Method for treatment of rosacea including patient reported outcomes thereof

Abstract

A regimen is described for the therapeutic treatment of rosacea including topically applying to the skin of a subject in need of the treatment a pharmaceutical composition. The pharmaceutical composition includes about 1% w/w to about 10% w/w benzoyl peroxide as an active ingredient, and a pharmaceutically acceptable carrier or excipient. The benzoyl peroxide is the only active ingredient in said pharmaceutical composition, and the pharmaceutical composition is applied once daily for a period of at least about 2 weeks, about 4 weeks, about 8 weeks or about 12 weeks. A decrease in Patient Assessment of Papulopustular Rosacea Signs and Symptoms (PAPSS) is at least about 40% after treatment with the pharmaceutical composition for about 4 weeks, and a decrease in Patient Assessment of Papulopustular Rosacea Impacts (PAPI) is from about 60% to about 70% after treatment with the pharmaceutical composition for at least about 8 weeks.

What is claimed is: 
     
         1 . A regimen for the therapeutic treatment of rosacea, the regimen comprising topically applying to the skin of a subject in need of said treatment a pharmaceutical composition, the pharmaceutical composition comprising about 2.5% w/w to about 10% w/w benzoyl peroxide as an active ingredient, and a pharmaceutically acceptable carrier or excipient, wherein the benzoyl peroxide is the only active ingredient in said pharmaceutical composition, wherein said pharmaceutical composition is applied once daily for a period of at least about 2 weeks, about 4 weeks, about 8 weeks or about 12 weeks, wherein a decrease in Patient Assessment of Papulopustular Rosacea Signs and Symptoms (PAPSS) is at least about 30% after treatment with said pharmaceutical composition for about 2 weeks compared with a decrease of about 20% after 2-week treatment with vehicle alone. 
     
     
         2 . The regimen of  claim 1 , wherein the decrease in PAPSS is at least about 40% after treatment with said pharmaceutical composition for about 4 weeks compared with a decrease of less than about 40% after 4-week treatment with vehicle alone. 
     
     
         3 . The regimen of  claim 1 , wherein the decrease in PAPSS is from about 50% to about 65% after treatment with said pharmaceutical composition for at least about 8 weeks compared with a decrease from about 25% to about 40% after 8-week treatment with vehicle alone. 
     
     
         4 . The regimen of  claim 1 , wherein the benzoyl peroxide is the sole active ingredient administered to the subject in need of said treatment during the duration of the regimen. 
     
     
         5 . The regimen of  claim 1 , wherein the pharmaceutical composition comprises about 5% w/w of benzoyl peroxide. 
     
     
         6 . The regimen of  claim 1 , wherein said benzoyl peroxide is in a form selected from solid, solution or suspension. 
     
     
         7 . The regimen of  claim 1 , wherein the rosacea is any of erythematotelengietatic, papulopustular, phymatous or ocular rosacea. 
     
     
         8 . The regimen of  claim 1 , wherein said pharmaceutical composition is a cream or an emulsion. 
     
     
         9 . The regimen of  claim 1 , wherein said pharmaceutical composition is an extended release formulation, wherein the extended-release effect is obtained by encapsulation, microencapsulation, microspheres or coating. 
     
     
         10 . The regimen of  claim 1 , wherein the papulopustular rosacea signs and symptoms are selected from burning, itching, redness, bumps, and combinations thereof, on the skin of a subject. 
     
     
         11 . A regimen for the therapeutic treatment of rosacea, the regimen comprising topically applying to the skin of a subject in need of said treatment a pharmaceutical composition, the pharmaceutical composition comprising about 2.5% w/w to about 10% w/w benzoyl peroxide as an active ingredient, and a pharmaceutically acceptable carrier or excipient, wherein the benzoyl peroxide is the only active ingredient in said pharmaceutical composition, wherein said pharmaceutical composition is applied once daily for a period of at least about 2 weeks, about 4 weeks, about 8 weeks or about 12 weeks, wherein a decrease in Patient Assessment of Papulopustular Rosacea Impacts (PAPI) is at least about 35% after treatment with said pharmaceutical composition for about 2 weeks compared with a decrease of about 23% after treatment with vehicle alone. 
     
     
         12 . The regimen of  claim 11 , wherein the decrease in PAPI is from about 60% to about 70% after treatment with said pharmaceutical composition for at least about 8 weeks compared with a decrease of about 35% after 8-week treatment with vehicle alone. 
     
     
         13 . The regimen of  claim 11 , wherein the benzoyl peroxide is the sole active ingredient administered to the subject in need of said treatment during the duration of the regimen. 
     
     
         14 . The regimen of  claim 11 , wherein the pharmaceutical composition comprises about 5% w/w of benzoyl peroxide. 
     
     
         15 . The regimen of  claim 11 , wherein said benzoyl peroxide is in a form selected from solid, solution or suspension. 
     
     
         16 . The regimen of  claim 11 , wherein the rosacea is any of erythematotelengietatic, papulopustular, phymatous or ocular rosacea. 
     
     
         17 . The regimen of  claim 11 , wherein said pharmaceutical composition is a cream or an emulsion. 
     
     
         18 . The regimen of  claim 11 , wherein said pharmaceutical composition is an extended release formulation, wherein the extended-release effect is obtained by encapsulation, microencapsulation, microspheres or coating. 
     
     
         19 . The regimen of  claim 11 , wherein an average decrease in the PAPI after treatment with said pharmaceutical composition for at least about 8 weeks is approximately about 1.2 to two times an average decrease in the PAPI after 8-week treatment with vehicle alone. 
     
     
         20 . The regimen of  claim 11 , wherein the papulopustular rosacea impact is selected from embarrassment, self-consciousness and frustration.