Combinations of adapalene and benzoyl peroxide for treating acne lesions

Abstract

Adapalene or a pharmaceutically acceptable salt thereof formulated into a pharmaceutical composition is useful for reducing the number of acne lesions, via daily topical application, in combination or in association with benzoyl peroxide (BPO); such treatment may be via administration of a pharmaceutical composition combining adapalene and BPO or by a concomitant application of two pharmaceutical compositions, one containing adapalene and the other containing BPO.

1 .- 10 . (canceled) 
     
     
         11 . A method for achieving early onset of action in treatment of acne lesions, said method comprising topically applying to a subject's skin, said subject being in need of said treatment, as active ingredients, 0.1% to 0.3% adapalene or pharmaceutically acceptable salt thereof and 2.5% benzoyl peroxide, combined at fixed doses in a single formula that delivers said active ingredients together, wherein the percentages of adapalene and benzoyl peroxide are percentages by weight relative to the total weight of said single formula, wherein said single formula is applied daily for a period of 4 weeks or 1 month, and wherein the reduction in total lesion counts in a group of such subjects achieved at week 4 is synergistic and numerically superior to the reduction in total lesion counts achieved by the same dose of adapalene alone or of benzoyl peroxide alone at the same time point. 
     
     
         12 . The method according to  claim 11 , wherein the amount of adapalene in the single formula is 0.1%. 
     
     
         13 . The method according to  claim 11 , wherein the single formula is a gel. 
     
     
         14 . The method according to  claim 12 , wherein the single formula is a gel. 
     
     
         15 . A method for achieving early onset of action in treatment of acne lesions, said method comprising topically applying to a subject's skin, said subject being in need of said treatment, as active ingredients, 0.1% to 0.3% adapalene or pharmaceutically acceptable salt thereof and 2.5% benzoyl peroxide, combined at fixed doses in a single formula that delivers said active ingredients together, wherein the percentages of adapalene and benzoyl peroxide are percentages by weight relative to the total weight of said single formula, wherein said single formula is applied daily for a period of 2 weeks to 4 weeks or 1 month, and wherein the reduction in total lesion counts in a group of such subjects achieved at week 2 is synergistic and numerically superior to the reduction in total lesion counts achieved by the same dose of adapalene alone or of benzoyl peroxide alone at the same time point. 
     
     
         16 . The method according to  claim 15 , wherein the amount of adapalene in the single formula is 0.1%. 
     
     
         17 . The method according to  claim 15 , wherein the single formula is a gel. 
     
     
         18 . The method according to  claim 16 , wherein the single formula is a gel. 
     
     
         19 . A method for achieving early onset of action in treatment of acne lesions, said method comprising topically applying to a subject's skin, said subject being in need of said treatment, as active ingredients, 0.1% to 0.3% adapalene or pharmaceutically acceptable salt thereof and 2.5% benzoyl peroxide, combined at fixed doses in a single formula that delivers said active ingredients together, wherein the percentages of adapalene and benzoyl peroxide are percentages by weight relative to the total weight of said single formula, wherein said single formula is applied daily for a period of 2 weeks to 4 weeks or 1 month, and wherein the reduction in total lesion counts in a group of such subjects achieved at week 1 is synergistic and numerically superior to the reduction in total lesion counts achieved by the same dose of adapalene alone or of benzoyl peroxide alone at the same time point. 
     
     
         20 . The method according to  claim 19 , wherein the amount of adapalene in the single formula is 0.1%. 
     
     
         21 . The method according to  claim 19 , wherein the single formula is a gel. 
     
     
         22 . The method according to  claim 20 , wherein the single formula is a gel. 
     
     
         23 . A method for achieving early onset of action in treatment of acne lesions, said method comprising topically applying to a subject's skin, said subject being in need of said treatment, as active ingredients, 0.1% to 0.3% adapalene or pharmaceutically acceptable salt thereof and 2.5% benzoyl peroxide, combined at fixed doses in a single formula that delivers said active ingredients together, wherein the percentages of adapalene and benzoyl peroxide are percentages by weight relative to the total weight of said single formula, wherein said single formula is applied daily for a period of 4 weeks or 1 month, and wherein the reduction in inflammatory lesion counts in a group of such subjects achieved at week 4 is synergistic and numerically superior to the reduction in inflammatory lesion counts achieved by the same dose of adapalene alone or of benzoyl peroxide alone at the same time point. 
     
     
         24 . The method according to  claim 23 , wherein the amount of adapalene in the single formula is 0.1%. 
     
     
         25 . The method according to  claim 23 , wherein the single formula is a gel. 
     
     
         26 . The method according to  claim 24 , wherein the single formula is a gel. 
     
     
         27 . A method for achieving early onset of action in treatment of acne lesions, said method comprising topically applying to a subject's skin, said subject being in need of said treatment, as active ingredients, 0.1% to 0.3% adapalene or pharmaceutically acceptable salt thereof and 2.5% benzoyl peroxide, combined at fixed doses in a single formula that delivers said active ingredients together, wherein the percentages of adapalene and benzoyl peroxide are percentages by weight relative to the total weight of said single formula, wherein said single formula is applied daily for a period of 2 weeks to 4 weeks or 1 month, and wherein the reduction in inflammatory lesion counts in a group of such subjects achieved at week 1 is synergistic and numerically superior to the reduction in inflammatory lesion counts achieved by the same dose of adapalene alone or of benzoyl peroxide alone at the same time point. 
     
     
         28 . The method according to  claim 27 , wherein the amount of adapalene in the single formula is 0.1%. 
     
     
         29 . The method according to  claim 27 , wherein the single formula is a gel. 
     
     
         30 . The method according to  claim 28 , wherein the single formula is a gel. 
     
     
         31 . A method for achieving early onset of action in treatment of acne lesions, said method comprising topically applying to a subject's skin, said subject being in need of said treatment, as active ingredients, 0.1% to 0.3% adapalene or pharmaceutically acceptable salt thereof and 2.5% benzoyl peroxide, combined at fixed doses in a single formula that delivers said active ingredients together, wherein the percentages of adapalene and benzoyl peroxide are percentages by weight relative to the total weight of said single formula, wherein said single formula is applied daily for a period of 4 weeks or 1 month, and wherein the reduction in non-inflammatory lesion counts in a group of such subjects achieved at week 4 is synergistic and numerically superior to the reduction in non-inflammatory lesion counts achieved by the same dose of adapalene alone or of benzoyl peroxide alone at the same time point. 
     
     
         32 . The method according to  claim 31 , wherein the amount of adapalene in the single formula is 0.1%. 
     
     
         33 . The method according to  claim 31 , wherein the single formula is a gel. 
     
     
         34 . The method according to  claim 32 , wherein the single formula is a gel. 
     
     
         35 . A method for treatment of acne lesions, said method comprising topically applying to a subject's skin, said subject being in need of said treatment, as active ingredients, 0.2% to 0.3% adapalene or pharmaceutically acceptable salt thereof and 2.5% benzoyl peroxide, combined at fixed doses in a sing formula that delivers said active ingredients together, wherein the percentages of adapalene and benzoyl peroxide are percentages by weight relative to the total weight of said single formula, wherein said single formula is applied daily for a period of 4 weeks or 1 month, and wherein the reduction in total lesion counts, in inflammatory lesion counts or in non-inflammatory lesion counts in a group of such subjects achieved at week 4 is synergistic and numerically superior to the reduction in total lesion counts, in inflammatory lesion counts or in non-inflammatory lesion counts, respectively, achieved by the same dose of adapalene alone or of benzoyl peroxide alone at the same time point.