Hill 1998.
Methods | Randomised, parallel‐group design. The study was conducted in a secondary care setting at different dermatology departments in the UK |
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Participants | 120 participants with diagnosis of eczema on one or both hands, and with suspected or confirmed infection
Dropouts: 10 Inclusion criteria of the trial
Exclusion criteria of the trial
Study population
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Interventions |
Intervention • Betamethasone‐valerate 0.1% + clioquinol 3% cream twice daily for 4 weeks in 57/61 participants • Betamethasone‐v 0.1% + fusidic acid 2% cream twice daily in 53/55 participants for 4 weeks Duration 4 weeks |
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Outcomes |
Primary outcome of the trial
Other outcomes
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Notes | Primary outcome assessed at last on‐treatment visit: probably for most participants at week 4, but unclear how much earlier for dropouts (graph suggests after week 4). Not clear if data for secondary outcome number 2 (participant‐rated response) are presented The primary outcome percentage of participants with self‐rated good/excellent control and the secondary outcomes ‐ reduction in severity, investigator‐ and participant‐rated scoring ‐ were included but provided no reproducible data Declarations of interest: one study author was an employee of Leo Pharmaceuticals, Princes Risborourg, UK Funding: the study was designed and sponsored by Leo Pharmaceuticals, Princes Risborough, UK, manufacturer of the study drug Sample size rationale: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "treatment was allocated at random" Comment: the article states only that treatment was allocated at random, without further details |
Allocation concealment (selection bias) | Unclear risk | No details about how allocation was concealed from participants and clinicians |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "this was a multicentre, prospective, randomized, open‐parallel‐group comparison" Comment: not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "this was a multicentre, prospective, randomized, open‐parallel‐group comparison" Comment: not blinded, which might have affected observer‐rated outcomes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "... and were included in an intention‐to‐treat analysis in respect of the primary efficacy criterion only" Comment: intention‐to‐treat analysis |
Selective reporting (reporting bias) | Unclear risk | No trial registration found. We did not find major differences between what was stated in the Methods section and in the Results section; however the subscores for clinical signs and symptoms were not given, and it was stated only whether they were statistically significantly different |
Other bias | Unclear risk | Baseline comparisons: more 'severe' classification of signs in the betamethasone/fusidic acid group; unclear whether this constitutes a significant difference and was controlled for Diagnostic certainty: yes The study was completed |