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ALDARA CREAM (IMIQUIMOD): CLINICAL PHARMACOLOGY
Mechanism of Action
The mechanism of action of Imiquimod (Aldara) topical cream in treating AK and sBCC lesions is unknown.
In a study of 18 subjects with AK comparing Imiquimod (Aldara) cream 5% to vehicle, increases from baseline in week 2 biomarker levels were reported for CD3, CD4, CD8, CD11c, and CD68 for Aldara treated subjects; however, the clinical relevance of these findings is unknown.
Superficial Basal Cell Carcinoma
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 subjects with genital / perianal warts comparing Aldara (Imiquimod) and vehicle shows that this medicine induces mRNA encoding cytokines including interferon-ƒ¿ 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.
Systemic absorption of imiquimod across the affected skin of 58 subjects with AK was observed with a dosing frequency of 3 applications per week for 16 weeks. Mean peak serum drug concentrations at the end of week 16 were approximately 0.1, 0.2, and 3.5 ng / ml for the applications to face (12.5 mg imiquimod, 1 single-use packet), scalp (25 mg, 2 packets) and hands / arms (75 mg, 6 packets), respectively.
The application surface area was not controlled when more than one packet was used. Dose proportionality was not observed. However it appears that systemic exposure may be more dependent on surface area of application than amount of applied dose. The apparent half-life was approximately 10 times greater with topical dosing than the 2 hour apparent half-life seen following subcutaneous dosing, suggesting prolonged retention of drug in the skin. Mean urinary recoveries of imiquimod and metabolites combined were 0.08 and 0.15% of the applied dose in the group using 75 mg (6 packets) for males and females, respectively following 3 applications per week for 16 weeks.
Systemic absorption of imiquimod was observed across the affected skin of 12 subjects with genital / perianal warts, with an average dose of 4.6 mg. Mean peak drug concentration of approximately 0.4 ng / ml was seen during the study. Mean urinary recoveries of imiquimod and metabolites combined over the whole course of treatment, expressed as percent of the estimated applied dose, were 0.11 and 2.41% in the males and females, respectively.
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|Aciclovir Quimioterapico - Acyclovir (Acyclovir)
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|Opridan - Isotretinoin
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