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The present prospective, multicenter, double-blind, randomized, vehicle-controlled trial evaluated the efficacy and safety of daily patient-applied imiquimod for up to 16 weeks for the treatment of external genital warts. Wart recurrence was investigated during a 12-week treatment-free follow-up period. In the intent-to-treat analysis, baseline warts cleared from 49 of 94 (52%) patients treated with 5% imiquimod cream, 13 of 90 (14%) patients treated with 1% imiquimod cream, and 3 of 95 (4%) vehicle-treated patients; the differences between the groups treated with vehicle and imiquimod were significant (<jats:italic>P<\/jats:italic>&lt; 0.0001). For subjects who completed the follow-up period, recurrence rates after a complete response were 19% (9 of 48 patients) in the 5% imiquimod cream group, 17% (2 of 12) in the 1% imiquimod cream group, and 0% (0 of 3) in the vehicle-treated group. There were no systemic reactions, although local skin reactions (generally of mild or moderate severity) were common, particularly in the 5% imiquimod cream group. Local reactions caused two patients to discontinue treatment. The most frequently reported local skin reactions were erythema, excoriation or flaking, and erosion. Patient-applied 5% imiquimod cream is effective for the treatment of external genital warts and has a favorable safety profile.<\/jats:p>","DOI":"10.1128\/aac.42.4.789","type":"journal-article","created":{"date-parts":[[2018,10,9]],"date-time":"2018-10-09T00:31:10Z","timestamp":1539045070000},"page":"789-794","update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":179,"title":["Imiquimod, a Patient-Applied Immune-Response Modifier for Treatment of External Genital Warts"],"prefix":"10.1128","volume":"42","author":[{"given":"Karl R.","family":"Beutner","sequence":"first","affiliation":[{"name":"<!--label omitted: 1-->Department of Dermatology, University of California, San Francisco, California 941431;"},{"name":"<!--label omitted: 2-->Department of Medicine, Sutter-Solano Medical Center, Vallejo, California 945892;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen K.","family":"Tyring","sequence":"additional","affiliation":[{"name":"<!--label omitted: 3-->Departments of Dermatology and Microbiology\/ Immunology, University of Texas Medical Branch, Galveston, Texas 770583;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr.","given":"Kenneth F.","family":"Trofatter","sequence":"additional","affiliation":[{"name":"<!--label omitted: 4-->Department of Obstetrics and Gynecology, Mt. Sinai Medical Center, Cleveland, Ohio 441064;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr.","given":"John M.","family":"Douglas","sequence":"additional","affiliation":[{"name":"<!--label omitted: 5-->Disease Control Service, Denver Department of Public Health, Denver, Colorado 802045;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Spotswood","family":"Spruance","sequence":"additional","affiliation":[{"name":"<!--label omitted: 6-->Division of Infectious Diseases, University of Utah, Salt Lake City, Utah 841326; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary L.","family":"Owens","sequence":"additional","affiliation":[{"name":"<!--label omitted: 7-->3M Pharmaceuticals, St. Paul, Minnesota 551447"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Terry L.","family":"Fox","sequence":"additional","affiliation":[{"name":"<!--label omitted: 7-->3M Pharmaceuticals, St. Paul, Minnesota 551447"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrina J.","family":"Hougham","sequence":"additional","affiliation":[{"name":"<!--label omitted: 7-->3M Pharmaceuticals, St. Paul, Minnesota 551447"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathy A.","family":"Schmitt","sequence":"additional","affiliation":[{"name":"<!--label omitted: 7-->3M Pharmaceuticals, St. Paul, Minnesota 551447"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"crossref","first-page":"197","DOI":"10.1016\/S0190-9622(84)70149-6","article-title":"Response of warts in epidermodysplasia verruciformis to treatment with systemic and intralesional alpha interferon.","volume":"11","author":"Androphy E.","year":"1984","unstructured":"Androphy E. 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