Topical compositions comprising a corticosteroid

Abstract

Topical compositions comprising a corticosteroid, at least one alcohol, and a penetration enhancing agent.

1 .- 12 . (canceled) 
     
     
         13 . A method of treating moderate to severe plaque psoriasis in a subject comprising:
 administering to the subject twice daily, for a period of up to about two weeks, a topical composition comprising about 0.025% (w/w) of clobetasol, an oil phase; an aqueous phase; and at least one pharmaceutically acceptable excipient;   wherein the oil phase comprises at least one penetration enhancing agent in an amount from about 0.01% to about 15.0% of the total weight of the composition and a non-polymeric thickening agent; wherein the at least one penetration enhancing agent is diethylene glycol monoethyl ether; wherein the at least one pharmaceutically acceptable excipient is isopropyl myristate; and   wherein treating moderate to severe plaque psoriasis in the subject results in an investigator global assessment score of 0 to 1.   
     
     
         14 . The method of  claim 13 , wherein the investigator global assessment score is measured at day 15. 
     
     
         15 . The method of  claim 13 , wherein treating moderate to severe plaque psoriasis in the subject results in at least 70% of subjects not having hypothalamic pituitary adrenal (HPA) axis suppression. 
     
     
         16 . The method of  claim 13 , wherein treating moderate to severe plaque psoriasis in the subject results in at least 80% of subjects not having hypothalamic pituitary adrenal (HPA) axis suppression. 
     
     
         17 . The method of  claim 13 , wherein treating moderate to severe plaque psoriasis in the subject results in at least 90% of subjects not having hypothalamic pituitary adrenal (HPA) axis suppression. 
     
     
         18 . The method of  claim 13 , wherein treating moderate to severe plaque psoriasis in the subject results in the subject being substantially free of adverse effects. 
     
     
         19 . The method of  claim 18 , wherein the adverse effect is skin irritation. 
     
     
         20 . The method of  claim 13 , wherein the topical composition provides a mean clobetasol plasma level less than about 150 pg/mL. 
     
     
         21 . The method of  claim 13 , wherein the topical composition provides a mean clobetasol plasma level less than about 130 pg/mL. 
     
     
         22 . The method of  claim 13 , wherein the subject has moderate to severe plaque psoriatic lesions involving at least about 5% body surface area. 
     
     
         23 . The method of  claim 13 , wherein the subject has moderate to severe plaque psoriatic lesions involving at least about 10% body surface area. 
     
     
         24 . The method of  claim 13 , wherein the clobetasol is clobetasol propionate. 
     
     
         25 . The method of  claim 13 , wherein the non-polymeric thickening agent is cetosteryl alcohol. 
     
     
         26 . The method of  claim 13 , wherein the at least one pharmaceutically acceptable excipient is selected from the group consisting of a carrier, emulsifier, co-emulsifier, solvent, co-solvents, emollient, antioxidant, preservative, gelling or thickening agent, polymer, surfactant, soothing agent, pH modifier, solubilizer, humectants, moisturizer, oily base, and any combination thereof. 
     
     
         27 . The method of  claim 26 , wherein the at least one pharmaceutically acceptable excipient is an emulsifier and the emulsifier is a mixture of glyceryl stearate and PEG 100 stearate. 
     
     
         28 . The method of  claim 27 , wherein the mixture of glyceryl stearate and PEG 100 Stearate is about 6% of the total weight of the composition. 
     
     
         29 . The method of  claim 13 , wherein the isopropyl myristate is about 10% of the total weight of the composition. 
     
     
         30 . The method of  claim 26 , wherein the at least one pharmaceutically acceptable excipient is an emollient and the emollient is cyclomethicone. 
     
     
         31 . The method of  claim 30 , wherein the cyclomethicone is about 5% of the total weight of the composition. 
     
     
         32 . The method of  claim 26 , wherein the at least one pharmaceutically acceptable excipient is an antioxidant and the antioxidant is butylated hydroxytoluene. 
     
     
         33 . The method of  claim 32 , wherein the butylated hydroxytoluene is about 0.05% of the total weight of the composition. 
     
     
         34 . The method of  claim 26 , wherein the at least one pharmaceutically acceptable excipient is a preservative and the antioxidant is selected from methylparaben, propylparaben and a combination thereof. 
     
     
         35 . The method of  claim 34 , wherein the preservative is methylparaben and the methylparaben is about 0.2% of the total weight of the composition. 
     
     
         36 . The method of  claim 34 , wherein the preservative is propylparaben and the propylparaben is about 0.4% of the total weight of the composition. 
     
     
         37 . The method of  claim 26 , wherein the at least one pharmaceutically acceptable excipient is a gelling or thickening agent and the gelling or thickening agent is white wax. 
     
     
         38 . The method of  claim 37 , wherein the white wax is about 1% of the total weight of the composition. 
     
     
         39 . The method of  claim 13 , wherein the aqueous phase is water. 
     
     
         40 . The method of  claim 39 , the water is at least 60% of the total weight of the composition. 
     
     
         41 . The method of  claim 13 , wherein the topical composition is substantially free of propylene glycol. 
     
     
         42 . The method of  claim 13 , wherein the topical composition is substantially free of polymers. 
     
     
         43 . The method of  claim 13 , wherein the oil phase comprises at least one penetration enhancing agent in an amount from about 0.01% to about 10.0% of the total weight of the composition, wherein the at least one penetration enhancing agent is diethylene glycol monoethyl ether. 
     
     
         44 . The method of  claim 13 , wherein the oil phase comprises at least one penetration enhancing agent in an amount up to about 5.0% of the total weight of the composition, wherein the at least one penetration enhancing agent is diethylene glycol monoethyl ether. 
     
     
         45 . The method of  claim 13 , wherein the oil phase comprises at least one penetration enhancing agent in an amount of about 3.0% of the total weight of the composition, wherein the at least one penetration enhancing agent is diethylene glycol monoethyl ether. 
     
     
         46 . The method of  claim 13 , wherein the topical composition comprises about 0.025% clobetasol; an oil phase of about 3% diethylene glycol monoethyl ether as the penetration enhancing agent and about 1% white wax as the non-polymeric thickening agent; about 10% isopropyl myristate; water as the aqueous phase; and wherein the at least one pharmaceutically acceptable excipient is about 6% of a mixture of glyceryl stearate and PEG 100 stearate, about 0.05% butylated hydroxytoluene, about 5% cyclomethicone, about 0.2% methylparaben; and about 0.4% propylparaben.