Treatment of submental fat

Abstract

This disclosure relates to compositions, kits and methods for non-surgical reduction of localized subcutaneous fat such as that associated with a cosmetic fat accumulation. The methods employ compositions having specific concentrations of a salt of deoxycholic acid which provides a superior fat cell necrosis with modest adverse effects. Examples of localized subcutaneous fat are found in the submental area, in particular under the chin.

1 . A non-surgical method for the reduction of submental fat in a subject, said method comprising a plurality of subcutaneous injections of a solution of deoxycholic acid or a salt thereof into said submental fat, each injection of said plurality administering about 0.1 mg to about 0.2 mg of said deoxycholic acid or salt thereof per square centimeter of the skin area over said submental fat. 
     
     
         2 . The method of  claim 1 , wherein the sites for injection are at least about 1 cm apart from each other. 
     
     
         3 . The method of  claim 1 , wherein the reduction of submental fat enhances the facial appearance of said subject. 
     
     
         4 . The method of  claim 3 , wherein said enhanced facial appearance is due to the reduced appearance or the lack of the double-chin display. 
     
     
         5 . The method of  claim 1 , wherein said reduction is determined by at least a physical measurement and/or reading from a scale. 
     
     
         6 . The method of  claim 5 , wherein said physical measurement comprises MRI and/or caliper. 
     
     
         7 . The method of  claim 5 , wherein said submental fat is reduced in thickness and/or volume as determined by MRI. 
     
     
         8 . The method of  claim 7 , wherein said thickness and/or volume is reduced by at least 10%. 
     
     
         9 . The method of  claim 5 , wherein said scale is selected from the group consisting of: CR-SMFRS, RS-SMFRS, PRSMFIS, any combinations thereof. 
     
     
         10 . The method of  claim 3 , wherein said facial appearance is enhanced by at least 1 grade. 
     
     
         11 . The method of  claim 10 , wherein said facial appearance is enhanced by at least 1 grade, as determined by CR-SMFRS. 
     
     
         12 . The method of  claim 11 , wherein said enhancement is achieved within eight weeks from said injection. 
     
     
         13 . The method of  claim 11 , wherein said enhancement is achieved within twelve weeks from said injection. 
     
     
         14 . The method of  claim 3 , wherein said facial appearance is enhanced by at least 2 grades, as determined by CR-SMFRS. 
     
     
         15 . The method of  claim 11 , wherein said CR-SMFRS is determined with a score card as shown in  FIG. 3 . 
     
     
         16 . The method of  claim 1 , wherein the volume for each injection is about 0.1 ml to about 0.2 ml. 
     
     
         17 . The method of  claim 16 , wherein said deoxycholic acid or salt thereof is in an aqueous solution buffered at a pH of between about 8.0 and about 8.5. 
     
     
         18 . The method of  claim 1 , wherein the total of said deoxycholic acid or salt thereof administered is between about 50 mg to about 100 mg. 
     
     
         19 . The method of  claim 1 , which is performed in a plurality of visit by said subject, said plurality of visit is according to the schedule shown in  FIG. 2 . 
     
     
         20 . The method of  claim 1 , wherein said deoxycholic acid is biologically derived or de novo synthesized. 
     
     
         21 . The method of  claim 20 , wherein said deoxycholic acid is animal derived. 
     
     
         22 . The method of  claim 20 , wherein said deoxycholic acid is de novo synthesized and wherein the solution comprising thereof is free of primary bile acids and/or other secondary bile acids. 
     
     
         23 . The method of  claim 22 , wherein said primary bile acid is cholic acid. 
     
     
         24 . The method of  claim 1 , wherein the solution further comprises benzyl alcohol at a concentration of about 0.8% to about 1%. 
     
     
         25 . The method of  claim 1 , comprising co-administering an agent selected from the group consisting of: anesthetic, anti-microbial agents, vasoconstrictors, anti-thrombotic agents, anti-coagulation agents, suds-depressants, anti-inflammatory agents, analgesics, dispersion agents, anti-dispersion agents, penetration enhancers, steroids, tranquilizers, muscle relaxants, and anti-diarrhea agents, or any combinations thereof. 
     
     
         26 . The method of  claim 25 , wherein said co-administering is prior to, at the same time, or following the said plurality of injection. 
     
     
         27 . The method of  claim 1 , wherein said injection further comprises a lipase. 
     
     
         28 . The method of  claim 1 , wherein said injection further comprises a phospholipid. 
     
     
         29 . The method of  claim 28 , wherein said phospholipid comprises phosphatidylcholine. 
     
     
         30 . The method of  claim 29 , wherein the ratio of said deoxycholic acid or salt thereof and said phosphatidylcholine is about 1:0.005, about 1:0.05, or about 1:0.5.