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Abstract Actinic keratoses (AKs) are considered precursor lesions of cutaneous squamous cell carcinoma, with a reported conversion rate of 3–16%. Photodynamic therapy (PDT) is a widely approved therapy for AKs. Conventional PDT (c-PDT) using red light is limited by pain and a small treatment field. Daylight PDT (d-PDT), an approved alternative, is limited by geographical location and weather conditions. Simulated daylight PDT (sd-PDT) with light-emitting diode (LED) light sources is now commercially available due to robust evidence that these devices are effective, but the devices are limited by cost (∼€30 000). We hypothesized that sd-PDT with a 4000 K white-light LED floodlight, costing €961, is equally as effective and well tolerated as d-PDT in the treatment of AKs across treatment fields of up to 55 cm2 on the scalp. Twenty-two men with a mean age of 74.5 years (SD 7.0) and multiple scalp AKs were enrolled in this prospective, randomized, single-blinded study, which employed a split-scalp design to compare the effectiveness and adverse events of d-PDT and sd-PDT. Block randomization was used to determine which side of the scalp would be treated with d-PDT. Each patient received four treatments in total, two d-PDT and two sd-PDT, each a week apart. The AKs were counted, graded, mapped and photographed at baseline, at blinded 1- and 3-month reviews and at unblinded 6-, 9- and 12-month reviews. The primary endpoint was mean lesion-specific clearance, defined as the mean number and percentage of cleared AKs per treatment field at 3 months. At baseline, the mean (SD) number of AKs per field was 44 (17.4) for the d-PDT group and 45.5 (17.8) for the sd-PDT group (P = 0.4). The mean lesion-specific clearance (percentage reduction) in AKs per field was 35.3 (71.5%) for d-PDT and 35.0 (75.1%) for sd-PDT at 1 month (P 0.99), 33.6 (66.4%) for d-PDT and 30.3 (61.6%) for sd-PDT at 3 months (P = 0.6). Both d-PDT and sd-PDT were effective, with a significant reduction in AKs from baseline at 1 and 3 months (P 0.01). Pain was reported by 15 patients with d-PDT and 12 with sd-PDT (median maximum score out of 100, 3.5 vs. 4.5; P = 0.6). Erythema was observed in 17 after d-PDT and 15 after sd-PDT. On a scale of 0 (intolerable) to 10 (very tolerable), patients rated d-PDT as 10 and sd-PDT as 9.8 (P = 0.08). We conclude that sd-PDT with a 4000 K white-light LED floodlight is equally as effective and well tolerated as d-PDT and is an affordable treatment option not limited by pain, small treatment field, geographical location or weather conditions.
Drumm et al. (Fri,) studied this question.