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.
Topical treatments for fungal infections of the skin and nails of the foot.
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Aly 2003<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<br />
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: no<br />
Intention to treat analysis: no<br />
A Priori sample size calculation: no<br />
Fungi identified: yes<br />
Distribution <strong>of</strong> species between groups: not stated<br />
Adverse events reported: yes<br />
Number <strong>of</strong> drop outs stated: 57<br />
Participants Total evaluable sample size: 317<br />
Setting: Multicentre study in USA.<br />
Exclusion criteria<br />
treatment with any medication that could affect <strong>the</strong> course <strong>of</strong> <strong>the</strong> disease. Fungal infection else where on<br />
<strong>the</strong> body. <strong>Topical</strong> anti<strong>fungal</strong>s had a 14 day wash-out period <strong>and</strong> systemic a 28 day washout period.<br />
Interventions a. Ciclopirox Gel 0.77%<br />
Duration X 2 daily <strong>for</strong> 28 days<br />
b. Vehicle<br />
Duration X 2 daily <strong>for</strong> 28 days<br />
Outcomes Primary outcome:<br />
treatment success defined as mycological cure <strong>and</strong> > % 75% clinical improvement<br />
Notes Interdigital tinea pedis<br />
Adverse effects; 14 ciclopirox <strong>and</strong> 13 vehicle subjects reported burning sensations <strong>of</strong> <strong>the</strong> <strong>skin</strong>. Four<br />
ciclopirox <strong>and</strong> one vehicle subjects reported pruritus.<br />
Risk <strong>of</strong> bias<br />
Item Authors’ judgement Description<br />
Allocation concealment? Yes A - Adequate<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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