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. 2007 Jul 18;2007(3):CD001434. doi: 10.1002/14651858.CD001434.pub2

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
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear