| 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: not stated
Inclusion and exclusion criteria specified: not stated
Interventions well described: yes
Assessment of compliance: no
Intention to treat analysis: no
A Priori sample size calculation: no
Fungi identified: yes
Distribution of species between groups: no
Adverse events reported: yes
Number of drop outs stated: 13 |
| Participants |
Total evaluable sample size: 88
Treatment setting: Four different sites |
| Interventions |
a. Naftifine 1% gel
Duration: four weeks
Frequency: applied twice daily
b. Placebo gel
Duration: four weeks
Frequency: applied twice daily |
| Outcomes |
Primary outcome: Cure
Secondary Outcomes: Signs and symptoms
‐ fissuring, pruritus,vesiculation
Global improvement
Adverse events: a. 8 b. 18 burning, stinging, itching |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
