CA2679067A1 — Method and packages to enhance safety when using imiquimod to treat children diagnosed with skin disorders

USPTO Abstract

Pharmaceutical packages and methods for enhancing the safety of imiquimod when used to treat children affected by skin disorders are disclosed. More particularly, the safety profile of imiquimod use is enhanced by providing information to the children, guardians of the children, including parents and health care professionals, that systemic absorption of imiquimod and other effects may be observed when imiquimod therapy is used to treat children of between about 2 and about 12 years of age. Examples of systemic absorption include a serum imiquimod concentrations of less than about 2 ng/mL, a decrease in median white blood cell count by about 1.4*109/L or a decrease in median absolute neutrophil count by about 1.42*109/L Topical and/or transdermal delivery of imiquimod, including creams, ointments, gels, lotions, salves and pressure- sensitive adhesive compositions to treat dermatological disorders in children, namely, molluscum contagiosum, viral infections, such as Type 1 or Type Il Herpes simplex infections and condyloma acuminata, genital warts and perianal warts, actinic keratosis and superficial basal cell carcinoma, and to induce interferon biosynthesis, are disclosed.