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

Liao 2007.

Methods DESIGN
Between‐patient
 Participant delivery
 ALLOCATION 
 Random
 Method of randomisation: not stated
 Concealment: unclear
 BLINDING 
 Double‐blind (participant/investigator)
 WITHDRAWAL/DROPOUT 
 Described
Participants N: 50
Treatment duration: 6 wks; FU: 6 wks
LF: 1 (2.0%)
BC: yes
Age: 39.6 (12.8SD); range 21 to 69
Gender (per cent men): 73.5%
Target lesion: face (89.8%); genitofemoral (10.2%)
Severity: TAS (0 to 12) = 6.2 (3.32SD)
INCLUSION CRITERIA

  • People aged 18 to 70 with chronic plaque psoriasis affecting facial and genitofemoral areas


EXCLUSION CRITERIA

  • Topical therapies within previous 1 wk

  • UV therapy or sunbathing within previous 2 wks

  • Systemic therapy within previous 4 wks

  • Concurrent use of oral calcium or Vitamin D supplements, or lithium, beta‐blockers, or ACE inhibitors
Interventions

  • Calcitriol 3 mcg/g ointment BD (C)

  • Tacrolimus 0.3 mg/g ointment BD (T)


No concomitant topical therapies or emollients were permitted. Dosing frequency could be reduced or medication discontinued depending on level of irritancy.
Outcomes

  1. Target Area Score (TAS): 0 to 12 (erythema, plaque elevation, scaling)

  2. Physician Global Assessment of improvement (PGA) on a 7‐pt scale (worse to clear)

  3. Safety: erythema (0 to 4), perilesional oedema (0 to 4), stinging/burning (0 to 4), hot sensation (0 to 4), folliculitis/acne (0 to 1)
Notes Galderma, Taiwan, sponsored the trial.
Individual safety measures were reported, but the total number of participants experiencing any adverse event were not reported.
The trial author supplied unpublished data.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 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 2.0%
Baseline assessments Low risk These were reported.
Baseline comparability demonstrated Low risk This was demonstrated.