Uggeldahl 1986.
Methods | Within‐participant, randomised controlled trial This study was conducted in a secondary care setting, probably at 2 centres in Finland |
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Participants | 50 (46) participants (1.5 to 70 years) with bilateral moderate hand/wrist/lower arm eczema, with left‐right comparable severity, were included; 4 were excluded because of asymmetrical hand eczema
Dropouts: 2 Inclusion criteria of the trial
Exclusion criteria of the trial
Study population
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Interventions |
Intervention • Desonide cream 0.1% twice daily for 2 weeks in 44/46 hands • Desonide cream 0.05% twice daily in 44/46 contralateral hands for 2 weeks Duration 2 weeks |
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Outcomes |
Primary outcomes of the trial Not defined Other outcomes
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Notes | In fact, 50 participants were randomised, but 4 participants were excluded at the start. Not clear whether inclusion criteria of the trial (hand/wrist/lower arm) stipulated that the hands had to be involved in all participants. The youngest participant was 1.5 years old Aim was to study equivalency, but this was not reflected in the analysis The secondary outcomes ‐ reduction in severity, investigator‐rated and participant‐rated ‐ were included but did not provide reproducible data Declarations of interest: 2 study authors were employees of the research department at Apothekernes Laboratorium A.S., Oslo, Norway, the manufacturer of the study drugs Funding: see above item 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: "the study consisted of a double‐blind, randomized, left‐right comparative study..." Comment: stated only that this was a randomised study. No further details provided |
Allocation concealment (selection bias) | Low risk | Quote: "each patient was given 2 tubes identical in appearance...." Quote: "according to the double‐blind nature of the study, the creams were randomly allocated to the left and right side..." Comment: no details about how allocation was concealed from participants and clinicians. The identical tubes were randomly allocated to left and right sides |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "each patient was given 2 tubes identical in appearance...." Comment: the only difference between the 2 tubes was the concentration, wherefore this is considered as low risk |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "...double‐blind nature..." Comment: unclear whether observers were aware of the treatment modalities, although study authors claim double‐blind design |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No intention‐to‐treat analysis but per protocol (44 or 46 of 50 = more than 80%) |
Selective reporting (reporting bias) | Low risk | No trial registration found. No major discrepancies between Methods and Results sections |
Other bias | Low risk | Baseline comparisons: within‐participant study not applicable Diagnostic certainty: yes The study was completed |