Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using a1-adrenoceptor agonists

Abstract

The present invention is directed to the treatment of skin erythema as exhibited in rosacea and other conditions characterized by increased erythema (redness) of the skin. These conditions exhibit dilation of blood vessels due to a cutaneous vascular hyper-reactivity. In particular, the present invention is directed to a novel composition and method for the treatment of skin erythema using α 1 -adrenergic receptor (α 1 -adrenoceptor) agonists incorporated into cosmetic, pharmacological or dermatological compositions for topical application to the skin.

1 . A method of treating facial erythema associated with rosacea in a human subject in need of such treatment, said method comprising: administering topically to the face of the human subject, a pharmaceutical composition comprising 0.001% w/w to 3% w/w of oxymetazoline hydrochloride as the sole active ingredient and a pharmaceutically acceptable carrier, wherein said pharmaceutical composition is a cream. 
     
     
         2 . The method of  claim 1 , wherein said administering involves spreading the pharmaceutical composition over one or more affected areas of the face. 
     
     
         3 . The method of  claim 1 , wherein said pharmaceutically acceptable carrier comprises about 50% to about 99.999% of the composition. 
     
     
         4 . The method of  claim 1 , wherein the pharmaceutically acceptable carrier comprises one or more emulsifying agents. 
     
     
         5 . The method of  claim 1 , wherein the pharmaceutically acceptable carrier comprises one or more oils. 
     
     
         6 . The method of  claim 5 , wherein the one or more oils comprise lanolin and fatty alcohols. 
     
     
         7 . The method of  claim 1 , wherein the pharmaceutically acceptable carrier comprises one or more preservatives, solvents, antioxidants, emulsifying agents, oils, or combinations thereof. 
     
     
         8 . A method of treating erythema associated with rosacea in a human subject, the method comprising: administering topically to an area of skin of the human subject, a pharmaceutical cream comprising 0.001% w/w to 3% w/w of oxymetazoline hydrochloride as the sole active ingredient and a pharmaceutically acceptable carrier, wherein the area of skin is affected by, or is prone to be affected by, persistent erythema associated with rosacea. 
     
     
         9 . The method of  claim 8 , wherein the area of skin affected by, or prone to be affected by, persistent erythema associated with rosacea includes cheeks, forehead, and nose of the human subject. 
     
     
         10 . The method of  claim 8 , wherein said administering involves spreading the pharmaceutical cream over the one or more areas of skin on the human subject affected by, or prone to be affected by, persistent erythema associated with rosacea. 
     
     
         11 . The method of  claim 8 , wherein said pharmaceutically acceptable carrier comprises about 50% to about 99.999% of the composition. 
     
     
         12 . The method of  claim 8 , wherein the pharmaceutically acceptable carrier comprises one or more emulsifying agents. 
     
     
         13 . The method of  claim 8 , wherein the pharmaceutically acceptable carrier comprises one or more oils. 
     
     
         14 . The method of  claim 13 , wherein the one or more oils comprise lanolin and fatty alcohols. 
     
     
         15 . The method of  claim 8 , wherein the pharmaceutically acceptable carrier comprises one or more preservatives, solvents, antioxidants, emulsifying agents, oils, or combinations thereof.