Schnopp 2002.
Methods | Within‐participant, randomised controlled study This study was carried out in a secondary care setting at a single dermatology department in Germany |
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Participants | 16 participants with moderate to severe chronic relapsing dyshidrotic eczema on hands No dropouts Inclusion criteria of the trial
Exclusion criteria of the trial
Study population
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Interventions |
Intervention • Tacrolimus 0.1% ointment twice daily on 12/12 hands for 4 weeks • Mometasone furoate 0.1% ointment twice daily on 12/12 contralateral hands for 4 weeks Follow‐up period was up to 8 weeks after the end of treatment Duration 12 weeks (4 weeks of active treatment, up to 8 weeks of follow‐up) |
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Outcomes |
Primary outcome of the trial
Other outcomes
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Notes | Originally, 20 participants with hand and/or foot involvement, 4 of whom were excluded due to poor disease control during the trial‐preceding washout phase. Study in 16 participants, of whom 12 had their hands involved. The limited data on the 4‐week post‐treatment follow‐up period are difficult to interpret. Outcome scores at week 4 presented graphically, without exact numbers Scoring of outcome (DASI) same as the study by Odia The secondary outcomes ‐ reduction in severity, participant‐rated, and time until relapse ‐ were included but did not provide reproducible data Study authors were contacted 3 March 2014 and replied 4 March 2014 Declarations of interest: none declared Funding: no funding Sample size rationale: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patients were randomly assigned....." Comment: no further details were given in the article; however personal communication with study authors clarified that they threw dice to create a randomisation list |
Allocation concealment (selection bias) | Low risk | No details in the article about how allocation was concealed from participants and clinicians. Contact with study authors clarified that the randomisation list was composed by a third person. This person was involved in the distribution of study drugs, but not in the recruiting. The third person held office in a different building of the hospital that was not accessible for physicians |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "this study was a randomized, observer‐blinded, intraindividual comparison study..." Comment: participants were not blinded during the study |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "all assessments were performed by an independent observer on separate sheets on different premises. Patients were instructed not to talk about treatment modalities" Comment: study authors clearly described how they tried to prevent detection bias. Observers were blinded adequately |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None of the participants dropped out during the study; all participants were included in the analyses (16 of 16 = 100%) |
Selective reporting (reporting bias) | Low risk | No trial registration found; however the DASI is a valid score for hand eczema and was described in the Methods and Results sections without major discrepancies |
Other bias | Low risk | Baseline comparisons: within‐participant study not applicable Diagnostic certainty: yes The study was completed |