Medicis Pharmaceutical Corporation

3M Innovative Properties Company

James H Lee

Michael T Nordsiek

Kodumudi S Balaji

James H Kulp

Tze-Chiang Meng

Jason J Wu

Sharon F Levy

Valyn S Bahm

Robert Babilon

Richard L Miller

Mary L Owens

Terrance L Fox

David M Hammerbeck

Elaine A Egging

Pharmaceutical formulations and methods for the topical or transdermal delivery of 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine or 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine, i.e., imiquimod, to treat actinic keratosis with short durations of therapy, than currently prescribed for the commercially available Aldara&#xae; 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration ('FDA'), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating actinic keratosis with an acceptable safety profile and dosing regimens that are short and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration ('FDA') for Aldara&#xae; 5% imiquimod cream to treat actinic keratosis are also disclosed and described.

2&#xd7;2&#xd7;2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75 % imiquimod

Methods of improving skin quality are disclosed. Generally, the methods include topically administering an IRM compound to a treatment area of skin for a period of time and in an amount effective for improving the quality of the skin. Suitable IRM compound compounds include agonists of one or more TLRs.

Methods of improving skin quality

A method of treating actinic keratosis including applying topically to an actinic keratosis lesion twice per week for a duration of 8 weeks a formulation comprising 2-methyl-1-(2-methylpropyl)-1H-imidazo[4,5-c][1,5]naphthyridin-4-amine.

Method of treating actinic keratosis

Pharmaceutical formulations and methods for the topical or transdermal delivery of 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine or 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine, i.e., imiquimod, to treat actinic keratosis with short durations of therapy, than currently prescribed for the commercially available ALDARA 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration ('FDA'), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating actinic keratosis with an acceptable safety profile and dosing regimens that are short and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration ('FDA') for ALDARA 5% imiquimod cream to treat actinic keratosis are also disclosed and described.

Method of treating actinic keratosis with 3.75% imiquimod cream

2&#xd7;2&#xd7;2 week treatment regimen for treating actinic keratosis with pharmaceutical compositions formulated with 2.5% imiquimod

The present invention provides a method of protecting a subject against UV-induced epidermal neoplasia. Generally, the method includes administering to a subject an IRM compound in an amount effective to provide protection against UV-induced epidermal neoplasia. The present invention also provides compositions that include an IRM compound in an amount effective for providing protection against UV-induced epidermal neoplasia.

Prophylactic treatment of UV-induced epidermal neoplasia

Methods for diagnosing skin lesions are disclosed. Generally, the method include topically administering an IRM compound to a treatment area for a period of time and in an amount effective to cause a visible change in the appearance of a skin lesion including, in some cases, causing subclinical lesions to become visible. Suitable IRM compounds include agonists of one or more TLRs.

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Saint Paul, MN, United States of America

James H Lee