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. 2020 Jul 7;2020(7):CD008946. doi: 10.1002/14651858.CD008946.pub3

Rook 2010.

Study characteristics
Methods This was a randomised, double‐blind (verified by author contact), within‐participant trial, which lasted 6 weeks.
Participants The study recruited 12 participants (with 1 lesion per treatment): men or non‐pregnant women aged 18 to 70 with stable patch or plaque phase MF of at least 4 months' duration.
Demographics of the included participants
  • 8 men and 4 women

  • Mean age (SD) = 55 years (16.5 years)

  • 0 participants were lost to follow‐up, resulting in 12 lesions per treatment group


Exclusion criteria of the trial
These were not reported.
Interventions
  • The intervention group was given hypericin (0.05%, 0.1%, or 0.25%) applied twice a week for 24 hours before radiation with visible light (590 nm to 650 nm): 8 to 20 J/cm² up to 15 minutes, twice weekly, separated by at least 1 day.

  • The control group was given placebo cream applied twice a week for 24 hours before radiation with visible light (590 nm to 650 nm): 8 to 20 J/cm² up to 15 minutes, twice weekly, separated by at least 1 day.

Outcomes Outcomes of the trial
  1. Common adverse effects of the treatments

  2. Percentage of participants demonstrating complete response

  3. Overall survival

  4. Objective response rate

Notes The study was supported in part by the USA's Department of Energy Merit Review.
Funding came from the Department of Veterans Affairs (Dr Wood) and Vimrx Inc. Disclosure: Dr Rook has been a consultant to Hy BioPharma Inc.
This study was conducted in 4 tertiary care centres in the USA.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The study did not provide information about this. We sought information and had an email response: "The corresponding author no longer had access to data from the former employer."
Allocation concealment (selection bias) Unclear risk The study did not provide information about this. We sought information and had an email response: "The corresponding author no longer had access to data from the former employer."
Blinding of participants and personnel (performance bias)
All outcomes Low risk The study was described in the publication as "double‐blind" and "open‐label". The email response from the author confirmed that the study was double‐blind.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk The study did not provide information about this. We sought information and had an email response: "The corresponding author no longer had access to data from the former employer."
Incomplete outcome data (attrition bias)
All outcomes Low risk There were no dropouts.
Selective reporting (reporting bias) Unclear risk This was unknown. We sought information and had an email response: "The corresponding author no longer had access to data from the former employer."
Other bias Unclear risk It was unclear if previous treatment was stopped and if concomitant medication was permitted.