A randomized trial of topical 5% 5-fluorouracil (Efudix® cream) in the treatment of actinic keratoses comparing daily with weekly treatment

Summary Background Topical 5‐fluorouracil (5‐FU) cream is widely used in the treatment of actinic keratoses (AKs) but the optimum treatment regimen that provides efficacy while minimizing side‐effects remains unclear. Objectives A randomized trial to compare the efficacy and side‐effects of daily vs. weekly application of 5% 5‐FU in the treatment of AKs of the scalp and face. Patients/methods Twenty patients were recruited and randomized to two groups. Group 1 (13 patients) applied 5% 5‐FU twice daily for 3 weeks, group 2 (seven patients) applied 5% 5‐FU twice daily for 1 day per week for 12 weeks. Patients were reviewed at weeks 3, 12, 24 and 52. At each review a lesion count and lesion map were completed and patients were asked to score efficacy and inflammation. Results At week 0 the median lesion count was the same in both groups, 17·5 lesions. At 12 weeks the median lesion count in group 1 had fallen to 0 where it remained for the duration of follow‐up. In group 2 the median lesion count fell to 6 at 12 weeks, 5·5 at 24 weeks and was 3 at 52 weeks. The difference in the lesion count was significant at all time points after week 0: P