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

Firooz 2006.

Methods Study type: individual RCT
Randomisation method: computer‐generated randomisation list
Blinding: investigator‐blind
Intention‐to‐treat analysis used: yes
Participants Inclusion criteria of the trial
  • Facial seborrhoeic dermatitis


Exclusion criteria of the trial
  • Malignant or active viral lesions on the face

  • People who had used antibiotics, immunosuppressive drugs, or phototherapy 1 month before treatment, and any topical therapy suspected to affect facial SeD during the 1 week before the beginning of the study


Number of randomised participants: 40 in total (pimecrolimus N = 20, hydrocortisone N = 20)
Number of dropouts: 3 (8%)
Sex: 28 males, 12 females
Age (mean): pimecrolimus arm = 28.65 years, hydrocortisone arm = 37.45 years
Country: Iran
Interventions Treatment
  • Pimecrolimus 1% cream, applied to the face twice daily for 2 weeks


Comparator/s
  • Hydrocortisone 1% cream, applied to the face twice daily for 2 weeks

Outcomes
  1. Complete disappearance of disease

  2. Severity of pruritus, erythema, and scaling (scales 0 to 3)

  3. Adverse events

  4. Relapses

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was computer‐generated
Allocation concealment (selection bias) Unclear risk This was not reported
Similarity of the study groups (selection bias) Low risk There were no statistically significant differences between groups
Blinding of participants (performance bias) High risk Only investigators were blinded
Blinding of care providers (performance bias) Unclear risk Quote: "investigator blind"
This probably refers to outcome assessment
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The investigator was blinded. We assume this refers to outcome assessment
Incomplete outcome data (attrition bias) 
 All outcomes Low risk The number of dropouts was acceptable
Selective reporting (reporting bias) Low risk Predefined outcomes were reported
Other bias Unclear risk The pharmaceutical industry provided ‐ free of charge ‐ the intervention creams