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Claims for Patent: 9,089,587

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Claims for Patent: 9,089,587

Title: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.
Inventor(s): Jacovella; Jean (Sophia Antipolis, FR), Chappuis; Jean-Paul (Valbonne, FR), Sordello Wagner; Nathalie (Pegomas, FR)
Assignee: Galderma S.A. (Chem, CH)
Application Number:14/257,567
Patent Claims: 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 the inflammatory lesions of rosacea a therapeutically effective amount of a pharmaceutical composition comprising about 0.1% to about 1% by weight ivermectin and a pharmaceutically acceptable carrier to thereby obtain an onset of a significant reduction in inflammatory lesion count in the subject 2 weeks after the initial administration of the pharmaceutical composition without co-administration of another active ingredient, wherein the subject has moderate to severe papulopustular rosacea or 10 or more of the inflammatory lesions before the treatment.

2. The method of claim 1, wherein the subject has 15 or more inflammatory lesions of the papulopustular rosacea before the treatment.

3. The method of claim 1, wherein the pharmaceutical composition comprises about 0.5% to about 1% by weight ivermectin.

4. The method of claim 3, wherein the pharmaceutical composition comprises about 1% by weight ivermectin.

5. The method of claim 3, wherein the pharmaceutically acceptable carrier comprises one or more ingredients selected from the group consisting of: an oily phase comprising one or more selected from the group consisting of dimethicone, cyclomethicone, isopropyl palmitate, isopropyl myristate, and a fatty substance 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 comprising more than one of a solvent or propenetrating agent 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.

6. The method of claim 1, wherein the once daily topical administration to the subject the pharmaceutical composition 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.

7. The method of claim 1, wherein the once daily topical administration to the subject the pharmaceutical composition results in longer relapse-free time of the papulopustular 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.

8. 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 the inflammatory lesions of rosacea a pharmaceutical composition comprising about 0.1% to about 1% by weight ivermectin and a pharmaceutically acceptable carrier to thereby obtain a significant reduction in inflammatory lesion count in the subject, and a significant improvement in at least one selected from the group consisting of a higher investigator's global assessment success rate and a delayed time to first relapse 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.

9. The method of claim 8, wherein the subject has 10 or more of the inflammatory lesions before the treatment.

10. The method of claim 8, wherein an onset of the significant reduction in inflammatory lesion count is observed 2 weeks after the initial administration of the pharmaceutical composition without co-administration of another active ingredient.

11. The method of claim 8, wherein the pharmaceutical composition comprises about 0.5% to about 1% by weight ivermectin.

12. The method of claim 11, wherein the pharmaceutical composition comprises about 1% by weight ivermectin.

13. The method of claim 11, wherein the pharmaceutically acceptable carrier comprises one or more ingredients selected from the group consisting of: an oily phase comprising one or more selected from the group consisting of dimethicone, cyclomethicone, isopropyl palmitate, isopropyl myristate, and a fatty substance 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 comprising more than one of a solvent or propenetrating agent 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.

14. The method of claim 8, wherein the once daily topical administration to the subject the pharmaceutical composition 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.

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 of rosacea a pharmaceutical composition comprising about 0.1% to about 1% by weight ivermectin and a pharmaceutically acceptable carrier to thereby obtain an onset of a significant reduction in inflammatory lesion count in the subject 2 weeks after the initial administration of the pharmaceutical composition without co-administration of another active ingredient, wherein the subject has 10 or more of the inflammatory lesions before the treatment, and the pharmaceutically acceptable carrier comprises one or more ingredients selected from the group consisting of an oily phase, a surfactant-emulsifier, a solvent or propenetrating agent, a gelling agent, and water.

16. The method of claim 15, wherein the oily phase comprises one or more selected from the group consisting of dimethicone, cyclomethicone, isopropyl palmitate, isopropyl myristate, and a fatty substance selected from the group consisting of cetyl alcohol, cetostearyl alcohol, stearyl alcohol, palmitostearic acid, stearic acid and self-emulsifiable wax.

17. The method of claim 15, wherein the surfactant-emulsifier comprises one or more selected from the group consisting of glyceryl/PEG100 stearate, sorbitan monostearate, sorbitan palmitate, Steareth-20, Steareth-2, Steareth-21 and Ceteareth-20.

18. The method of claim 15, wherein the solvent or propenetrating agent comprises one or more selected from the group consisting of propylene glycol, oleyl alcohol, phenoxyethanol and glyceryl triacetate.

19. The method of claim 15, wherein the gelling agent comprises one or more 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.

20. The method of claim 15, wherein the pharmaceutical composition comprises about 1% by weight ivermectin, and one or more other ingredients selected from the group consisting of carbomer; 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.

21. The method of claim 15, wherein the method reduces the incidence of one or more adverse events, as compared to the administration of a vehicle control.

22. The method of claim 15, wherein no more than 1% of the subjects treated with the method for at least 3 months have an adverse reaction of skin irritation.

23. 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 the inflammatory lesions of rosacea a pharmaceutical composition comprising about 0.1% to about 1% by weight ivermectin and a pharmaceutically acceptable carrier to thereby obtain a significant reduction in inflammatory lesion count in the subject, and a significant improvement in at least one selected from the group consisting of a higher investigator's global assessment success rate and a delayed time to first relapse 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, and the pharmaceutically acceptable carrier comprises one or more ingredients selected from the group consisting of an oily phase, a surfactant-emulsifier, a solvent or propenetrating agent, a gelling agent, and water.

24. The method of claim 23, wherein the oily phase comprises one or more selected from the group consisting of dimethicone, cyclomethicone, isopropyl palmitate, isopropyl myristate, and a fatty substance selected from the group consisting of cetyl alcohol, cetostearyl alcohol, stearyl alcohol, palmitostearic acid, stearic acid and self-emulsifiable wax.

25. The method of claim 23, wherein the surfactant-emulsifier comprises one or more selected from the group consisting of glyceryl/PEG100 stearate, sorbitan monostearate, sorbitan palmitate, Steareth-20, Steareth-2, Steareth-21 and Ceteareth-20.

26. The method of claim 23, wherein the solvent or propenetrating agent comprises one or more selected from the group consisting of propylene glycol, oleyl alcohol, phenoxyethanol and glyceryl triacetate.

27. The method of claim 23, wherein the gelling agent comprises one or more 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.

28. The method of claim 23, wherein the subject has 10 or more of the inflammatory lesions before the treatment.

29. The method of claim 28, wherein an onset of the significant reduction in inflammatory lesion count is observed 2 weeks after the initial administration of the pharmaceutical composition without co-administration of another active ingredient.

30. The method of claim 29, wherein the pharmaceutical composition comprises about 1% by weight ivermectin, and one or more other ingredients selected from the group consisting of carbomer; 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.

31. The method of claim 23, wherein the method reduces the incidence of one or more adverse events, as compared to the administration of a vehicle control.

32. The method of claim 23, wherein no more than 1% of the subjects treated with the method for at least 3 months have an adverse reaction of skin irritation.
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