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 base consisting 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)-1 H -imidazo [4,5-c]quinolin-4-amine. Imiquimod has a molecular formula of C 14 H 16 N 4 and a molecular weight of 240.3.
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-(alpha) 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.
INDICATIONS AND USAGE
Aldara Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults.
Aldara Cream is indicated for the topical treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults, with a maximum tumor diameter of 2.0 cm, located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured. The histological diagnosis of superficial basal cell carcinoma should be established prior to treatment, since safety and effectiveness of Aldara Cream have not been established for other types of basal cell carcinomas, including nodular, morpheaform (fibrosing or sclerosing) types.
Aldara Cream is indicated for the treatment of external genital and perianal warts/condyloma acuminata in individuals 12 years old and above.
This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity to any of its ingredients is noted.
The diagnosis of sBCC should be confirmed prior to treatment, since safety and effectiveness of Aldara Cream have not been established for other types of basal cell carcinomas, including nodular, morpheaform (fibrosing or sclerosing) types and is not recommended for treatment of BCC subtypes other than the superficial variant (i.e., sBCC). Patients with sBCC treated with Aldara Cream are recommended to have regular follow-up of the treatment site. See table of Estimated Clinical Clearance Rates for Superficial Basal Cell Carcinoma in the CLINICAL STUDIES section.
Aldara Cream has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and is not recommended for these conditions.
The safety and efficacy of Aldara Cream in immunosuppressed patients have not been established.
Aldara Cream administration is not recommended until the skin is completely healed from any previous drug or surgical treatment.
Aldara Cream has the potential to exacerbate inflammatory conditions of the skin, including chronic graft versus host disease.
Aldara Cream should be used with caution in patients with pre-existing autoimmune conditions.
Intense local inflammatory reactions including skin weeping or erosion can occur after only a few applications of Aldara Cream. Local inflammatory reactions may be accompanied, or even preceded, by flu-like systemic signs and symptoms including malaise, fever, nausea, myalgias and rigors. An interruption of dosing should be considered.
Exposure to sunlight (including sunlamps) should be avoided or minimized during use of Aldara Cream because of concern for heightened sunburn susceptibility. Patients should be warned to use protective clothing (hat) when using Aldara Cream. Patients with sunb