A randomized split-face clinical trial of conventional vs indoor-daylight photodynamic therapy for the treatment of multiple actinic keratosis of the face and scalp and photoaging
Mariachiara Arisi, Mariateresa Rossi, Luigi Spiazzi, Edoardo Guasco Pisani, Anna Venturuzzo, Chiara Rovati, Cesare Tomasi, Marina Venturini, Piergiacomo Calzavara‐Pinton
Abstract
Background Recently, indoor daylight photodynamic therapy (idl-PDT) has been developed; however, its efficacy and tolerability remain to be assessed.Objective This is a not-inferiority study to compare treatment outcomes of cPDT with a red LED lamp and idlPDT with a polychromatic white LED lamp in adult patients affected by symmetrical AKs of face and/or scalp.Methods In this comparative, intra-patient, split-face, randomized clinical trial forty-three adult patients were enrolled. Two contralateral and symmetrical target areas of the face and/or scalp harboring at least 5 AKs were selected and randomized 1:1 to treatment with cPDT and idlPDT. The AKs number and cumulative area were assessed at baseline (T0). Efficacy and cosmetic outcome were assessed 3 months after treatment (T1).Results Total AKs number and area reduced significantly with both idlPDT (p < .0001) and cPDT (p < .0001) in comparison to baseline. cPDT was more painful (p < .0001) and induced a more severe inflammation (p < .0001). Twenty-nine patients (70.7%) gave their overall preference to idlPDT (p < .001).Conclusion idlPDT may represent an alternative treatment protocol to cPDT for in-office treatment of AKs patients with better tolerability and a not inferior efficacy.