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: 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
• Journal: Infectious diseases in obstetrics and gynecology (Infect Dis Obstet Gynecol) Vol. 2011 Pg. 806105 ( 2011) ISSN: 1098-0997 [Electronic] Egypt
• PMID: 21876641 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Aminoquinolines
• Antiviral Agents
• Placebos
• Imiquimod

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Aminoquinolines (administration & dosage, adverse effects)
• Antiviral Agents (administration & dosage, adverse effects)
• Condylomata Acuminata (drug therapy)
• Data Interpretation, Statistical
• Female
• Genital Diseases, Female (drug therapy, virology)
• Humans
• Imiquimod
• Middle Aged
• Placebos
• Treatment Outcome