| Methods |
RCT
Study aim clearly defined: yes
Blinded assessor of primary outcome: not stated
Double blind study: yes
Participants comparable at baseline for age: not stated 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: not stated
A Priori sample size calculation: not stated
Fungi identified: yes
Distribution of species between groups: not given
Adverse events reported: yes
Number of drop outs stated: three |
| Participants |
Total evaluable sample size: 321
Inclusion criteria: minimum severity score of six at least 1.5 for erythema and 2 for pruritus
Treatment setting: 17 centres U.S.A |
| Interventions |
a. Oxiconazole nitrate 1% and fluticazole 0.05% combination cream
Duration: one week of above, 3 weeks of oxiconazole nitrate 1%
Frequency: applied twice daily
b. Oxiconazole nitrate 1% cream
Duration: four weeks
Frequency: applied twice daily
c. Placebo cream
Duration: four weeks
Frequency: Twice daily |
| Outcomes |
Primary outcome: cure
Secondary Outcomes: Signs and symptoms
‐ itching, erythema, scaling, fissuring, exudation, pustules, maceration, vesiculation
Adverse events: a. 5.3% b. 7.5% c. 6% burning and pruritus |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
