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

Kousidou 1992.

Methods Study type: individual RCT
Randomisation method: not reported
Blinding: double‐blind
Intention‐to‐treat analysis used: not reported
Participants Inclusion criteria of the trial
  • Seborrhoeic dermatitis


Exclusion criteria of the trial
  • Not reported


Number of randomised participants: 40 in total (hydrocortisone N = 20, ketoconazole N = 20)
Number of dropouts: 1 (3%)
Sex: 21 males, 19 females
Age (mean): 33.7 years
Country: Greece
Interventions Treatment
  • Hydrocortisone 1% cream, applied to the affected areas once daily for 4 weeks


Comparator/s
  • Ketoconazole 2% cream, applied to the affected areas once daily for 4 weeks

Outcomes
  1. Erythema score (scale 0 to 9), scaling score (scale 0 to 10), pruritus score (scale 0 to 6), decrease in the number of Pityrosporum ovale colonies, and global evaluation (total improvement, good, fair, poor)

  2. Adverse events

Notes No standard deviations nor exact P values were given in the report. We have approximated the actual numbers from figures
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "They were randomized"
Allocation concealment (selection bias) Unclear risk This was not reported
Similarity of the study groups (selection bias) Low risk Quote: "At the start of treatment, erythema, scaling, and pruritus were present in all patients of both groups without any statistically significant difference in the mean scores"
Blinding of participants (performance bias) Unclear risk Whilst the study was reported to be double‐blind, it was not clear who was blinded
Blinding of care providers (performance bias) Unclear risk Whilst the study was reported to be double‐blind, it was not clear who was blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Whilst the study was reported to be double‐blind, it was not clear who was blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk The dropout rate was small
Selective reporting (reporting bias) Low risk Predefined outcomes were reported
Other bias Unclear risk 2 authors were affiliated to the pharmaceutical industry