Claims for Patent: 9,782,425

Summary for Patent: 9,782,425

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 (Antibes, FR), Chappuis; Jean-Paul (Valbonne, FR), Kaoukhov; Alexandre (Newport Beach, CA), Graeber; Michael (Lawrenceville, NJ), Salin; Laurence (La Roquette sur Siagne, FR), Poncet; Michel (Mougins, FR), Briantais; Philippe (Antibes, FR)
Assignee:	Galderma S.A. (Cham, CH)
Application Number:	14/903,906
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,782,425
Patent Claims:	1. A method of treating papulopustular rosacea in a subject in need thereof, comprising topically administering, once daily, to a skin area affected by the papulopustular rosacea a therapeutically effective amount of a pharmaceutical composition comprising ivermectin and a pharmaceutically acceptable carrier without co-administration of another active pharmaceutical ingredient, wherein the pharmaceutical composition comprises 0.5% to 1.5% by weight ivermectin. 2. The method of claim 1, wherein the subject has moderate to severe papulopustular rosacea before the treatment. 3. The method of claim 1, wherein the subject has 15 or more inflammatory lesions of the papulopustular rosacea before the treatment. 4. The method of claim 1, wherein an onset of a significant reduction in inflammatory lesion count in the subject is observed 2 weeks after the initial administration of the pharmaceutical composition. 5. The method of claim 4, wherein at least about 27.3% (p<0.01) reduction of inflammatory lesion counts in the subject is observed by 2 weeks after the initial administration of the pharmaceutical composition. 6. The method of claim 1, wherein the pharmaceutical composition comprises about 1% by weight ivermectin. 7. 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. 8. The method of claim 1, wherein once daily topically administering 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. 9. The method of claim 1, wherein once daily topically administering 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. 10. A method of treating inflammatory lesions of papulopustular rosacea in a subject in need thereof, comprising topically administering, once daily, to a skin area affected by the inflammatory lesions of papulopustular rosacea a pharmaceutical composition comprising ivermectin and a pharmaceutically acceptable carrier, without co-administration of another active pharmaceutical ingredient, wherein the pharmaceutical composition comprises 0.5% to 1.5% by weight ivermectin. 11. The method of claim 10, wherein the subject has moderate to severe papulopustular rosacea before the treatment. 12. The method of claim 10, wherein the subject has 15 or more of the inflammatory lesions before the treatment. 13. The method of claim 10, wherein an onset of a significant reduction in inflammatory lesion count in the subject is observed 2 weeks after the initial administration of the pharmaceutical composition. 14. The method of claim 13, wherein at least about 27.3% (p<0.01) reduction of inflammatory lesion counts in the subject is observed by 2 weeks after the initial administration of the pharmaceutical composition. 15. The method of claim 10, wherein the pharmaceutical composition comprises about 1% by weight ivermectin. 16. The method of claim 10, 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. 17. The method of claim 16, wherein the subject has moderate to severe papulopustular rosacea before the treatment. 18. The method of claim 16, wherein the subject has 15 or more of the inflammatory lesions before the treatment. 19. The method of claim 16, wherein the pharmaceutical composition comprises about 1% by weight ivermectin. 20. The method of claim 16, wherein about 27.3% (p<0.01) or more reduction in inflammatory lesion counts in the subject is observed by 2 weeks after the initial administration of the pharmaceutical composition. 21. The method of claim 10, wherein once daily topically administering 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. 22. The method of claim 10, wherein once daily topically administering to the subject the pharmaceutical composition results in longer relapse-free time of the inflammatory lesions 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.