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. 2021 Apr 19;2021(4):CD011535. doi: 10.1002/14651858.CD011535.pub4

Olsen 1989.

Study characteristics
Methods RCT, placebo‐controlled, double‐blind trial
Date of study: not stated
Setting: not stated
Participants Randomised: 15 participants, age range 23 ‐ 72 years, 11 male
Inclusion criteria
  • Moderate‐severe psoriasis

  • BSA ≥ 10


Exclusion criteria
  • Pregnancy, kidney insufficiency, liver insufficiency


Dropouts and withdrawals
  • 3/15 (20%)

  • Disease flare‐up (n = 3)

Interventions Intervention
A. Acitretin (n = 10), orally, 25/50 mg, daily, 8 weeks
Control intervention
B. Placebo (n = 5), orally, daily, 8 weeks
Outcomes Assessments at 8 weeks
Primary outcomes of the trial
  • Not clearly defined


Secondary outcomes of the trial
  • Body surface area

  • Scale

  • Side effects

Notes Funding by Hoffman‐La Roche Inc
Declarations of interest: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote (p 681): "Patients were assigned to... in a random, double‐blind fashion"
Comment: no description of the method used to guarantee random sequence generation
Allocation concealment (selection bias) Unclear risk Quote (p 681): "Patients were assigned to... in a random, double‐blind fashion"
Comment: no description of the method used to guarantee allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote (p 681): "Patients were assigned to... in a random, double‐blind fashion"
Comment: visible adverse effects of acitretin such as cheilitis were visible
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote (p 681): "Patients were assigned to... in a random, double‐blind fashion"
Comment: visible adverse effects of acitretin such as cheilitis were visible
Incomplete outcome data (attrition bias)
All outcomes Unclear risk 15 included / Number of participants analysed not stated
Comment: no description of the methods used to perform the efficacy analyses and to manage the missing data
Selective reporting (reporting bias) Unclear risk Comment: no protocol was available. The prespecified outcomes mentioned in the Methods section were reported