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

Basak 2001.

Methods Study type: individual RCT
Randomisation method: not reported
Blinding: not reported
Intention‐to‐treat analysis used: not reported
Participants Inclusion criteria of the trial
  • Not reported, but all had seborrhoeic dermatitis of the scalp clinically characterised by erythema, scaling, and itching


Exclusion criteria of the trial
  • Not reported


Number of randomised participants: 60 in total (betamethasone N = 30, calcipotriol N = 30)
Number of dropouts: 7, all from 1 treatment arm (23%)
Sex: not reported
Age: not reported
Country: Turkey
Interventions Treatment
  • Calcipotriol solution 50 μg/ml, applied on the scalp twice daily for 28 days


Comparator/s
  • Betamethasone 17‐valerate 1 mg/ml, applied on the scalp twice daily for 28 days


If there was only slight improvement at the end of 4 weeks, treatment was continued for another 4‐week period After cessation of treatment, participants entered a follow‐up period for 4 weeks
Before the start of treatment, there was a 1‐week wash‐out period, during which only a mild non‐medicated shampoo was used
Outcomes
  1. Severity of erythema, scaling, and itching of the scalp rated on a 4‐point scale (0 to 3)

  2. Total clearance

  3. Total score (the sum of the individual scores)

  4. Adverse events

  5. Routine biochemical analysis including serum total calcium levels

Notes Results were reported mainly at 4 weeks. The dropout rate was unbalanced and considerable
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk This was not reported in detail
Quote: "randomly assigned"
Allocation concealment (selection bias) Unclear risk This was not reported
Similarity of the study groups (selection bias) Unclear risk This was not reported in sufficient detail
Blinding of participants (performance bias) High risk There was no mention of blinding in the report
Blinding of care providers (performance bias) High risk There was no mention of blinding in the report
Blinding of outcome assessment (detection bias) 
 All outcomes High risk There was no mention of blinding in the report
Incomplete outcome data (attrition bias) 
 All outcomes High risk More than 20% of participants withdrew from the calcipotriol arm
Selective reporting (reporting bias) Unclear risk Not all results related to predefined outcomes were reported in sufficient detail
Other bias Unclear risk No other bias was identified