Administration of adapalene and benzoyl peroxide for the long-term treatment of acne vulgaris

Abstract

A regimen for the safe and effective long-term treatment of acne vulgaris entails topically applying onto the affected skin area of a subject afflicted therewith, for a period of time of at least four (4) months, e.g., for at least twelve (12) months and advantageously on a daily basis and preferably once a day, a thus effective amount of a topical medicament containing adapalene and benzoyl peroxide, formulated into a pharmaceutically acceptable medium therefor.

1 .- 19 . (canceled) 
     
     
         20 . A regimen for safe and effective long-term treatment of acne vulgaris, comprising topically applying onto an affected skin area of a subject afflicted therewith, at least once every two days for a period of time of 9 to 12 months, a thus effective amount of a topical medicament which comprises a fixed-dose combination of 0.01% to 0.5% by weight of adapalene and 2.5% to 5% by weight of benzoyl peroxide, formulated into a pharmaceutically acceptable medium therefor, the percentages by weight being relative to the total weight of the topical medicament,
 wherein said adapalene and said benzoyl peroxide are the only active ingredients in said fixed-dose combination, and   wherein a percent reduction in each of total, inflammatory and non-inflammatory lesion counts after at least 9 months is at least 65%.   
     
     
         21 . The regimen for long-term treatment of acne vulgaris as defined by  claim 20 , comprising administering said topical medicament once a day. 
     
     
         22 . The regimen for long-term treatment of acne vulgaris as defined by  claim 20 , comprising administering said topical medicament every two days. 
     
     
         23 . The regimen for long-term treatment of acne vulgaris as defined by  claim 20 , comprising administering said topical medicament in evening after washing said affected skin area. 
     
     
         24 . The regimen for long-term treatment of acne vulgaris as defined by  claim 20 , said topical medicament comprising a gel composition. 
     
     
         25 . The regimen for long-term treatment of acne vulgaris as defined by  claim 20 , wherein the topical medicament comprises 0.1% to 0.5% by weight of adapalene and 2.5% by weight of benzoyl peroxide, relative to the total weight thereof. 
     
     
         26 . The regimen for long-term treatment of acne vulgaris as defined by  claim 20 , said affected skin area containing from 20 to 100 non-inflammatory lesions, 20 to 50 inflammatory lesions, and no active nodules or cysts. 
     
     
         27 . A regimen for safe and effective long-term treatment of acne vulgaris, comprising topically applying onto an affected skin area of a subject afflicted therewith, at least once every two days for a period of time of 10 to 12 months, a thus effective amount of a topical medicament which comprises a fixed-dose combination of 0.01% to 0.5% by weight of adapalene and 2.5% to 5% by weight of benzoyl peroxide, formulated into a pharmaceutically acceptable medium therefor, the percentages by weight being relative to the total weight of the topical medicament,
 wherein said adapalene and said benzoyl peroxide are the only active ingredients in said fixed-dose combination, and   wherein a percent reduction in each of total, inflammatory and non-inflammatory lesion counts after at least 10 months is at least 68%.   
     
     
         28 . The regimen for long-term treatment of acne vulgaris as defined by  claim 27 , comprising administering said topical medicament once a day. 
     
     
         29 . The regimen for long-term treatment of acne vulgaris as defined by  claim 20 , comprising administering said topical medicament every two days. 
     
     
         30 . The regimen for long-term treatment of acne vulgaris as defined by  claim 27 , comprising administering said topical medicament in evening after washing said affected skin area. 
     
     
         31 . The regimen for long-term treatment of acne vulgaris as defined by  claim 27 , said topical medicament comprising a gel composition. 
     
     
         32 . The regimen for long-term treatment of acne vulgaris as defined by  claim 27 , wherein the topical medicament comprises 0.1% to 0.5% by weight of adapalene and 2.5% by weight of benzoyl peroxide, relative to the total weight thereof. 
     
     
         33 . The regimen for long-term treatment of acne vulgaris as defined by  claim 27 , said affected skin area containing from 20 to 100 non-inflammatory lesions, 20 to 50 inflammatory lesions, and no active nodules or cysts.