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. 2013 Mar 28;2013(3):CD005028. doi: 10.1002/14651858.CD005028.pub3

Papp 2003 (P).

Methods DESIGN 
 Between‐patient
 Participant delivery
 ALLOCATION 
 Random
 Method of randomisation: computer‐generated random code
 Concealment: adequate
 BLINDING 
 Double‐blind (participant/investigator)
 WITHDRAWAL/DROPOUT 
 Described
Participants N: 1043
 Treatment duration: 4 wks; FU: 4 wks
 LF: 15 (1.4%)
 BC: yes
 Age: 47.1
 Gender (per cent men): 58.4%
 Severity: mean PASI = 10.8 (range = 1 to 36)
 Duration: 18.7 years
INCLUSION CRITERIA
  • Chronic plaque psoriasis

  • Aged at least 18

  • BSA ≥10%


EXCLUSION CRITERIA
  • Other types of psoriasis or skin diseases

  • Hypercalcaemia

  • Systemic antipsoriatic treatment or UV therapy within previous 6 wks

  • Topical antipsoriatic therapy within previous 2 wks

  • Other concomitant medication that might affect psoriasis

  • Contraindications for corticosteroid treatment

  • Planned exposure to UV light

  • Pregnancy

  • Lactation

Interventions
  • Calcipotriol 50 mcg/g + betamethasone dipropionate 0.5 mg/g combination ointment BD (D)

  • Calcipotriol 50 mcg/g in combination vehicle ointment BD (C)

  • Betamethasone dipropionate 0.5 mg/g in combination vehicle ointment BD (B)

  • Placebo (combination vehicle) ointment BD (P)

Outcomes
  1. PASI (head excluded)

  2. Total Severity Score (9‐pt, absent to very severe)

  3. IAGI (6‐pt: worse to clearance)

  4. PAGI (6‐pt: worse to clearance)

Notes Leo Pharmaceuticals sponsored the trial.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk Treatments were assigned by computer‐generated code and assigned chronologically at each centre.
Blinding (performance bias and detection bias) 
 All outcomes Low risk The trial was double‐blind (participant/investigator), and treatments were identifiable only by a code number.
Randomisation method reported Low risk Randomisation was computer‐generated. (3:3:3:1)
Loss to follow up Low risk 1.4%
Baseline assessments Low risk
Baseline comparability demonstrated Low risk