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

Lassus 1983.

Methods Randomised, parallel‐arm trial
Number of centres not stated
Period of inclusion not stated
Participants Inclusion criteria
  • Severe palmoplantar pustulosis

  • Remission after maximum 16 weeks of Tigason


Exclusion criteria
  • Not stated


Baseline data: randomised to Tigason 0.14 to 0.38 mg/kg/d (n = 11) or placebo (n = 14)
  • Mean age, male/female, duration of the condition: not stated for this particular group of participants

  • Proportion with psoriatic lesions elsewhere: not specified


Withdrawal: 4 participants (in the placebo group) were lost because of adverse events (marked hair loss) but not specified if they were included in the analysis
Interventions Intervention
A: oral Tigason 0.14 to 0.38 mg/kg/d (11 participants)
Control intervention
B: placebo (14 participants)
Co‐interventions: none
Duration of treatment: 6 months
Outcomes No primary or secondary outcomes pre‐specified
Notes Funding: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Patients were randomised to either Tigason or placebo for 6 months"
Comment: insufficient information about the sequence generation process to permit judgement
Allocation concealment (selection bias) Unclear risk Comment: no information on method to guarantee allocation concealment
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "double‐blind placebo‐controlled"
Comment: likely that blinding could have been broken because of Tigason's side effects, mainly symptoms from skin and/or nasobuccal mucous membranes
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "double‐blind placebo‐controlled"
Comment: likely that blinding could have been broken because of etretinate's side effects, mainly symptoms from skin and/or nasobuccal mucous membranes
Incomplete outcome data (attrition bias) 
 All outcomes High risk Quote: "In the placebo group, there were initially 14 patients but 4 of them were dropouts (side effects = marked hair loss)"
Comment: all dropouts were in the placebo group, and not clearly mentioned if they were included in the analysis
Selective reporting (reporting bias) Unclear risk Comment: no protocol found to guarantee that all planned outcomes are presented in the results