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

Hattel 1974.

Methods Randomised controlled trial with cross‐over
One centre in Copenhagen
Period of inclusion: year 1972
Participants Inclusion criteria
  • Palmoplantar pustulosis: yellowish sterile pustules on the palms and on the sole or sides of the heel

  • Histologically, typical spongiosiform pustules of pustular psoriasis were absent


Exclusion criteria
Not stated
Baseline data
Not stated but typical psoriatic lesions were absent
Withdrawal: no mention of missing data
Interventions Intervention
A: hydroxyurea 0.5 g thrice daily (13 participants, cross‐over design)
Control Intervention
B: placebo (13 participants, cross‐over design)
Co‐interventions: none
Duration of treatment: 3 weeks
Outcomes No primary or secondary outcomes pre‐specified
  • Total number of pustules

  • Score (0 to 3): sum of 4 pustule scores and 4 redness‐thickness scores

  • Side effects


Photographs were taken before and after each 3‐week period
Notes Hydrea was supplied by Squibb and Sons
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomised"
Comment: insufficient information about the sequence generation process to permit judgement
Allocation concealment (selection bias) Unclear risk Comment: the method to guarantee allocation concealment is not described
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "double‐blind, cross‐over"
Comment: use of placebo but insufficient information to permit judgement
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "double‐blind, cross‐over"
Comment: use of placebo but insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: no mention of missing data
Selective reporting (reporting bias) Unclear risk Comment: no protocol found to guarantee that all planned outcomes are presented in the results