Baskan 2005.
Methods | Within‐participant, placebo‐controlled, randomised controlled trial The study was conducted in the secondary setting at a single centre in Turkey |
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Participants | 25 participants with moderate to severe bilateral hand dermatitis with a minimal duration of 6 months Dropouts: 1 Inclusion criteria of the trial
Exclusion criteria of the trial
Study population
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Interventions |
Intervention • Pimecrolimus 1% cream twice daily in 24/25 hands presumably for 8 weeks Control intervention • Placebo cream twice daily presumably for 8 weeks in 24/25 hands • Participants were followed up for the same period Duration 16 weeks (8 weeks active treatment, 8 weeks follow‐up) |
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Outcomes |
Primary outcomes of the trial Not defined Other outcomes • Clinical response to therapy; erythema, desquamation, lichenification, oedema, vesiculation, and fissuring were scored between 0 and 4 and were controlled at 2nd, 4th, 6th, and 8th weeks of therapy • Clinical response to therapy for pruritus • At the end of therapy, participants were followed up for the same period to observe recurrences • Adverse events |
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Notes | Conference abstract from which only limited information can be extracted Study authors were contacted for additional information, which led to review of an additional full‐text article in Turkish. The secondary outcome ‐ reduction in severity, investigator‐rated ‐ was included but did not provide reproducible data Declarations of interest: not stated Funding: not stated in the paper, but personal communication clarified that study authors did not receive any 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 | Study authors stated randomised but gave no clear description of how this was attained. Personal communication with study authors clarified that they used a card drawing system Quote: "a simple randomisation method by card drawing was performed" |
Allocation concealment (selection bias) | Low risk | No information on how allocation was concealed from participants and investigators is provided in the abstract Personal communication clarified that one investigator drew the cards after participants gave their consent. The topical drugs were packed in yellow and red boxes, and staff gave participants the corresponding boxes for treatment, without knowledge about the content of those boxes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Not clear from the abstract; however personal communication clarified that dispensation of study drug was done by a third person in boxes labelled for each hand. The vehicle and pimecrolimus were packed in similar boxes and were indistinguishable for participants |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not clear from the abstract; however personal communication clarified that observation was done by another physician who was not involved in randomisation or drug dispensation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Unclear whether an intention‐to‐treat analysis was conducted; however 24 of the 25 included participants completed the study, which is more than 80% |
Selective reporting (reporting bias) | Low risk | No trial registration found. All relevant clinical signs were scored in the symptom score, and all described outcomes were depicted in the Results section |
Other bias | Low risk | No baseline comparisons were conducted or reported, as within‐participant study was not applicable Diagnostic certainty: yes The study was completed |