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
|
|
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:
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
|
|
Notes |
Intervention product information/details
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 |