BACKGROUND: Actinic damage is responsible for the development of multiple, recurrent non-melanoma skin cancers (NMSCs), including actinic keratoses (AKs). Photodynamic therapy (PDT) and imiquimod cream (IMIQ) 5% are recommended as field-directed treatment options. OBJECTIVES: To compare efficacy and safety of methyl aminolevulinate (MAL)-PDT vs. IMIQ 5% in the prevention of new NMSCs development patients with field changes. METHODS:Patients with field cancerization of the face or scalp were randomized to receive MAL-PDT on one side, and IMIQ 5% on the mirror field. The primary endpoint was the number of new lesions on the treated fields during a 12-month follow-up period. Secondary assessments included adverse events and patient preference. RESULTS:Forty-four patients completed the study. MAL-PDT and IMIQ did not differ concerning the primary endpoint, as there was no statistically significant difference in terms of development of new NMSCs at any point of follow-up. Both treatment regimens were safe and well tolerated. Patients' preference based on the procedure, response rates and future choice favoured MAL-PDT. CONCLUSIONS:MAL-PDT and IMIQ 5% are safe and well-tolerated treatments that equally prevent development of new AKs in patients suffering from field changes. MAL-PDT treatment appears to be superior in terms of patients' preference.
RCT Entities:
BACKGROUND: Actinic damage is responsible for the development of multiple, recurrent non-melanoma skin cancers (NMSCs), including actinic keratoses (AKs). Photodynamic therapy (PDT) and imiquimod cream (IMIQ) 5% are recommended as field-directed treatment options. OBJECTIVES: To compare efficacy and safety of methyl aminolevulinate (MAL)-PDT vs. IMIQ 5% in the prevention of new NMSCs development patients with field changes. METHODS:Patients with field cancerization of the face or scalp were randomized to receive MAL-PDT on one side, and IMIQ 5% on the mirror field. The primary endpoint was the number of new lesions on the treated fields during a 12-month follow-up period. Secondary assessments included adverse events and patient preference. RESULTS: Forty-four patients completed the study. MAL-PDT and IMIQ did not differ concerning the primary endpoint, as there was no statistically significant difference in terms of development of new NMSCs at any point of follow-up. Both treatment regimens were safe and well tolerated. Patients' preference based on the procedure, response rates and future choice favoured MAL-PDT. CONCLUSIONS: MAL-PDT and IMIQ 5% are safe and well-tolerated treatments that equally prevent development of new AKs in patients suffering from field changes. MAL-PDT treatment appears to be superior in terms of patients' preference.
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