TY - JOUR
T1 - Imiquimod 3.75 cream applied daily to treat anogenital warts
T2 - Combined results from women in two randomized, placebo-controlled studies
AU - Baker, David A.
AU - Ferris, Daron G.
AU - Martens, Mark G.
AU - Fife, Kenneth H.
AU - Tyring, Stephen K.
AU - Edwards, Libby
AU - Nelson, Anita
AU - Ault, Kevin
AU - Trofatter, Kenneth F.
AU - Liu, Tiepu
AU - Levy, Sharon
AU - Wu, Jason
N1 - Copyright:
Copyright 2011 Elsevier B.V., All rights reserved.
PY - 2011
Y1 - 2011
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.
AB - 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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U2 - 10.1155/2011/806105
DO - 10.1155/2011/806105
M3 - Article
C2 - 21876641
AN - SCOPUS:80053521377
SN - 1064-7449
VL - 2011
JO - Infectious Diseases in Obstetrics and Gynecology
JF - Infectious Diseases in Obstetrics and Gynecology
M1 - 806105
ER -