# US 2019/0167649 A1 · Topical rapamycin therapy > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2019/0167649 A1 - Document ID: US20190167649A1 - Status: Published application - Kind: A1 - Application number: 16/324,274 - Filed: 2017-08-10 - Published: 2019-06-06 - Earliest claimed: 2016-08-10 - Assignees: Board of Regents, The University of Texas System - Applicants: The Board of Regents of the University of Texas System - Inventors: Mary Kay KOENIG; Hope NORTHRUP; Adelaide A. HEBERT - Web page: https://patentgrep.com/patent/US20190167649A1 ## CPC - A61K 31/436: the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin - A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)} - A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)} - A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers - A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like - 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 A topical composition containing rapamycin and an alcohol-free carrier is used to deliver rapamycin to skin cells while preventing systemic absorption, allowing for safe and effective treatment of various skin conditions, including angiofibromas that arise from conditions such as Tuberous Sclerosis Complex (TSC). ## Claims ### Claim 1 A composition for use in treating facial angiofibromas, or other skin lesions, in a patient in need thereof, the composition comprising rapamycin in an amount of from 0.1% to 5% by weight, a liquid glycol, and a dermatologically acceptable carrier, wherein the composition is free of alcohol. ### Claim 2 (depends on 1) The composition of claim 1, wherein the patient in need of treatment is a patient diagnosed with Tuberous Sclerosis Complex (TSC). ### Claim 3 (depends on 1) The composition of claim 1, wherein the other skin lesions are selected from hemangiomas, vascular malformations, pyogenic granulomas, essential telangiectasias, familial multiple discoid fibromas, and cherry angiomas. ### Claim 4 (depends on 3) The composition of claim 3, wherein the vascular malformations are port wine stains or lymphangiomas. ### Claim 5 (depends on 1) The composition of claim 1, wherein the use is for treating other skin lesions and the patient in need of treatment is a patient diagnosed with Proteus, Brooke-Speigler syndrome, nevus sebaceous, epidermal nevus, oral lichen planus, chelitis granulomatosis, neurofibromatosis type 1, overgrowth syndromes, or gingival hypertrophy. ### Claim 6 (depends on 1, 2, 3, 4, 5) The composition of any one of claims 1-5, wherein the rapamycin is present in an amount of about 0.1% to about 1%, or from about 0.5% to 1%, or from about 1% to 3%, or from about 2.5% to 5%, or from about 3% to 5% by weight based on the total weight of the composition. ### Claim 7 (depends on 1, 2, 3, 4, 5) The composition of any one of claims 1-5, wherein the rapamycin is present in an amount of 1%, 2%, 3%, 4%, or 5% by weight based on the total weight of the composition. ### Claim 8 (depends on 1, 2, 3, 4, 5, 6, 7) The composition of any one of claims 1-7, wherein the composition is free of added formaldehyde, fragrances, and dyes. ### Claim 9 (depends on 1, 2, 3, 4, 5, 6, 7) The composition of any one of claims 1-7, wherein the composition is free of added acetone. ### Claim 10 (depends on 1, 2, 3, 4, 5, 6, 7) The composition of any one of claims 1-7, wherein the composition is free of added polyvinylidene fluoride. ### Claim 11 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10) The composition of any one of claims 1-10, wherein the liquid glycol is selected from propylene glycol, polyethylene glycol, and glycerol. ### Claim 12 (depends on 11) The composition of claim 11, wherein the liquid glycol is propylene glycol. ### Claim 13 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11) The composition of any one of claims 1-11, wherein the carrier comprises one or more of purified water, white petrolatum, sorbitol solution, cetearyl alcohol, propylene glycol, ceteareth-20, simethicone, glyceryl monostearate, polyethylene glycol monostearate, sorbic acid, and butylated hydroxytoluene (BHT). ### Claim 14 A composition for use in treating facial angiofibromas in a patient in need thereof, the composition comprising rapamycin in an amount of from greater than 2% up to 5%, or from about 2.5% or 3% up to about 5% by weight, a liquid glycol in an amount of from 1-8% by weight, and a dermatologically acceptable carrier, wherein the composition is free of added alcohol, acetone, and polyvinylidene fluoride, and all weight percentages are based on the total weight of the composition. ### Claim 15 (depends on 14) The composition of claim 14, wherein the liquid glycol is selected from propylene glycol, polyethylene glycol, and glycerol. ### Claim 16 (depends on 15) The composition of claim 15, wherein the liquid glycol is propylene glycol. ### Claim 17 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16) The composition of any one of claims 1-16, wherein the composition is effective to treat facial angiofibromas as determined by a reduction in average size and number of lesions. ### Claim 18 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16) The composition of any one of claims 1-16, wherein the dermatologically acceptable carrier is formulated as a cream.