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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.
AuthorsK R Beutner, S K Tyring, K F Trofatter Jr, J M Douglas Jr, S Spruance, M L Owens, T L Fox, A J Hougham, K A Schmitt
JournalAntimicrobial agents and chemotherapy (Antimicrob Agents Chemother) Vol. 42 Issue 4 Pg. 789-94 (Apr 1998) ISSN: 0066-4804 [Print] United States
PMID9559784 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Aminoquinolines
  • Interferon Inducers
  • Imiquimod
Topics
  • Administration, Topical
  • Adolescent
  • Adult
  • Aminoquinolines (administration & dosage, adverse effects, therapeutic use)
  • Condylomata Acuminata (drug therapy, pathology)
  • Double-Blind Method
  • Female
  • Humans
  • Imiquimod
  • Interferon Inducers (administration & dosage, adverse effects, therapeutic use)
  • Male
  • Papillomaviridae
  • Recurrence

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