Aldara Mechanism of Action





Agencia Lei Va Hong
Full Prescribing Info
Immune response modifier.
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-α. 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 <0.9% 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 with genital/perianal warts were treated with Aldara 5% cream or vehicle control 3 times a week for a maximum of 16 weeks. The median baseline wart area was 69 mm2 (range 8-5525 mm2).
Patient accountability is shown in the following diagram. (See diagram.)

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Data on complete clearance are listed in Table 1 (see Table 1). The median time to complete wart clearance was 10 weeks.

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Reference:1. Edwards et al. Self-Administered topical 5% Imiquimod Cream for Exrternal Anogenital Warts. Arch Dermatol.1998; 134:25-30.
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