Hollmen 2002.
Methods | RCT Study aim clearly defined: yes Blinded assessor of primary outcome: not stated Double blind study; yes Participants comparable at baseline for age: yes Sex: not stated Duration of complaint: not stated Inclusion and exclusion criteria specified: yes Interventions well described: yes Assessment of compliance: not stated Intention to treat analysis: yes A Priori sample size calculation: yes Fungi identified: not stated Distribution of species between groups: not stated Adverse events reported: not stated Number of drop outs stated: yes | |
Participants | Total evaluable sample size: 70 Exclusion criteria: less than 12 years of age. Inclusion criteria; tinea pedis. Treatment setting Six centres (three Belgium, three Finland) | |
Interventions | a. Terbinafine 1% gel Duration: Seven days Frequency: applied once daily b. Placebo Duration: seven days Frequency: applied once daily | |
Outcomes | Primary outcome; Mycological cure
Minimal signs of clinical disease erythema, desquamation, pruritis < 2 with no individual score > 1 and a severity score for pustulation, encrustation, and vesiculation of 0 Clinical cure; 6 symptoms assessed; 0= absent, 3= severe |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |