Efficacy and safety of short-term itraconazole in tinea pedis: A double-blind, randomized, placebo-controlled trial

Background: Treatment of plantar or moccasin-type tinea pedis with conventi onal oral antifungal agents produces poor response rates. Itraconazole is a synthetic, broad-spectrum, orally active antifungal agent with pronounced antimycotic activity. Objective: To confirm the efficacy and safety of shor t-term treatment with itraconazole for plantar or moccasin-type tinea pedis . Methods: The study was a double-blind, randomized, placebo-controlled, mu lticenter trial. Seventy-two patients with tinea pedis (plantar or moccasin -type) were treated with itraconazole (200 mg twice daily) or placebo for 1 week with an 8-week treatment-free follow-up period. Results: Thirty-six p atients were randomized to each treatment group. The overall success rate ( mycological cure and clinical response) at the end-point of follow-up was s ignificantly higher in the itraconazole group than in the placebo group (53 vs. 3%; p<0.001). Mycological cure (56 vs. 8%; p<0.001) and clinical respo nse rates (75 vs. 11%; p<0.001) were significantly higher after itraconazol e treatment compared with placebo treatment. During treatment, adverse even ts were recorded in 7 patients in the itraconazole group and 2 patients in the placebo group. Adverse events were noted in 3 patients in the placebo g roup during follow-up. No serious adverse events were reported in either gr oup. Conclusions: Short-term treatment with itraconazole was significantly more effective than placebo in tinea pedis. The safety and tolerability pro file or itraconazole was comparable with placebo.