A randomized, double-blind, phase III, multicentre study to evaluate the safety and efficacy of BF-200 ALA (Ameluz â) vs. placebo in the field-directed treatment of mild-tomoderate actinic keratosis with photodynamic therapy (PDT) when using the BF-RhodoLED â lamp.
To our knowledge, this is the first nationwide study to characterize and determine the prevalence of HF-BCC patients. Similar to the more typical patients with 1-2 BCCs, HF-BCC patients have an increasing number of BCCs with increased age. 2 Our data suggest that the HF-BCC population develops BCCs continuously; therefore, most HF-BCC patients should have been captured during the catchment period and the limited-duration prevalence is a good estimate of total prevalence. This HF-BCC prevalence is more than 15-fold higher than the highest population prevalence reported for Gorlin syndrome patients (3.2/ 100 000), and thus any inadvertent inclusion of Gorlin syndrome patients in this study would have a relatively small effect on the estimated frequency. 8 This study shows a high prevalence and consistent burden of disease for HF-BCC patients, warranting the need for alternate methods of care for and monitoring of this patient population. Further research into this population and potential risk factors would be beneficial for physicians to develop diagnostic and treatment guidelines for those at highest risk.
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