Abstract | BACKGROUND: 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.
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Authors | E Svejgaard, C Avnstorp, B Wanscher, J Nilsson, A Heremans |
Journal | Dermatology (Basel, Switzerland)
(Dermatology)
Vol. 197
Issue 4
Pg. 368-72
( 1998)
ISSN: 1018-8665 [Print] Switzerland |
PMID | 9873176
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antifungal Agents
- Placebos
- Itraconazole
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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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