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      Improved patient satisfaction using ingenol mebutate gel 0.015% for the treatment of facial actinic keratoses: a prospective pilot study

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          Abstract

          Actinic keratoses (AKs), especially on areas of the face, have a negative impact on a patient’s quality of life (QoL). These lesions manifest on sun-damaged skin and have the potential to progress to squamous cell carcinoma. Field-directed therapy alone and in combination with lesion-directed treatment is effective in clearing both visible and nonvisible AK lesions. Topical treatments of AKs thus have the potential to improve a patient’s well-being. However, evidence demonstrating improvements in patient QoL is limited, and is mostly based on observational or retrospective studies. Some prospective studies have reported unchanged or even worsening QoL despite excellent treatment outcomes. Our prospective, pilot study demonstrated a significant increase in QoL in 28 subjects with AKs of the face treated with ingenol mebutate gel 0.015%. QoL was assessed at days 0 and 60 using the Skindex-16 survey. Mean overall scores improved from 24.5% at baseline to 15.5% at day 60 ( P=0.031). Improvements in QoL were consistent with an 80% reduction in AK lesion number at day 60. These improved QoL findings are in line with those from a recent retrospective study using ingenol mebutate 0.015% gel. This study therefore further demonstrates the potential for field therapy to improve both treatment outcomes and patient satisfaction.

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          The Skindex instruments to measure the effects of skin disease on quality of life.

          Skindex-29 and Skindex-16 are validated measures of the effects of skin diseases on patients' quality of life. This article reviews the development of both versions of Skindex, discusses their measurement properties and interpretability, and gives examples of how they have been used and adapted for dermatologic research internationally. Studies of quality of life in patients with nonmelanoma skin cancer are described to illustrate the use of Skindex to understand quality of life and to compare effectiveness of different treatments for this highly prevalent condition.
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            Epidemiology of actinic keratoses and squamous cell carcinoma.

            S Salasche (1999)
            The purpose of this article was to review the frequency, distribution, and determinants of actinic keratoses (AKs) and squamous cell carcinoma (SCC). A review of the literature was done. AKs are extremely common lesions on the sun-exposed skin of Caucasian persons. The most important risk factors are a combination of genetic propensity ("fair skin phenotype") and cumulative sun exposure. Their prevalence increases with advancing age. The epidemiology of SCC is virtually the same, but the lesions occur most often on the head rather than on the upper extremities where most AKs are located. AKs are the most important risk factor identifying those most predisposed to the development of an SCC. AKs are a reliable marker for those people most predisposed to development of an invasive SCC. In addition, AKs are probably an early stage in a biologic continuum that culminates in SCC. However, there are many more AKs than SCCs, and it is difficult to predict exactly which lesions will progress to invasive cancer.
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              Measurement properties of Skindex-16: a brief quality-of-life measure for patients with skin diseases.

              An accurate, sensitive, but brief quality-of-life outcomes measure is needed for studies of dermatologic care. To construct a single-page version of Skindex (a dermatologic quality-of-life instrument) that would have two new features compared with the current 29-item version: (1) fewer items to which a majority of patients choose the same response, and (2) measurement of bother rather than frequency of patient experiences. Random samples of patients waiting for dermatology appointments in clinics of Veterans Affairs hospitals and in private dermatology practices completed questionnaires; 692 patients responded to the parent instrument and 541 additional patients responded to the brief version. Reproducibility, internal consistency reliability, validity, and responsiveness of the brief version of Skindex were determined. For 16 items of the current 29-item version (55%), more than 50% of patients responded "Never." After an explicit process of item analysis and elimination, a single-page 16-item version was composed that asks patients about bother from their experiences; responses are reported as three scales, Symptoms, Emotions, and Functioning. For 6 items of the 16-item version (38%), more than 50% of patients responded "Never." Scale scores were reproducible after 72 hours (r = 0.88-0.90) and were internally reliable (Cronbach's alpha = 0.86-0.93). The instrument demonstrated both content and construct validity: Most patients' responses to an open-ended question about their skin disease was addressed by the items; patients with inflammatory dermatoses had higher scores than those with isolated lesions; and in an exploratory principal axes factor analysis with an oblique rotation, 74% of the common variance was explained by three factors that correlated with the a priori scales. Mean scale scores stayed the same or changed in the expected direction in patients who reported that their skin was the same or had improved. This brief single-page version of Skindex accurately and sensitively measures how much patients are bothered by their skin conditions.
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                Author and article information

                Journal
                Clin Cosmet Investig Dermatol
                Clin Cosmet Investig Dermatol
                Clinical, Cosmetic and Investigational Dermatology
                Clinical, Cosmetic and Investigational Dermatology
                Dove Medical Press
                1178-7015
                2016
                20 April 2016
                : 9
                : 89-93
                Affiliations
                [1 ]Department of Dermatology, NYIT College of Osteopathic Medicine, Old Westbury, Brooklyn, NY, USA
                [2 ]Department of Dermatology, SUNY Downstate Medical Center, Brooklyn, NY, USA
                [3 ]Department of Dermatology, NY Harbor Healthcare System, Brooklyn, NY, USA
                [4 ]Department of Dermatology, Mount Sinai Medical Center, New York, NY, USA
                Author notes
                Correspondence: Orit Markowitz, Department of Dermatology, Mount Sinai Medical Center, 5 East 98th Street, 5th Floor, New York, NY 10029, USA, Tel +1 212 241 9728, Fax +1 212 978 1197, Email omarkowitz@ 123456gmail.com
                Article
                ccid-9-089
                10.2147/CCID.S100999
                4845892
                27143946
                b3ca7ccc-1068-4a0e-a7b1-32b49d4c6e34
                © 2016 Emilio et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                History
                Categories
                Original Research

                Dermatology
                actinic keratosis,squamous cell carcinoma,ingenol mebutate gel,local skin reaction,quality of life,skindex-16

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