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. 2012 Sep 12;2012(9):CD001781. doi: 10.1002/14651858.CD001781.pub3

Fuchs 2004.

Study characteristics
Methods This study was carried out in a secondary care setting.
The blinding within this study was unclear.
It was unclear if ITT analysis was carried out
This study was conducted in Germany.
Participants 80 participants were recruited: 12 dropped out.
Inclusion criteria of the trial
  • Adults

  • Refractory warts

  • Warts on the hands or feet

Interventions
  • 20% 5‐aminolevulinic acid (5‐ALA) + visible light (VIS) + water‐filtered infrared‐A (wIRA) versus

  • Placebo + visible light + wIRA versus

  • 20% 5‐ALA + visible light versus

  • Placebo + visible light


There were 1 to 3 therapy cycles every 3 weeks for a total duration of 18 weeks.
Outcomes Outcomes of the trial
  1. Per cent change in wart area at 0, 3, 6, 9, 12, and 18 weeks

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote (page 2): "80 patients were randomised within 10 time blocks of 8 patients to 4 therapy groups purely on sequence of the patients being included in the study."
Comment: This was probably done.
Allocation concealment (selection bias) Low risk Quote (page 5): "...smallest possible block size which allows no information about the allocation of another patient of the same time block to a therapy group, not even that he or she belongs to a different therapy group."
Comment: The method of allocation concealment was unclear, but randomisation was done in blocks, preventing knowledge of allocation. Therefore, this was probably done.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote (page 1): "...prospective randomised controlled blind study."
No further information was given in the published trial report other than that the placebo could not be distinguished by inspection nor by smell from the treatment cream.
Quote (page 6): "Presence or absence of wIRA can be felt by the treating physician by comparing the radiation, the study was performed single instead of double blind."
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Quote (page 1): "...prospective randomised controlled blind study."
No further information was given in the published trial report.
Incomplete outcome data (attrition bias)
All outcomes High risk Quote (page 9): "Out of the 80 patients, 68 completed the entire study."
Comment: The reasons for attrition were given in the trial report (page 8). The dropout rate between the groups was similar.
Selective reporting (reporting bias) Low risk All outcomes were reported.