Aldara is the brand name for imiquimod which is an immune response modifier. Each gram of the 5% cream contains 50 mg of imiquimod in an off-white oil-in-water vanishing cream baseconsisting of isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60,



sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl alcohol, methylparaben,and propylparaben.Chemically, imiquimod is 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine. Imiquimod has a molecular formula of C14H16N4 and a molecular weight of 240.3.

How Taken

Aldara cream is easy to use at home. It's rubbed on the warts and left on during sleeping hours. Then it's washed off after waking. Use Aldara Cream exactly as prescribed by your healthcare provider. Aldara Cream is for skin use only. Do not take by mouth or use in or near your eyes, lips or nostrils. Do not use Aldara Cream unless your healthcare provider has taught you the right way to use it. Talk to your healthcare provider if you have any questions. Aldara Cream is used for several skin conditions. Use Aldara Cream only on the area of your body to be treated. Your healthcare provider will tell you where to apply Aldara cream and how often and for how long to apply it for your condition. Do not use Aldara Cream longer than prescribed. Using too much Aldara Cream, or using it too often, or for too long can increase your chances for having a severe skin reaction or other side effect. Talk to your healthcare provider if Aldara Cream does not work for you. For external genital and perianal warts Aldara Cream is usually used once a day for 3 days a week. For these conditions, Aldara Cream is usually left on the skin for 6 to 10 hours. Treatment should continue until the warts are completely gone, or up to 16 weeks. For actinic keratosis, Aldara Cream is usually used once a day for 2 days a week. For this condition, Aldara Cream is usually left on the skin for about 8 hours. Treatment should continue for the full 16 weeks even if all actinic keratoses appear to be gone, unless you are told otherwise by your healthcare provider. The area you treat with Aldara Cream should be no larger than approximately the size of your forehead or one cheek (for example 2 inches).

CLINICAL PHARMACOLOGY

Pharmacodynamics

Actinic Keratosis

The mechanism of action of Aldara Cream in treating actinic keratosis (AK) lesions is unknown.In a study of 18 patients with AK comparing Aldara Cream to vehicle, increases from baseline in week 2 biomarker levels were reported for CD3, CD4, CD8, CD11c, and CD68 for Aldara Cream treated patients; however, the clinical relevance of these findings is unknown.

Superficial Basal Cell Carcinoma

The mechanism of action of Aldara? cream in treating superficial basal cell carcinoma (sBCC) lesions is unknown. An open label study in six subjects with sBCC suggests that treatment with Aldara Cream may increase the infiltration of lymphocytes, dendritic cells, and macrophages into the tumor lesion; however, the clinical significance of these findings is unknown.

External Genital Warts

Imiquimod has no direct antiviral activity in cell culture. A study in 22 patients with genital/perianal warts comparing Aldara Cream and vehicle shows that Aldara Cream induces

mRNA encoding cytokines including interferon-a at the treatment site. In addition HPVL1 mRNA and HPV DNA are significantly decreased following treatment. However, the clinical relevance of these findings is unknown.