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041 _afre
042 _adc
100 1 0 _aDiepgen, Thomas L.
_eauthor
700 1 0 _a Eicke, Christoph
_eauthor
700 1 0 _a Bastian, Mike
_eauthor
245 0 0 _aIngenol mebutate as topical treatment for actinic keratosis based on a prospective, non-interventional, multicentre study of real-life clinical practice in Germany: efficacy and quality of life
260 _c2019.
500 _a48
520 _aBackground: The use of ingenol mebutate (IM) as a field-directed therapy over a short period of time has been shown to be effective and well tolerated in randomized Phase III trials. Objectives: To assess the efficacy and patient-reported outcomes for IM as treatment for actinic keratosis (AK) under daily “real-life” practice conditions. Materials and Methods: A total of 826 adult patients with AK were enrolled by 292 dermatologists in Germany in a prospective, open, non-interventional, non-controlled, multicentre study. All patients were treated with IM and followed for eight weeks. Results: The mean number of clinically visible AK lesions decreased significantly from 7.1±6.8 to 2.8±4.5 ( p<0.0001). Most dermatologists (79.0%) rated global efficacy of IM as “very good”/“good” and 82.6% of the patients were “very satisfied” or “rather satisfied” with the efficacy of IM. Patient-reported outcomes showed greater efficacy and treatment comfort with IM compared to any last previous AK treatment with a comparable tolerability profile. Skin-related QoL data revealed a significant improvement of 50.2% after IM treatment ( p<0.0001). Adverse events were reported in 7.0% of all patients, which were in most cases mild in intensity. Conclusion: Field-directed treatment with IM over a short period was associated with a high level of treatment satisfaction, as reported by dermatologists and patients. This observational study demonstrates the effectiveness and tolerability of IM in everyday clinical practice in addition to the known efficacy and safety obtained by randomized controlled clinical trials.
690 _afield-directed therapy
690 _aquality of life
690 _areal-life clinical practice
690 _aingenol mebutate gel
690 _aactinic keratosis
786 0 _nEuropean Journal of Dermatology | 29 | 4 | 2019-07-01 | p. 401-408 | 1167-1122
856 4 1 _uhttps://shs.cairn.info/revue-european-journal-of-dermatology-2019-4-page-401?lang=en&redirect-ssocas=7080
999 _c602153
_d602153