Imiquimod 3.75 cream applied daily to treat anogenital warts: Combined results from women in two randomized, placebo-controlled studies

David A. Baker, Daron G. Ferris, Mark G. Martens, Kenneth H. Fife, Stephen K. Tyring, Libby Edwards, Anita Nelson, Kevin Ault, Kenneth F. Trofatter, Tiepu Liu, Sharon Levy, Jason Wu

Research output: Contribution to journalArticle

31 Scopus citations

Abstract

Objective. To evaluate if new imiquimod formulations using a shorter treatment duration are safe and efficacious to treat anogenital warts. Methods. In two studies 534 women ≥12 years of age (mean 33.4) with 2-30 warts (mean 7.9) and total wart area ≥ 10 mm (mean 166.3) were randomized (1:2:2) to placebo (106), imiquimod 2.5 (212) or 3.75 (216) creams applied once daily until complete clearance or a maximum of 8 weeks. Results. For placebo, imiquimod 2.5 and 3.75, respectively, complete clearance of all warts was achieved in 14.2, 28.3, and 36.6 of women (intent-to-treat, P = 0.008 imiquimod 2.5, and P < 0.001 3.75 versus placebo). Mean changes in wart counts were -10.7, -50.9, and -63.5 (per-protocol, P < 0.001 each active versus placebo) and safety-related discontinuation rates 0.9, 1.4, and 2.3. Conclusions. Imiquimod 3.75 applied daily for up to 8 weeks was well tolerated and superior to placebo in treating women with external anogenital warts.

Original languageEnglish (US)
Article number806105
JournalInfectious Diseases in Obstetrics and Gynecology
Volume2011
DOIs
StatePublished - 2011

ASJC Scopus subject areas

  • Dermatology
  • Obstetrics and Gynecology
  • Infectious Diseases

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    Baker, D. A., Ferris, D. G., Martens, M. G., Fife, K. H., Tyring, S. K., Edwards, L., Nelson, A., Ault, K., Trofatter, K. F., Liu, T., Levy, S., & Wu, J. (2011). Imiquimod 3.75 cream applied daily to treat anogenital warts: Combined results from women in two randomized, placebo-controlled studies. Infectious Diseases in Obstetrics and Gynecology, 2011, [806105]. https://doi.org/10.1155/2011/806105