Effects of topical 0.8% piroxicam and 50+ sunscreen filters on actinic keratosis in hypertensive patients treated with or without photosensitizing diuretic drugs: an observational cohort study
Received 27 June 2018
Accepted for publication 8 August 2018
Published 12 October 2018 Volume 2018:11 Pages 485—490
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Dr Jeffrey Weinberg
Sara Mazzilli,1 Virginia Garofalo,1 Alessandra Ventura,1 Laura Diluvio,1 Massimo Milani,2 Luca Bianchi,1 Elena Campione1
1Department of Dermatology, University of Rome “Tor Vergata”, Rome, Italy; 2Medical Department, Cantabria Labs Difa Cooper, Caronno Pertusella, Italy
Background: Photosensitizing diuretics use (especially thiazide compounds) is associated with a significantly higher risk of squamous cell carcinoma (SCC). Actinic keratosis (AK) is a precursor of SCC.
Study aim: To evaluate in a prospective cohort study the efficacy of topical piroxicam 0.8% and sunscreen 50+ (ACTX) in the treatment of AK in hypertensive subjects with or without TD treatment.
Subjects and methods: A total of 119 hypertensive subjects with multiple AK (39 under chronic TD treatment; and 80 treated with other non-TD, non-photosensitizing antihypertensive drugs) were enrolled after their informed consent in a 6-month observational cohort study. All the subjects were treated with ACTX twice daily. The primary endpoint was the evolution of AK lesions at baseline, after 3 and 6 months. The secondary endpoint was the clearance of AK target lesions and field of cancerization by dermoscopic evaluation using a score evaluating erythema, scaling, pigmentation, and follicular plugs (ESPFP score; ranging from 0 to 20). An investigator, unaware of the type of antihypertensive treatments (TD or non-TD), performed all the clinical and dermoscopy evaluations.
Results: At baseline, AK mean (SD) lesion number in TD group was 14.1(4) and 14.6(4) in the non-TD group. ESPFP mean (SD) score at baseline was 5.8(1.2) in both groups. A significant reduction of AK lesions in comparison with baseline was observed in both groups. A statistically significant greater reduction was observed in TD in comparison with the non-TD group (−54% vs −32%). ESPFP score was reduced in a higher proportion in the TD group in comparison with the non-TD group (−60% vs −37%, respectively). ACTX treatment was very well tolerated.
Conclusion: In hypertensive subjects with multiple AK, the topical use of ACTX is associated with a significant reduction of lesions count with an improvement in the field cancerization. The clinical efficacy is more pronounced in subjects under thiazide diuretics treatment.
Keywords: actinic keratosis, piroxicam, thiazide diuretics, skin cancer
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