Efficacy of ablative fractional laser‐assisted photodynamic therapy for the treatment of actinic cheilitis: 12‐month follow‐up results of a prospective, randomized, comparative trial

Summary Background Early identification and treatment of actinic cheilitis ( AC ) is recommended. Although photodynamic therapy ( PDT ) is an attractive therapeutic option for AC , PDT for AC does not result in the same satisfactory outcomes as in actinic keratosis ( AK ). Objectives The aim of our study was to compare efficacy, recurrence rate, cosmetic outcome and safety between erbium:yttrium–aluminium–garnet ablative fractional laser‐assisted methyl aminolaevulinate– PDT (Er: YAG AFL MAL ‐ PDT ) and standard MAL ‐ PDT . Methods Thirty‐three patients with histologically confirmed AC randomly received either one session of Er: YAG AFL MAL ‐ PDT or two sessions of MAL ‐ PDT . In the MAL ‐ PDT group, the second session of MAL ‐ PDT was administered 7 days later. Patients were followed up at 1 week and 3 and 12 months, and biopsies were taken from all patients at 3 and 12 months after the last treatment session. At the final 12‐month follow‐up, cosmetic outcomes were assessed. Adverse events were assessed at week 1 of the treatment phase and every subsequent follow‐up visit. Results In the per‐protocol ( PP ) population, Er: YAG AFL MAL ‐ PDT was significantly more effective (92% complete response rate) than MAL ‐ PDT (59%; P  =   0·040) at the 3‐month follow‐up, and differences in efficacy remained significant at the 12‐month follow‐up (85% in Er: YAG AFL MAL ‐ PDT and 29% in MAL ‐ PDT ). The recurrence rate was significantly lower for Er: YAG AFL MAL ‐ PDT (8%) than for MAL ‐ PDT (50%) group at 12 months ( P  =   0·029). No significant difference in cosmetic outcome or safety was observed between Er: YAG AFL MAL ‐ PDT and MAL ‐ PDT . Conclusions Ablative fractional laser pretreatment has significant benefit for the treatment of AC with PDT .