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

Hersle 1996.

Methods Study type: individual RCT
Randomisation method: not reported
Blinding: double‐blind
Intention‐to‐treat analysis used: no
Participants Inclusion criteria of the trial
  • Seborrhoeic dermatitis of the scalp


Exclusion criteria of the trial
  • Known hypersensitivity to any of the components of the test medication

  • Need for other medication that might affect the disease (e.g. systemic corticosteroids or systemic antimycotics)

  • Use of topical remedies for SeD during the 7 days before enrolment or any investigated drug within 1 month before enrolment


Number of randomised participants: 54 in total (the initial assignment numbers were not reported by treatment group; at 4 weeks, 27 participants were treated with mometasone, and 22 participants were treated with ketoconazole)
Number of dropouts: 5 (9%)
Sex: 40 males, 14 females
Mean age (range): 58 (22 to 85) years
Country: Sweden
Interventions Treatment
  • Mometasone furoate 0.1% solution, applied to the scalp once daily for 4 weeks


Comparator/s
  • Ketoconazole 2% shampoo, applied twice a week for 4 weeks

Outcomes
  1. Erythema, scaling, and pruritus (scale 0 to 3)

  2. Total clearance

Notes Participants and investigators evaluated reduction of pruritus, scaling, and erythema scores, but numerical information of these was not reported. We approximated the numbers from figures. The actual number of participants randomised to each group was unknown
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomised, but not reported in sufficient detail
Allocation concealment (selection bias) Unclear risk No information was provided
Similarity of the study groups (selection bias) Unclear risk No information was provided
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 Unclear risk The actual number of participants randomised to each group was unknown. The dropout rate was 10%, but the study did not report if this was balanced between groups
Selective reporting (reporting bias) Unclear risk The primary outcomes were not prespecified in detail, yet the outcomes reported were those that are usually used in such studies
Other bias Unclear risk The pharmaceutical industry supported the study