Conventional vs. daylight methyl aminolevulinate photodynamic therapy for actinic keratosis of the face and scalp: an intra-patient, prospective, comparisonstudy in Italy.

Abstract

Daylight photodynamic therapy (DL-PDT) with methyl aminolevulinate (MAL) is a simplified PDT procedure that was recently shown in a few trials to be effective for grade I actinic keratosis (AK), with improved tolerability and reduced time of clinical attendance as compared to conventional PDT (c-PDT). To evaluate the efficacy and tolerability of DL-PDT vs. c-PDT with MAL in the treatment of grade I AK on the face and scalp in Italy. Thirty-five patients with AKs on the face (n=17) or scalp (n=18) were prospectively enrolled in an intra-patient, left-right, prospective, comparison study between DL-PDT and c-PDT at a single centre between September and October 2013. Weather conditions and outdoor temperature during daylight exposure were recorded for each DL-PDT session. Pain was assessed after the PDT session and local adverse events 2days after treatment. Lesion response rate was evaluated on both sides at 3months. AKs with complete regression were followed until 6months. Patient's preference for either treatment was recorded. There was no difference in complete response (CR) rate of AK I at 3months between DL-PDT and c-PDT (87% vs. 91%; RR=0.96; P=0.16). A lower CR rate was observed with DL-PDT than with c-PDT for AK II (36% vs. 61%; RR=0.58, P=0.06) and III (25% vs. 46%; RR=0.50, P=0.20). Recurrence rate at 6months was slightly higher for cleared AK I after DL-PDT than after c-PDT (17% vs. 12%, RR=1.50, P<0.05). DL-PDT was associated with lower pain (ΔVAS=-2.2, P<0.01) and reduced severity of local adverse events (ΔLSR=-1.4, P<0.01) than c-PDT. Increasing outdoor temperature was associated with the efficacy of DL-PDT and the severity of adverse events. DL-PDT was preferred by 88% of the patients. MAL DL-PDT showed similar efficacy to c-PDT in the treatment of AK I of the face/scalp but was less effective than c-PDT for AKs II and III. DL-PDT was better tolerated being associated with lower pain and occurrence of fewer adverse events. Clinical response to DL-PDT was significantly moderated by outdoor temperature, increasing at higher temperatures.