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. 2017 Dec 22;2017(12):CD011535. doi: 10.1002/14651858.CD011535.pub2
Methods RCT, active‐controlled, open‐label trial
Date of study: not stated
Location: not stated
Participants Randomised: 22 participants (mean age 45.9 years, 18 male)
Inclusion criteria
  • Participants with moderate‐severe psoriasis (PASI > 16)


Exclusion criteria
  • Pregnancy, kidney insufficiency, liver insufficiency,

  • Had an active infection

  • Had uncontrolled cardiovascular disorder

  • Had past history of malignant tumours


Dropouts and withdrawals
  • Not stated

Interventions Intervention
A. Ciclosporin A (n = 10), orally, 1.25 mg/kg/d (increase to 2.5 if PASI > 50% of initial PASI), 12 months
Control intervention
B. Ciclosporin A, (n = 12), orally, 2.5 mg/kg/d (increase to 5 if PASI > 50% of initial PASI), 12 months
Outcomes Assessment period: not stated but longer than 16 weeks
Primary or secondary outcomes of the trial: not stated
Outcomes of the trial
  • PASI score

  • Blood pressure

  • Blood count

  • Urine samples

Notes Funding: not stated
Declarations of interest: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote (p 189): "Patients enrolled in the study were randomised..."
Comment: no description of the method used to guarantee random sequence generation
Allocation concealment (selection bias) Unclear risk Quote (p 189): "Patients enrolled in the study were randomised..."
Comment: no description of the method used to guarantee allocation concealment
Blinding of participants and personnel (performance bias) All outcomes High risk Comment: not blinded (open‐label)
Blinding of outcome assessment (detection bias) All outcomes High risk Comment: not blinded (open‐label)
Incomplete outcome data (attrition bias) All outcomes Unclear risk Dropouts and withdrawals
  • Not stated


Management of missing data: no description of the method used to guarantee management of missing data, ITT analyses not mentioned
Selective reporting (reporting bias) High risk Comment: no protocol was available. The pre‐specified outcomes mentioned in the methods section were not reported in results section