Roflumilast, a topical preparation with antifungal properties.

Abstract

The present invention provides a composition for use in a method of treating seborrheic dermatitis. [Solution] A composition is provided comprising (i) an antifungal effective amount of roflumilast, (ii) a solvent, (iii) a surfactant, and (iv) water, which reduces the number of at least one species of Malassezia fungus in a subject.

Claims

1. A method for treating a fungal infection in a subject requiring treatment for a fungal infection, comprising the step of administering a therapeutically effective amount of roflumilast or a pharmaceutically acceptable salt thereof to the subject, wherein the fungal infection is caused by a species of Malassezia.

2. The method according to claim 1, wherein the roflumilast is administered locally.

3. The method according to claim 1, wherein the Malassezia species is selected from the group consisting of M. furfur, M. restricta, and M. globosa.

4. The method according to claim 3, wherein the Malassezia species is M. furfur.

5. The method according to claim 1, wherein the fungal infection includes the abnormal proliferation of fungi on the hair, skin, or nails.

6. The method according to claim 1, wherein the subject is suffering from seborrheic dermatitis, dandruff, dupilumab facial erythema, tinea versicolor, tinea versicolor, tinea circularis, tinea pedis, tinea unguium, tinea manus, tinea cruris, tinea corporis, tinea faciei, tinea capitis, or tinea incognito.

7. The method according to claim 6, wherein the subject is suffering from seborrheic dermatitis.

8. The method according to claim 1, wherein the composition comprises a carrier suitable for local administration.

9. The method according to claim 1, wherein the composition is selected from the group consisting of aerosols, foams, sprays, emulsions, gels, liquids, ointments, pastes, shampoos, suspensions, and systems.

10. The method according to claim 9, wherein the composition is a foam.

11. The method according to claim 1, wherein the composition comprises 0.3% w / w roflumilast.

12. The method according to claim 1, wherein the composition comprises loflumilast, white petrolatum, isopropyl palmitate, cetearyl alcohol, dicetyl phosphate, ceteth-10 phosphate, hexylene glycol, diethylene glycol monoethyl ether, methylparaben, propylparaben, and water.

13. The composition is Loflumilast 0.3% w / w White petrolatum 10.0% w / w Isopropyl palmitate 5.0% w / w Cetearyl alcohol, Dicetyl phosphate and a blend of Ceteth-10 phosphate 10.0% w / w Hexylene glycol 2.0% w / w Diethylene glycol monoethyl ether 25.0% w / w Methylparaben 0.2% w / w Propylparaben 0.05% w / w and Add purified water to make a total of 100 (47.45%) The method according to claim 1, comprising:

14. The method according to claim 1, further comprising the step of administering an additional antifungal agent and / or anti-inflammatory agent.

15. The method according to claim 14, wherein the additional antifungal agent is selected from the group consisting of drugs including miconazole, cyclopyroxolamine, clotrimazole, butenafine, terbinafine, amorolfine, naphthifine, tolnaftate, ketoconazole, efinaconazole, griseofulvin, imidazole, triazole, voriconazole, benzimidazole, ethylparaben, flucytosine, salicylic acid, selenium sulfide, and undecylenic acid.

16. The method according to claim 14, wherein the additional anti-inflammatory agent is a corticosteroid or a calcineurin inhibitor.

17. A method for reducing facial redness or inflammation caused by Malassezia infection, treatment of Malassezia infection and / or Malassezia hypersensitivity, comprising the step of topically administering an effective amount of roflumilast to a patient in need of such treatment.

18. The method according to claim 17, wherein the Malassezia hypersensitivity is treated with dupilumab.

19. The method according to claim 17, wherein the roflumilast is administered in a composition that does not contain ethanol, isopropyl alcohol, or denatured alcohol.

20. The method according to claim 19, wherein the composition comprises loflumilast, white petrolatum, isopropyl palmitate, cetearyl alcohol, dicetyl phosphate, ceteth-10 phosphate, hexylene glycol, diethylene glycol monoethyl ether, methylparaben, propylparaben, and water.

21. The method according to claim 17, wherein the Malassezia hypersensitivity is caused by M. furfur, M. restricta, and / or M. globosa.

22. The method according to claim 17, further comprising the step of administering an anti-inflammatory agent.

23. A method for treating a fungal infection, fungal overgrowth, and / or hypersensitivity to a Malassezia species in a subject requiring treatment, comprising the step of topically administering a therapeutically effective amount of roflumilast or a pharmaceutically acceptable salt thereof to the subject, wherein the fungal infection or overgrowth is caused by a Malassezia species.

24. A method for reducing facial redness and inflammation caused by the treatment of moderate to severe atopic dermatitis, comprising the step of topically administering a therapeutically effective amount of roflumilast or a pharmaceutically acceptable salt thereof to a subject in need of such treatment, wherein the facial redness and inflammation are caused by an infection of a Malassezia species.

25. The method according to claim 24, wherein the infection of the Malassezia species has been treated with dupilumab or is currently being treated with dupilumab.

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