Topical roflumilast formulation having antifungal properties
Inventors
BERK, David Reuben • BURNETT, Patrick Eugene • Kato, Saori • Osborne, David W.
Assignees
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Publication Number
US-12329751-B2
Publication Date
2025-06-17
Expiration Date
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.
Core Innovation
The invention provides topical treatment for fungal infection or overgrowth in a subject in need thereof by administering a composition comprising an antifungal effective amount of roflumilast or a pharmaceutically acceptable salt. The subject is suffering from seborrheic dermatitis, and the fungal infection or overgrowth is caused by Malassezia species. The composition is administered topically to treat fungal infection, overgrowth and/or hypersensitivity in the context of seborrheic dermatitis caused by Malassezia species.
A further aspect of the invention is the use of a foam composition format in connection with roflumilast. The document describes a method for treating a fungal infection or overgrowth in a human suffering from seborrheic dermatitis by topically administering a foam composition comprising an antifungal effective amount of roflumilast or a pharmaceutically acceptable salt, where the fungal infection or overgrowth is caused by Malassezia furfur. The document also provides a quantitative roflumilast amount for the foam composition as 0.3% w/w.
The invention also includes reducing a count of at least one Malassezia species in a patient suffering from seborrheic dermatitis by topically administering a composition comprising an antifungal effective amount of roflumilast. The targeted Malassezia species include Malassezia furfur, Malassezia restricta, or Malassezia globosa. The composition can additionally include a phosphate ester surfactant, and can include diethylene glycol monoethyl ether and/or hexylene glycol within stated w/w amounts in dependent refinements.
Claims Coverage
The independent claims cover four related therapeutic approaches centered on topical roflumilast for seborrheic dermatitis associated with Malassezia species, including treatment of infection/overgrowth, treatment of infection/overgrowth and/or hypersensitivity, use of a foam formulation, and reduction of Malassezia counts.
Topical roflumilast for seborrheic dermatitis caused by Malassezia species
Topically administering to a subject a composition comprising an antifungal effective amount of roflumilast or a pharmaceutically acceptable salt, wherein the subject is suffering from seborrheic dermatitis and the fungal infection or overgrowth is caused by Malassezia species.
Topical roflumilast for fungal infection or overgrowth and/or hypersensitivity in seborrheic dermatitis caused by Malassezia species
Topically administering to a subject suffering from seborrheic dermatitis a composition comprising an antifungal effective amount of roflumilast or a pharmaceutically acceptable salt, wherein the fungal infection, overgrowth and/or hypersensitivity is caused by Malassezia species.
0.3% w/w roflumilast foam for Malassezia furfur in human seborrheic dermatitis
Topically administering to a human suffering from seborrheic dermatitis a foam composition comprising an antifungal effective amount of roflumilast or a pharmaceutically acceptable salt, wherein the fungal infection or overgrowth is caused by Malassezia furfur and the antifungal effective amount of roflumilast is 0.3% w/w.
Reducing Malassezia counts in seborrheic dermatitis by topical roflumilast
Topically administering a composition comprising an antifungal effective amount of roflumilast to reduce a count of at least one Malassezia species in a patient suffering from seborrheic dermatitis.
Across the independent claims, the core inventive subject matter is topical administration of an antifungal effective amount of roflumilast, or a pharmaceutically acceptable salt, for seborrheic dermatitis associated with Malassezia species, including treatment of fungal infection or overgrowth, treatment of infection or overgrowth and/or hypersensitivity, use of a foam composition with roflumilast at 0.3% w/w for Malassezia furfur, and reduction of Malassezia counts.
Stated Advantages
Quick antifungal activity.
Reduced Malassezia gene counts measured by qPCR over two weeks in a small clinical study.
Nonclinical evidence including reduced CFU counts after a 24-hour formulation study against Malassezia furfur.
Documented Applications
Treating seborrheic dermatitis, including dandruff, caused by Malassezia species using a topical roflumilast composition.
Reducing Malassezia counts in a patient suffering from seborrheic dermatitis by topical roflumilast administration.
Treating dupilumab facial redness (DFR) using a roflumilast-based topical approach.
Treating superficial fungal infections including tinea and onychomycosis, including Tinea versicolor (pityriasis versicolor), Tinea circinata, Tinea pedis, and Tinea unguium (onychomycosis).
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