Walsoe 1990.
Methods | Design: double‐blind RCT | |
Participants | Number of participants randomised: 20 Sex: not stated for toenail subgroup (both sexes included) Mean age: not stated Number included in analysis: 20 Number completing treatment: 20 Inclusion criteria Type/location/characteristics of infection: toenail or fingernail onychomycosis caused by T rubrum or T mentagrophytes Duration of infection: not stated Exclusion criteria: antimycotic therapy within 1 month of start of study, pregnancy or serious concurrent disease Washout period: not explicitly stated, by participants with antimycotic therapy within 1 month of start of study were excluded Setting: not stated, study authors are all from Copenhagen Comorbidities: not stated |
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Interventions |
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Outcomes | Duration of follow‐up: 12 months Outcomes measured: cure (defined as clinical and mycological cure), marked improvement (defined as positive microscopy and negative culture), and improvement (50% clinical improvement compared to baseline and positive mycology) Safety and tolerability: side effects reported |
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Source of funding | No information available | |
Conflict of interest | No conflict of interest identified | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "double‐blind study ... randomised basis" Comment: method not stated |
Allocation concealment (selection bias) | Unclear risk | Quote: "double‐blind study ... randomised basis" Comment: method not stated |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "[f]or each patient, 12 boxes were prepared, each containing blister packs" Comment: blister packs were used, but it was not clear whether any visual differences remained between treatments |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double‐blind study ... randomised basis" Comment: method not stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants included in analysis |
Selective reporting (reporting bias) | Low risk | All results presented as set out in the Methods. All prespecified outcomes appear to be reported. |
Other bias | Low risk | No other risks of bias identified |