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

INTRODUCTION

Daylight 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.

METHODS

Two symmetrical contralateral areas of 25cm2, harboring a similar (5-10) number of AKs, were selected and randomly assigned either to a 3days' IMB treatment cycle or to a single session of dlPDT. The day after the local skin reaction (LSR) score was registered. Patients' scored pain (assessed through VAS method) after the treatment, and time needed for wound closure, were subsequently registered. After 90days, the complete remission (CR) rate recorded for both single lesions and patients, the cosmetic outcome and the patients' preference, were assessed.

RESULTS

22 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. The mean days necessary for 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 were 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 AKs did not show any inferiority for one 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.

CONCLUSIONS

A 3days' 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, better cosmetic outcome and higher patients' preference.