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. 2020 Jan 20;2020(1):CD011628. doi: 10.1002/14651858.CD011628.pub2

Schroder 1989.

Methods Randomised, parallel‐arm trial
Three centres in Germany (community centre clinics)
Period of inclusion: March 1986 to February 1988
Participants Inclusion criteria
  • Age: 17 to 74 years

  • Weight: 55 to 94 kg


Exclusion criteria
  • Pregnancy

  • Pretreatment with etretinate or steroids

  • Serious common disease


Baseline data: participants were randomised to receive etretinate (n = 15) or placebo (n = 15)
  • Male/female: 12/18

  • Age (range): 20 to 73

  • Proportion of participants with psoriatic lesions elsewhere: not specified


Withdrawal: not stated
Interventions Intervention 1
A: etretinate 50 mg once per day (15 participants)
Intervention 2
B: placebo (15 participants)
Co‐interventions: 2% salicylic ointment
Duration of treatment: 4 weeks
Outcomes No primary or secondary outcome pre‐specified
  • Nb of pustules/4 cm²

  • Percentage of affected area

  • Clinical aspect: 4‐point score

Notes Funding: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The patients were admitted using a list of randomisation"
Comment: no precision on how it was generated
Allocation concealment (selection bias) Unclear risk Quote: "either etretin or placebo"
Comment: no information on method to guarantee allocation concealment
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "double‐blind study"
Comment: however, 65% of participants treated with Tigason had side effects (mainly mucocutaneous side effects), so likely that blinding could have been broken
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "double‐blind study"
Comment: however, 65% of participants treated with Tigason had side effects (mainly mucocutaneous side effects), so likely that blinding could have been broken
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: no mention of missing data
Selective reporting (reporting bias) High risk Comment: no protocol found to guarantee that all planned outcomes are presented in the results. Not all outcomes cited in the methods were found in the results (clinical aspect: 4‐point‐score)