# US 10,307,360 B2 · Topical application of dihydrotestosterone and testosterone fixed combination formulation for promoting hair growth containing formulations > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,307,360 B2 - Document ID: US10307360B2 - Status: Granted - Kind: B2 - Application number: 15/970,339 - Filed: 2018-05-03 - Published: 2018-09-06 - Granted: 2019-06-04 - Earliest claimed: 2012-06-13 - Applicants: Edward Dunne Corboy, Jr. - Inventors: Edward Dunne Corboy, Jr. - Web page: https://patentgrep.com/patent/US10307360B2 ## CPC - A61K 8/63: Steroids; Derivatives thereof - A61K 8/42: Amides - A61K 8/4953: {containing pyrimidine ring derivatives, e.g. minoxidil} - A61K 31/5575: having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha - A61K 31/568: substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61Q 7/00: Preparations for affecting hair growth - 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) - A61Q: SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS ## Abstract The present invention relates to the composition and method of use for the topical application of the potent androgen hormone dihydrotestosterone (DHT), used alone or in fixed combination with other hair growth medications; including other androgens, bimatoprost, other prostamides, prostaglandins, minoxidil or apocrine hair growth factors to promote and enhance hair growth of terminal mustache hair, beard hair, also chest hair, and other male androgen sensitive or dependent hair growth in humans or animals. ## Claims ### Claim 1 A method for promoting or enhancing facial hair growth, comprising topically administering an effective amount of a pharmaceutically acceptable fixed combination formulation of dihydrotestosterone and testosterone to a target skin area, which is the mustache region, beard region, or both of an adult human male, who has completed puberty, and who is unable to grow full beards and/or mustaches, and wherein the target skin area has sparse mature terminal hair and the human male has a level of circulating total serum testosterone that is within a normal physiologic reference range, thereby promoting or enhancing growth of mature terminal hair at the target skin area. ### Claim 2 (depends on 1) The method of claim 1, wherein the dihydrotestosterone formulation is applied daily. ### Claim 3 (depends on 1) The method of claim 1, wherein the fixed combination dihydrotestosterone and testosterone formulation is in the form of a liquid, lotion, cream, ointment, gel, foam, aerosol, or spray. ### Claim 4 (depends on 1) The method of claim 1, wherein the fixed combination dihydrotestosterone and testosterone formulation comprises one or more dermal penetration enhancement agents that optimize hair shaft absorption of the topically applied fixed combination dihydrotestosterone and testosterone formulation and absorption into the hair follicle structures in a targeted manner and then lead to the drug delivery of the topically applied dihydrotestosterone via the hair shaft and via the hair follicle structures to the hair follicle bulb and the dermal papilla cells of the hair follicle located in the hair follicle bulb; and wherein hair follicle structures can be reservoirs for applied formulations. ### Claim 5 (depends on 1) The method of claim 1, wherein a dermal penetration enhancement agent comprises methanol, ethanol, propanol, isopropanol, or any combination thereof; and wherein the dihydrotestosterone and testosterone formulation is delivered to the hair follicle by trans-epidermal diffusion in a targeted manner. ### Claim 6 (depends on 1) The method of claim 1, wherein the fixed combination dihydrotestosterone and testosterone formulation comprises benzalkonium chloride in a range of about 0.2 mg/mL to 0.5 mg/m L. ### Claim 7 (depends on 1) The method of claim 1, wherein the fixed combination dihydrotestosterone and testosterone formulation comprises sodium chloride, dibasic sodium phosphate, citric acid, purified water, or any combination thereof. ### Claim 8 (depends on 1) The method of claim 1, wherein the fixed combination dihydrotestosterone and testosterone formulation is applied topically to achieve targeted delivery of dihydrotestosterone and testosterone to the hair follicle bulbs and mesenchymal dermal papilla cells with minimal drug reaching the systemic circulation. ### Claim 9 (depends on 1) The method of claim 1, wherein the generally accepted normal physiologic reference range of total serum testosterone is about 300 ng/dL to about 1000 ng/dL in human males who have completed puberty. ### Claim 10 A method for promoting or enhancing facial hair growth, comprising topically administering an effective amount of a pharmaceutically acceptable fixed combination formulation of dihydrotestosterone and testosterone to a target skin area, or areas, of the mustache region, beard region, or both of an adult human male, who has completed puberty, who is unable to grow a robust and full beard and/or mustache, wherein the target skin area, or areas, has or have sparse mature terminal hair growth and the human male does not suffer from below normal levels of circulating total serum testosterone, thereby promoting or enhancing growth of mature terminal hair at the target skin area, or areas; and wherein the fixed combination dihydrotestosterone and testosterone formulation is targeted to the hair shaft and the hair follicle structures with the goal of dihydrotestosterone and testosterone delivery to the hair follicle bulbs and mesenchymal dermal papilla cells located in the hair follicle bulb area, with minimal drug reaching the systemic circulation. ### Claim 11 (depends on 10) The method of claim 10, wherein the below normal level of total serum testosterone is below the generally accepted lower limit of 300 ng/dL in a human male who has completed puberty.