PMID- 25257941 OWN - NLM STAT- MEDLINE DCOM- 20160217 LR - 20150424 IS - 1468-3083 (Electronic) IS - 0926-9959 (Linking) VI - 29 IP - 5 DP - 2015 May TI - 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. PG - 881-9 LID - 10.1111/jdv.12702 [doi] AB - BACKGROUND: Actinic keratoses (AKs) 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 AKs (NCT01358851). METHODS: In an exploratory, open, randomized study, patients with histologically confirmed moderate/severe hyperkeratotic AKs 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 (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. CI - (c) 2014 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of the European Academy of Dermatology and Venereology. FAU - Simon, J-C AU - Simon JC AD - Department of Dermatology, Venereology and Allergology, University of Leipzig Medical Center, Leipzig, Germany. FAU - Dominicus, R AU - Dominicus R FAU - Karl, L AU - Karl L FAU - Rodriguez, R AU - Rodriguez R FAU - Willers, C AU - Willers C FAU - Dirschka, T AU - Dirschka T LA - eng SI - ClinicalTrials.gov/NCT01358851 PT - Clinical Trial, Phase II PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20140925 PL - England TA - J Eur Acad Dermatol Venereol JT - Journal of the European Academy of Dermatology and Venereology : JEADV JID - 9216037 RN - 0 (Drug Combinations) RN - 0 (Immunosuppressive Agents) RN - 0 (Keratolytic Agents) RN - O414PZ4LPZ (Salicylic Acid) RN - U3P01618RT (Fluorouracil) SB - IM MH - Administration, Cutaneous MH - Aged MH - Aged, 80 and over MH - *Cryosurgery MH - Drug Combinations MH - Facial Dermatoses/pathology/therapy MH - Female MH - Fluorouracil/*administration & dosage/adverse effects MH - Humans MH - Immunosuppressive Agents/*administration & dosage/adverse effects MH - Keratolytic Agents/*administration & dosage/adverse effects MH - Keratosis, Actinic/pathology/*therapy MH - Male MH - Middle Aged MH - Prospective Studies MH - Recurrence MH - Salicylic Acid/*administration & dosage/adverse effects MH - Scalp MH - Severity of Illness Index MH - Treatment Outcome EDAT- 2014/09/27 06:00 MHDA- 2016/02/18 06:00 CRDT- 2014/09/27 06:00 PHST- 2014/02/18 00:00 [received] PHST- 2014/07/17 00:00 [accepted] PHST- 2014/09/27 06:00 [entrez] PHST- 2014/09/27 06:00 [pubmed] PHST- 2016/02/18 06:00 [medline] AID - 10.1111/jdv.12702 [doi] PST - ppublish SO - J Eur Acad Dermatol Venereol. 2015 May;29(5):881-9. doi: 10.1111/jdv.12702. Epub 2014 Sep 25.