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 - 27 . (canceled) 
     
     
         28 . A composition comprising an oil-in-water emulsion comprising:
 (a) about 6% allantoin;   (b) about 40% to about 90% water;   (c) about 8% to about 30% an emollient;   (d) about 1% to about 15% an emulsifier;   (e) about 0.01% to about 1% a pH modifier;   (f) about 1% to about 10% a viscosity agent;   (g) about 1% to about 20% a solubilizing agent selected from the group consisting of propylene glycol, glycerin, and a combination thereof;   (h) about 0.01% to about 2% a chelating agent selected from the group consisting of alanine, sodium polyphosphate, sodium methaphosphate, citric acid, phosphoric acid, tartaric acid, dihydroxyethyl glycine, ethylenediamine tetra acetic acid (EDTA) and derivatives and salts thereof, and a combination thereof;   (i) about 0.001% to about 3% an antioxidant selected from the group consisting of vitamin B, nordihydroguaiaretic acid, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), propyl gallate, erythorbate acid, sodium erythorbate, ascorbir palmitate, ascorbir stearate, butyl hydroxyanisole, and gallic esters; and   (j) about 0.01% to about 3.0% a preservative.   
     
     
         29 . The composition of  claim 28  comprising:
 (a) about 6% allantoin; 
 (b) about 40% to about 90% water; 
 (c) about 8% to about 30% emollient selected from the group consisting of lanolin oil, cod liver oil, mineral oil, an alcohol, and any combination thereof; 
 (d) about 1% to about 15% emulsifier selected from the group consisting of sodium lauryl sulfate, a white wax, and a combination thereof; 
 (e) about 0.01% to about 1% pH modifier selected from the group consisting of citric acid, lactic acid, and a combination thereof; 
 (f) about 1% to about 10% viscosity enhancing agent selected from the group consisting of cetyl alcohol, stearyl alcohol, and a combination thereof; 
 (g) about 1% to about 20% solubilizing agent selected from the group consisting of propylene glycol, glycerin, and a combination thereof; 
 (h) about 0.01% to about 2% chelating agent selected from the group consisting of alanine, sodium polyphosphate, sodium methaphosphate, citric acid, phosphoric acid, tartaric acid, dihydroxyethyl glycine, ethylenediamine tetra acetic acid (EDTA) and derivatives and salts thereof, and a combination thereof; 
 (i) 0.01% to about 1% antioxidant selected from the group consisting of vitamin B, nordihydroguaiaretic acid, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), propyl gallate, erythorbate acid, sodium erythorbate, ascorbir palmitate, ascorbir stearate, butyl hydroxyanisole, and gallic esters; and 
 (j) about 0.01% to about 3.0% preservative selected from the group consisting of methylparaben, propylparaben, and a combination thereof. 
 
     
     
         30 . The composition of  claim 29 , comprising:
 (a) about 6% allantoin;   (b) about 40% to about 90% water;   (c) about 1% to about 6% cetyl alcohol;   (d) about 1% to about 3% stearyl alcohol;   (e) about 1.5% to about 3% beeswax;   (f) about 1.5% to about 3% sodium lauryl sulfate in a 30% solution;   (g) about 0.05% to about 0.2% citric acid;   (h) about 5% to about 15% lanolin oil;   (i) about 2% to about 8% propylene glycol;   (j) about 0.05% to about 0.5% tetrasodium EDTA;   (k) about 0.05% to about 5% cod liver oil;   (l) about 0.05% to about 1% butylated hydroxytoluene;   (m) about 0.05% to about 0.5% methylparaben; and   (n) about 0.05% to about 0.5% propylparaben.   
     
     
         31 . The composition of  claim 30 , comprising:
 (a) about 42% to about 68% water;   (b) about 2% to about 6% cetyl alcohol;   (c) about 1% to about 3% stearyl alcohol;   (d) about 1.5% to about 3% beeswax;   (e) about 1.5% to about 3% sodium lauryl sulfate in a 30% solution;   (f) about 0.06% to about 0.1% citric acid;   (g) about 5% to about 15% lanolin oil;   (h) about 2% to about 8% propylene glycol;   (i) about 0.05% to about 0.35% tetrasodium EDTA;   (j) about 0.05% to about 5% cod liver oil;   (k) about 0.05% to about 1% butylated hydroxytoluene;   (l) about 0.05% to about 0.5% methylparaben; and   (m) about 0.05% to about 0.5% propylparaben.   
     
     
         32 . The composition of  claim 31 , comprising:
 (a) about 65.11% water;   (b) about 3.6% cetyl alcohol;   (c) about 1.7% stearyl alcohol;   (d) about 2.0% beeswax;   (e) about 2.0% sodium lauryl sulfate in a 30% solution;   (f) about 0.09% citric acid;   (g) about 10.6% lanolin oil;   (h) about 5.7% propylene glycol;   (i) about 0.15% tetrasodium EDTA;   (j) about 2% cod liver oil;   (k) about 0.5% butylated hydroxytoluene;   (l) about 0.3% methylparaben; and   (m) about 0.25% propylparaben.   
     
     
         33 . The composition of  claim 28  further comprising a fragrance. 
     
     
         34 . A method for treating epidermolysis bulosa in a patient in need thereof, comprising contacting the patient's skin with an effective amount of the composition of  claim 28 . 
     
     
         35 . The method of  claim 34 , wherein the composition is administered to the patient daily. 
     
     
         36 . The method of  claim 34 , wherein the composition results in penetration of the allantoin across the skin membrane of the patient in a dose dependent manner. 
     
     
         37 . The method of  claim 34 , wherein the composition results in penetration of the allantoin across the skin membrane of the patient without an increase in systemic blood levels of allantoin in the patient.