No new safety signals were observed with the addition of an emollient to 4% 5-FU.

Skin reactions were the most common treatment-emergent adverse events in both groups, leading to treatment discontinuation in nine patients (12.3%) in the intervention group and seven (9.9%) in the control group. LSR scores with topical 4% 5-FU alone were lower than expected. There were no statistically or clinically significant differences between the treatment groups in terms of LSR total score at week 4 (overall and by subgroups defined by the number of lesions and patient age at baseline), scores of individual LSR items at any time point, and AK lesion clearance rates at week 8. In total, 141 patients were included in the efficacy analysis (71 in the intervention group and 70 in the control group). Key secondary objectives were LSR total scores at weeks 2 and 8, the scores of individual LSR items at each visit, and the proportions of patients with 100% and ≥ 75% AK lesion clearance at week 8. erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation and erosion/ulceration) at week 4 of treatment (or before, in case of a major local reaction). The primary objective was to assess the severity of LSRs (i.e. The aim of this international, phase IV clinical trial was to investigate whether addition of an emollient to topical 4% 5-FU would reduce the frequency and severity of LSRs over 4 weeks of treatment (intervention group) compared with 4% 5-FU alone (control group) in patients with AK.

Topical 5-fluorouracil (5-FU)-containing treatments are effective for actinic keratosis (AK) however, they frequently lead to transient local skin reactions (LSRs), which often result in treatment non-adherence.

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