Skip to main content
. 2014 May 19;2014(5):CD009446. doi: 10.1002/14651858.CD009446.pub2

Ludvigsen 1983.

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


Exclusion criteria of the trial
  • Not reported


Number of randomised participants: 30 in total (betamethasone N = 15, hydrocortisone N = 15, but 1 of the participants in the latter group proved to be too young to be included, and the results were not used)
Number of dropouts: 1 participant was excluded after randomisation because of their young age (not considered a dropout); 1 participant was lost to follow up (considered a dropout, 3%)
Sex: 17 males, 12 females
Mean age (range): 49.9 (19 to 82) years
Country: Denmark
Interventions Treatment
  • Betamethasone 0.05% lotion, applied to the scalp twice daily for 3 weeks


Comparator/s
  • Hydrocortisone 0.1%, applied to the scalp twice daily for 3 weeks

Outcomes
  1. Erythema, scaling, follicular papule formation, crusting, itching, and burning/local irritation scores (scale 0 to 3)

  2. Total clearance evaluated by participants and clinician

  3. Adverse events

Notes Participants used drugs for 3 weeks or until complete healing. Outcomes were assessed at 3 weeks. Scores were calculated only for those who had the symptom
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "A computer programme was used to give the randomization code, which was stratified into blocks of 10 with a restriction against more than three successive patients receiving the same therapy"
Allocation concealment (selection bias) Unclear risk Quote: "randomization code, which was stratified into blocks of 10 with a restriction against more than three successive patients receiving the same therapy"
Similarity of the study groups (selection bias) Low risk Quote: "No statistically significant difference in patient classification of mean age, sex distribution and initial symptom score distribution was found between the two treatment groups but there was a numerically lower mean age in the HCB‐treated group"
44 years versus 56 years
Blinding of participants (performance bias) Unclear risk The study was "double‐blind"; this was not reported in detail. The participants were given Locoid® or Diproderm®, and it was not reported if the packages were 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) Unclear risk Predefined outcomes were reported, but they were assessed as scores only for those who had the symptom
Other bias Low risk No other bias was identified