title: Imiquimod 3.75% cream applied daily to treat anogenital warts: combined results from women in two randomized, placebo-controlled studies.
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(2) (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.
authors.affiliation: Division of Infectious Disease, Department of Obstetrics, Gynecology & Reproductive Medicine, Stony Brook Health Science Center, Stony Brook University Medical Center, Stony Brook, NY 11794-8091, USA. dbaker@notes.cc.sunysb.edu
authors.forename: David A
authors.initials: DA
authors.lastname: Baker
authors.forename: Daron G
authors.initials: DG
authors.lastname: Ferris
authors.forename: Mark G
authors.initials: MG
authors.lastname: Martens
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Fife
authors.forename: Stephen K
authors.initials: SK
authors.lastname: Tyring
authors.forename: Libby
authors.initials: L
authors.lastname: Edwards
authors.forename: Anita
authors.initials: A
authors.lastname: Nelson
authors.forename: Kevin
authors.initials: K
authors.lastname: Ault
authors.forename: Kenneth F
authors.initials: KF
authors.lastname: Trofatter
authors.forename: Tiepu
authors.initials: T
authors.lastname: Liu
authors.forename: Sharon
authors.initials: S
authors.lastname: Levy
authors.forename: Jason
authors.initials: J
authors.lastname: Wu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000634:Aminoquinolines / Q000008:administration & dosage* / Q000009:adverse effects; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003218:Condylomata Acuminata / Q000188:drug therapy*; D003627:Data Interpretation, Statistical; D005260:Female; D005831:Genital Diseases, Female / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077271:Imiquimod; D008875:Middle Aged; D010919:Placebos; D016896:Treatment Outcome
chemical_list: D000634:Aminoquinolines; D000998:Antiviral Agents; D010919:Placebos; D000077271:Imiquimod