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      Prevalence, Discontinuation Rate, and Risk Factors for Severe Local Site Reactions with Topical Field Treatment Options for Actinic Keratosis of the Face and Scalp

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          Abstract

          Actinic keratoses (AKs) are common lesions on chronically sun damaged skin, which are morphologically characterized by lower third to full thickness atypia of epidermal keratinocytes. These lesions carry a risk of progression towards invasive squamous cell carcinoma (SCC); therefore, treatment of visible lesions and the field in case of field cancerization is recommended. Treatment of AK includes the destruction of atypical keratinocytes that clinically presents with various degrees of erythema, scaling, crusting, erosion, and other visible and subjective symptoms. Such inflammatory reactions may have an impact on the patient’s social life and have shown to decrease compliance and adherence to therapy. Additionally, as various topical treatments have been proven to be effective in treating AK, tolerability of local site reactions (LSRs) might drive the decision for appropriate treatment in an individual scenario. Therefore, we aimed to review prevalence of severe LSRs among various topical treatments for AK. In addition, we summarized discontinuation rates due to LSRs and possible therapy-unrelated risk factors for the development of LSRs with increased severity.

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          Ingenol mebutate gel for actinic keratosis.

          Neil Swanson, Anita Melgaard, Brian Berman … (2012)
          Actinic keratosis is a common precursor to sun-related squamous-cell carcinoma. Treating actinic keratoses and the surrounding skin area (i.e., field therapy) can eradicate clinical and subclinical actinic keratoses. Topical field therapy currently requires weeks or months of treatment. We investigated the efficacy and safety of a new topical field therapy for actinic keratosis, ingenol mebutate gel (0.015% for face and scalp and 0.05% for trunk and extremities). In four multicenter, randomized, double-blind studies, we randomly assigned patients with actinic keratoses on the face or scalp or on the trunk or extremities to receive ingenol mebutate or placebo (vehicle), self-applied to a 25-cm(2) contiguous field once daily for 3 consecutive days for lesions on the face or scalp or for 2 consecutive days for the trunk or extremities. Complete clearance (primary outcome) was assessed at 57 days, and local reactions were quantitatively measured. In a pooled analysis of the two trials involving the face and scalp, the rate of complete clearance was higher with ingenol mebutate than with placebo (42.2% vs. 3.7%, P<0.001). Local reactions peaked at day 4, with a mean maximum composite score of 9.1 on the local-skin-response scale (which ranges from 0 to 4 for six types of reaction, yielding a composite score of 0 to 24, with higher numbers indicating more severe reactions), rapidly decreased by day 8, and continued to decrease, approaching baseline scores by day 29. In a pooled analysis of the two trials involving the trunk and extremities, the rate of complete clearance was also higher with ingenol mebutate than with placebo (34.1% vs. 4.7%, P<0.001). Local skin reactions peaked between days 3 and 8 and declined rapidly, approaching baseline by day 29, with a mean maximum score of 6.8. Adverse events were generally mild to moderate in intensity and resolved without sequelae. Ingenol mebutate gel applied topically for 2 to 3 days is effective for field treatment of actinic keratoses. (Funded by LEO Pharma; ClinicalTrials.gov numbers, NCT00742391, NCT00916006, NCT00915551, and NCT00942604.).
          Article 0 comments Cited 90 times – based on 0 reviews     Review now
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            Prevalence of actinic keratosis and its risk factors in the general population: the Rotterdam Study.

            J A Heerden, Tamar Nijsten, Claudie Flohil … (2013)
            Limited data are available on the prevalence and risk factors of actinic keratoses (AKs). Within the Rotterdam Study, full-body skin examinations were performed among participants aged 45 years or older to estimate the age- and sex-standardized prevalence of AK and its associated risk factors. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated for associations between risk factors and the presence of 1-3, 4-9, and ≥ 10 AKs. Of the 2,061 inspected cohort members (mean age 72 years), 21% had 1-3, 9% had 4-9, and 8% had ≥ 10 AKs. AK prevalence was 49% (95% CI: 46-52%) for men and 28% (26-31%) for women. Male gender, older age, light pigmentation status, severe baldness, skin wrinkling, and high tendency for sunburn were significantly associated with extensive actinic damage (≥ 10 AKs) in the multivariate analyses. Especially bald males were at an increased risk of severe actinic skin damage (adjusted OR=7.0 (3.8-13.1)). The prevalence of AK is very high, especially among elderly bald males. The prevention and management of AK is a true challenge for patients, physicians, and health-care policymakers.
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              A double-blind, vehicle-controlled study evaluating masoprocol cream in the treatment of actinic keratoses on the head and neck.

              Elise A Olsen, M. Lisa Abernethy, Carol Kulp-Shorten … (1991)
              This double-blind, vehicle-controlled, multicenter study evaluated the efficacy and safety of a new topical antineoplastic agent, masoprocol, in the treatment of actinic keratoses of the head and neck. Of the 113 patients who applied topical masoprocol twice a day for 14 to 28 days, there was a mean decrease in actinic keratoses from 15.0 to 5.4 and a median percent reduction from baseline actinic keratosis count of 71.4% at the 1-month follow-up visit. Comparable numbers for the vehicle-treated group were 13.4 to 11.1 actinic keratoses and 4.3% median percent reduction. Irritation, as manifested by erythema or flaking, occurred in 61.5% of topical masoprocol-treated patients versus 26.7% of those treated with vehicle and did not correlate with clinical response. Topical masoprocol appears to be useful in the treatment of actinic keratoses.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Medicina (Kaunas)
                Journal ID (publisher-id): medicina
                Title: Medicina
                Publisher: MDPI
                ISSN (Print): 1010-660X
                ISSN (Electronic): 1648-9144
                Publication date (Electronic): 04 April 2019
                Publication date Collection: April 2019
                Volume: 55
                Issue: 4
                Electronic Location Identifier: 92
                Affiliations
                [1 ]Department of Infectiology and Dermatology, Riga Stradiņš University, LV-1006 Riga, Latvia; dr.mararonekupfere@ 123456gmail.com (M.R.K.); Angelika.Krumina@ 123456rsu.lv (A.K.)
                [2 ]Department of Oral Medicine, Riga Stradiņš University, LV-1007 Riga, Latvia; Ingrida.Cema@ 123456rsu.lv
                Author notes
                Author information
                https://orcid.org/0000-0003-0726-3375
                Article
                Publisher ID: medicina-55-00092
                DOI: 10.3390/medicina55040092
                PMC ID: 6524034
                PubMed ID: 30987411
                SO-VID: 5cfbbee8-fff1-438b-98e9-87f31aa5d429
                Copyright © © 2019 by the authors.
                License:

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                Date received : 21 February 2019
                Date accepted : 01 April 2019
                Categories
                Subject: Review

                Keywords: actinic keratosis,topical therapy,severe local site reactions,risk factors,review
                Data availability:
                Keywords: actinic keratosis, topical therapy, severe local site reactions, risk factors, review

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