| Methods |
RCT
Study aim clearly defined: yes
Blinded assessor of primary outcome: yes
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: yes
Intention to treat analysis: yes
A Priori sample size calculation: not stated
Fungi identified: yes
Distribution of species between groups: yes
Adverse events reported: yes
Number of drop outs stated: yes |
| Participants |
Total evaluable sample size: 271
Inclusion criteria: Erythema and at least scaling or pruritus
Exclusion criteria: concomittant fungal infections
diffuse moccasin type tinea pedis
use of topical antifungals within two weeks prior to study
use of systemic antifungals within two months of study
Treatment setting: ten study sites |
| Interventions |
a. Butenafine 1% cream
Duration: one week
Frequency: applied twice daily
b. Placebo cream
Duration: one week
Frequency: applied twice daily |
| Outcomes |
Primary outcome: cure
Secondary Outcomes: Signs and symptoms
‐ itching, erythema, scaling, fissuring, exudation, pustules, maceration, vesiculation
Adverse events: a. burning and stinging b. burning, tingling, elevated AST and ALT levels |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
