Combination/association of adapalene and benzoyl peroxide for treating acne

Abstract

Acne lesions, whether of inflammatory and/or non-inflammatory type, are simultaneously or sequentially treated and their number reduced, via daily topical regimen, with the combination or association of adapalene or pharmaceutically acceptable salt thereof and benzoyl peroxide (BPO).

What is claimed is: 
     
         1 . A method of treating acne of severe intensity, the method comprising topically administering to a patient having acne of severe intensity and in need of treatment thereof, a fixed-dose combination of 0.1 wt % to 0.3 wt % adapalene and 2.5 wt % benzoyl peroxide relative to the total weight of the fixed-dose combination, wherein the adapalene and benzoyl peroxide are combined in a single formula that delivers the adapalene and benzoyl peroxide together synergistically to achieve, in a group of subjects in need of treatment for acne of severe intensity, a degree of success of at least about 20%, wherein the adapalene and the benzoyl peroxide are the only active agents present in the fixed-dose combination and in the method; and wherein the single formula is applied once daily for a period of at least 12 weeks. 
     
     
         2 . The method of  claim 1 , wherein the degree of success achieved is at least about 30% within 12 weeks of treatment. 
     
     
         3 . The method of  claim 1 , wherein the fixed-dose combination comprises 0.3 wt % adapalene. 
     
     
         4 . The method of  claim 1 , wherein the single formula is a gel. 
     
     
         5 . A method of achieving success rates better than a vehicle in patients having acne of severe intensity, the method comprising topically administering to a patient having acne of severe intensity and in need of treatment thereof, a fixed-dose combination of 0.1 wt % to 0.3 wt % adapalene and 2.5 wt % benzoyl peroxide relative to the total weight of the fixed-dose combination, wherein the adapalene and benzoyl peroxide are combined in a single formula that delivers the adapalene and benzoyl peroxide together synergistically to achieve, in a group of subjects in need of treatment for acne of severe intensity, a degree of success of at least about 20%, wherein the degree of success for a subject is a clear or almost clear rating; wherein the adapalene and the benzoyl peroxide are the only active agents present in the fixed-dose combination and in the method; and wherein the single formula is applied once daily for a period of at least 12 weeks. 
     
     
         6 . The method of  claim 5 , wherein the degree of success achieved is at least about 30% within 12 weeks of treatment. 
     
     
         7 . The method of  claim 5 , wherein the fixed-dose combination comprises 0.3 wt % adapalene. 
     
     
         8 . The method of  claim 5 , wherein the single formula is a gel.