Compositions and methods for treating alopecia

Abstract

The present invention is directed to a composition for treating alopecia containing minoxidil, cyclosporine A and a compound that binds FK506 binding protein 4 suitable for administration to humans. The present invention is further directed to treating alopecia in humans by administering a composition of the invention.

What is claimed is: 
     
         1 . A composition for the treatment of alopecia comprising a compound that binds FK506 binding protein 4. 
     
     
         2 . The composition of  claim 1  further comprising one or more additional active agents selected from the group consisting of minoxidil, cyclosporine A, and a combination thereof. 
     
     
         3 . The composition of  claim 1 , wherein the one or more additional agents consists of a combination of minoxidil and cyclosporine A. 
     
     
         4 . A composition for the treatment of alopecia comprising a compound of formula (I) 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt or ester thereof, minoxidil and cyclosporine A,
 wherein R 1  is selected from the group consisting of COOH, a methoxy, a phenyl, a benzyl, a substituted phenyl and a substituted benzyl. 
 
     
     
         5 . The composition of  claim 2  wherein the substituted phenyl and the substituted benzyl are each individually substituted with an alkyl group, a methoxy group or a halogen. 
     
     
         6 . The composition of  claim 4  wherein the compound of formula (I) is selected from the group consisting of 
       
         
           
           
               
               
           
         
       
       and a pharmaceutically acceptable salt or ester thereof. 
     
     
         7 . A composition for the treatment of alopecia comprising a compound of formula (II) 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt or ester thereof, minoxidil and cyclosporine A. 
     
     
         8 . The composition of  claim 1  further comprising one or more excipients selected from the group consisting of urea, polyoxyl 40 stearate, a carbomer, cetyl alcohol, glyceryl monostearate, mineral oil, ethanol, propylene glycol, polyglycol 300, citric acid, sodium phosphate dibasic, stearyl alcohol, isopropyl myristate, sodium hydroxide, petroleum jelly, xanthan gum, white petrolatum, sorbitol solution, cetearyl alcohol, ceteareth-20, simethicone, sodium benzoate, glyceryl monostearate, polyethylene glycol monostearate, sorbic acid, butylated hydroxytoluene and water. 
     
     
         9 . The composition of  claim 7  wherein minoxidil is at a concentration from about 1% to about 10% w/v, cyclosporine A is at a concentration from about 0.01% to about 1% w/v and the compound of formula (II) or a pharmaceutically acceptable salt or ester thereof is at a concentration from about 0.000001% to about 0.0001% w/v, wherein w/v denotes weight by volume. 
     
     
         10 . The composition of  claim 9  further comprising ethanol at a concentration from about 10% to about 50% w/v, propylene glycol at a concentration from about 10% to about 70% w/v and water at a concentration from about 10% to about 50% w/v. 
     
     
         11 . The composition of  claim 9  further comprising 40% w/v urea. 
     
     
         12 . The composition of  claim 11  further comprising polyoxyl 40 stearate, citric acid, polyglycol 300, sodium phosphate, cetyl alcohol, stearyl alcohol, isopropyl myristate and sodium benzoate. 
     
     
         13 . The composition of  claim 9  wherein minoxidil is at a concentration of about 5% w/v, cyclosporine A is at a concentration of about 0.12% w/v and the compound of formula (II) or a pharmaceutically acceptable salt or ester thereof is at a concentration of about 0.000012% w/v. 
     
     
         14 . The composition of  claim 9  further comprising ethanol at a concentration of about 28% w/v, propylene glycol at a concentration of about 47% w/v and water at a concentration of about 19% w/v. 
     
     
         15 . A method of treating alopecia comprising topically administering to a human in need thereof an effective amount of the composition of  claim 1 . 
     
     
         16 . The method of  claim 15  wherein the alopecia is androgenic alopecia. 
     
     
         17 . A method of treating achromotrichia comprising topically administering to a human in need thereof an effective amount of the composition of  claim 1 . 
     
     
         18 . The method of  claim 16  wherein the achromotrichia is due to aging. 
     
     
         19 . A method of enhancing facial hair growth comprising topically administering to a human in need thereof an effective amount of the composition of  claim 1 .