Low-dose 5-fluorouracil in combination with salicylic acid as a new lesion-directed option to treat topically actinic keratoses – histological and clinical study results

Abstract

Background:  Actinic keratoses (AKs) arise after chronic sun exposure. Since long-term UV damage may induce proliferation of atypical keratinocytes, treatment of AKs is recommended.


Objectives:  To compare 5-fluorouracil 0.5%/salicylic acid 10.0% (low-dose 5-FU/SA [Actikerall®]) with 3% diclofenac in hyaluronic acid (diclofenac HA) and vehicle for the treatment of AKs.


Methods:  Randomised, placebo-controlled, double-blind, parallel-group, multicentre trial. Patients received topical low-dose 5-FU/SA once daily, its vehicle, or diclofenac HA twice daily for a maximum of 12 weeks. Final evaluation was at Week 20. Primary objectives: to demonstrate the histological clearance rate of one ...

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