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: yes Duration of complaint: yes
Inclusion and exclusion criteria specified: yes
Interventions well described: yes
Assessment of compliance: not stated
Reoccurrence status: yes
Intention to treat analysis: not stated
A Priori sample size calculation: not stated
Fungi identified: yes
Distribution of species between groups: no
Adverse events reported: yes
Number of drop outs stated: 41 |
Participants |
Total evaluable sample size: 183
Inclusion criteria: 12 yrs and older
Exclusion criteria: Hyperkeratotic plantar type tinea pedis
Treatment setting: eight different sites |
Interventions |
a. Naftifine 1% cream
Duration: four weeks
Frequency: applied once daily
b. Placebo cream
Duration: four weeks
Frequency: applied once daily |
Outcomes |
Primary outcome: Cure
Secondary Outcomes: Signs and symptoms
‐ erythems, maceration, pruritus
Global improvement
Adverse events: a. 2 b. 5 soreness, burning, eczema, exacerbation of folliculitis, itching |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |