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

Faergemann 1986.

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 of the scalp


Exclusion criteria of the trial
  • No topical or systemic treatment with antifungal agents or corticosteroids for 3 weeks prior to the start of the study


Number of randomised participants: 70 participants in the whole study. In this review, we only considered the participants in the hydrocortisone (N = 24) and miconazole (N = 23) arms
Number of dropouts: 3 (5%)
Sex: 36 males, 34 females
Mean age (range): 38 (21 to 69) years
Country: Sweden
Interventions Treatment
  • Hydrocortisone 1% solution, applied to the scalp once daily for 3 weeks


Comparator/s
  • Miconazole 2%

  • Miconazole 2% and hydrocortisone 1% solution, applied to the scalp once daily for 3 weeks

Outcomes
  1. Number of cured participants and treatment failures

  2. Relapse rate

  3. Efficacy of prophylaxis

Notes The combination treatment arm of the trial was not included in this review. Adverse events were not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomly allocated"
Allocation concealment (selection bias) Unclear risk This was not reported
Similarity of the study groups (selection bias) Unclear risk Baseline data were not reported
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 number of dropouts was small
Selective reporting (reporting bias) Low risk Predefined outcomes were reported
Other bias Unclear risk The pharmaceutical industry provided the intervention solutions