{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,8,8]],"date-time":"2024-08-08T22:33:44Z","timestamp":1723156424067},"reference-count":19,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2018,1,23]],"date-time":"2018-01-23T00:00:00Z","timestamp":1516665600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"LEO Pharma A\/S"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2018,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Anogenital warts (<jats:styled-content style=\"fixed-case\">AGW<\/jats:styled-content>) can cause physical discomfort and decreased quality of life. Recent case reports suggest that ingenol mebutate gel might be an effective treatment of <jats:styled-content style=\"fixed-case\">AGW<\/jats:styled-content>.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To explore primarily the safety, and secondarily the efficacy of ingenol mebutate gel 0.05% in patients with <jats:styled-content style=\"fixed-case\">AGW<\/jats:styled-content>.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This was an exploratory, open\u2010label, 1\u2010arm trial of ingenol mebutate gel 0.05% administered up to three times to patients with <jats:styled-content style=\"fixed-case\">AGW<\/jats:styled-content>. Safety was assessed by occurrence and severity of local skin reactions (<jats:styled-content style=\"fixed-case\">LSR<\/jats:styled-content>s) and treatment\u2010related adverse events (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s). Efficacy was assessed by complete clearance and reduction in <jats:styled-content style=\"fixed-case\">AGW<\/jats:styled-content> count 14 days after last treatment, and recurrence 12 weeks after clearance.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 41 patients enrolled, 40 received treatment and 26 completed the trial. Patients had a median <jats:styled-content style=\"fixed-case\">AGW<\/jats:styled-content> count of 11.0 and <jats:styled-content style=\"fixed-case\">AGW<\/jats:styled-content> duration of 3.0 years at baseline. All patients experienced transient <jats:styled-content style=\"fixed-case\">LSR<\/jats:styled-content>s following treatment with a maximum composite <jats:styled-content style=\"fixed-case\">LSR<\/jats:styled-content> score of 7.5 (on a scale from 0 to 18). A total of 93% of patients reported treatment\u2010related <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s, most frequently pain (85%) and procedural complications (35%) due to smearing of the gel. 78% of patients took mild analgesics for the pain, typically for 1\u20132 days following treatment. The majority of <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s were of moderate\u2010to\u2010severe intensity.<\/jats:p><jats:p>Seventeen of 39 patients (43.6%) had complete clearance 14 days after last treatment, and <jats:styled-content style=\"fixed-case\">AGW<\/jats:styled-content> count was reduced by 90.9%. There was a tendency towards lower clearance rate in patients with longer duration of <jats:styled-content style=\"fixed-case\">AGW<\/jats:styled-content>. Eight of 14 patients (57.1%) had <jats:styled-content style=\"fixed-case\">AGW<\/jats:styled-content> recurrence 12 weeks after clearance.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Ingenol mebutate gel was associated with a high number of <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s and withdrawals due to painful local and adjacent skin reactions. Furthermore, it showed promising efficacy in reducing <jats:styled-content style=\"fixed-case\">AGW<\/jats:styled-content> despite a difficult\u2010to\u2010treat population. Optimization of the formulation is warranted to improve the safety profile of the treatment.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdv.14625","type":"journal-article","created":{"date-parts":[[2017,10,10]],"date-time":"2017-10-10T15:02:40Z","timestamp":1507647760000},"page":"825-831","source":"Crossref","is-referenced-by-count":7,"title":["An exploratory, prospective, open\u2010label trial of ingenol mebutate gel 0.05% for the treatment of external anogenital warts"],"prefix":"10.1111","volume":"32","author":[{"given":"H.K.","family":"Larsen","sequence":"first","affiliation":[{"name":"Department of Dermato\u2010Venereology University Hospital of Copenhagen Bispebjerg Hospital Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C.A.","family":"Banzhaf","sequence":"additional","affiliation":[{"name":"Department of Dermato\u2010Venereology University Hospital of Copenhagen Bispebjerg Hospital Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.F.","family":"Thomsen","sequence":"additional","affiliation":[{"name":"Department of Dermato\u2010Venereology University Hospital of Copenhagen Bispebjerg Hospital Copenhagen Denmark"},{"name":"Department of Biomedical Sciences University of Copenhagen Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Gormsen","sequence":"additional","affiliation":[{"name":"LEO Pharma A\/S Ballerup Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"R.E.","family":"Schopf","sequence":"additional","affiliation":[{"name":"Department of Dermatology Johannes Gutenberg University Mainz Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Haedersdal","sequence":"additional","affiliation":[{"name":"Department of Dermato\u2010Venereology University Hospital of Copenhagen Bispebjerg Hospital Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,1,23]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2334-13-39"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2458-10-113"},{"key":"e_1_2_6_4_1","first-page":"1","article-title":"Sexually transmitted diseases treatment guidelines, 2015, Ano\u2010genital warts","volume":"64","author":"Centers for Disease Control and Prevention","year":"2015","journal-title":"MMWR Recomm Rep"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-3083.2012.04493.x"},{"key":"e_1_2_6_6_1","unstructured":"Clinical Review Zyclara (imiquimod) cream 3.75% (NDA 201153).http:\/\/www.fda.gov\/downloads\/Drugs\/DevelopmentApprovalProcess\/DevelopmentResources\/UCM252892.pdf(last accessed 21 March 2017)."},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.3310\/hta20240"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2016-052768"},{"key":"e_1_2_6_9_1","first-page":"25","article-title":"Genital warts: a comprehensive review","volume":"5","author":"Yanofsky VR","year":"2010","journal-title":"J Clin Aesthet Dermatol"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1111170"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.13097"},{"key":"e_1_2_6_12_1","doi-asserted-by":"crossref","first-page":"616","DOI":"10.1111\/ddg.12879","article-title":"Successful treatment of perianal condylomata acuminata with ingenol mebutate gel","volume":"14","author":"Braun SA","year":"2016","journal-title":"J Dtsch Dermatol Ges"},{"issue":"1","key":"e_1_2_6_13_1","first-page":"S105","article-title":"Condylomata acuminata: Novel treatment by topical ingenol mebutate","volume":"134","author":"Schopf RE","year":"2014","journal-title":"J Invest Dermatol"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.42.4.789"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2133.2009.09375.x"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1155\/2011\/806105"},{"key":"e_1_2_6_17_1","first-page":"277","article-title":"Imiquimod cream 2.5% and 3.75% applied once daily to treat external genital warts in men","volume":"96","author":"Rosen T","year":"2015","journal-title":"Cutis"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2133.2008.08520.x"},{"key":"e_1_2_6_19_1","first-page":"16","article-title":"Treatment of external genital warts: a randomised clinical trial comparing podophyllin, cryotherapy and electrodesiccation","volume":"66","author":"Stone KM","year":"1990","journal-title":"Genitourin Med"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.1097\/00007435-200302000-00006"}],"container-title":["Journal of the European Academy of Dermatology and Venereology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fjdv.14625","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jdv.14625","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,18]],"date-time":"2023-09-18T03:24:51Z","timestamp":1695007491000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jdv.14625"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,1,23]]},"references-count":19,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2018,5]]}},"alternative-id":["10.1111\/jdv.14625"],"URL":"https:\/\/doi.org\/10.1111\/jdv.14625","archive":["Portico"],"relation":{},"ISSN":["0926-9959","1468-3083"],"issn-type":[{"value":"0926-9959","type":"print"},{"value":"1468-3083","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,1,23]]}}}