CLINICAL PHARMACOLOGY

Pharmacodynamics

The mechanism of action of imiquimod in treating genital/perianal warts is unknown. Imiquimod has no direct antiviral activity in cell culture. Mouse skin studies suggest that imiquimod induces cytokines including interferon-a. However, the clinical relevance of these findings is unknown.

Pharmacokinetics

Percutaneous absorption of [14C] imiquimod was minimal in a study involving 6 healthy subjects treated with a single topical application (5 mg) of [14C] imiquimod cream formulation. No radioactivity was detected in the serum (lower limit of quantitation: 1 ng/mL) and <.9% of the radiolabelled dose was excreted in the urine and feces following topical application.

CLINICAL STUDIES

In a double-blind, placebo-controlled clinical trial, 209 otherwise healthy patients 18 years of age and older with genital/perianal warts were treated with Aldara 5% cream or vehicle control 3X/week for a maximum of 16 weeks. The median baseline wart area was 69 mm2 (range 8 to 5525 mm2).

Data on complete clearance are listed in the table below. The median time to complete wait clearance was 10 weeks.