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

Abstract

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.

Efficacy and Safety of 5-Fluorouracil 0.5%/Salicylic Acid 10% in the Field-Directed Treatment of Actinic Keratosis: A Phase III, Randomized, Double-Blind, Vehicle-Controlled Trial

“…This was similar to the 89% reported in the non-interventional study by Szeimies and colleagues [20]. Overall treatment satisfaction, as measured using the TSQM questionnaire, was greater among patients in the 5-FU 0.5%/salicylic acid 10% arm than in the vehicle arm ( P  = 0.0019), as was satisfaction in relation to treatment effectiveness ( P  = 0.0064).…”

“…Eight weeks following the end of treatment, 5-FU 0.5%/salicylic acid 10% was associated with a significant 78% decrease in the number of AK lesions. This is comparable to the corresponding decrease in lesion count of approximately 70% observed in a non-interventional study of 1051 patients [20]. It should be borne in mind that 48.6% (498/1025) of patients in the study by Szeimies and colleagues received 5-FU 0.5%/salicylic acid 10% treatment for less than 6 weeks, which may account for the slight difference in lesion count reduction.…”

Use of reflectance confocal microscopy to evaluate 5‐fluorouracil 0.5%/salicylic acid 10% in the field‐directed treatment of subclinical lesions of actinic keratosis: subanalysis of a Phase III, randomized, double‐blind, vehicle‐controlled trial

“…Data shown are n (%). [17][18][19][20] As the majority of clinical studies of 5-FU 0.5%/ salicylic acid 10% have so far focussed on lesion-directed treatment, the effectiveness in the field cancerization setting and its ability to target both clinical and subclinical lesions, as demonstrated in this analysis, represents an exciting prospect. The vast majority of topical treatments aim for the clearance of clinically visible AK lesions.…”

Topical 5‐fluorouracil in dermatologic disease

“…Sixty‐three percent of patients experienced more irritation on the upper extremity receiving dual therapy. A large multicenter prospective case series ( n = 1051) examined the effect of low‐dose 0.5% 5‐FU/10% salicylic acid combination therapy once daily in treating AKs . At the end of a treatment period of maximum 14 weeks, there was a reduction in both the number (69.7% reduction, P < 0.001) and size (82.1% reduction, P < 0.001) of AKs.…”