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Topical treatments for fungal infections of the skin and nails of the foot.

Topical treatments for fungal infections of the skin and nails of the foot.

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Ellis 1989<br />

Methods RCT<br />

Study aim clearly defined: yes<br />

Blinded assessor <strong>of</strong> primary outcome: not stated<br />

Double blind study: yes<br />

Participants comparable at baseline <strong>for</strong> age: yes Sex: yes Duration <strong>of</strong> complaint: yes<br />

Inclusion <strong>and</strong> exclusion criteria specified: yes<br />

Interventions well described: yes<br />

Assessment <strong>of</strong> compliance: yes<br />

Intention to treat analysis: yes<br />

A Priori sample size calculation: not stated<br />

Fungi identified:yes<br />

Distribution <strong>of</strong> species between groups: yes<br />

Adverse events reported: yes<br />

Number <strong>of</strong> drop outs stated: 108<br />

Participants Total evaluable sample size: 163<br />

Exclusion criteria: use <strong>of</strong> topical anti<strong>fungal</strong> <strong>the</strong>rapy within 7 days prior to study<br />

use <strong>of</strong> systemic anti<strong>fungal</strong> <strong>the</strong>rapy within 30 days prior to study<br />

Treatment setting: twelve centres<br />

Interventions a. Oxiconazole nitrate cream<br />

Duration: four weeks<br />

Frequency: once daily plus once daily Placebo<br />

b. oxiconazole nitrate cream<br />

Duration: four weeks<br />

Frequency: twice daily<br />

c. Placebo<br />

Duration: four weeks<br />

Frequency: twice daily<br />

Outcomes Primary outcome: cure<br />

Secondary Outcomes: Signs <strong>and</strong> symptoms<br />

- ery<strong>the</strong>ma, scaling, fissuring, pustules, maceration, burning, crusting<br />

Global response<br />

Adverse events: burning, irritation, pruritus<br />

Notes<br />

Risk <strong>of</strong> bias<br />

Item Authors’ judgement Description<br />

Allocation concealment? Unclear B - Unclear<br />

<strong>Topical</strong> <strong>treatments</strong> <strong>for</strong> <strong>fungal</strong> <strong>infections</strong> <strong>of</strong> <strong>the</strong> <strong>skin</strong> <strong>and</strong> <strong>nails</strong> <strong>of</strong> <strong>the</strong> <strong>foot</strong>. (Review)<br />

Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.<br />

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