Claims for Patent: 12,594,252

Summary for Patent: 12,594,252

Title:	Methods for treating inflammatory skin conditions
Abstract:	The present application relates to a method of treating an inflammatory skin condition by administering a pharmaceutical composition comprising a reduced dose of minocycline to a subject in need thereof, wherein said administration provides an effective plasma or interstitial fluid concentration of minocycline for treating the inflammatory skin condition.
Inventor(s):	Swati KULKARNI, Bijay Kumar Padhi, Shanvas ALIKUNJU, Rajeev Singh Raghuvanshi, Srinivas Ramchandra SIDGIDDI, Anirudh GAUTAM
Assignee:	Journey Medical Corp
Application Number:	US17/844,715
Patent Claims:	1. A method of treating inflammatory lesions and/or erythema of rosacea in a subject in need thereof, comprising: administering an oral pharmaceutical composition comprising a body-weight independent dose of about 10 mg to about 40 mg of minocycline to the subject in need thereof, wherein administering the oral pharmaceutical composition reduces the severity of inflammatory lesions and/or erythema of rosacea as compared to the severity of inflammatory lesions and/or erythema of rosacea before administering the oral pharmaceutical composition; and wherein the number of inflammatory lesions is reduced by at least about 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or 100% compared to the number of inflammatory lesions before administering the oral pharmaceutical composition. 2. The method of claim 1, wherein the severity of inflammatory lesions and/or erythema of rosacea is reduced to an equal or greater extent as compared to administration of an oral doxycycline composition comprising 40 mg of doxycycline. 3. The method of claim 1, wherein the severity of the rosacea is reduced as assessed by counting inflammatory lesions before and after administering the oral pharmaceutical composition. 4. The method of claim 1, wherein the number of inflammatory lesions is reduced by 80% compared to the number of inflammatory lesions before administering the oral pharmaceutical composition. 5. The method of claim 1, wherein the administering occurs daily for 2 weeks, 4 weeks, 8 weeks, 12 weeks, or 16 weeks. 6. The method of claim 1, wherein the oral pharmaceutical composition is administered at a sub-antimicrobial dose having no antimicrobial effect on the subject. 7. The method of claim 1, wherein the administration of the oral pharmaceutical composition reduces the Investigator's Global Assessment (IGA) score of the subject by at least one grade compared to the IGA score before administration of the oral pharmaceutical composition. 8. The method of claim 7, wherein the IGA score before administration is obtained 1 to 28 days before administration of the oral pharmaceutical composition. 9. The method of claim 1, wherein the oral pharmaceutical composition comprises about 20 mg to about 40 mg minocycline. 10. The method of claim 1, wherein the oral pharmaceutical composition comprises about 30 mg to about 40 mg minocycline. 11. The method of claim 1, wherein the oral pharmaceutical composition comprises about 40 mg minocycline. 12. A method of treating inflammatory lesions and/or erythema of rosacea in a subject in need thereof, comprising: administering an oral pharmaceutical composition comprising a body-weight independent dose of about 10 mg to about 40 mg of minocycline to the subject in need thereof, wherein administering the oral pharmaceutical composition results in: (i) a maximum plasma concentration (CmaxP) of about 55 ng/ml to about 450 ng/ml minocycline in the subject; and (ii) an area under the plasma concentration-time curve (AUC0-tP) of about 830 ng*hour/ml to about 4080 ng*hour/ml minocycline in the subject, and wherein the number of inflammatory lesions is reduced by at least about 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or 100% compared to the number of inflammatory lesions before administering the oral pharmaceutical composition. 13. The method of claim 12, wherein administering the oral pharmaceutical composition results in: (iii) an average plasma concentration (CavgP) within 24 hours from administration of about 30 ng/ml to about 215 ng/ml minocycline in the subject. 14. The method of claim 12, wherein the oral pharmaceutical composition comprises about 20 mg to about 40 mg minocycline and wherein administering the oral pharmaceutical composition results in: (i) a maximum plasma concentration (CmaxP) of about 110 ng/ml to about 450 ng/ml minocycline in the subject; and (ii) an area under the plasma concentration-time curve (AUC0-tP) of about 1210 ng*hour/ml to about 4080 ng*hour/ml minocycline in the subject. 15. The method of claim 14, wherein administering the oral pharmaceutical composition results in: (iii) an average plasma concentration (CavgP) within 24 hours from administration of about 60 ng/ml to about 215 ng/ml minocycline in the subject. 16. The method of claim 12, wherein the oral pharmaceutical composition comprises about 30 mg to about 40 mg minocycline and wherein administering the oral pharmaceutical composition results in: (i) a maximum plasma concentration (CmaxP) of about 224 ng/ml to about 450 ng/ml minocycline in the subject; and (ii) an area under the plasma concentration-time curve (AUC0-tP) of about 2215 ng*hour/ml to about 4080 ng*hour/ml minocycline in the subject. 17. The method of claim 16, wherein administering the oral pharmaceutical composition results in: (iii) an average plasma concentration (CavgP) within 24 hours from administration of about 90 ng/ml to about 215 ng/ml minocycline in the subject. 18. The method of claim 12, wherein the oral pharmaceutical composition comprises about 40 mg minocycline and wherein administering the oral pharmaceutical composition results in: (i) a maximum plasma concentration (CmaxP) of about 325 ng/ml to about 440 ng/ml minocycline in the subject; and (ii) an area under the plasma concentration-time curve (AUC0-tP) of about 3115 ng*hour/ml to about 4080 ng*hour/ml minocycline in the subject. 19. The method of claim 18, wherein administering the oral pharmaceutical composition results in: (iii) an average plasma concentration (CavgP) within 24 hours from administration of about 160 ng/ml to about 215 ng/ml minocycline in the subject. 20. The method of claim 12, wherein administering the oral pharmaceutical composition reduces the severity of inflammatory lesions and/or erythema of rosacea as compared to the severity of inflammatory lesions and/or erythema of rosacea before administering the oral pharmaceutical composition. 21. The method of claim 20, wherein the severity of inflammatory lesions and/or erythema of rosacea is reduced to an equal or greater extent as compared to administration of an oral doxycycline composition comprising 40 mg of doxycycline. 22. The method of claim 20, wherein the severity of the rosacea is reduced as assessed by counting inflammatory lesions before and after administering the oral pharmaceutical composition. 23. The method of claim 12, wherein the number of inflammatory lesions is reduced by at least about 70% compared to the number of inflammatory lesions before administering the oral pharmaceutical composition. 24. The method of claim 12, wherein the administering occurs daily for 2 weeks, 4 weeks, 8 weeks, 12 weeks, or 16 weeks. 25. The method of claim 12, wherein the oral pharmaceutical composition is administered at a sub-antimicrobial dose having no antimicrobial effect on the subject. 26. The method of claim 12, wherein the administration of the oral pharmaceutical composition reduces the Investigator's Global Assessment (IGA) score of the subject by at least one grade compared to the IGA score before administration of the oral pharmaceutical composition. 27. The method of claim 26, wherein the IGA score before administration is obtained 1 to 28 days before administration of the oral pharmaceutical composition. 28. A method of treating inflammatory lesions and/or erythema of rosacea in a subject in need thereof, comprising: administering an oral pharmaceutical composition comprising a body-weight independent dose of about 10 mg to about 40 mg of minocycline to the subject in need thereof, wherein the oral pharmaceutical composition comprises an immediate release (IR) portion and an extended release (ER) portion, wherein the IR portion and the ER portion are combined in a ratio in a range from about 10:90 to about 90:10, and wherein the number of inflammatory lesions is reduced by at least about 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or 100% compared to the number of inflammatory lesions before administering the oral pharmaceutical composition. 29. The method of claim 28, wherein the IR portion and the ER portion are combined in a ratio selected from the group consisting of about 10:90, about 20:80, about 25:75, about 30:70, about 40:60, about 50:50, about 60:40, about 70:30, about 75:25, about 80:20, or about 90:10. 30. The method of claim 28, wherein administering the oral pharmaceutical composition reduces the severity of inflammatory lesions and/or erythema of rosacea as compared to the severity of inflammatory lesions and/or erythema of rosacea before administering the oral pharmaceutical composition. 31. The method of claim 30, wherein the severity of inflammatory lesions and/or erythema of rosacea is reduced to an equal or greater extent as compared to administration of an oral doxycycline composition comprising 40 mg of doxycycline. 32. The method of claim 30, wherein the severity of the rosacea is reduced as assessed by counting inflammatory lesions before treatment. 33. The method of claim 28, wherein the number of inflammatory lesions is reduced by at least about 70% compared to the number of inflammatory lesions before administering the oral pharmaceutical composition. 34. The method of claim 28, wherein the administering occurs daily for 2 weeks, 4 weeks, 8 weeks, 12 weeks, or 16 weeks. 35. The method of claim 28, wherein the oral pharmaceutical composition is administered at a sub-antimicrobial dose having no antimicrobial effect on the subject. 36. The method of claim 28, wherein the administration of the oral pharmaceutical composition reduces the Investigator's Global Assessment (IGA) score of the subject by at least one grade compared to the IGA score before administration of the oral pharmaceutical composition. 37. The method of claim 36, wherein the IGA score before administration is obtained 1 to 28 days before administration of the oral pharmaceutical composition. 38. The method of claim 1, wherein the method comprises treating inflammatory lesions. 39. The method of claim 38, wherein the inflammatory lesions are papules or pustules.