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. 2020 Jan 20;2020(1):CD011628. doi: 10.1002/14651858.CD011628.pub2

Kragballe 1991.

Methods Randomised, open, prospective, right‐left comparative trial
Number of centres not stated
Period of inclusion not stated
Participants Inclusion criteria
  • Palmoplantar pustulosis or localised pustular psoriasis with symmetrical lesions (palms, soles, or both) for 0.5 to 40 years

  • Age 18 to 71 years


Exclusion criteria
  • Unstable lesions during the 2‐week washout period

  • Systemic antipsoriatic treatment or UV radiation within 2 months before study entry

  • Infected skin lesions

  • Allergy to any of the treatment materials


Baseline data: randomised comparison of Actiderm plus triamcinolone acetonide 0.1% cream applied every third day (19) vs clobetasol 0.1% cream applied twice daily (19)
  • Mean age, years: 44

  • Male/female: 16/3

  • Mean duration of condition (range), years: 12 (0.5 to 40)

  • Proportion of participants with psoriatic lesions elsewhere: not specified

  • Severity at baseline on each randomised and treated side not specified


Withdrawal: no dropouts
Interventions Intervention 1
A: Actiderm plus triamcinolone acetonide (TAA) 0.1% cream every third day (19 participants)
Intervention 2
B: clobetasol 0.05% cream twice per day (19 participants)
Co‐interventions: none
Duration of treatment: 4 weeks
Outcomes No primary or secondary outcome pre‐specified
  • Severity of eruption on a 4‐point scale for erythema, scaling, thickness, and pustules

  • Degree of itch

  • Overall response to therapy

  • Presence of skin atrophy

  • Adverse events


Outcomes were evaluated at each visit (‐2, 0, 2, 4, and 8 weeks)
Notes Funding: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "This was a randomised comparison"
Comment: insufficient information about the sequence generation process to permit judgement
Allocation concealment (selection bias) Unclear risk Comment: no information on method to guarantee allocation concealment
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "Actiderm plus TAA 0.1% cream was replaced every third day. Clobetasol 0.05% cream was applied twice daily"
Comment: no evidence of blinding, which is very difficult in this case
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Comment: no evidence of blinding
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: no mention of missing data
Selective reporting (reporting bias) High risk Comment: no protocol found to guarantee that all planned outcomes are presented in the results and not all outcomes cited in the methods were reported in the results (skin atrophy)