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

Rudner 1970.

Methods Study type: individual RCT
Randomisation method: a standard randomisation sheet was used
Blinding: double‐blind
Intention‐to‐treat analysis used: no
Participants Inclusion criteria of the trial
  • Not reported. Each had seborrhoeic dermatitis occurring primarily in the nasolabial folds


Exclusion criteria of the trial
  • Not reported


Number of randomised participants: 50 in total (the initial group assignment numbers have not been reported. By the end of the study, there were 24 participants in the fluocinolone group and 19 participants in the vehicle group)
Number of dropouts: 7 (14%)
Sex of those who completed (baseline was not reported): 21 males and 22 females
Age: not reported as mean, median, or range (reported as number of participants in 6 different age groups)
Country: USA
Interventions Treatment
  • Fluocinolone acetonide solution 0.01%, applied on the face twice a day for 84 days (12 weeks)


Comparator/s
  • Propylene glycol solution, applied on the face twice daily for 84 days (12 weeks)


Each participant was instructed to shampoo the scalp once weekly with Drytergent®
Outcomes
  1. Clinical severity scores (erythema and scaling, scale 1+ to 3+) excluding scalp, clinical photographs

Notes Only inpatients were included
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk This was not reported in detail
Quote: "standard randomization sheet"
Allocation concealment (selection bias) Unclear risk This was not reported
Similarity of the study groups (selection bias) Unclear risk This was not reported
Blinding of participants (performance bias) Low risk The study was double‐blind, but it was not reported specifically which parties were blinded. Nevertheless, the participants received the intervention and the comparison in identical containers
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 Unclear risk The dropout rate was 24% in the control group. The initial group assignment numbers were not reported
Selective reporting (reporting bias) Unclear risk Prespecified outcomes were reported
Other bias Low risk No other bias was identified