title: Imiquimod, a patient-applied immune-response modifier for treatment of external genital warts.
abstract: Genital human papillomavirus infection is one of the most common sexually transmitted diseases. Imiquimod is a new agent, an immune-response modifier, that has been demonstrated to have potent in vivo antiviral and antitumor effects in animal models. 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 (P < 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.
authors.affiliation: Department of Dermatology, University of California, San Francisco 94143, USA. kbeutner@solderm.com
authors.forename: K R
authors.initials: KR
authors.lastname: Beutner
authors.forename: S K
authors.initials: SK
authors.lastname: Tyring
authors.forename: K F
authors.initials: KF
authors.lastname: Trofatter
authors.forename: J M
authors.initials: JM
authors.lastname: Douglas
authors.forename: S
authors.initials: S
authors.lastname: Spruance
authors.forename: M L
authors.initials: ML
authors.lastname: Owens
authors.forename: T L
authors.initials: TL
authors.lastname: Fox
authors.forename: A J
authors.initials: AJ
authors.lastname: Hougham
authors.forename: K A
authors.initials: KA
authors.lastname: Schmitt
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000634:Aminoquinolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003218:Condylomata Acuminata / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000077271:Imiquimod; D007369:Interferon Inducers / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D027383:Papillomaviridae; D012008:Recurrence
chemical_list: D000634:Aminoquinolines; D007369:Interferon Inducers; D000077271:Imiquimod