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Background Five per cent 5-fluorouracil (5- FU) cream is a well-established treatment for actinic keratosis ( AK), and ingenol mebutate gel ( IMB) is a novel topical field-directed therapy. Objective To compare the tolerability and safety of IMB with that of 5- FU for the treatment of facial AK. Methods An open-label, prospective, randomized, controlled clinical trial with 100 patients with AKs within a 25-cm2 contiguous field on the face was conducted. IMB was applied daily for three consecutive days. 5- FU was applied twice a day for 4 weeks. The treatment effect and the adverse events were evaluated at baseline and on days 2, 3, 4, 8, 15, 22, 29, 36 and 43 for intent-to-treat populations. Results The mean (± SD) maximum local skin reactions ( LSR) for patients treated with IMB was 10.85 (± 3.12), compared with 10.86 (± 3.55) for those who received 5- FU. Patients in the IMB group presented LSR that peaked at day 4 and almost completely regressed after 15 days. Differently, in the 5- FU group, the LSR peaked at day 29 and lasted until visit 36. Additionally, the area under the curve ( LSR × visit) was significantly smaller for IMB. No differences between the treatments for pruritus, pain, tearing, conjunctival hyperaemia or headaches were noted, but the eyelid oedema rate was higher for IMB group. No significant difference in the proportion of dropouts was observed between groups. Both treatments demonstrated a suitable safety profile. Conclusion For treating AKs, the local skin reactions in the IMB group were more short-lived compared with those of 5- FU, but both treatments seemed to be safe and tolerable. [ABSTRACT FROM AUTHOR]