A prospective randomized exploratory study comparing the efficacy of once‐daily topical 0.5% 5‐fluorouracil in combination with 10.0% salicylic acid (5‐FU/SA) vs. cryosurgery for the treatment of hyperkeratotic actinic keratosis

Abstract

A prospective randomized exploratory study comparing the efficacy of once-daily topical 0.5% 5-fluorouracil in combination with 10.0% salicylic acid (5-FU/SA) vs. cryosurgery for the treatment of hyperkeratotic actinic keratosis Mean change in lesion count from baseline to Day 98 was À5.2 and À5.7 lesions per patient for 0.5% 5-FU/SA and cryotherapy groups respectively. Histological AK clearance rates on Day 98 were 62.1% and 41.9% respectively. At 6-month posttreatment follow-up, recurrence of cleared lesions (no clinically visible lesions in treatment area) occurred in 39.4% of 0.5% 5-FU/SA and 84.8% of cryosurgery patients. Drug-related adverse events (AEs), including local skin reactions considered 'severe' by the investigator, were reported in 24.2% of 0.5% 5-FU/SA and 6.1% of cryosurgery patients. All drug-related AEs were skin reactions.Conclusions Although the study was not powered to explore statistical differences in clinical efficacy between treatments, a short (6-week) schedule of topical treatment with 0.5% 5-FU/SA achieved greater histological clearance and lower recurrence of grade II/III hyperkeratotic AKs than cryosurgery. AE incidence across both treatment groups was relatively low and AEs were generally mild or moderate. Clinical trials.gov identifier: NCT01358851.

Treatment monitoring of 0.5% 5‐fluorouracil and 10% salicylic acid in clinical and subclinical actinic keratoses with the combination of optical coherence tomography and reflectance confocal microscopy

“…The aim of this study was to evaluate in vivo the changes in skin affected with AK and subclinical AK using different imaging technologies and the effect of treatment with 0.5% 5‐fluorouracil and 10% salicylic acid on the lesions. Recent studies have confirmed the efficacy of this drug and cost‐effectiveness in the treatment of AKs . Recently, Ulrich et al .…”

Relative efficacy of 5‐fluorouracil compared with other treatments among patients with actinic keratosis: A network meta‐analysis

“…Cryosurgery has been the treatment of choice for focal lesions, and the British Association of Dermatologists suggests that it could be used for hypertrophic lesions (Bourke, Coulson, & English, ). One research group (Simon et al, ) compared 5‐FU/SA and cryosurgery as AK treatments. At the 6‐month post‐treatment follow‐up, total clearance of the lesions was observed in 60.6% of the patients in the 0.5% 5‐FU/SA group and 15.2% of the patients in the cryosurgery group.…”

Actinic keratoses show variable histological basal growth patterns – a proposed classification adjustment

“…Our study showed more than a half (51.2%) of pro III graded AKs had adnexal involvement. This may have an impact on the choice of treatment as many lesion directed treatments target superficial disease and are not effective when there is deep follicular involvement, increasing the risk of recurrence …”