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.

Abstract

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). 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. 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. 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. Ablative fractional laser pretreatment has significant benefit for the treatment of AC with PDT.