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. 2007 Jul 18;2007(3):CD001434. doi: 10.1002/14651858.CD001434.pub2

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