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

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.