SHORT-TERM ITRACONAZOLE VERSUS TERBINAFINE IN THE TREATMENT OF SUPERFICIAL DERMATOMYCOSIS OF THE GLABROUS SKIN (TINEA-CORPORIS OR CRURIS)

The ability of itraconazole to inhibit the fungal cytochrome P450-depe ndent enzyme, 14 alpha-demethylase and the rapid and persistent accumu lation of itraconazole in the stratum corneum provide a rationale for the efficacy of a short-term, relatively high-dose treatment regimen i n patients with superficial dermatomycosis. The aim of the present dou ble-blind, multicentre trial,was to compare the efficacy and safety of itraconazole, 200 mg/day for 7 days with that of terbinafine, 250 mg/ day for 7 days in 230 patients with tinea corporis or cruris. Randomis ation occurred at a 2:1 ratio. After 5 weeks of follow-up, 81% of itra conazole-treated patients and 68% of terbinafine-treated patients were mycologically cured (p < 0.05). The clinical response rate was 84% in itraconazole-treated patients and 71 % in terbinafine-treated patient s (p < 0.05). In the patient self-assessment analysis during treatment , the area under the curve analysis over the first 7 days, expressed a s a percentage of the maximum possible value, showed that patients tre ated with itraconazole reported significantly less scaling (p = 0.035) , redness (p = 0.052) and itching (p = 0.012) than patients treated wi th terbinafine. At the end of treatment, 84% of itraconazole-treated p atients rated their treatment as good or excellent, compared with 56% of terbinafine-treated patients (p < 0.05). Both medications displayed good safety profiles, but tolerability was rated significantly higher in the itraconazole group than in the terbinafine group (p = 0.001). In conclusion, both I-week treatment regimens were effective against s uperficial dermatomycosis (tinea corporis or cruris), but itraconazole achieved significantly better mycological and clinical results, was s ignificantly better tolerated and received a significantly higher pati ent evaluation than terbinafine.