Methods for the treatment of rosacea

Abstract

The present invention relates to pharmaceutical compositions for topical use (including also dermatological compositions), for treating skin conditions and afflictions, such as rosacea and symptoms and conditions associated there from.

What is claimed: 
     
         1 . A method of treating rosacea in a patient in need thereof, comprising:
 topically administering to a rosacea affected skin surface of said patient a composition comprising as a sole pharmaceutical active agent 1-10% by weight benzoyl peroxide in solid form,   wherein said composition has a benzoyl peroxide dissolution rate of less than about 80% weight/h as measured in a medium of a 55%:45% mixture of water and acetonitrile at ambient temperature.   
     
     
         2 . The method of  claim 1 , wherein the benzoyl peroxide dissolution rate is less than about 60% weight/h. 
     
     
         3 . The method of  claim 1 , wherein said benzoyl peroxide comprises 5% by weight of the composition. 
     
     
         4 . The method of  claim 1 , wherein said composition is a formulation selected from the group consisting of an oil based cream formulation, an aqueous based cream formulation, an oil-in-water emulsion, and a gel formulation. 
     
     
         5 . The method of  claim 4 , wherein said composition is an oil-in-water emulsion comprising a polyoxylstearate, a glycerylstearate and at least one fatty alcohol, wherein the ratio of the polyoxylstearate to the glycerylstearate is in the range of 0.1:10 to 10:01. 
     
     
         6 . The method of  claim 1 , wherein said benzoyl peroxide is encapsulated as a core of a microcapsule having a shell comprising at least one inorganic polymer, the core consisting of the solid benzoyl peroxide. 
     
     
         7 . A method of treating rosacea in a patient in need thereof, comprising:
 topically administering to a rosacea affected skin surface of said patient a composition comprising as a sole pharmaceutical active agent 1-10% by weight benzoyl peroxide in solid form,   wherein said composition is administered once daily over 12 weeks and provides more than 20% success rate of treatment, the success rate being a 2-grade improvement over baseline in an Investigator Global Assessment (IGA).   
     
     
         8 . The method of  claim 7 , wherein said benzoyl peroxide comprises 5% by weight of the composition. 
     
     
         9 . The method of  claim 7 , wherein the success rate is about 30%. 
     
     
         10 . The method of  claim 7 , wherein said composition has a benzoyl peroxide dissolution rate of less than about 80% weight/h as measured in a medium of a 55%:45% mixture of water and acetonitrile at ambient temperature. 
     
     
         11 . The method of  claim 7 , wherein said corrrposition is a formulation selected from the group consisting of an oil based cream formulation, an aqueous based cream formulation, an oil-in-water emulsion, and a gel formulation. 
     
     
         12 . The method of  claim 11 , wherein said composition is an oil-in-water emulsion comprising a polyoxylstearate, a glycerylstearate and at least one fatty alcohol, wherein the ratio of the polyoxylstearate to the glycerylstearate is in the range of 0.1:10 to 10:0.1. 
     
     
         13 . The method of  claim 7 , wherein said benzoyl peroxide is encapsulated as a core of a microcapsule having a shell comprising at least one inorganic polymer, the core consisting of the solid benzoyl peroxide. 
     
     
         14 . A method of treating rosacea in a patient in need thereof, comprising:
 topically administering to a rosacea affected skin surface of said patient a composition comprising as a sole pharmaceutical active agent 1-10% by weight benzoyl peroxide in solid form,   wherein said treatment has an adverse events values of not more than 40%.   
     
     
         15 . The method of  claim 14 , wherein said benzoyl peroxide comprises 5% by weight of the composition. 
     
     
         16 . The method of  claim 14 , wherein said composition is administered once daily over 12 weeks and provides more than 20% success rate of treatment, the success rate being a 2-grade improvement over baseline in an Investigator Global Assessment (IGA). 
     
     
         17 . The method of  claim 16 , wherein said composition has a benzoyl peroxide dissolution rate of less than about 80% weight/h as measured in a medium of a 55%:45% mixture of water and acetonitrile at ambient temperature. 
     
     
         18 . The method of  claim 14 , wherein said composition is a formulation selected from the group consisting of an oil based cream formulation, an aqueous based cream formulation, an oil-in-water emulsion, and a gel formulation. 
     
     
         19 . The method of  claim 18 , wherein said composition is an oil-in-water emulsion comprising a polyoxylstearate, a glycerylstearate and at least one fatty alcohol, wherein the ratio of the polyoxylstearate to the glycerylstearate is in the range of 0.1:10 to 10:0.1. 
     
     
         20 . The method of  claim 1 , wherein said benzoyl peroxide is encapsulated as a core of a microcapsule having a shell comprising at least one inorganic polymer, the core consisting of the solid benzoyl peroxide.