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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
Author(s) -
Simon J.C.,
Dominicus R.,
Karl L.,
Rodríguez R.,
Willers C.,
Dirschka T.
Publication year - 2015
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/jdv.12702
Subject(s) - medicine , tolerability , cryosurgery , cryotherapy , fluorouracil , adverse effect , surgery , randomized controlled trial , lesion , dermatology , chemotherapy
Background Actinic keratoses ( AK s) are clinically significant and require therapy. Efficacy of low‐dose (0.5%) 5‐fluorouracil with 10% salicylic acid (5‐ FU / SA ) has been shown in randomized comparative trials of hyperkeratotic lesions of various grades. Objectives To evaluate the efficacy, tolerability and safety of low‐dose 5‐ FU / SA topical solution vs. cryosurgery in patients with moderate/severe (grade II / III ) hyperkeratotic AK s ( NCT 01358851). Methods In an exploratory, open, randomized study, patients with histologically confirmed moderate/severe hyperkeratotic AK s on the face/forehead or bald scalp received 6 weeks of once‐daily topical 0.5% 5‐ FU / SA , or up to two cryosurgery treatments (3 weeks apart). Histological outcomes were determined from punch biopsies. Clinical, cosmetic and tolerability outcomes were also assessed. Results Sixty‐six patients received treatment (33 per arm). The baseline total number of lesions was 266 (8.1/patient) in the 0.5% 5‐ FU / SA and 263 (8.0/patient) in the cryosurgery group. Most (74.5%) lesions were grade II (grade III , 25.5%). Mean change in lesion count from baseline to Day 98 was −5.2 and −5.7 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 ( AE s), 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 AE s 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 AK s than cryosurgery. AE incidence across both treatment groups was relatively low and AE s were generally mild or moderate. Clinical trials.gov identifier: NCT01358851.