Methods of Treating Residual Lesions of Vascular Anomalies

Abstract

Compositions comprising bile acids or their salts and methods of use thereof for the treatment of residual lesions of vascular anomalies.

1 . A method for the treatment of a residual lesion of a vascular anomaly in a patient in need thereof, the method comprising contacting the residual lesion with a composition comprising a pharmaceutically-acceptable formulation comprising at least one bile acid or its salt. 
     
     
         2 . The method of  claim 1 , wherein the vascular anomaly is selected from the group consisting of involuting infantile hemangioma, involuted infantile hemangioma, congenital hemangioma, kaposiform hemangiomendothelioma, tufted angioma, and lymphatic malformation. 
     
     
         3 . The method of  claim 2 , wherein the vascular anomaly is an involuted infantile hemangioma, which optionally comprises one or more sequelae selected from the group consisting of telangiectasia, fibrofatty residue, and anetoderma. 
     
     
         4 . The method of  claim 1 , wherein the bile acid is selected from the group consisting of cholic acid, glycocholic acid, taurocholic acid, deoxycholic acid, chenodeoxycholic acid, glycochenodeoxycholic acid, tautochenodeoxycholic acid, lithochlic acid, 7-alpha-dehydroxylate, ursodeoxycholic acid, obeticholic acid, dihydroxy- and trihydroxy-bile acids. 
     
     
         5 . The method of  claim 4 , wherein the bile acid is conjugated to taurine or glycine. 
     
     
         6 . The method of  claim 1 , wherein the composition is administered as an aqueous solution. 
     
     
         7 . The method of  claim 6 , wherein the solution comprises deoxycholic acid at a concentration of about 1% w/v to about 5% w/v. 
     
     
         8 . The method of  claim 7 , wherein the solution comprises deoxycholic acid at a concentration of 1% w/v. 
     
     
         9 . The method of  claim 1 , wherein the solution comprises sodium deoxycholate. 
     
     
         10 . The method of  claim 1 , wherein the composition is administered to the patient more than once. 
     
     
         11 . The method of  claim 1 , wherein the composition is administered intralesionally. 
     
     
         12 . The method of  claim 1 , wherein duration of treatment is at least 2 months. 
     
     
         13 . The method of  claim 12 , wherein the duration of treatment at least 6 months. 
     
     
         14 . The method of  claim 12 , wherein the duration of treatment is at least 1 year. 
     
     
         15 . The method of  claim 12 , wherein the duration of treatment is effective to achieve at least a 5% reduction in the size of the lesion. 
     
     
         16 . The method of  claim 12 , wherein the duration of treatment is effective to achieve at least a 25% reduction in the size of the lesion. 
     
     
         17 . The method of  claim 12 , wherein the duration of treatment is effective to achieve at least a 50% reduction in the size of the lesion. 
     
     
         18 . The method of  claim 12 , wherein the duration of treatment is effective to achieve an improvement in at least one symptom of the lesion. 
     
     
         19 . A method for the treatment of a residual lesion of a vascular anomaly in a patient in need thereof, the method comprising contacting the residual lesion with an aqueous pharmaceutical formulation comprising:
 a) deoxycholic acid at a concentration of 10 mg/mL;   b) benzyl alcohol at a concentration of 9 mg/mL;   c) dibasic sodium phosphate at a concentration of 1.42 mg/mL;   d) sodium chloride at a concentration of 4.38 mg/mL; and   e) sodium hydroxide at a concentration of 1.43 mg/mL,   
       wherein the pharmaceutical formulation has a pH of about 8.3. 
     
     
         20 . The method of  claim 19 , wherein the pharmaceutical formulation is administered intralesionally in an amount effective to achieve reduction in size and/or improvement in the visual appearance of the lesion. 
     
     
         21 .- 80 . (canceled)