Compositions and methods of treatment of inflammatory skin conditions using allantoin

Abstract

Embodiments herein provide formulations and methods for treatment of inflammatory skin diseases using allantoin in an amount from about 0.5% to about 15.0% by weight. Inflammatory skin diseases treated by embodiments herein include, without limitation, cutaneous porphyria, sclerodema, epidermolysis bulosa, psoriasis, decubitus ulcers, pressure ulcers, diabetic ulcers, venous stasis ulcers, sickle cell ulcers, ulcers caused by burns, eczema, urticaria, atopic dermatitis, dermatitis herpetiform, contact dermatitis, arthritis, gout, lupus erythematosus, acne, alopecia, carcinomas, psoriasis, rosacea, miliaria, skin infections, post-operative care of incisions, post-operative skin care following any variety of plastic surgery operations, skin care following radiation treatment, care of dry, cracked or aged skin and skin lines as well as other conditions affecting the skin and having an inflammatory component, symptoms thereof, or a combination thereof. Symptoms treated may include pain, inflammation, redness, itching, scarring, skin thickening, milia, or a combination thereof.

1 . A composition comprising an oil-in-water emulsion comprising allantoin in an amount from about 3.0% to about 15% by weight and a pharmaceutically acceptable excipient, wherein the composition further comprises an emollient, an emulsifier, a solvent, and a pH modifier; and the pH is between about 4.0 and about 5.0. 
     
     
         2 . The composition of  claim 1 , wherein the amount of allantoin is about 6.0% to about 15% by weight. 
     
     
         3 . The composition of  claim 1 , wherein the amount of allantoin is about 6.0% to about 10% by weight. 
     
     
         4 . The composition of  claim 1  further comprising a solubilizing agent, an antioxidant, a preservative, a chelating agent, an additive, a viscosity agent or a combination thereof. 
     
     
         5 . The composition of  claim 1  further comprising a fragrance. 
     
     
         6 . The composition of  claim 1  further comprising tetrasodium EDTA. 
     
     
         7 . The composition of  claim 6 , wherein the tetrasodium EDTA is in an amount from about 0.05% to about 0.5%. 
     
     
         8 . The composition of  claim 1 , wherein the emulsion comprises: water; cetyl alcohol; stearyl alcohol; beeswax; sodium lauryl sulfate in a 30% solution; citric acid; lanolin oil; propylene glycol; tetrasodium EDTA; cod liver oil; butylated hydroxytoluene; methylparaben; propylparaben or a combination thereof. 
     
     
         9 . The composition of  claim 8 , wherein the emulsion comprises: water in an amount from about 40 to about 90%; cetyl alcohol in an amount from about 0.5 to about 15%; stearyl alcohol in an amount from about 1% to about 3%; beeswax in an amount from about 1.5% to about 3%; sodium lauryl sulfate in a 30% solution in an amount from about 1.5% to about 3%; citric acid in an amount from about 0.5% to about 0.2%; lanolin oil in an amount from about 5% to about 15%; propylene glycol in an amount from about 2% to about 8%; tetrasodium EDTA in an amount from about 0.05% to about 0.5%; cod liver oil in an amount from about 0.05% to about 5%; butylated hydroxytoluene in an amount from about 0.05% to about 1%; methylparaben in an amount from about 0.05% to about 0.5%; propylparaben in an amount from about 0.05% to about 0.5% by weight of the formulation or a combination thereof. 
     
     
         10 . The composition of  claim 1 , wherein the emulsion comprises: water; cetyl alcohol; stearyl alcohol; beeswax; sodium lauryl sulfate in a 30% solution; citric acid; lanolin oil; glycerin; tetrasodium EDTA; cod liver oil; butylated hydroxytoluene; methylparaben; propylparaben or a combination thereof. 
     
     
         11 . The composition of  claim 1 , wherein the emulsion comprises: water; cetyl alcohol; stearyl alcohol; beeswax; sodium lauryl sulfate in a 30% solution; lactic acid; lanolin oil; propylene glycol; tetrasodium EDTA; cod liver oil; butylated hydroxytoluene; methylparaben; propylparaben or a combination thereof. 
     
     
         12 . The composition of  claim 1 , wherein the emulsion comprises: water; cetyl alcohol; stearyl alcohol; beeswax; sodium lauryl sulfate in a 30% solution; lactic acid; lanolin oil; glycerin; tetrasodium EDTA; cod liver oil; butylated hydroxytoluene; methylparaben; propylparaben or a combination thereof. 
     
     
         13 . The composition of  claim 1 , wherein said composition is stable at room temperature for about 4 to about 6 years. 
     
     
         14 - 27 . (canceled) 
     
     
         28 . The composition of  claim 1 , wherein allantoin is the sole active ingredient. 
     
     
         29 . The composition of  claim 4 , wherein the emollient is an emulsifier system comprising sodium lauryl sulfate and beeswax. 
     
     
         30 . The composition of  claim 1 , further comprising a solubilizing agent, an antioxidant, and a preservative. 
     
     
         31 . The composition of  claim 1 , wherein the composition does not comprise a penetration enhancer. 
     
     
         32 . The composition of  claim 1 , wherein the composition delivers allantoin across intact skin barrier without an increase in systemic blood levels. 
     
     
         33 . The composition of  claim 1 , wherein the amount of allantoin is about 3.0%. 
     
     
         34 . The composition of  claim 1 , wherein the amount of allantoin is about 6.0%. 
     
     
         35 . The composition of  claim 1 , wherein the amount of allantoin is about 9.0%.