A randomized split-face clinical trial of daylight photodynamic therapy with methyl aminolaevulinate vs ingenol mebutate gel for the treatment of multiple actinic keratoses of the face and scalp

Publication date: Available online 13 August 2016
Source:Photodiagnosis and Photodynamic Therapy
Author(s): Erica Moggio, Mariachiara Arisi, PierGiacomo Calzavara-Pinton
IntroductionDaylight photodynamic therapy with methyl aminolaevulinate (dlPDT) and ingenol mebutate gel (IMB) are approved therapeutic options for multiple actinic keratoses (AKs).The aim of this comparative, intra-patient, split- face, randomized clinical trial was to compare treatment outcomes of dlPDT and IMB.MethodsTwo symmetrical contralateral areas of 25cm² harboring a similar (≥5) number of AKs were selected and randomly assigned to 3 days' IMB treatment cycle or an only session of dlPDT. The next day the local skin reaction (LSR) score was registered. Patients scored pain (VAS) after the treatment and time to wound closure. After 90 days, the complete remission (CR) rate of lesions and patients, the cosmetic outcome and patients' preference were assessed.Results22 patients with a total of 311 AKs were enrolled. The mean pain VAS score was 3.55± 1.82 with IMB and 2.05± 0.72 with dlPDT (p<0.01). The mean LSR score was 9.91 ±4.24 and 4.59± 4.03 (p<0.01), respectively; mean days to wound closure were 9.45± 3.51 and 4.36 ±1.18days (p<0.01), respectively. After 3 months, 119 lesions with IMB and 120 lesions with dlPDT healed and the CR rate with IMB (75.8%) was non-inferior to the CR rate with dlPDT (77.9%). The comparisons of CR rates of grade I and II of AKs did not show an inferiority of a treatment compared to the other. Eight patients (36.4%) had all lesions cleared with IMB and 7 (31.8%) with dlPDT (p=NS). The cosmetic outcome was better with dlPDT and 17 patients evaluated dlPDT as their preferred treatment.ConclusionsA 3 days' treatment cycle with IMB and a single session of dlPDT had a similar efficacy for both grade I AKs and grade II AKs but dl PDT showed lower pain and inflammation scores, quicker wound closure and better cosmetic outcome and patients preference.



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