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 conventional 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 short-term treatment with itraconazole for plantar or moccasin-type tinea pedis.


METHODS
The study was a double-blind, randomized, placebo-controlled, multicenter 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 patients were randomized to each treatment group. The overall success rate (mycological cure and clinical response) at the end-point of follow-up was significantly 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 response rates (75 vs. 11%; p <0.001) were significantly higher after itraconazole treatment compared with placebo treatment. During treatment, adverse events 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 group during follow-up. No serious adverse events were reported in either group.


CONCLUSIONS
Short-term treatment with itraconazole was significantly more effective than placebo in tinea pedis. The safety and tolerability profile or itraconazole was comparable with placebo.
Svejgaard
E
E
Department of Dermatology, Bispebjerg Hospital, Copenhagen.
Avnstorp
C
C
Wanscher
B
B
Nilsson
J
J
Heremans
A
A
D015746:Abdominal Pain / Q000139:chemically induced; D000328:Adult; D000935:Antifungal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017964:Itraconazole / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D010352:Patient Dropouts; D010919:Placebos; D013997:Time Factors; D014008:Tinea Pedis / Q000188:drug therapy*; D016896:Treatment Outcome
D000935:Antifungal Agents; D010919:Placebos; D017964:Itraconazole