Claims for Patent: 12,295,935

Summary for Patent: 12,295,935

Title:	Method for therapeutic treatment of rosacea
Abstract:	A regimen and a pharmaceutical composition for the treatment of a skin condition and/or skin affliction are described. The regimen includes topically applying to the skin of a subject in need of such treatment a pharmaceutical composition comprising about 2.5% w/w to about 10% w/w benzoyl peroxide as an active ingredient, and a pharmaceutically acceptable carrier or excipient.
Inventor(s):	Ofer Toledano, Ori NOV
Assignee:	Mayne Pharma LLC
Application Number:	US18/123,702
Patent Claims:	1. A regimen for the therapeutic treatment of a skin condition and/or skin affliction, the regimen comprising topically applying to the skin of a subject in need of said treatment a pharmaceutical composition, the pharmaceutical composition comprising about 2.5% w/w to about 10% w/w benzoyl peroxide as an active ingredient, and a pharmaceutically acceptable carrier or excipient, wherein: the benzoyl peroxide is not encapsulated within a microcapsule or microsphere consisting of a metal oxide or a semi-metal oxide; and said pharmaceutical composition comprises a fatty phase and/or an oily phase that forms a barrier between the benzoyl peroxide and its surrounding environment in the composition. 2. The regimen of claim 1, wherein said pharmaceutical composition comprises about 2.5% w/w to about 5% w/w of benzoyl peroxide. 3. The regimen of claim 1, wherein the benzoyl peroxide is not encapsulated within a microcapsule. 4. The regimen of claim 1, wherein after the topical application, skin irritation of the subject, and the amount of benzoic acid in the dermis of the skin of the subject, are decreased, compared to skin irritation of the subject and the amount of benzoic acid in the dermis of the skin of the subject, respectively, after topical application of a corresponding pharmaceutical composition without the fatty phase and/or the oily phase. 5. The regimen of claim 1, wherein an amount of benzoic acid in the stratum corneum and the epidermis of the skin of the subject after treatment with said pharmaceutical composition is higher than an amount of benzoic acid in the dermis of the skin of the subject after treatment with said pharmaceutical composition. 6. The regimen of claim 1, wherein the benzoyl peroxide is the sole active ingredient administered to the subject during the duration of the regimen. 7. The regimen of claim 1, wherein the pharmaceutical composition comprises about 3% w/w or about 5% w/w of benzoyl peroxide. 8. The regimen of claim 1, wherein the benzoyl peroxide is selected from a solid, solution or suspension form. 9. The regimen of claim 1, wherein said pharmaceutical composition is an extended-release formulation. 10. The regimen of claim 9, wherein the extended-release effect is obtained by encapsulation, microencapsulation, microspheres or coating. 11. The regimen of claim 1, wherein irritation observed on the skin of the subject after treatment with said pharmaceutical composition remains constant over time. 12. The regimen of claim 9, wherein the extended-release effect is obtained by the fatty phase and/or the oily phase that forms a barrier between the benzoyl peroxide and its surrounding environment in the composition. 13. The regimen of claim 1, wherein the benzoyl peroxide is not encapsulated within a microcapsule comprising an inorganic polymer. 14. The regimen of claim 1, wherein the pharmaceutical composition does not comprise a gelling agent. 15. The regimen of claim 1, wherein: the fatty phase and/or the oily phase is dispersed in an aqueous phase; or the pharmaceutical composition comprises an aqueous phase dispersed in the fatty phase and/or the oily phase. 16. The regimen of claim 1, wherein said pharmaceutical composition is a cream. 17. The regimen of claim 1, wherein the irritation is reduced when evaluated on a 0-3 scale. 18. The regimen of claim 1, wherein the skin condition and/or skin affliction is rosacea. 19. The regimen of claim 18, wherein the rosacea is any of erythematotelangiectatic rosacea, papulopustular rosacea, phymatous rosacea or ocular rosacea. 20. The regimen of claim 1, wherein the benzoyl peroxide is not encapsulated within a microcapsule or microsphere comprising a metal oxide or a semi-metal oxide. 21. A regimen for the therapeutic treatment of a skin condition and/or skin affliction, the regimen comprising topically applying to the skin of a subject in need of said treatment a pharmaceutical composition, the pharmaceutical composition comprising about 2.5% w/w to about 10% w/w benzoyl peroxide as an active ingredient, and a pharmaceutically acceptable carrier or excipient, wherein the benzoyl peroxide is encapsulated within a microcapsule, wherein said pharmaceutical composition is a cream, and wherein an amount of benzoic acid in the stratum corneum and the epidermis of the skin of the subject after treatment with said pharmaceutical composition is higher than an amount of benzoic acid in the dermis of the skin of the subject after treatment with said pharmaceutical composition. 22. The regimen of claim 21, wherein the amount of benzoic acid in the stratum corneum and the epidermis of the skin of the subject is higher than the amount of benzoic acid in the dermis of the skin of the subject when measured by high-performance liquid chromatography (HPLC). 23. The regimen of claim 21, wherein the amount of benzoic acid in the stratum corneum and the epidermis of the skin of the subject is higher than the amount of benzoic acid in the dermis of the skin of the subject when measured by HPLC about 24 hours following the application of the pharmaceutical composition to the skin of the subject. 24. The regimen of claim 21, wherein the amount of benzoic acid in the stratum corneum and the epidermis of the skin of the subject is substantially higher than the amount of benzoic acid in the dermis of the skin of the subject after treatment with said pharmaceutical composition. 25. The regimen of claim 21, wherein irritation observed on the skin of the subject after treatment with said pharmaceutical composition is reduced compared to after treatment with a corresponding pharmaceutical composition in which the benzoyl peroxide is not encapsulated within a microcapsule. 26. The regimen of claim 25, wherein the irritation is reduced when evaluated on a 0-3 scale. 27. The regimen of claim 21, wherein the microcapsule comprises an inorganic polymer. 28. The regimen of claim 21, wherein the benzoyl peroxide is the sole active ingredient administered to the subject during the duration of the regimen. 29. The regimen of claim 21, wherein the pharmaceutical composition comprises about 3% w/w or about 5% w/w of benzoyl peroxide. 30. The regimen of claim 21, wherein the benzoyl peroxide is selected from a solid, solution or suspension form. 31. The regimen of claim 21, wherein said pharmaceutical composition is an extended-release formulation. 32. The regimen of claim 21, wherein the pharmaceutical composition does not comprise a gelling agent. 33. The regimen of claim 21, wherein irritation observed on the skin of the subject after treatment with said pharmaceutical composition remains constant over time. 34. The regimen of claim 21, wherein the skin condition and/or skin affliction is rosacea. 35. The regimen of claim 34, wherein the rosacea is any of erythematotelangiectatic rosacea, papulopustular rosacea, phymatous rosacea or ocular rosacea. 36. A regimen for the therapeutic treatment of a skin condition and/or skin affliction, the regimen comprising topically applying to the skin of a subject in need of said treatment a pharmaceutical composition, the pharmaceutical composition comprising about 2.5% w/w to about 10% w/w benzoyl peroxide as an active ingredient, and a pharmaceutically acceptable carrier or excipient, wherein a total amount of benzoic acid in the skin of the subject after treatment with said pharmaceutical composition is less than about 18,333 ng/cm2, and wherein said pharmaceutical composition is a cream. 37. The regimen of claim 36, wherein the amount of benzoic acid in the skin of the subject after treatment with said pharmaceutical composition ranges from about 6,667 ng/cm2 to about 10,000 ng/cm2. 38. The regimen of claim 36, wherein the amount of benzoic acid in the skin of the subject after treatment with said pharmaceutical composition ranges from about 7,500 ng/cm2 to about 9,167 ng/cm2. 39. The regimen of claim 36, wherein the benzoyl peroxide is not encapsulated within a microcapsule or a coating. 40. The regimen of claim 36, wherein the benzoyl peroxide is encapsulated within a microcapsule or a coating. 41. The regimen of claim 40, wherein the benzoyl peroxide is encapsulated within a microcapsule comprising an inorganic polymer. 42. The regimen of claim 36, wherein the benzoyl peroxide is the sole active ingredient administered to the subject during the duration of the regimen. 43. The regimen of claim 36, wherein the pharmaceutical composition comprises about 3% w/w or about 5% w/w of benzoyl peroxide. 44. The regimen of claim 36, wherein the benzoyl peroxide is selected from a solid, solution or suspension form. 45. The regimen of claim 36, wherein said pharmaceutical composition is an extended-release formulation. 46. The regimen of claim 36, wherein the pharmaceutical composition does not comprise a gelling agent. 47. The regimen of claim 36, wherein irritation observed on the skin of the subject after treatment with said pharmaceutical composition remains constant over time. 48. The regimen of claim 36, wherein irritation observed on the skin of the subject after treatment with said pharmaceutical composition is reduced compared to after treatment with a corresponding pharmaceutical composition that is not a cream. 49. The regimen of claim 48, wherein the irritation is reduced when evaluated on a 0-3 scale. 50. The regimen of claim 39, wherein irritation observed on the skin of the subject after treatment with said pharmaceutical composition is reduced compared to after treatment with a corresponding pharmaceutical composition that is not a cream. 51. The regimen of claim 50, wherein the irritation is reduced when evaluated on a 0-3 scale. 52. The regimen of claim 40, wherein irritation observed on the skin of the subject after treatment with said pharmaceutical composition is reduced compared to after treatment with a corresponding pharmaceutical composition that is not a cream. 53. The regimen of claim 52, wherein the irritation is reduced when evaluated on a 0-3 scale. 54. The regimen of claim 36, wherein the skin condition and/or skin affliction is rosacea. 55. The regimen of claim 54, wherein the rosacea is any of erythematotelangiectatic rosacea, papulopustular rosacea, phymatous rosacea or ocular rosacea.