Claims for Patent: 11,364,212

Summary for Patent: 11,364,212

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:	US17/132,825
Patent Claims:	1. A method of treating rosacea in a subject in need thereof, comprising: administering an oral pharmaceutical composition comprising about 10 mg to about 40 mg of minocycline to the subject in need thereof, wherein administering the oral pharmaceutical composition results in a steady state maximum interstitial fluid concentration (CmaxSSIF) of not more than about 200 ng/ml of minocycline and a maximum plasma concentration (Cmaxp) of about 55 ng/ml to about 450 ng/ml of minocycline; and wherein the administering the oral pharmaceutical composition reduces the IGA score of the subject by at least one grade compared to the IGA score before administering of the oral pharmaceutical composition. 2. The method of claim 1, wherein said rosacea is selected from the group consisting of: a papulopustular rosacea, an erythematotelangiectatic rosacea, a phymatous rosacea, an ocular rosacea, acne rosacea, a pyoderma faciale, a rosacea conglobata, a mild rosacea, a moderate rosacea, a severe rosacea, a mild to moderate rosacea, and a moderate to severe rosacea. 3. The method of claim 1, wherein said rosacea is characterized by papules, pustules and/or nodules. 4. The method of claim 1, wherein administering the oral pharmaceutical composition comprises a body-weight independent dose of minocycline. 5. The method of claim 1, wherein the oral pharmaceutical composition comprises about 20 mg to 40 mg of minocycline. 6. The method of claim 1, wherein the oral pharmaceutical composition comprises about 20 mg of minocycline. 7. The method of claim 1, wherein the oral pharmaceutical composition comprises about 30 mg of minocycline. 8. The method of claim 1, wherein the oral pharmaceutical composition comprises about 40 mg of minocycline. 9. The method of claim 5, wherein administering the oral pharmaceutical composition reduces the severity of rosacea as compared to the severity of rosacea before the treatment as assessed by counting a number of inflammatory lesions. 10. The method of claim 9, wherein administering the oral pharmaceutical composition reduces the number of inflammatory lesions of the subject 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. 11. The method of claim 9, wherein administering the oral pharmaceutical composition reduces the number of inflammatory lesions of the subject by at least about 70% compared to the number of inflammatory lesions before administering the oral pharmaceutical composition. 12. The method of claim 5, wherein administering the oral pharmaceutical composition reduces the number of inflammatory lesions to an equal or greater extent as compared to administration of an oral doxycycline composition comprising 40 mg of doxycycline as assessed by counting number of inflammatory lesions. 13. The method of claim 5, wherein administering the oral pharmaceutical composition reduces the severity of rosacea equivalent or improved compared to that of the 40 mg of doxycycline as assessed by counting a number of inflammatory lesions. 14. The method of claim 8, wherein administering the oral pharmaceutical composition reduces the severity of rosacea compared to that of the 40 mg of doxycycline as assessed by counting number of inflammatory lesions. 15. The method of claim 14, wherein administering the oral pharmaceutical composition reduces the number of inflammatory lesions by at least about 15%, 30%, 50%, or 75% compared to the number of inflammatory lesions reduced following the administration of an oral doxycycline composition comprising 40 mg of doxycycline. 16. The method of claim 14, wherein administering the oral pharmaceutical composition reduces the number of inflammatory lesions by at least about 15% compared to the number of inflammatory lesions reduced following the administration of an oral doxycycline composition comprising 40 mg of doxycycline. 17. The method of claim 14, wherein administering the oral pharmaceutical composition reduces the number of inflammatory lesions by at least about 30% compared to the number of inflammatory lesions reduced following the administration of an oral doxycycline composition comprising 40 mg of doxycycline. 18. The method of claim 14, wherein administering the oral pharmaceutical composition reduces the number of inflammatory lesions by at least about 50% compared to the number of inflammatory lesions reduced following the administration of an oral doxycycline composition comprising 40 mg of doxycycline. 19. The method of claim 14, wherein administering the oral pharmaceutical composition reduces the number of inflammatory lesions by at least about 75% compared to the number of inflammatory lesions reduced following the administration of an oral doxycycline composition comprising 40 mg of doxycycline. 20. The method of claim 5, wherein administering the oral pharmaceutical composition results in equivalent or improved efficacy as compared to an oral doxycycline composition comprising 40 mg of doxycycline. 21. The method of claim 8, wherein administering the oral pharmaceutical composition results in improved efficacy as compared to an oral doxycycline composition comprising 40 mg of doxycycline. 22. The method of claim 1, wherein administering the oral pharmaceutical composition results in a CmaxIF of not more than about 150 ng/ml of minocycline on day 1 after administration. 23. The method of claim 1, wherein administering the oral pharmaceutical composition results in a CmaxIF at about 3.5 hours after administration on day 1. 24. The method of claim 1, wherein administering the oral pharmaceutical composition results in a AUC0-tIF of not more than about 1625 ng*hr/ml of minocycline on day 1 after administration. 25. The method of claim 1, wherein administering the oral pharmaceutical composition results in a CavgIF of not more than about 75 ng/ml of minocycline on day 1 after administration. 26. The method of claim 1, wherein administering the oral pharmaceutical composition to the subject results in at least one steady state pharmacokinetic parameter selected from the group consisting of: (a) CmaxSSIF of about 15 ng/ml to about 150 ng/ml, (b) AUC0-tssiF of about 375 ng*hr/ml to about 1845 ng*hr/ml, and (c) CavgSSIF of about 8 ng/ml to about 90 ng/ml, when measured in interstitial fluid samples. 27. The method of claim 1, wherein administering the oral pharmaceutical composition to the subject results in at least one steady state pharmacokinetic parameters selected from the group consisting of: (a) CmaxIF/D of about 1.8 ng/ml/mg to about 3 ng/ml/mg; and (b) AUC0-tIF/D of about 25 ng/ml/mg to about 40 ng/ml/mg, when measured in interstitial fluid samples. 28. The method of claim 1, wherein the oral pharmaceutical composition is administered once or twice daily in the form of a tablet, a capsule, a pill, a minitablet, a pellet, granules, powder, suspension, or syrup.