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

Ruzicka 1998.

Methods DESIGN 
 Between‐patient
 Participant delivery
 ALLOCATION 
 Random
 Method of randomisation: not stated
 Concealment: unclear
 BLINDING 
 Double‐blind (participant/assessor)
 WITHDRAWAL/DROPOUT 
 Described
Participants N: 178
Treatment duration: 2 + 4 wks; FU: 14 wks
LF: 7 (3.9%)
BC: psoriasis comparable, demographics not reported
Age: 42 (range = 18 to 80)
Gender (per cent men): 55.6%
Severity: PASI = 6.0
INCLUSION CRITERIA
  • Adults

  • Chronic plaque‐type psoriasis

  • BSA ≥ 30%

  • Calcium levels, renal, and liver function within normal range


EXCLUSION CRITERIA
  • Pregnancy

  • Lactation

  • Recent systemic or UV therapy

Interventions
  1. Calcipotriol 0.005% ointment BD 6 weeks (C)

  2. Calcipotriol 0.005% ointment BD 2 weeks, then calcipotriol ointment 0.005% OM plus Betamethasone valerate ointment ON 4 weeks (CB)

Outcomes
  1. PASI

  2. Investigator Global Assessment (6‐pt: deterioration to complete healing)

  3. Patient evaluation of overall response (5‐pt: scale NR)

Notes The trial did not state sponsorship.
 Schering AG employed 1 author.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk The trial reported insufficient details.
Blinding (performance bias and detection bias) 
 All outcomes Low risk The trial was double‐blind (participant/investigator).
Randomisation method reported Unclear risk The trial did not report this.
Loss to follow up Low risk 3.9%
Baseline assessments Low risk These were partially done.
Baseline comparability demonstrated Unclear risk This was partially demonstrated.