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One-week treatment with once-daily fluorouracil cream 0.5% in participants with actinic keratoses.

Actinic keratoses (AKs) are common in fair-skinned individuals with a history of chronic and excessive sun exposure and may progress to squamous cell carcinoma (SCC). Topical fluorouracil is an effective therapeutic option for patients with AKs, but it is associated with substantial skin irritation. The efficacy and tolerability of 1-week treatment using microsponge-based fluorouracil cream 0.5% were analyzed in 356 participants with AK lesions. One-week treatment with once-daily fluorouracil cream 0.5% was significantly more effective than vehicle control in reducing AK lesions and in achieving complete clearance (P<.001). No serious treatment-related adverse events occurred. The most frequent treatment-related adverse events were facial and eye irritations, which were predominantly mild to moderate in severity. No participants in the fluorouracil cream 0.5% treatment group discontinued the study because of treatment-related adverse events. One-week treatment with once-daily fluorouracil cream 0.5% is an effective well-tolerated therapy for AKs. Using this short treatment duration period in combination with cryosurgery may prove beneficial in clinical practice. Extending treatment for up to 4 weeks will further improve AK lesion clearance rates.