Treatment of papulopustular rosacea with ivermectin

Abstract

Methods and compositions for safe and effective treatment of papulopustular rosacea in a subject are described. The methods involve topically applying to an affected skin area a topical composition containing ivermectin and a pharmaceutically acceptable carrier. Treatment with ivermectin represents an innovative therapy that is more robust and effective than the conventional treatments.

I/We claim: 
     
         1 . A method of treating papulopustular rosacea or inflammatory lesions of rosacea in a subject in need thereof, comprising topically administering, once daily, to a skin area affected by the papulopustular rosacea or inflammatory lesions of rosacea a therapeutically effective amount of a pharmaceutical composition comprising 1% by weight ivermectin and a pharmaceutically acceptable carrier. 
     
     
         2 . The method of  claim 1 , wherein the method results in less adverse events than a vehicle control. 
     
     
         3 . The method of  claim 1 , wherein no more than 1% of the subjects treated with the method for at least 3 months have an adverse reaction of skin irritation. 
     
     
         4 . The method of  claim 1 , wherein the therapeutically effective amount of the pharmaceutical composition is administered at bedtime. 
     
     
         5 . The method of  claim 1 , wherein starting from 2 weeks of treatment, the method results in a significant reduction in inflammatory lesion count. 
     
     
         6 . The method of  claim 1 , wherein starting from 4 weeks of treatment, the method results in more effective treatment than the vehicle control, as measured by a reduction in inflammatory lesion count and a reduction in investigator's global assessment (IGA) score. 
     
     
         7 . The method of  claim 1 , wherein the subject has moderate to severe papulopustular rosacea before the treatment. 
     
     
         8 . The method of  claim 1 , wherein the subject has 15 or more inflammatory lesions of the papulopustular rosacea before the treatment. 
     
     
         9 . The method of  claim 1 , wherein the pharmaceutical composition further comprises one or more ingredients selected from the group consisting of: an oily phase comprising dimethicone, cyclomethicone, isopropyl palmitate and/or isopropyl myristate, the oily phase further comprising fatty substances selected from the group consisting of cetyl alcohol, cetostearyl alcohol, stearyl alcohol, palmitostearic acid, stearic acid and self-emulsifiable wax; at least one surfactant-emulsifier selected from the group consisting of glyceryl/PEG100 stearate, sorbitan monostearate, sorbitan palmitate, Steareth-20, Steareth-2, Steareth-21 and Ceteareth-20; a mixture of solvents and/or propenetrating agents selected from the group consisting of propylene glycol, oleyl alcohol, phenoxyethanol and glyceryl triacetate; one or more gelling agents selected from the group consisting of carbomers, cellulose gelling agents, xanthan gums, aluminum magnesium silicates but excluding aluminum magnesium silicate/titanium dioxide/silica, guar gums, polyacrylamides and modified starches; and water. 
     
     
         10 . The method of  claim 9 , wherein the pharmaceutical composition further comprises carbomer copolymer type B; cetyl alcohol; citric acid monohydrate; dimethicone 20 Cst; edetate disodium; glycerin; isopropyl palmitate; methyl paraben; oleyl alcohol; phenoxyethanol; polyoxyl 20 cetostearyl ether; propylene glycol; propyl paraben; purified water; sodium hydroxide; sorbitan monostearate and stearyl alcohol. 
     
     
         11 . A method of treating papulopustular rosacea or inflammatory lesions of rosacea in a subject in need thereof, comprising topically administering, once daily, to a skin area affected by the papulopustular rosacea or inflammatory lesions of rosacea a therapeutically effective amount of a pharmaceutical composition comprising 1% by weight ivermectin and a pharmaceutically acceptable carrier, wherein the method results in more reduction in inflammatory lesion count in the subject in comparison to that achieved by topically administering to the subject, twice daily, a second pharmaceutical composition comprising 0.75% by weight metronidazole. 
     
     
         12 . The method of  claim 11 , wherein the subject has moderate to severe papulopustular rosacea before the treatment. 
     
     
         13 . The method of  claim 11 , wherein the subject has 15 or more inflammatory lesions of the papulopustular rosacea before the treatment. 
     
     
         14 . The method of  claim 11 , wherein the pharmaceutical composition further comprises carbomer copolymer type B; cetyl alcohol; citric acid monohydrate; dimethicone 20 Cst; edetate disodium; glycerin; isopropyl palmitate; methyl paraben; oleyl alcohol; phenoxyethanol; polyoxyl 20 cetostearyl ether; propylene glycol; propyl paraben; purified water; sodium hydroxide; sorbitan monostearate and stearyl alcohol. 
     
     
         15 . A method of treating papulopustular rosacea or inflammatory lesions of rosacea in a subject in need thereof, comprising topically administering, once daily, to a skin area affected by the papulopustular rosacea or inflammatory lesions a therapeutically effective amount of a pharmaceutical composition comprising 1% by weight ivermectin and a pharmaceutically acceptable carrier, wherein the method results in longer relapse-free time of the papulopustular rosacea or inflammatory lesions of rosacea in the subject in comparison to that achieved by topically administering to the subject, twice daily, a second pharmaceutical composition comprising 0.75% by weight metronidazole. 
     
     
         16 . The method of  claim 15 , wherein the subject has moderate to severe papulopustular rosacea before the treatment. 
     
     
         17 . The method of  claim 15 , wherein the subject has 15 or more inflammatory lesions of the papulopustular rosacea before the treatment. 
     
     
         18 . The method of  claim 15 , wherein the pharmaceutical composition further comprises carbomer copolymer type B; cetyl alcohol; citric acid monohydrate; dimethicone 20 Cst; edetate disodium; glycerin; isopropyl palmitate; methyl paraben; oleyl alcohol; phenoxyethanol; polyoxyl 20 cetostearyl ether; propylene glycol; propyl paraben; purified water; sodium hydroxide; sorbitan monostearate and stearyl alcohol.