# US 12,594,252 B2 · Methods for treating inflammatory skin conditions > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,594,252 B2 - Document ID: US12594252B2 - Status: Granted - Kind: B2 - Application number: 17/844,715 - Filed: 2022-06-20 - Published: 2023-04-27 - Granted: 2026-04-07 - Earliest claimed: 2018-01-07 - Assignees: Journey Medical Corporation - Applicants: Journey Medical Corporation - Inventors: Swati Kulkarni; Bijay Kumar Padhi; Shanvas Alikunju; Rajeev Singh Raghuvanshi; Srinivas Ramchandra Sidgiddi; Anirudh Gautam - Web page: https://patentgrep.com/patent/US12594252B2 ## CPC - A61K 31/165: having aromatic rings, e.g. colchicine, atenolol, progabide - A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration} - A61K 31/65: Tetracyclines - A61P 17/00: Drugs for dermatological disorders - A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like - A61P 17/04: Antipruritics - A61P 17/06: Antipsoriatics - A61P 17/10: Anti-acne agents - A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## 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. ## Claims ### Claim 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. ### Claim 2 (depends on 1) 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. ### Claim 3 (depends on 1) 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. ### Claim 4 (depends on 1) 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. ### Claim 5 (depends on 1) The method of claim 1, wherein the administering occurs daily for 2 weeks, 4 weeks, 8 weeks, 12 weeks, or 16 weeks. ### Claim 6 (depends on 1) The method of claim 1, wherein the oral pharmaceutical composition is administered at a sub-antimicrobial dose having no antimicrobial effect on the subject. ### Claim 7 (depends on 1) 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. ### Claim 8 (depends on 7) The method of claim 7, wherein the IGA score before administration is obtained 1 to 28 days before administration of the oral pharmaceutical composition. ### Claim 9 (depends on 1) The method of claim 1, wherein the oral pharmaceutical composition comprises about 20 mg to about 40 mg minocycline. ### Claim 10 (depends on 1) The method of claim 1, wherein the oral pharmaceutical composition comprises about 30 mg to about 40 mg minocycline. ### Claim 11 (depends on 1) The method of claim 1, wherein the oral pharmaceutical composition comprises about 40 mg minocycline. ### Claim 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. ### Claim 13 (depends on 12) 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. ### Claim 14 (depends on 12) 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. ### Claim 15 (depends on 14) 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. ### Claim 16 (depends on 12) 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. ### Claim 17 (depends on 16) 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. ### Claim 18 (depends on 12) 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. ### Claim 19 (depends on 18) 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. ### Claim 20 (depends on 12) 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. ### Claim 21 (depends on 20) 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. ### Claim 22 (depends on 20) 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. ### Claim 23 (depends on 12) 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. ### Claim 24 (depends on 12) The method of claim 12, wherein the administering occurs daily for 2 weeks, 4 weeks, 8 weeks, 12 weeks, or 16 weeks. ### Claim 25 (depends on 12) The method of claim 12, wherein the oral pharmaceutical composition is administered at a sub-antimicrobial dose having no antimicrobial effect on the subject. ### Claim 26 (depends on 12) 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. ### Claim 27 (depends on 26) The method of claim 26, wherein the IGA score before administration is obtained 1 to 28 days before administration of the oral pharmaceutical composition. ### Claim 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. ### Claim 29 (depends on 28) 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. ### Claim 30 (depends on 28) 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. ### Claim 31 (depends on 30) 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. ### Claim 32 (depends on 30) The method of claim 30, wherein the severity of the rosacea is reduced as assessed by counting inflammatory lesions before treatment. ### Claim 33 (depends on 28) 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. ### Claim 34 (depends on 28) The method of claim 28, wherein the administering occurs daily for 2 weeks, 4 weeks, 8 weeks, 12 weeks, or 16 weeks. ### Claim 35 (depends on 28) The method of claim 28, wherein the oral pharmaceutical composition is administered at a sub-antimicrobial dose having no antimicrobial effect on the subject. ### Claim 36 (depends on 28) 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. ### Claim 37 (depends on 36) The method of claim 36, wherein the IGA score before administration is obtained 1 to 28 days before administration of the oral pharmaceutical composition. ### Claim 38 (depends on 1) The method of claim 1, wherein the method comprises treating inflammatory lesions. ### Claim 39 (depends on 38) The method of claim 38, wherein the inflammatory lesions are papules or pustules.