Claims for Patent: 12,329,751

Summary for Patent: 12,329,751

Title:	Topical roflumilast formulation having antifungal properties
Abstract:	The present invention is directed to a method of treating a fungal infection comprising administering topically, to a subject in need thereof, an anti-fungal effective amount of roflumilast. Preferably, topically administered roflumilast is used to treat fungal infections, fungal growth of and/or hypersensitivity to the fungi Malassezia spp. Patients may also be suffering from seborrheic dermatitis, dandruff, dupilumab facial redness, Tinea versicolor, Pityriasis versicolor, Tinea circinata, Tinea pedis, Tinea unguium, Tinea manus, Tinea cruris, Tinea corporis, Tinea faciei, Tinea capitis, and/or Tinea incognito. Topically administered roflumilast is a quick and effective antifungal agent and presents a viable alternative to current antifungal treatments.
Inventor(s):	David Reuben BERK, Patrick Eugene BURNETT, Saori Kato, David W. Osborne
Assignee:	Arcutis Biotherapeutics Inc
Application Number:	US18/335,315
Patent Claims:	1. A method of treating a fungal infection or overgrowth in a subject in need thereof, comprising topically administering to the subject, a composition comprising an antifungal effective amount of roflumilast or a pharmaceutically acceptable salt thereof, wherein the subject is suffering from seborrheic dermatitis, and wherein the fungal infection or overgrowth is caused by Malassezia species. 2. The method according to claim 1, wherein said subject is a human. 3. The method according to claim 1, wherein said composition is a foam. 4. The method according to claim 3, wherein said composition comprises 0.3% w/w roflumilast. 5. The method according to claim 1, wherein said fungal infection is caused by fungi selected from the group consisting of Malassezia furfur, Malassezia restricta, and Malassezia globosa. 6. The method according to claim 5, wherein said fungal infection is caused by Malassezia furfur. 7. The method according to claim 4, wherein said fungal infection is caused by fungi selected from the group consisting of Malassezia furfur, Malassezia restricta, and Malassezia globosa. 8. The method according to claim 7, wherein said fungal infection is caused by Malassezia furfur. 9. A method of treating a fungal infection, overgrowth and/or hypersensitivity in a subject suffering from seborrheic dermatitis, comprising topically administering to the subject a composition comprising an antifungal effective amount of roflumilast or a pharmaceutically acceptable salt thereof, wherein the fungal infection, overgrowth and/or hypersensitivity is caused by Malassezia species. 10. The method according to claim 9, wherein said subject is a human. 11. The method according to claim 9, wherein said composition is a foam. 12. The method according to claim 9, wherein said composition comprises 0.3% w/w roflumilast. 13. The method according to claim 9, wherein said fungal infection is caused by fungi selected from the group consisting of Malassezia furfur, Malassezia restricta, and Malassezia globosa. 14. The method according to claim 13, wherein said fungal infection is caused by Malassezia furfur. 15. The method according to claim 12, wherein said fungal infection is caused by fungi selected from the group consisting of Malassezia furfur, Malassezia restricta, and Malassezia globosa. 16. The method according to claim 15, wherein said fungal infection is caused by Malassezia furfur. 17. A method of treating a fungal infection or overgrowth in a human suffering from seborrheic dermatitis, comprising topically administering to the human, a foam composition comprising an antifungal effective amount of roflumilast or a pharmaceutically acceptable salt thereof, wherein the fungal infection or overgrowth is caused by Malassezia furfur and wherein said antifungal effective amount of roflumilast is 0.3% w/w. 18. The method according to claim 17, wherein said composition is a foam. 19. The method according to claim 1, wherein said composition further comprises a phosphate ester surfactant. 20. The method according to claim 19, wherein said phosphate ester surfactant comprises a blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10 phosphate. 21. The method according to claim 19, wherein said phosphate ester surfactant is in an amount between 1% to 25% w/w. 22. The method according to claim 21, wherein said phosphate ester surfactant is in an amount of 2% w/w. 23. The method according to claim 1, wherein said composition further comprises diethylene glycol monoethyl ether. 24. The method according to claim 23, wherein said diethylene glycol monoethyl ether is in an amount between 10% to 30% w/w. 25. The method according to claim 24, wherein said diethylene glycol monoethyl ether is in an amount of 25% w/w. 26. The method according to claim 1, wherein said composition further comprises hexylene glycol. 27. The method according to claim 26, wherein said hexylene glycol is in an amount between 0.1% to 20% w/w. 28. The method according to claim 27, wherein said hexylene glycol is in an amount of 0.5% to 2% w/w. 29. The method according to claim 28, wherein said hexylene glycol is in an amount of 2% w/w. 30. A method of reducing a count of at least one Malassezia species in a patient suffering from seborrheic dermatitis, comprising topically administering a composition comprising an antifungal effective amount of roflumilast. 31. The method according to claim 30, wherein said composition is a foam. 32. The method according to claim 31, wherein said composition further comprises a phosphate ester surfactant. 33. The method according to claim 32, wherein said phosphate ester surfactant comprises a blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10 phosphate. 34. The method according to claim 30, wherein said phosphate ester surfactant is in an amount between 1% to 25% w/w. 35. The method according to claim 32, wherein said phosphate ester surfactant is in an amount of 2% w/w. 36. The method according to claim 30, wherein said composition further comprises diethylene glycol monoethyl ether. 37. The method according to claim 36, wherein said diethylene glycol monoethyl ether is in an amount between 10% to 30% w/w. 38. The method according to claim 37, wherein said diethylene glycol monoethyl ether is in an amount of 25% w/w. 39. The method according to claim 30, wherein said composition further comprises hexylene glycol. 40. The method according to claim 30, wherein said Malassezia species is selected from the group consisting of Malassezia furfur, Malassezia restricta, and Malassezia globosa.