Method for Topically Treating Actinic Keratosis on the Trunk (except chest) or Extremities with Ingenol 3-(3,5-diethylisoxazole-4-carboxylate)

Abstract

The invention relates to the treatment of actinic keratosis on the trunk (except chest) or Extremities with ingenol 3-(3,5-diethylisoxazole-4-carboxylate).

1 . A method of treating a subject diagnosed with actinic keratosis on the trunk (except chest) or extremities, said method comprising applying an effective amount of ingenol 3-(3,5-diethylisoxazole-4-carboxylate) to a treatment area on the trunk (except chest) or extremities for two days. 
     
     
         2 . The method of  claim 1 , wherein the method provides a reduction in the number of actinic keratosis in the treatment area. 
     
     
         3 . The method of  claim 1 , wherein the two day treatment is two consecutive days. 
     
     
         4 . The method of  claim 1 , wherein the treatment area is up to about 250 cm 2 . 
     
     
         5 . The method of any of the  claim 1 , wherein the effective amount of the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is applied from a dosage strength formulation of ingenol 3-(3,5-diethylisoxazole-4-carboxylate) of between about 0.01% and about 0.1% 
     
     
         6 . The method of any of the  claim 1 , wherein the dosage strength formulation of ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is about 0.018%, about 0.025%, about 0.037%, about 0.05%, about 0.075% or about 0.1% 
     
     
         7 . The method of  claim 1 , wherein the amount of the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) applied is between about 0.162 mg ingenol 3-(3,5-diethylisoxazole-4-carboxylate)/per day/about 250 cm2 treatment area and about 0.9 mg ingenol 3-(3,5-diethylisoxazole-4-carboxylate)/per day/about 250 cm2 treatment area. 
     
     
         8 . The method of any of the  claim 1 , wherein the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is formulated in a gel. 
     
     
         9 . The method of  claim 1 , wherein the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is topically applied in a concentration of from about 0.018% to about 0.1%. 
     
     
         10 . The method of  claim 4 , wherein the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is topically applied in a concentration of from about 0.018% to about 0.1%. 
     
     
         11 . The method of  claim 5 , wherein the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is topically applied in a concentration of from about 0.018% to about 0.1%. 
     
     
         12 . The method of  claim 5 , wherein the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is topically applied in a concentration of from about 0.0% to about 0.1%. 
     
     
         13 . A method of treating a subject diagnosed with actinic keratosis on the trunk (except chest or extremities, said method comprising topically applying an effective amount of ingenol 3-(3,5-diethylisoxazole-4-carboxylate) to a treatment are on the trunk (except chest or extremities for two consecutive days, wherein said method provides a reduction in the number of actinic keratosis lesions in the treated area on the trunk (except chest or extremities, wherein the treatment area is of a size up to about 250 cm 2 , and wherein the dosage strength of the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is between about 0.018% and about 0.1%. 
     
     
         14 . A method of treating a subject diagnosed with actinic keratosis on the trunk (except chest or extremities, said method comprising topically applying an effective amount of ingenol 3-(3,5-diethylisoxazole-4-carboxylate) to a treatment are on the trunk (except chest or extremities for two consecutive days, wherein said method provides a reduction in the number of actinic keratosis lesions in the treated area on the trunk (except chest or extremities, wherein the treatment area is of a size up to about 250 cm 2 , and wherein the dosage strength of the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is between about 0.018% and about 0.1%. 
     
     
         15 . The method of  claim 4 , wherein the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is topically applied in a concentration of from about 0.01% to about 0.1%. 
     
     
         16 . The method of  claim 2 , wherein the treatment area is up to about 250 cm 2 . 
     
     
         17 . The method of  claim 3 , wherein the treatment area is up to about 250 cm 2 . 
     
     
         18 . The method of any of the  claim 2 , wherein the effective amount of the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is applied from a dosage strength formulation of ingenol 3-(3,5-diethylisoxazole-4-carboxylate) of between about 0.01% and about 0.1%. 
     
     
         19 . The method of any of the  claim 3 , wherein the effective amount of the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is applied from a dosage strength formulation of ingenol 3-(3,5-diethylisoxazole-4-carboxylate) of between about 0.01% and about 0.1%. 
     
     
         20 . The method of any of the  claim 2 , wherein the dosage strength formulation of ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is about 0.018%, about 0.025%, about 0.037%, about 0.05%, about 0.075% or about 0.1%. 
     
     
         21 . The method of any of the  claim 3 , wherein the dosage strength formulation of ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is about 0.018%, about 0.025%, about 0.037%, about 0.05%, about 0.075% or about 0.1%. 
     
     
         22 . The method of any of the  claim 2 , wherein the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is formulated in a gel. 
     
     
         23 . The method of any of the  claim 3 , wherein the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is formulated in a gel. 
     
     
         24 . The method of any of the  claim 4 , wherein the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is formulated in a gel. 
     
     
         25 . The method of any of the  claim 5 , wherein the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is formulated in a gel. 
     
     
         26 . The method of any of the  claim 6 , wherein the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is formulated in a gel. 
     
     
         27 . The method of any of the  claim 7 , wherein the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is formulated in a gel. 
     
     
         28 . The method of any of the  claim 16 , wherein the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is formulated in a gel. 
     
     
         29 . The method of any of the  claim 17 , wherein the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is formulated in a gel. 
     
     
         30 . The method of any of the  claim 18 , wherein the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is formulated in a gel. 
     
     
         31 . The method of any of the  claim 19 , wherein the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is formulated in a gel. 
     
     
         32 . The method of any of the  claim 20 , wherein the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is formulated in a gel. 
     
     
         33 . The method of any of the  claim 21 , wherein the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is formulated in a gel. 
     
     
         34 . The method of  claim 2 , wherein the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is topically applied in a concentration of from about 0.018% to about 0.1%. 
     
     
         35 . The method of  claim 3 , wherein the ingenol 3-(3,5-diethylisoxazole-4-carboxylate) is topically applied in a concentration of from about 0.018% to about 0.1%.