Rigopoulos 2004.
Methods | Study type: individual RCT Randomisation method: computer‐based randomisation Blinding: no (open‐label) Intention‐to‐treat analysis used: yes |
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Participants |
Inclusion criteria of the trial
Exclusion criteria of the trial
Number of randomised participants: 20 in total (pimecrolimus N = 11, betamethasone N = 9) Number of dropouts: 0 Sex: 16 males, 4 females Mean age (range): pimecrolimus arm = 36.4 (24 to 45) years, betamethasone arm = 37.2 (24 to 47) years Country: Greece |
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Interventions |
Treatment
Comparator/s
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Outcomes |
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Notes | The participants were instructed to discontinue use of the medicine as soon as symptoms were absent. All participants stopped treatment by day 9 because symptoms had disappeared We could not use erythema, pruritus, and scaling scores in the meta‐analysis because standard deviations or exact P values were not given in the report The location of SeD lesions were not mentioned as inclusion criteria, but other dermatoses of the face were reported as exclusion criteria suggesting that the skin of the face was a site of interest in the trial |
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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 to treatment...using a program that allocated every consecutive group of two patients to one patient in each group. The random numbers were generated by a computer and were assigned to the patients by the investigator's assistant" |
Allocation concealment (selection bias) | Unclear risk | The randomisation and allocation program allocated every consecutive group of 2 participants to 1 participant in each group, so the assistant would have known the latter participant's group in advance. However, the same assistant enrolled and assigned the treatment of the participants, whereas the investigator was masked |
Similarity of the study groups (selection bias) | Low risk | Quote: "The mean baseline score for erythema, pruritus and scaling did not differ significantly between the two treatment groups" |
Blinding of participants (performance bias) | High risk | The study was not blinded |
Blinding of care providers (performance bias) | Unclear risk | This was not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "in an attempt to make the assessments investigator masked" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None were identified |
Selective reporting (reporting bias) | Low risk | Predefined outcomes were reported |
Other bias | Low risk | No other bias was identified |