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 Fife, Stephen K. Tyring, Libby Edwards, Anita Nelson, Kevin Ault, Kenneth F. Trofatter, Tiepu Liu, Sharon Levy, Jason Wu

Research output: Contribution to journalArticle

27 Citations (Scopus)

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
Article number806105
JournalInfectious Diseases in Obstetrics and Gynecology
Volume2011
DOIs
StatePublished - 2011

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imiquimod
Warts
Placebos
Safety

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Infectious Diseases
  • Dermatology

Cite this

Imiquimod 3.75 cream applied daily to treat anogenital warts : Combined results from women in two randomized, placebo-controlled studies. / Baker, David A.; Ferris, Daron G.; Martens, Mark G.; Fife, Kenneth; Tyring, Stephen K.; Edwards, Libby; Nelson, Anita; Ault, Kevin; Trofatter, Kenneth F.; Liu, Tiepu; Levy, Sharon; Wu, Jason.

In: Infectious Diseases in Obstetrics and Gynecology, Vol. 2011, 806105, 2011.

Research output: Contribution to journalArticle

Baker, David A. ; Ferris, Daron G. ; Martens, Mark G. ; Fife, Kenneth ; Tyring, Stephen K. ; Edwards, Libby ; Nelson, Anita ; Ault, Kevin ; Trofatter, Kenneth F. ; Liu, Tiepu ; Levy, Sharon ; Wu, Jason. / Imiquimod 3.75 cream applied daily to treat anogenital warts : Combined results from women in two randomized, placebo-controlled studies. In: Infectious Diseases in Obstetrics and Gynecology. 2011 ; Vol. 2011.
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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.",
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N2 - 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.

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