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. 2013 Jan 31;2013(1):CD007633. doi: 10.1002/14651858.CD007633.pub2

Levell 1995.

Methods This was a randomised, actively‐controlled study.
The trial was not blinded.
It was unclear if intention‐to‐treat analysis was conducted.
Participants Inclusion criteria of the trial
  • A total of 60 participants with plaque psoriasis entered the study (33 women, 27 men: age range = 18 to 67 years; age range for ciclosporin = 18 to 61 years; age range for dithranol = 20 to 67 years). Of them, 29 participants had psoriatic nail disease.


Exclusion criteria of the trial
  • Systematic treatment for psoriasis taken less than 2 weeks before the study

Interventions
  • Oral ciclosporin was given as 2 daily doses of 2.5 mg/kg until 2 weeks after the psoriasis had cleared.

  • After a suberythemal dose of UVB, dithranol (2% to 8% with 0.5% salicylic acid in emulsifying ointment) was applied daily for 15 minutes and then washed off.


The Ingram regimen, using dithranol in Lassar's paste, was used for participants not improving on the short contact regime. Treatment was considered a failure and stopped if there were any residual lesions after 16 weeks of either treatment.
Participants were treated for 16 weeks until clear (the complete absence of visible or palpable lesions of psoriasis). All participants who cleared were followed up until relapse or until 8 months had elapsed. Visits for assessment were made twice before the treatment began and every 2 weeks thereafter until the rash was cleared and, after clearance, monthly until relapse or for 8 months.
Outcomes Outcomes of the trial
  1. Severity score from 0 to 2 points for individual nail involvement

  2. Psoriasis of the nails was assessed as improved, unchanged, or worsened.

Notes Systematic treatment for psoriasis was not allowed for the last 2 weeks before starting the treatment.
Adverse events included minimal toxicity (ciclosporin), burning (dithranol with salicylic acid and UVB), high blood pressure (ciclosporin), increasing serum creatinine (ciclosporin), increasing serum urate (ciclosporin and dithranol with salicylic acid and UVB), and increasing serum magnesium (ciclosporin).
There was a wash‐out period of 2 weeks for systematic therapy.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The participants were randomised by a code."
Comment: This was probably done.
Allocation concealment (selection bias) Low risk Quote: "...the code being available only to a hospital pharmacist who was otherwise uninvolved with the study."
Blinding (performance bias and detection bias) 
 Clinician/ Investigator High risk Quote: "The study was an open randomised comparison."
Comment: The trial did not use blinding.
Blinding (performance bias and detection bias) 
 Participants High risk Quote: "The study was an open randomised comparison."
Comment: The trial did not use blinding.
Blinding (performance bias and detection bias) 
 Outcome assessor High risk Quote: "The study was an open randomised comparison."
Comment: The trial did not use blinding.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Of the participants with nail psoriasis, 3 out of 13 participants in the ciclosporin group and 1 out of 16 participants in the dithranol with salicylic acid and UVB group withdrew before further assessment (reasons were difficulty in attending daily, objecting to the frequent assessment, and dyspepsia).
There was little information about the nail psoriasis group and scoring.
Selective reporting (reporting bias) High risk Quote: "The Ingram regimen, using dithranol in Lassar's paste, was used for participants not improving on the short contact regimen."
Comment: No information was given about the number of participants and results regarding who needed this cross‐over.
There was a discrepancy in the article between the improvement score showed in the figure and the text.
Other bias High risk Sandoz Pharmaceuticals sponsored the study.
Ciclosporin was given until 2 weeks after the psoriasis had cleared