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

Cornell 1986.

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


Exclusion criteria of the trial
  • Pregnant women

  • People with known allergies to any component of the test medications

  • People who had used topical or systemic corticosteroid or other treatment for SeD during the month preceding the study

  • People with clinical evidence of skin atrophy, those requiring topical or systemic medication that would affect the course of the dermatologic disease, or people requiring more than 90 gm (45 gm per side) of study medication applied bi‐weekly


Number of randomised participants: 51 in total
Number of dropouts: 6 (12%)
Sex: 23 males, 28 females
Age (range): 19 to 82 years
Country: USA
Interventions Treatment
  • Alclometasone 0.05% ointment, applied to the scalp, face, and trunk twice daily for 6 weeks


Comparator/s
  • Hydrocortisone 1.0% ointment, applied to the scalp, face, and trunk twice daily for 6 weeks

Outcomes
  1. Changes in telangiectasia

  2. Overall severity of the dermatoses (scaling, erythema, and crusting, scale 0 to 3)

  3. Total clearance

Notes The location of seborrhoeic dermatitis lesions was not mentioned as inclusion criteria. However, the outcomes were evaluated on the face/neck, retroauricular areas, and scalp. The primary objective of the study was to compare atrophogenic potential of the products, but their efficacy was also evaluated. This is 1 of 2 included studies that compared 2 mild steroids with each other. The results concerning side‐effects are controversial. Score data can not be used because standard deviations and P values are lacking
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Study was a randomized"
Allocation concealment (selection bias) Unclear risk This was not reported
Similarity of the study groups (selection bias) Low risk Pretreatment symptom scores were identical between groups
Blinding of participants (performance bias) Low risk Double‐blind: Colour‐coded side‐labelled tubes were used
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 None were identified
Selective reporting (reporting bias) Low risk Predefined outcomes were reported
Other bias Low risk No other bias was identified