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

Menter 2009.

Methods DESIGN 
 Between‐patient
 Participant delivery
 ALLOCATION 
 Random
 Method of randomisation: not reported
 Concealment: unclear
 BLINDING 
 Open (blinding NS but product vehicles differ)
 WITHDRAWAL/DROPOUT 
 Described
Participants N: 122
 Treatment duration: 4 wks; FU: 8 wks
 LF: 0 (0%)
 BC: yes
 Age: 46.5 (14.2SD)
 Gender (per cent men): 61.1%
 Duration (yrs): 16.4 (11.50SD)
 Severity: ODS = 3.06 (0.43SD)
 (participant demographics based on per‐protocol sample).
INCLUSION CRITERIA
  • People aged 18 to 80 with moderate to severe stable plaque psoriasis

  • BSA: 3 to 20%


EXCLUSION CRITERIA
  • Known allergy to study ingredients

  • Psoriasis affecting scalp, face, or groin only

  • Area affected required weekly treatment with > 50 g CP spray or > 100 g C‐BD ointment

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

  • Clobetasol propionate 0.05% spray (CP)

Outcomes
  1. Overall disease severity (ODS) on a 5‐pt scale: clear (0), almost clear, mild, moderate, severe/very severe (4)

  2. Based on erythema, scaling, and elevation

  3. Investigator Global Assessment (IGA) on a 4‐pt scale (0 to 3): clear (0), mild, moderate, severe (3). Based on per cent BSA affected (extent) rather than signs

Notes Galderma Laboratories, LP, sponsored the trial.
Atrophy was not assessed.
Telangiectasia was not assessed.
29 participants were 'non‐compliant' with treatment, but intention‐to‐treat (ITT) analysis included all enrolled participants.
The sponsor supplied unpublished data.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 High risk The trial was open (blinding not reported, but product vehicles differ).
Randomisation method reported Unclear risk The trial did not report this.
Loss to follow up Low risk 0%
Baseline assessments Low risk These were reported.
Baseline comparability demonstrated Low risk This was demonstrated.