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

AbstractBACKGROUND:
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.
AuthorsE Svejgaard, C Avnstorp, B Wanscher, J Nilsson, A Heremans
JournalDermatology (Basel, Switzerland) (Dermatology) Vol. 197 Issue 4 Pg. 368-72 ( 1998) ISSN: 1018-8665 [Print] Switzerland
PMID9873176 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antifungal Agents
  • Placebos
  • Itraconazole
Topics
  • Abdominal Pain (chemically induced)
  • Adult
  • Antifungal Agents (adverse effects, therapeutic use)
  • Double-Blind Method
  • Female
  • Humans
  • Itraconazole (adverse effects, therapeutic use)
  • Male
  • Patient Dropouts
  • Placebos
  • Time Factors
  • Tinea Pedis (drug therapy)
  • Treatment Outcome

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