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. 2013 Jun 24;2013(6):CD007281. doi: 10.1002/14651858.CD007281.pub2

Lui 2004.

Methods D: This was an open‐label, randomised phase II multicentred study
RD: The study randomised participants, although it did not provide details of the randomisation process. Randomisation was stratified by number of tumours and by centre
AC: This was unclear
B: There was no evidence of blinding in the study
Participants North America: 54 participants (421 multiple non‐melanoma skin cancers, including superficial and nodular basal cell carcinoma, and 34 Bowen's disease); 4 North American university‐based clinics. The study recruited participants with at least 2 non‐pigmented biopsy‐proven non‐melanoma skin cancers
Mean age = 55 years (22 to 79 years)
Most had Fitzpatrick skin type II or III
Inclusion criteria of the trial
  • All sites included

Interventions Single intravenous infusion of 14 mg m‐² verteporfin followed 1 to 3 hours later by exposure to 1 of 3 different light doses from a non‐thermal LED panel:
  • T1: 60 J cm‐² red light

  • T2: 120 J cm‐² red light

  • T3: 180 J cm‐² red light


The tumours were re‐treated 3 months after initial treatment if complete response was not achieved ‐ the re‐treatment dose increased to 18 mg m‐², but the dose remained the same
Outcomes The lesion was the unit of analysis
  1. Histopathological response at 6 months after first verteporfin PDT (using 2 mm punch biopsy)

  2. Clinical and cosmetic response assessed at 6 weeks, 3 months, and 6 months after treatment. Participants and investigators assessed the cosmetic outcome at each follow‐up visit

Notes Intervention product information/details
  • verteporfin (QLT Inc., Vancouver, British Columbia)

  • red light (688 +/‐ 10 nm)


The exposed area included a 3 to 4 mm peritumoural margin
Adverse events and cosmetic outcome was reported for all tumours with no stratification according to tumour type
Follow‐up visits after month 6 were optional, and 2‐year follow‐up data were only available for 66% (276/421) of tumours (breakdown according to tumour subtype was not provided). 7 participants (51 lesions) withdrew from the study prior to 6 months (2 were lost to follow up; 4 withdrew for unspecified reasons; and 1 requested withdrawal owing to inconvenience of travel and treatment site pain requiring the use of codeine)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The paper did not detail the randomisation process
Allocation concealment (selection bias) High risk The paper gave no details, but it was an open‐label study
Incomplete outcome data (attrition bias) 
 All outcomes Low risk The paper provided details of loss to follow up: 7 participants (51 tumours ‐ number of Bowen's disease not specified) withdrew from the study prior to month 6; 2 were lost to follow up, 4 withdrew for unspecified reasons, and 1 requested withdrawal for inconvenience
Blinding participants Unclear risk There was no evidence of blinding
Blinding clinicians Unclear risk There was no evidence of blinding
Blinding pathologist Unclear risk There was no evidence of blinding
Blinding outcome assessor Unclear risk There was no evidence of blinding
Baseline comparability Unclear risk There were more participants with SCC in situ in the lower light‐dose treatment arm