{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T03:45:12Z","timestamp":1793677512687,"version":"4.5.1"},"reference-count":17,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2007,10,23]],"date-time":"2007-10-23T00:00:00Z","timestamp":1193097600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2007,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p><jats:bold>Objective\u2002<\/jats:bold> Clinical efficacy and safety of Polyphenon\u00ae E, a defined green tea extract, in external genital warts.<\/jats:p><jats:p><jats:bold>Design\u2002<\/jats:bold> Randomized, double\u2010blind, placebo\u2010controlled study for up to 12\u00a0weeks with a 12\u2010week treatment\u2010free follow\u2010up.<\/jats:p><jats:p><jats:bold>Setting\u2002<\/jats:bold> Twenty\u2010eight hospitals and practices in Germany and Russia.<\/jats:p><jats:p><jats:bold>Patients\u2002<\/jats:bold> Two hundred forty\u2010two outpatients (125 men, 117 women) with 2 to 30 warts (total wart area, 12\u2013600\u00a0mm<jats:sup>2<\/jats:sup>).<\/jats:p><jats:p><jats:bold>Intervention(s)\u2002<\/jats:bold> Topical application of Polyphenon\u00ae E 10% Cream, Polyphenon\u00ae E 15% Ointment or placebo to all external genital warts three times a day.<\/jats:p><jats:p><jats:bold>Main outcome measure(s)\u2002<\/jats:bold> Measurement of total wart area and local reactions\/adverse events.<\/jats:p><jats:p><jats:bold>Results\u2002<\/jats:bold> For 15% ointment, statistically significant differences to placebo were achieved regarding complete clearance of all baseline external genital warts (61.0% vs. 40.5% in males, 56.8% vs. 34.1% in females; combined gender: <jats:italic>P<\/jats:italic>\u00a0=\u00a00.0066) and 75% to 100% clearance (80.8% vs. 51.8%; <jats:italic>P<\/jats:italic>\u00a0=\u00a00.0001) in both the intent\u2010to\u2010treat and per\u2010protocol populations. For 10% cream, 53.8% males and 39.5% females achieved complete clearance. Recurrence rates 12\u00a0weeks after end of treatment were 10.6%, 11.8% and 10.3% for 15% ointment, 10% cream and placebo, respectively.<\/jats:p><jats:p>Adverse events were observed in only 7.9% of patients, with no serious adverse events or deaths reported. Local skin reactions were generally mild to moderate and resolved with continued treatment without sequelae.<\/jats:p><jats:p><jats:bold>Conclusions\u2002<\/jats:bold> Polyphenon\u00ae E 15% ointment, composed of a defined green tea extract, proved to be efficacious and safe for both gender in the treatment of external genital warts.<\/jats:p>","DOI":"10.1111\/j.1468-3083.2007.02441.x","type":"journal-article","created":{"date-parts":[[2007,10,25]],"date-time":"2007-10-25T06:24:50Z","timestamp":1193293490000},"page":"1404-1412","source":"Crossref","is-referenced-by-count":87,"title":["A randomized, double\u2010blind, four\u2010arm parallel\u2010group, placebo\u2010controlled Phase II\/III study to investigate the clinical efficacy of two galenic formulations of Polyphenon\u00ae E in the treatment of external genital warts"],"prefix":"10.1111","volume":"21","author":[{"given":"G","family":"Gross","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K\u2010G","family":"Meyer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H","family":"Pres","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C","family":"Thielert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H","family":"Tawfik","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A","family":"Mescheder","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2007,10,23]]},"reference":[{"key":"e_1_2_6_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9343(97)00177-0"},{"key":"e_1_2_6_3_2","doi-asserted-by":"publisher","DOI":"10.1136\/sti.76.3.162"},{"key":"e_1_2_6_4_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.42.4.789"},{"key":"e_1_2_6_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0020-7292(02)00034-6"},{"key":"e_1_2_6_6_2","doi-asserted-by":"publisher","DOI":"10.1097\/00007435-200104000-00007"},{"key":"e_1_2_6_7_2","doi-asserted-by":"publisher","DOI":"10.1258\/0956462011924218"},{"key":"e_1_2_6_8_2","doi-asserted-by":"publisher","DOI":"10.1177\/095646240101200105"},{"key":"e_1_2_6_9_2","doi-asserted-by":"publisher","DOI":"10.1159\/000150569"},{"key":"e_1_2_6_10_2","first-page":"53","article-title":"Phase I pharmacokinetic study of tea polyphenols following single\u2010dose administration of epigallocatechin gallate and polyphenon E","volume":"10","author":"Chow HH","year":"2001","journal-title":"Cancer Epidemiol Biomarkers Prev"},{"key":"e_1_2_6_11_2","first-page":"1","article-title":"Cancer chemoprevention by tea polyphenols","volume":"24","author":"Lin JK","year":"2000","journal-title":"Proc Natl Sci Counc Repub China B"},{"key":"e_1_2_6_12_2","unstructured":"World Medical Association Declaration of Helsinki: Ethical Principles For Medical Research Involving Human Subjects.Somerset West (South Africa) 1996. Available at:http:\/\/www.wma.net\/e\/policy\/pdf\/17c.pdf. Accessed March 11 2004."},{"key":"e_1_2_6_13_2","doi-asserted-by":"publisher","DOI":"10.1086\/342109"},{"key":"e_1_2_6_14_2","doi-asserted-by":"publisher","DOI":"10.1086\/514722"},{"key":"e_1_2_6_15_2","first-page":"1232","article-title":"Genital warts","volume":"6","author":"Wiley DJ","year":"2001","journal-title":"Clin Evid"},{"key":"e_1_2_6_16_2","doi-asserted-by":"publisher","DOI":"10.1097\/00007435-200302000-00006"},{"key":"e_1_2_6_17_2","first-page":"598","article-title":"Management of anogenital warts (condylomata acuminata)","volume":"11","author":"Von Krogh G.","year":"2001","journal-title":"Eur J Dermatol"},{"key":"e_1_2_6_18_2","doi-asserted-by":"publisher","DOI":"10.1001\/archderm.134.1.25"}],"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%2Fj.1468-3083.2007.02441.x","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/j.1468-3083.2007.02441.x","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,11]],"date-time":"2023-10-11T00:27:41Z","timestamp":1696984061000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/j.1468-3083.2007.02441.x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2007,10,23]]},"references-count":17,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2007,11]]}},"alternative-id":["10.1111\/j.1468-3083.2007.02441.x"],"URL":"https:\/\/doi.org\/10.1111\/j.1468-3083.2007.02441.x","archive":["Portico"],"relation":{},"ISSN":["0926-9959","1468-3083"],"issn-type":[{"value":"0926-9959","type":"print"},{"value":"1468-3083","type":"electronic"}],"subject":[],"published":{"date-parts":[[2007,10,23]]}}}