88.6% in the more extensive forms of tinea pedis; with itraconazo le mycology was negative in 65.0% and 50.0% of patients, respectively. This study demonstrates that the primary fungicidal action of terbina fine, i.e. its ability to kill fungi at minimal inhibitory concentrati ons, is of substantial clinical and economic benefit to patients with tinea pedis. After a 2-week oral treatment period of any form of tinea pedis, terbinafine produced significantly higher mycological cure rat es and significantly better clinical improvement than itraconazole.