Spiekermann 1976b.
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: no Adverse events reported: yes Number of drop outs stated: no | |
Participants | Total evaluable sample size: 41 Exclusion criteria: use of topical/systemic anti infective or anti‐inflammatory agents within two weeks prior to study | |
Interventions | a. Clotrimazole 1% cream Duration: six weeks Frequency: applied twice daily b. Placebo cream Duration: six weeks Frequency: applied twice daily | |
Outcomes | Primary outcome: cure Secondary Outcomes: Signs and symptoms ‐ itching, erythema, scaling, fissuring, exudation, pustules, maceration, vesiculation, inflammation, edema Adverse events: a. irritation, stinging, burning | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |