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

Van de Kerkhof 1996a.

Methods DESIGN 
 Within‐patient
 Participant delivery
 ALLOCATION 
 Random
 Method of randomisation: not reported
 Concealment: unclear
 BLINDING 
 Double‐blind (participant/investigator)
 WITHDRAWAL/DROPOUT 
 Described
Participants N: 122
Treatment duration: 8 wks; FU: 12 wks
LF: 19 (15.6%)
BC: inadequately reported
Age: 44.8 (13.69SD)
Gender (per cent men): 62.3%
Severity: BSA = 5.6%
Duration (mths): 233.5 (175.9SD)
INCLUSION CRITERIA
  • Stable plaque psoriasis

  • Not localised on the scalp

  • BSA: 5.6%

  • Score ≥ 2 for erythema and desquamation and Score sum > 5

  • White adults and adolescents


EXCLUSION CRITERIA
  • Increased serum calcium or serum phosphate level

  • Recent systemic or topical antipsoriatic treatment

  • Serious disease

  • Known allergy to study medication

  • Recent participation in another clinical trial

  • Expected poor compliance

  • Calcium supplements

  • Drugs influencing calcium metabolism

  • Corticosteroids

  • Barbiturates

  • Phenytoin

  • NSAIDs

  • Pregnancy

Interventions
  • Tacalcitol 4 mcg/g OD (T)

  • Placebo (vehicle) (P)

Outcomes
  1. Signs: erythema; infiltration; desquamation

  2. Total Sign Score (0 to 12)

  3. Severity

  4. Preference assessment

  5. Area of test lesions

  6. Investigator Global Assessment (4‐pt: poor to very good)

  7. Patient Global Assessment (4‐pt: poor to very good)

  8. Assessment of benefit

  9. Post‐treatment relapse

Notes Hermal Kurt Herrmann sponsored the trial.
 Maximum treatment area: 10% BSA
 There was SD imputation (TSS).
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 15.6%
Baseline assessments Low risk
Baseline comparability demonstrated Unclear risk The trial did not report this.