IP Library Granted Patent US 10,206,939
Granted Patent B2
US 10,206,939 · App. 15/988,368 · Granted Feb 19, 2019

Treatment of papulopustular rosacea with ivermectin

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Quick Facts
Patent No.
US 10,206,939
App. No.
15/988,368
Granted
Feb 19, 2019
Kind
B2
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.

Claims (25)

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% by weight ivermectin, and a reduction in inflammatory lesion count in the subject is observed 2 weeks after the initial administration of the pharmaceutical composition.

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 the subject is treated once daily for 12 weeks or more.

5. The method of claim 1 , wherein at least about 27.3% 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 5 , 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 the subject has no adverse reaction, and the adverse reaction is skin burning sensation or skin irritation.

9. The method of claim 4 , wherein the subject has no adverse reaction, and the adverse reaction is skin burning sensation or skin irritation.

10. A method of treating inflammatory lesions of rosacea in a subject in need thereof, comprising topically administering, once daily, to a skin area affected by the inflammatory lesions of rosacea a pharmaceutical composition comprising ivermectin and a pharmaceutically acceptable carrier, without co-administration of another active pharmaceutical ingredient, wherein the pharmaceutical composition comprises 1% by weight ivermectin, wherein a reduction in inflammatory lesion count in the subject is observed 2 weeks after the initial administration of the pharmaceutical composition.

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 the subject is treated once daily for 12 weeks or more.

14. The method of claim 13 , wherein at least about 27.3% 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 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.

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 of the inflammatory lesions before the treatment.

18. The method of claim 15 , wherein the pharmaceutical composition comprises about 1% by weight ivermectin.

19. The method of claim 15 , wherein about 27.3% or more reduction in inflammatory lesion counts in the subject is observed by 2 weeks after the initial administration of the pharmaceutical composition.

20. The method of claim 10 , wherein the subject has no adverse reaction and the adverse reaction is skin burning sensation or skin irritation.

21. The method of claim 13 , wherein the subject has no adverse reaction, wherein the adverse reaction is skin burning sensation or skin irritation.

22. A method of treating inflammatory lesions of rosacea in a subject in need thereof, comprising topically administering, once daily, to a skin area affected by the inflammatory lesions of rosacea a pharmaceutical composition comprising 1.0% by weight ivermectin and a pharmaceutically acceptable carrier, without co-administration of another active pharmaceutical ingredient, wherein the subject has no adverse reaction and the adverse reaction is skin burning sensation or skin irritation.

23. The method of claim 22 , wherein a reduction in inflammatory lesion count in the subject is observed 2 weeks after the initial administration of the pharmaceutical composition.

24. The method of claim 23 , wherein the subject has 15 or more inflammatory lesions of the papulopustular rosacea before the treatment.

25. The method of claim 24 , 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.

Assignments (3)
MERGER AND CHANGE OF NAME Recorded Mar 10, 2022
From: NESTLÉ SKIN HEALTH SA; GALDERMA HOLDINGS SA
To: GALDERMA HOLDING SA
Reel/Frame 060044/0523 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2021
From: GALDERMA S.A.
To: NESTLÉ SKIN HEALTH SA
Reel/Frame 058962/0638 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 24, 2018
From: JACOVELLA, JEAN; CHAPPUIS, JEAN-PAUL; KAOUKHOV, ALEXANDRE; GRAEBER, MICHAEL; PONCET, MICHEL; BRIANTAIS, PHILIPPE; SALIN, LAURENCE
To: GALDERMA S.A.
Reel/Frame 045894/0752 →