Background Actinic cheilitis (AC) may progress into fully developed squamous cell carcinoma with a relatively high risk of metastasizing and therefore requires early identification and treatment. Objectives To assess the clinical and histological long-term outcome as well as the safety and tolerability of sequential use of photodynamic therapy (PDT) and imiquimod in AC. Methods Patients with histologically confirmed grade 1 and 2 AC received two methyl aminolaevulinate-PDT sessions 2 weeks apart. After a 2-week rest period the patients started applying imiquimod 5% cream 3 days per week for 4 weeks. At the first follow-up visits at 3 and 6 months, noncomplete clinical responders were biopsied and excluded from the study if histological alterations were indicative for AC. At the last 12-month follow-up all remaining patients were biopsied. Adverse events were noted at weeks 2, 4, 6 and 8 of the treatment phase and at every visit of the follow-up period. Results Of the 34 enrolled patients, 30 completed the study. Complete clinical response was achieved by 27 patients in 3 months. At 6 months, clinical and histological recurrence occurred in two patients, while at 12 months the complete clinical cure rate obtained was 80% and the histological complete cure rate was 73%. Treatment was well tolerated and adverse events were as expected and transient. Conclusion Sequential use of PDT and imiquimod cream is of significant benefit for the treatment of AC. Further studies are needed in order to confirm the improved outcome using the combination treatment, to clarify the involved mechanisms and to optimize the therapeutic protocol.
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