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

Hindsén 2006 (P).

Methods DESIGN 
 Between‐patient
 Participant delivery
 ALLOCATION 
 Random
 Method of randomisation: not stated
 Concealment: unclear
 BLINDING 
 Double‐blind (participant/investigator)
 WITHDRAWAL/DROPOUT 
 Not described
Participants N: 360
 Treatment duration: 2 or 6 wks; FU: 6 or 10 wks
 LF: NR
 BC: not demonstrated
 Age: NR
 Gender (per cent men): NR
 Severity: NR
 INCLUSION CRITERIA
  • People with moderately severe plaque psoriasis on elbows, knees, or both


EXCLUSION CRITERIA
  • Not stated

Interventions
  • Calcipotriol ointment 50 mcg/g, BD (no occlusion) for 6 wks (C)

  • Calcipotriol ointment 50 mcg/g plus occlusion, once/week for 2 wks (CO)

  • Placebo ointment plus occlusion, once/week for 2 wks (P)

Outcomes
  1. Total Sign Score (redness, thickness, scaliness) (TSS): 0 to 24

Notes Leo Pharma, Ballerup, sponsored the trial.
It was unclear how participants were blinded to treatment options where 2/3 involved occlusion.
The sponsor supplied unpublished data.
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 Unclear risk The trial was reported to be double‐blind (participant/investigator), but it was unclear how they blinded participants to treatment options where 2/3 involved occlusion.
Randomisation method reported Unclear risk The trial did not report this.
Loss to follow up Unclear risk The trial did not report this.
Baseline assessments Unclear risk The trial did not report these.
Baseline comparability demonstrated Unclear risk This was not demonstrated.