P61 Topical treatment of actinic keratoses with low dose 5-fluorouracil in combination with salicylic acid

Abstract

Introduction Actinic keratoses (AK) occur particularly in elderly patients with an increased UV light exposition over the course of life. AKs are carcinomas in situ and can progress to invasive squamous cell carcinomas. Various forms of therapy are available to treat AK such as physical ablation, cryotherapy, several topical therapies and photodynamic therapy. We report on a proof of concept study on topical therapy of AK with low dose 5-fluorouracil and salicylic acid. Methods We conducted a proof of concept study with 15 patients at the University Hospital of Leipzig. The trial was conducted as an open, monocenter, prospective, proof of concept study. The primary endpoint was healing of the AK during topical therapy with the study medication after 28 days of treatment and 56 days of follow-up (a total of 84 days, 12 weeks). Secondary endpoints were tolerability, safety as well as alteration in activity in fluorescence diagnostics from day 0 to day 84. The solution was applied three times per week by a small brush. Results On day 0 a total of 66 AK were registered in our patients which were located in the face and on the head in all patients. After 4 weeks of therapy with the study medication, 30 AK were healed completely (46%), 20 AK were healed partially (30%), 15 AK did not display response (23%), and 1 AK appeared worse (2%). Tolerability was on the whole rated as good by the patients. Three side effects were observed that were not related to the study medication. These results were confirmed by fluorescence diagnostics. The tolerability of the study medication was good. Patient satisfaction was good. Conclusion This low dose 5-fluorouracil in combination with salicylic acid solution shows significant effects in the treatment of AK. All patients demonstrated at least a partial response to a single four-week treatment. Although treatment was not continued, a persistent response was achieved. With the exception of burning shortly after application of the study medication most patients had a neutral skin sensation and perceived the product as ‘good’. In summary, this treatment appears to be an effective option for topical therapy of AK. Therapy was well tolerated. According to literature data of other topical treatments a substantially higher complete healing rate after four weeks use was achieved. The present study was supported financially by Almirall Hermal GmbH, Germany.