The use of ingenol mebutate to treat actinic keratosis in standard clinical practice: a prospective phase IV multicenter observational cohort study.

BACKGROUND: Actinic keratosis (AK) is a chronic, precancerous skin disease. Various treatments options exist, including ingenol mebutate gel. The aim of this study was to compare its effectiveness and tolerability as well as the impact of therapy on patients' quality of life in standard clinical practice. METHODS: A multicenter study was carried out involving a 12-month follow-up period. A sample of 440 patients was included. Medical history details were recorded. Effectiveness, compliance to treatment, quality of life (EQ-5D-5L), and treatment satisfaction questionnaire for medication (TSQM-9) at week 8 were assessed. RESULTS: Of the total 440 patients, 428 (97.3%) attended at 8 weeks assessment. The number of patients with complete clearance was 337 (78.7%). EQ VAS score was significantly increased (P < 0.001). As far as TSQM-9 is concerned, patients with complete clearance reported statistically significantly higher satisfaction in effectiveness, convenience, and global satisfaction. At the 12-month follow-up visit, 323 patients (95.8%) retained their clearance status. Nineteen patients did not apply the ingenol mebutate gel on consecutive days. For these patients, the complete clearance rate was 42.1%, while for those who were treated on consecutive days, the complete clearance rate was 80.6%. None of our patients developed skin cancer. CONCLUSIONS: This study supports that ingenol mebutate is effective for the treatment of AK with a good safety profile. It significantly improves quality of life. Limited adherence to treatment might be associated with reduced effectiveness.