Method of treating onychomycosis with urea and an antioxidant

Abstract

A method of treating onychomycosis is described which includes administration of a topical formulation containing an effective amount of urea and an antioxidant to an infected area around a nail of a patient.

We claim:  
     
         1 . A method of treating onychomycosis, comprising: 
 administering to a nail area of a patient a composition comprising urea as the active antifungal ingredient, Vitamin E, and one or more dermatologically acceptable excipients, wherein the urea is present from about 30 to about 50 wt-% urea.    
     
     
         2 . The method of  claim 1 , wherein the composition is in a topical form selected from the group consisting of cream, ointment, solution, lotion, lacquer, gel, and foam.  
     
     
         3 . The method of  claim 2 , wherein the topical form is lotion, and urea is present in an amount of about 35 wt-%.  
     
     
         4 . The method of  claim 2 , wherein the topical form is cream, and urea is present in an amount of about 50 wt-%.  
     
     
         5 . The method of  claim 2 , wherein the topical form is gel, and urea is present in an amount of about 50 wt-%.  
     
     
         6 . The method of  claim 1 , wherein the one or more dermatologically acceptable excipients are selected from the group consisting of petrolatum or a synthetic or semi-synthetic hydrocarbon, or a semi-solid mixture thereof; a liquid petrolatum or a synthetic or semi-synthetic oleaginous liquid fraction, or a mixture thereof; a C 16-18  aliphatic or branched chain fatty alcohol or fatty acid, or a mixture thereof; glyceryl stearate; xanthan gum; water; and optionally a mixture of a carbomer and triethanolamine.  
     
     
         7 . A method of treating onychomycosis, comprising: 
 administering to a nail area of a patient a composition comprising urea as the active antifungal ingredient, an antioxidant, and one or more dermatologically acceptable excipients, wherein the urea is present from about 30 to about 50 wt-% urea.    
     
     
         8 . The method of  claim 7 , wherein the administering step is carried out by topically applying the composition.  
     
     
         9 . The method of  claim 7 , wherein the antioxidant is selected from the group consisting of tocopherols, tocotrenols, ascorbic acid, selenium, grape seed extract, carotenoids, vitamin A, butylated hydroxytoluene, butylated hydroxyanisole, gallic esters, flavonoids, catechins, glutathione, cysteine, lipoic acid, N-acetylcysteine, ethylenediamine tetraacetic acid and mixtures thereof.  
     
     
         10 . The method of  claim 7 , wherein the composition is in a topical form selected from the group consisting of cream, ointment, solution, lacquer, gel, and foam.  
     
     
         11 . The method of  claim 7 , wherein the one or more dermatologically acceptable excipients are selected from the group consisting of petrolatum or a synthetic or semi-synthetic hydrocarbon, or a semi-solid mixture thereof; a liquid petrolatum or a synthetic or semi-synthetic oleaginous liquid fraction, or a mixture thereof; a C 16-18  aliphatic or branched chain fatty alcohol or fatty acid, or a mixture thereof; glyceryl stearate; xanthan gum; water; and optionally a mixture of a carbomer and triethanolamine.  
     
     
         12 . A method of treating onychomycosis, comprising: 
 administering to a nail area of a patient a composition comprising urea as the active antifungal ingredient, an antioxidant, and one or more dermatologically acceptable excipients, wherein the urea is present in an amount therapeutically effective for treating onychomycosis.    
     
     
         13 . The method of  claim 12 , wherein the antioxidant is vitamin E.