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

de Jong 1999.

Methods This was a randomised, double‐blind, internally‐controlled study.
Intention‐to‐treat analysis was performed.
Participants Inclusion criteria of the trial
  • The trial included 57 adult participants (2 x 57 hands) with dystrophic fingernail psoriasis. (There were 36 men and 21 women; age range = 21 to 77 years; mean age = 45.8 years). The duration of fingernail psoriasis had a mean of 9.9 years (range = 0 to 46 years).

  • A minimum NAS score of 5 was required for inclusion.


Exclusion criteria of the trial
  • The trial tested participants for onychomycosis by means of a KOH test and mycological culture, and they were excluded if positive.

Interventions Left hand versus right hand treated with either of the following:
  • 1% 5‐fluorouracil in Belanyx lotion; or

  • Vehicle Belanyx lotion


The intervention was applied once daily and covered with a plaster for 12 weeks, with a follow‐up period of 4 weeks.
Outcomes Outcomes of the trial
  1. Changes in NAS scores of a comparable target nail of each hand, according to a 5‐point rating scale (0 = none, 4 = very severe). Assessed NAS parameter were as follows: extent of the nail pitting area (0% to 100%), in steps of 25% + number of pits (0 to > 15), the average of which was defined as nail pitting; subungual keratosis (0 to > 3 mm: measured from nail bed to thickest part); onycholysis (0% to 100%); and oil spots (0% to 100%)

  2. Changes in severity score, investigators' opinion: 5‐point rating scale (0 = none, 4 = very severe)

  3. Changes in severity score, participants' opinion: 5‐point rating scale (0 = none, 4 = very severe)

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "...randomised trial."
Allocation concealment (selection bias) Unclear risk Comment: The paper provided insufficient details.
Blinding (performance bias and detection bias) 
 Clinician/ Investigator Low risk Quote: "...double‐blind study."
Blinding (performance bias and detection bias) 
 Participants Low risk Quote: "...double‐blind study."
Blinding (performance bias and detection bias) 
 Outcome assessor Low risk Quote: "...double‐blind study."
Comment: The blinded investigator was probably the assessor.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: There were no missing outcome data.
Selective reporting (reporting bias) Low risk Comment: The trial reported all the expected outcomes.
Other bias Low risk Comment: This was free of other sources of bias.