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. 2014 May 19;2014(5):CD009446. doi: 10.1002/14651858.CD009446.pub2

Rigopoulos 2004.

Methods Study type: individual RCT
Randomisation method: computer‐based randomisation
Blinding: no (open‐label)
Intention‐to‐treat analysis used: yes
Participants Inclusion criteria of the trial
  • Seborrhoeic dermatitis


Exclusion criteria of the trial
  • Other dermatoses of face

  • Topical treatments during the 6 months prior to entry in the study

  • Pregnancy or lactation


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
Interventions Treatment
  • Pimecrolimus 1% cream, applied to the face twice daily until symptoms were absent


Comparator/s
  • Betamethasone 0.1% cream, applied to the face twice daily until symptoms were absent

Outcomes
  1. Erythema, pruritus, and scaling scores (scale 0 to 3)

  2. Clearance and relapse rate

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
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