Fluorouracil Cream 0.5% for Actinic Keratoses on Multiple Body Sites: An 18-Month Open-Label Study

This prospective 18-month, open-label, multicenter study assessed the long-term safety and efficacy of fluorouracil cream 0.5% in 277 participants with multiple actinic keratoses (AKs) on the face/anterior scalp and other body sites. Two treatment/observation cycles were separated by 12 months. During treatment cycle 1 (TC1), all participants were treated with fluorouracil cream 0.5% for 4 weeks with 4-week follow-up. Twelve months later, all participants were assessed for treatment cycle 2 (TC2); participants with face/anterior scalp AKs (N=98) were re-treated with fluorouracil cream 0.5% for 4 weeks with 4-week follow-up. Only 4 participants (1.4%) experienced a treatment-related adverse event (AE) that was not an application site reaction or eye irritation. No unexpected AEs were reported; most were mild or moderate. After TC1 (week 8), the number of AK lesions was significantly reduced on the face/anterior scalp and all other treated body sites (P<.0001 clearance rates were scalp and after tc2 face aks significantly reduced class="article_abstract_nonital">P<.0001 and the clearance rate was this study indicates that fluorouracil cream with a patented microsponge delivery system well-tolerated effective in treating preventing recurrence of ak lesions up to months after initial treatment.>