Efficacy of low-dose 5-fluorouracil/salicylic acid in actinic keratoses in relation to treatment duration

Abstract

Background: In Germany, the number of actinic keratoses (AKs) diagnosed and dermatologically treated has steadily risen in recent years. As AKs represent an early form of squamous cell carcinoma, prompt initiation of treatment is pivotal. The objective of this non-interventional study (NIS) was to determine the efficacy of a low-dose (0.5 %) fluorouracil/10 % salicylic acid (low-dose 5-FU/SA) solution in the treatment of AKs (clinical grade I and II according to Olsen) in relation to treatment duration.

Patients and methods: This NIS followed 1,051 AK patients from 212 centers who were treated with low-dose 5-FU/SA. Data were collected at the start of treatment, at an optional follow-up appointment during the treatment period, at the end of treatment, and during the final assessment.

Results: During the observation period, there was a decrease in the mean number of lesions by approximately 70 % and in mean size by approximately 80 %. Roughly one-half of the patients were treated for less than six weeks. In the final global assessment, efficacy was rated as very good or good in approximately 89 % of patients; tolerability as very good or good in 87 %.

Conclusions: Under routine clinical conditions, treatment with low-dose 5-FU/SA effectively reduced AK lesions even during short treatment periods, while exhibiting good tolerability. These findings are in keeping with results obtained from a clinical phase III trial.