Hair serums and supplements

Abstract

The present invention relates to hair serums and supplements for use in the treatment and / or alleviation of symptoms and / or conditions associated with skin and / or hair, including hair loss, including dandruff, weakening and / or splitting or breaking of nails or hair. Treatment may include application of a cannabinoid-containing topical composition, such as a composition of cannabidiol and low molecular weight alcohols, formulated as a serum or the like, and / or ingestion of supplements including vitamins, zinc, selenium, and amino acids (e.g. one or more S-containing amino acids), and the like.

Description

[Technical field]

[0001] The present invention relates to hair serums and supplements for use in treating and / or alleviating conditions related to hair, scalp, skin, and / or nails in a subject. Treatment may include application of a cannabinoid-containing composition, such as a composition containing cannabidiol and a low molecular weight alcohol, formulated as a serum, and / or ingestion of supplements including vitamins, zinc, selenium, and amino acids (e.g., one or more S-containing amino acids). [Background technology]

[0002] WO2020024056 relates to a composition comprising cannabidiol (CBD), ethanol, and water for reducing hair loss and promoting hair growth.

[0003] CN110664663A (HANGZHOU AIBEIDA TECH CO LTD) relates to an anti-hair loss agent containing cannabidiol.

[0004] WO 2018 / 229072 A1 (CAPILLI MED GMBH [DE]) relates to a botanical drug for the treatment of hair loss which combines Capixyl and Rensyl.

[0005] KARACA N. et al., J COSMO TRICHOL (2019), Vol. 5, Issue 1, “A Comparative Study between Topical 5% Minoxidil and Topical “Redensyl, Capixyl, and Procapil” Combination in Men with Androgenetic Alopecia” relates, inter alia, to the use of Redensyl and Capixyl for the treatment of hair loss.

[0006] US8758826 relates to a composition for the treatment of hair disorders comprising CBD, ethanol, and water.

[0007] WO2019049142 relates to a composition for the treatment of alopecia areata, comprising spilanthol, a fatty acid amide isolated from Acanthus moniliforme, and a cannabinoid (such as CBD). Summary of the Invention [Means for solving the problem]

[0008] As demonstrated herein, the inventors have surprisingly and / or unexpectedly discovered that from a broad range of potential ingredients, a composition comprising CBD, Redensyl, and Capixyl is effective with respect to conditions associated with alpha-keratin-containing tissue, such as conditions associated with a subject's hair, scalp, skin, and / or nails.

[0009] I. A topically administered composition containing CBD and a low molecular weight alcohol, formulated as a serum or the like, can alleviate, reduce, and / or ameliorate the symptoms, conditions, or diseases associated with one or more alpha-keratin-containing tissues in a subject.

[0010] II. A composition for oral ingestion, such as a supplement, can alleviate, reduce, and / or improve the symptoms, conditions, or diseases associated with alpha-keratin-containing tissues in a subject. Such a composition may require only a few active ingredients from a long list of possibilities, such as amino acids, vitamins, zinc, and selenium ("selenium").

[0011] III. Further improvement of the above symptoms, conditions and / or diseases can be achieved by combined treatment of the application of the above CBD-containing composition and the above oral intake composition.

[0012] The present invention may include the following aspects and may be outlined as follows, for example.

[0013] First aspect In the present invention, i. Cannabidiol (CBD), ii. an alcohol, such as one or more low molecular weight alcohols, such as one or more C2-C4 Alcohols , for example, one or more of ethanol, propanol, butanol, isobutanol, and / or any combination thereof; iii.Water, iv. Redensyl, v. C3-C8 diols, such as 1,5-pentanediol; vi. Capixyl, vii. menthol, and optionally viii. Skin healing compounds, and / or ix. Caffeine The present invention relates to a composition comprising:

[0014] Suitable compositions may be formulated as topical compositions. In some embodiments, the compositions may be formulated as serums, such as hair serums. Such serums are considered to be particularly suitable for use and / or application in relation to the scalp and / or hair. However, they may also be applicable to the treatment of other alpha-keratin-containing tissues, such as nails and / or skin.

[0015] In some embodiments, the CBD used to provide the topical composition is crystalline, such as "Form A CBD" as disclosed herein. In some embodiments, the CBD is provided as or capable of forming needle-like crystals.

[0016] Second Aspect In the present invention, the present invention relates to a composition for oral intake, such as a supplement, comprising one or more vitamins, zinc, selenium, and one or more amino acids. In some embodiments, such a composition may comprise, for example, a. A vitamin, such as one or more B vitamins, e.g., - Vitamin B5 (pantothenic acid), - Vitamin B6, - Vitamin B7, and / or - Vitamin B12 (including any combination of these), b. Zinc, e.g., zinc gluconate; c. Selenium, e.g., L-selenomethionine, and d. An amino acid, such as one or more S-containing amino acids, such as - L-Methionine, - L-cysteine, and / or - L-Cystine (including any combination of these) may also include

[0017] In some embodiments, such compositions can be formulated, for example, as a supplement. Apart from being suitable for use and / or application in relation to the scalp and / or hair, the supplement is also suitable for use and / or application in relation to the nails and / or skin.

[0018] Third aspect In accordance with the present invention, there is provided a method of providing a composition, such as a topical composition (e.g. a hair serum) according to the first aspect, said method comprising the acts (or steps) of: - Providing a mixture of alcohol and water by adding alcohol directly to water; - providing the desired ingredients in their respective amounts; - mixing and / or dissolving the ingredients in the alcohol / water mixture; - Adjusting the pH, for example to 5-6, for example to 5.5.

[0019] In some embodiments, the CBD used to provide the topical composition is crystalline, such as "Form A CBD" as disclosed herein. In some embodiments, the CBD is provided as or capable of forming needle-like crystals.

[0020] Fourth aspectIn the present invention, the present invention relates to a composition obtained or obtainable according to the method according to the third aspect.

[0021] Fifth aspect In the present invention, the present invention relates to a topically administered composition for use in treating a condition associated with hair, scalp, skin and / or nails in a subject, said treatment comprising topically applying a composition as disclosed herein, such as a CBD-containing composition according to the first or fourth aspect, to one or more of the skin, hair, scalp, nails and / or nail bed of the subject.

[0022] Sixth Aspect In the present invention, the present invention relates to a composition for oral ingestion, such as a supplement, for use in treating a condition related to hair, skin, scalp and / or nails in a subject, said treatment comprising ingestion of a supplement as disclosed herein, such as in the second aspect.

[0023] Seventh aspect In the present invention, the present invention relates to a method of treating a condition associated with hair, skin, scalp, and / or nails, the method comprising topically applying a composition, such as a topically administered composition as disclosed herein (e.g. according to the first, fourth, or fifth aspect), to one or more of the skin, hair, scalp, nails, or nail bed of a subject. In some embodiments, the treatment may comprise ingestion of an oral dosage form, such as a supplement. In some embodiments, the oral dosage form (e.g. a supplement) is a composition as disclosed herein, such as according to the second or sixth aspect.

[0024] Eighth aspectIn the present invention, the present invention relates to a method of treating a condition associated with hair, skin, scalp, and / or nails, said method comprising the ingestion of an oral dosage form such as a supplement as disclosed herein (e.g. according to the second or sixth aspect). Such treatment may further comprise applying a topical composition, such as a cannabinoid-containing composition (e.g. a CBD-containing composition as disclosed herein, e.g. according to the first, fourth, or fifth aspect) to said hair, skin, scalp, and / or nails.

[0025] Ninth aspect The present invention relates to one or more compositions and / or methods as disclosed herein, such as a CBD-containing composition for treatment according to the fifth aspect, an oral dosage form for treatment according to the sixth aspect, and / or a method according to the seventh or eighth aspect, wherein said treatment is one or more of a hair treatment, a skin treatment, and / or a nail treatment.

[0026] 10th In an aspect, the invention relates to a container comprising a composition according to any one of the above aspects.

[0027] 11th In an aspect, the present invention provides a method for producing a method for the treatment of a cancer, comprising: 10th A kit comprising one or more containers according to the embodiment, instructions for use, and optionally packaging.

[0028] 12th In an aspect, the present invention relates to a CBD-containing composition, such as a topical composition, wherein the CBD used in said formulation is crystalline. In some embodiments, said composition is a topical composition as disclosed herein and / or in the third and / or fourth aspects. In some embodiments, said CBD is Form A (needle-shaped crystals) or capable of forming needle-shaped crystals, such as those disclosed in the first aspect and / or examples.

[0029] 13thIn an aspect, the present invention relates to a dosing regimen comprising administering an orally administered supplement as disclosed herein in combination with a topical composition, in particular a CBD-containing topical composition as disclosed herein, in some embodiments, the CBD being "type A". [Brief description of the drawings]

[0030] [Figure 1] A micrograph of cannabinol (CBD) forming needle-like crystals. CBD crystals were obtained from www.enecta.com. [Diagram 2] A micrograph of cannabinol (CBD) forming cluster or cluster crystals. CBD crystals were obtained from www.pharma-hemp.com. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] definition In the context of the present invention, unless the context clearly indicates otherwise, the singular form of a word may include the plural and vice versa. Thus, "a," "an," and "the" generally include the plural of the respective term. For example, a "component" or a "method" may include a plurality of "components" or "methods."

[0032] Similarly, the words "comprise", "contain", and "contain" should be interpreted inclusively, not exclusively. The embodiments provided by the present disclosure may lack elements not specifically disclosed herein. Thus, the disclosure of an embodiment defined using the terms "comprise" and "contain" is also the disclosure of an embodiment "consisting of" and "consisting essentially of" the disclosed components. Thus, the terms "comprise" and "contain" should generally be interpreted as specifying the presence of the recited parts, steps, features, or components, but not excluding the presence of one or more additional parts, steps, features, or components. Thus, for example, a composition containing a compound may contain additional compounds.

[0033] Generally, compositions as disclosed herein, particularly compositions for topical administration and / or oral ingestion, may include one or more pharma- ceutically acceptable carriers, excipients, stabilizers, and the like.

[0034] As used herein, particularly when followed by a list of terms, terms such as "for example" or "such as" are exemplary and descriptive only and should not be considered exclusive or inclusive. Any embodiment disclosed herein may be combined with any other embodiment disclosed herein.

[0035] Unless otherwise specified, all percentages expressed herein are by weight of the total weight of the composition. Thus, unless otherwise specified, "%" refers to "weight / weight (w / w) %" and is referred to as "weight %" or "wt%."

[0036] In the context of the present invention, the terms "about", "approximately", "approximately", or the symbol "~" may be interchangeable and are meant to include variations and / or uncertainties generally accepted in the art, such as analytical error. Thus, "about" may also refer to measurement uncertainties commonly experienced in the art, such as on the order of + / -1, 2, 5, 10, or even 20 percent (%). Furthermore, "about" may be understood to refer to numbers in a numerical range, such as a range of + / -20, + / -15, + / -10, + / -5, + / -2, + / -1, + / -0.5, + / -0.1% of the referenced number. Additionally, all numerical ranges herein should be interpreted as including all integers or fractions within the range.

[0037] As used herein, the term "in some embodiments" is meant to include "in one embodiment," "in some embodiments," and "in one or more embodiments."

[0038] In the context of the present invention, the term "subject" or "patient" may be interchangeable and is meant to include humans, animals, and / or mammals.In particular, human subjects can be selected from, for example, one or more of females, males, elderly, adults, adolescents, children, or infants.Animal subjects can be selected from, for example, pets, livestock, mammals, reptiles, birds, and / or zoo animals.

[0039] In some embodiments, the subject or patient may be diagnosed with, affected by, and / or suffering from one or more symptoms, conditions, and / or diseases associated with and / or manifested in alpha-keratin-containing tissues, such as one or more of nails, hair, and / or skin. If the subject is an animal, the alpha-keratin-containing tissues may be, for example, one or more of claws, hooves, horns, and antlers.

[0040] In the context of the present invention, the term "treatment" refers to actions aimed at alleviating, reducing, ameliorating and / or curing any symptom, condition or disease in a subject.

[0041] In general, "hair" is primarily composed of proteins, especially alpha-keratin. Hair is a protein filament that grows from hair follicles found in the dermis. Hair can be considered a defining feature of mammals. The human body, apart from areas of hairless skin, is covered with hair follicles that produce thick terminal hair and fine vellus hair. In general, the term "hair" is meant to include not only human hair growing from the scalp, but also animal hair, thus including underfur, awn hair, and setae. In some embodiments, "hair" is thick terminal hair growing from the scalp. In some embodiments, "hair" may be or include body hair, such as vellus hair, armpit hair, pubic hair, facial, chest and belly, arm, and / or leg hair.

[0042] Generally, a "nail" is a keratinous plate at the end of fingers and toes commonly common to primates. Nails can be considered to correspond to claws in other animals. Fingernails and toenails are composed of a tough protective protein called alpha-keratin, which is a polymer found in vertebrate hooves, hair, claws, and horns. In the context of the present invention, the term "nail" is meant to include corresponding and / or similar tissues in animals, such as claws, hooves, etc.

[0043] In the context of the present invention, the term "scalp" is meant to include the anatomical region bounded by the front of the face and the sides and back of the neck in humans. The scalp is usually described as having five layers: (1) the skin of the head where the hair grows. It contains numerous sebaceous glands and hair follicles; (2) the connective tissue, a dense subcutaneous layer of fat and fibrous tissue that contains the nerves and blood vessels of the scalp and lies beneath the skin; (3) the next layer is the aponeurosis, the galea aponeurosis, a tough layer of dense fibrous tissue that extends from the frontalis muscle in front to the occipitalis muscle in back; (4) a loose, orbicular connective tissue layer that provides an easy separation surface between the three upper layers and the pericranium; (5) the pericranium is the periosteum of the skull bones, which provides nutrition and repair capacity for the bones. In the context of the present invention, the term "scalp" is meant to include the skin where the thick, warm hair grows, especially in animals.

[0044] "Dandruff" is a skin condition that primarily affects the scalp. Symptoms include flaking and in some cases itching. A more severe condition involving inflammation of the skin is known as seborrheic dermatitis. The cause of dandruff is unknown and is thought to include a number of genetic and environmental factors. In general, the pathogenesis involves excessive growth of skin cells. To the inventor's knowledge, there is no reliable treatment for dandruff.

[0045] In the context of the present invention, symptoms, conditions or diseases associated with and / or manifested by alpha-keratin-containing tissues may include one or more of the following: i. nail : Weakened nails, cracked nails, broken nails, ii. hairWeak hair, hair breakage, reduced hair stylability, split ends, reduced hair strength, reduced hair volume, hair loss, thinning hair (e.g., one or more of the following: receding hairline, hair loss on the top of the scalp, thinning hair over the entire scalp), alopecia, alopecia areata, traction alopecia, telogen effluvium, anagen effluvium, baldness, male pattern baldness, female pattern baldness, hereditary baldness, hereditary thinning hair, and / or iii. skin / scalp :Dandruff, seborrheic dermatitis, psoriasis, itching, burning sensation, dryness, oiliness, rash.

[0046] Conditions related to hair loss and thinning in men: Androgenetic alopecia It is thought to be the most common form of male baldness and is caused by a number of factors related to the hormone DHT, which causes hair follicle shrinkage resulting in varying degrees of male pattern baldness. As in women, genetics is an important factor in the disease.

[0047] Telogen Effluvium (TE) - Hair loss in men: When a subject is exposed to some trauma such as poor nutrition, infection, major surgery, or other forms of excessive stress, many of the approximately 90 percent of hairs that are in the anagen (growth) or catagen (resting) phases switch to the regressive (telogen) phase. Usually, about six weeks to three months after the stressful event is when the phenomenon known as telogen effluvium begins. A handful of hairs can be lost as the TE phase peaks. In most people with stress-related hair loss (TE), hair loss appears to continue as long as the body is subject to the stress. In some men, telogen effluvium may be a chronic disorder and can continue for months or even years without a true understanding of the trigger or stressor.

[0048] Anagen hair loss- Hair loss in men: Anagen effluvium occurs when hair follicles are affected from the inside, impairing their mitotic or metabolic activity. This type of hair loss is often associated with chemotherapy. Because chemotherapy targets the rapidly dividing cancer cells of the body, other rapidly dividing cells of the body, such as hair follicles in the growth (anagen) phase, are also severely affected. Soon after the start of chemotherapy, about 90 percent or more of the hair falls out while the hair is still in the anagen phase.

[0049] Conditions related to hair loss and thinning in women: Androgenetic alopecia - Generally, women with androgenic alopecia have widespread thinning of hair over the entire scalp. Men, on the other hand, rarely have widespread thinning, but instead have several distinct patterns of baldness. Some women may have a combination of the two patterns. Androgenic alopecia in women is due to the action of androgens, male hormones that are typically present in very small amounts. Androgenic alopecia can be caused by many factors related to the action of hormones, including ovarian cysts, discontinuation of high androgenic index contraceptives, pregnancy, and menopause. As in men, the hormone DHT may be responsible for the shrinking of hair follicles in women with female pattern baldness. However, this is most often only seen after the age of 50. Heredity is an important factor in this disease / condition.

[0050] Telogen Effluvium (TE) - When a subject experiences something traumatic like childbirth, malnutrition, a serious infection, major surgery, or extreme stress, many of the approximately 90 percent of hairs that are in the anagen (growth) or catagen (resting) phases switch to the regressive (telogen) phase. Usually, about six weeks to three months after the stressful event is when the phenomenon known as telogen effluvium begins. A handful of hairs can be lost as the TE phase peaks. In most people with stress-related hair loss (TE), the hair loss appears to continue as long as the body is affected by the stress. In some women, telogen effluvium may be a chronic disorder and can continue for months or even years without a true understanding of the trigger or stressor.

[0051] Anagen hair loss Hair loss occurs when hair follicles are affected from within, impairing their mitotic or metabolic activity. This type of hair loss is often associated with chemotherapy. Because chemotherapy targets the body's rapidly dividing cancer cells, other rapidly dividing cells in the body, such as hair follicles in the growth (anagen) phase, are also severely affected. Soon after chemotherapy begins, approximately 90 percent or more of the hair falls out while the hair is still in the growth phase.

[0052] traction alopecia Traction alopecia is usually only seen in women and is caused by trauma to hair follicles from tight hairstyles that pull on the hair over time. If the condition is detected and corrected early enough, the hair can grow back. Traction alopecia can occur with braids, ponytails, and other tightly styled hairstyles.

[0053] First aspect In the present invention, the present invention relates to a composition comprising: i. Cannabidiol (CBD), ii. an alcohol, for example one or more low molecular weight alcohols, for example one or more C2-C4 alcohols, for example one or more of ethanol, propanol, butanol, isobutanol, and / or any combination thereof; iii. Water and one or more of the following: iv. Redensyl, v. C3-C8 diols, such as 1,5-pentanediol; vi. Capixyl, and / or vii.Menthol.

[0054] Optionally, the composition may further comprise (viii) a skin healing compound and / or (ix) caffeine. Thus, such compositions may comprise: (I) components (i)-(vi) or (i)-(vii) but not including a skin healing compound or caffeine; (II) components (i)-(vi) or (i)-(vii) and a skin healing compound but not including caffeine; (III) components (i)-(vi) or (i)-(vii) and caffeine but not including a skin healing compound; or (IV) components (i)-(vi) or (i)-(vii), a skin healing compound, and caffeine.

[0055] Suitable concentration ranges for CBD include, for example, 0.001-2.0 wt%, 0.05-0.5 wt%, 0.075-0.2 wt%, or about 0.1 wt% CBD. In some embodiments, the concentration can be less than 0.001. In some embodiments, the concentration can be greater than 2.0.

[0056] CBD is believed to provide one or more of the following positive effects: (i) cell replenishment / renewal, (ii) stimulation and / or increase of hair growth, and / or (iii) reduction and / or inhibition of dihydrotestosterone (DHT). DHT is believed to be involved in the process that reduces the growth phase of hair due to a lower amount of energy, thereby causing hair loss. Hair follicles become gradually smaller and are eventually destroyed, causing baldness over time.

[0057] Generally, the CBD-containing composition according to the first aspect comprises water and an alcohol, such as one or more low molecular weight alcohols, such as one or more C2-C4 alcohols, such as ethanol, propanol, butanol, isobutanol, and / or any combination thereof (also referred to herein as a CBD-containing composition). Typically, the alcohol is miscible with water and provides and / or contributes to the solubilization of the CBD and optionally any one or more further components. In some embodiments, the low molecular weight alcohol is or comprises a C2, C3, and / or C4 alcohol. In some embodiments, the low molecular weight alcohol is or comprises a C2 or C3 alcohol. In some embodiments, the low molecular weight alcohol is or comprises ethanol.

[0058] Suitable concentration ranges of alcohol may include, for example, 10-60%, 30-55%, 40-50%, or about 30% by weight alcohol, such as a low molecular weight alcohol (e.g., ethanol). In some embodiments, the concentration may be less than 10%. In some embodiments, the concentration may be greater than 60%.

[0059] In the context of the present invention, low molecular weight alcohols such as ethanol are believed to act as penetration enhancers, thereby contributing to, mediating and / or facilitating the delivery of active substances to the skin and / or scalp. In some embodiments, low molecular weight ethanol may act as a penetration enhancer, a sorption enhancer and / or an enhancer.

[0060] CBD-containing compositions include water, and water is typically provided to 100% by weight. Water may act as a solvent, diluent, carrier, and / or vehicle for one or more active ingredients. In general, water is also believed to be less irritating than alcohol and more "skin-friendly" and / or "hair-friendly," thus reducing and mitigating the undesirable effects of alcohol and / or other ingredients, etc.

[0061] Suitable concentration ranges of water may include, for example, 30-70% by weight, 35-60% by weight, 40-55% by weight, or about 45% by weight water. Water may be provided "up to 100%" in the final composition. In some embodiments, the concentration may be less than 30%. In some embodiments, the concentration may be greater than 70%.

[0062] In some embodiments, the CBD-containing composition comprises Redensyl, component (iv). In some embodiments, the CBD- and low molecular weight alcohol-containing composition comprises component (iv) and one or more of components (v), (vi), and / or (vii).

[0063] Suitable concentration ranges for Redensyl may include, for example, 0.5-6.0%, 1.0-5.0%, 2.0-4.0%, or about 3% by weight Redensyl. In some embodiments, the concentration may be less than 0.5%. In some embodiments, the concentration may be greater than 6.0%.

[0064] Redensyl is believed to provide hair growth stimulating effects. Without wishing to be bound by any theory, it is believed that the combination of CBD and Redensyl provides a positive synergistic effect. Redensyl is reported to comprise, consist of, or consist essentially of dihydroquercetin-glucoside (DHQG: 0.005%), epigallocatechin glucoside gallate (EGCG2: 0.0009%), glycine (0.005%), zinc chloride (0.002%), metabisulfite (0.015%), glycerin: 50%, and water QSP 100%. Further information on Redensyl® can be found, for example, here: http: / / www.google.com / url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwjUzM3s2JbvAhVltIsKHXmuAyoQFjABegQIARAD&url=http%3A%2F%2Fwww.nardev.com%2FUploadSection%2FProdCat-276-1446515551.pdf&usg=AOvVaw26ucjjgXwnMona4A9m-t_I or at www.gomo-energy.com / media / pdf / ae / c6 / 32 / redensyl_studie.pdf.

[0065] In some embodiments, the CBD-containing composition comprises a diol, such as a C3-C8 diol (e.g., 1,5-pentanediol) = component (v). In some embodiments, the CBD- and low molecular weight alcohol-containing composition comprises component (v) and one or more of components (iv), (vi), and / or (vii).

[0066] Suitable concentration ranges for the C3-C8 diol may include, for example, 0.5-5.0 wt%, 1.0-4.0 wt%, 1.5-2.5 wt%, or about 2 wt% C3-C8 diol (e.g., 1,5-pentanediol). In some embodiments, the concentration may be less than 0.5%. In some embodiments, the concentration may be greater than 5.0%.

[0067] It is believed that the diol, such as a C3-C8 diol (e.g., 1,5-pentanediol), acts as a solvent and provides a cleansing / cleansing effect on the blocked hair follicles. Additionally, the diol may act as a penetration enhancer, sorption enhancer and / or promoter.

[0068] In some embodiments, the CBD-containing composition comprises Capixyl = component (vi). In some embodiments, the CBD- and low molecular weight alcohol-containing composition comprises component (vi) and one or more of components (iv), (v), and / or (vii).

[0069] Suitable concentration ranges of Capixyl may include, for example, 0.1-2.0% by weight, or 0.2-1.0% by weight, 0.4-0.8% by weight, or about 0.57% by weight of Capixyl. In some embodiments, the concentration may be less than 0.1%. In some embodiments, the concentration may be greater than 2.0%, such as 2.5% or more, or 3.0% or more.

[0070] Capixyl is believed to provide increased and / or stimulation of hair growth and / or to serve as a DHT inhibitor. Without wishing to be bound by any theory, it is believed that the combination of CBD and Capixyl provides a positive synergistic effect. Capixyl TM (INCI) is reported to comprise, consist of, or consist essentially of butylene glycol, water, dextran, acetyl tetrapeptide-3, red clover (clover) flower extract. Further details can be found, for example, here: https: / / www.lucasmeyercosmetics.com / sites / lucasmeyer-corp-v2 / files / products / pdf / 6-tech-file-capixyl.pdf, or at www.foligain.nl / media / downloads / Capixyl.pdf.

[0071] In some embodiments, the CBD-containing composition comprises menthol, component (vii).In some embodiments, the CBD- and low molecular weight alcohol-containing composition comprises component (vii) and one or more of components (iv), (v), and / or (vi).

[0072] Suitable concentration ranges for menthol may include, for example, 0.1-2.0%, 0.2-1.0%, 0.4-0.8%, or about 0.6% by weight of menthol. In some embodiments, the concentration may be less than 0.1%. In some embodiments, the concentration may be greater than 2.0%.

[0073] Menthol is believed to stimulate blood flow and / or circulation in the skin and / or scalp, especially in the small blood vessels of the skin / scalp.

[0074] Optionally, for example, viii. Skin healing compounds, and / or ix. Caffeine One or more further ingredients such as

[0075] Thus, in some embodiments, the CBD-containing composition as disclosed above may further comprise one or more skin healing compounds = ingredient (viii).

[0076] Suitable concentration ranges of the skin healing compound may include, for example, 0.01-3.0%, 0.1-2.0%, 0.5-1.5%, or about 1.0% by weight of the skin healing compound. In some embodiments, the concentration may be less than 0.1%. In some embodiments, the concentration may be greater than 3.0%.

[0077] The effect of the skin healing compound may be one or more of increased skin healing, improved repair of skin lesions, and / or wound healing.

[0078] In some embodiments, the skin healing compound is or comprises hyaluronic acid / hyaluronate. In some embodiments, the CBD-containing composition comprises 0.01-2.0%, 0.1-1.5%, 0.85-1.15%, or about 0.95% of a skin healing compound, such as hyaluronic acid / hyaluronate.

[0079] Hyaluronic acid / salts (e.g., sodium hyaluronate) are believed to contribute to retaining moisture in the hair shaft and / or making the hair easier to comb or brush, thereby reducing breakage. Additionally, hyaluronic acid / salts (e.g., Na hyaluronate) may provide one or more of the following: stimulation of hair growth, exfoliation of dry scalp, promotion of hair body, elasticity, and softness, and / or support and strengthening of weakened hair strands.

[0080] Additionally, in some embodiments, the CBD-containing composition as disclosed above may contain caffeine, component (vii), and one or more of components (iv), (v), and / or (vi).

[0081] Suitable concentration ranges for caffeine may include, for example, 0.01-2.0%, 0.02-0.5%, 0.04-0.07%, or about 0.05% by weight of caffeine. In some embodiments, the concentration may be less than 0.01%. In some embodiments, the concentration may be greater than 2.0%.

[0082] Caffeine's effects are believed to involve its biological activity and ability to penetrate the skin barrier. Caffeine is also believed to increase blood microcirculation in the skin / scalp. Caffeine is also believed to stimulate hair growth by inhibiting 5-alpha reductase activity, an enzyme that can convert testosterone to DHT.

[0083] Suitably, the composition may be formulated as a topically administered composition. In some embodiments, the composition may be formulated as a serum, such as a hair serum. Such a serum is believed to be particularly suitable for use and / or application in relation to the scalp and / or hair. Although the term "serum" may not be clearly defined in the art, it appears to be generally accepted that a skin or hair serum is a skin and / or hair care product designed to deliver a high concentration of a particular active ingredient to the skin, and in the context of hair serums, the scalp. In many cases, serums appear clear, may be gel-like, or liquid, and tend to have a lower viscosity than moisturizers. It is believed that the relevant active ingredient / molecule can penetrate the skin. In general, active ingredients in serums tend to be more concentrated than traditional non-serum formulations. Thus, great care must be taken to avoid undesirable reactions, such as irritation and / or dryness, during treatment with a serum, especially if the subject has sensitive skin. It is believed that the CBD-containing composition according to the first aspect is designed and / or formulated to avoid such negative reactions.

[0084] In some embodiments, a CBD-containing composition as disclosed herein (e.g., a hair serum) may provide a positive effect on nail-related conditions. This can be accomplished, for example, by simultaneously applying the hair serum to the scalp and massaging the composition into the scalp and hair with the fingers.

[0085] Thus, in some embodiments, the CBD-containing composition as disclosed above may further comprise one or more additional compounds, such as one or more components selected from components (x)-(xviii) below. x.=propylene glycol, xi.=glycerin, xii.=Skin conditioning agents, emollients, and / or binders, such as isopropyl palmitate; xiii.=Triethanolamine, xiv.=arginine, xv.=Panthenol, xvi.= Vitamins, such as vitamin B (e.g. vitamin B7 (biotin)), xvii.= pH adjusters, such as citric acid monohydrate; xviii.=Thickeners, such as xanthan gum.

[0086] In some embodiments, the CBD-containing composition as disclosed above may further comprise propylene glycol = component (x) and optionally one or more of components (xi-xviii).

[0087] Suitable concentration ranges for propylene glycol may include, for example, 1.0-20%, 2-10%, 4-6%, or about 5.0% by weight propylene glycol. In some embodiments, the concentration may be less than 1.0%. In some embodiments, the concentration may be greater than 20%.

[0088] It is believed that propylene glycol and / or closely related compounds may also provide a humectant (moisturizing) benefit and / or act as a penetration enhancer.

[0089] In some embodiments, the CBD-containing composition as disclosed above may further comprise glycerin = component (xi) and optionally one or more of components (x, xii-xviii).

[0090] Suitable concentration ranges for glycerin may include, for example, 1.0-20% by weight, 2-15% by weight, 5-8% by weight, or about 6.5% by weight glycerin. In some embodiments, the concentration may be less than 1.0%. In some embodiments, the concentration may be greater than 20%.

[0091] It is believed that glycerin may also provide a humectant effect and / or act as a type of humectant that "attracts" water to the outer layers of the skin / scalp.

[0092] In some embodiments, the CBD-containing composition as disclosed above may further comprise one or more skin conditioning agents, emollients, and / or binders (including any combination thereof), such as isopropyl palmitate (component (xii) and optionally one or more of components (x, xi, xiii-xviii).

[0093] Suitable concentration ranges of skin conditioners, emollients, and / or binders (including any combination thereof), such as isopropyl palmitate, may include, for example, 0.05-2.0 wt%, 0.1-1.0 wt%, 0.7-1.2 wt%, or 0.9 wt% of skin conditioners, emollients, and / or binders (including any combination thereof), such as isopropyl palmitate. In some embodiments, this concentration may be less than 0.05%. In some embodiments, this concentration may be greater than 2.0%.

[0094] Isopropyl palmitate is believed to act as a moisturizer by helping bind moisture to the skin. It is also an emollient that helps the product spread smoothly and can be used as a fragrance ingredient. Conditioning agents are generally believed to provide positive benefits, such as skin care benefits. Isopropyl palmitate and / or related compounds are believed to provide skin conditioning benefits, such as acting as a moisturizer and / or emollient. Isopropyl palmitate may also function as a binding agent, providing positive benefits in formulating the composition and / or in terms of its storage stability.

[0095] In some embodiments, the CBD-containing composition as disclosed above may further comprise triethanolamine = component (xiii) and optionally one or more of components (x-xii, xiv-xviii).

[0096] Suitable concentration ranges for triethanolamine may include, for example, 0.1-2.0 wt.%, 0.15-1.0 wt.%, 0.2-0.4 wt.%, or about 0.28 wt.% triethanolamine. In some embodiments, the concentration may be less than 0.1%. In some embodiments, the concentration may be greater than 2.0%.

[0097] Triethanolamine is believed to function as a surfactant, may function as a pH adjuster, a hair fixative, and may have a preservative effect. Thus, triethanolamine (or related compounds) may have one or more positive effects in formulations as disclosed herein.

[0098] In some embodiments, the CBD-containing composition as disclosed above may further comprise arginine = component (xiv) and optionally one or more of components (x-xiii, xv-xviii).

[0099] Suitable concentration ranges for arginine may include, for example, 0.0001-1.0 wt%, 0.0005-0.1 wt%, 0.001-0.003 wt%, or about 0.002 wt% arginine. In some embodiments, the concentration may be less than 0.0001%. In some embodiments, the concentration may be greater than 1.0%.

[0100] It is believed that arginine relaxes blood vessels, thereby improving blood flow to the skin and / or scalp and hair follicle base.It is also believed that this stimulates hair growth and / or has hair regeneration effects.It is believed that the presence of arginine in topical administration composition can prevent poor development of hair follicles and / or promote better hair health.

[0101] In some embodiments, the CBD-containing composition as disclosed above may further comprise panthenol = component (xv) and optionally one or more of components (x-xiv, xvi-xviii).

[0102] Suitable ranges of panthenol concentrations may include, for example, 0.5-5.0%, 1.0-4.0%, 2.5-3.0%, or about 2.7% by weight of panthenol. In some embodiments, the concentration may be less than 0.5%. In some embodiments, the concentration may be greater than 5.0%.

[0103] Panthenol is believed to strengthen hair, retain moisture and / or improve the texture of damaged hair.

[0104] In some embodiments, the CBD-containing composition as disclosed above may further comprise a vitamin, such as vitamin B (e.g. vitamin B7 (biotin)) = component (xvi) and optionally one or more of components (x-xv, xvii, xviii).

[0105] Suitable concentration ranges for vitamins may include, for example, 0.1-2.0%, 0.2-1.5%, 0.8-1.2%, or about 1.0% by weight of vitamins. In some embodiments, the concentration may be less than 0.1%. In some embodiments, the concentration may be greater than 2.0%.

[0106] Vitamins, particularly the B vitamins, such as biotin, are thought to be related to the health of hair, skin, and / or nails, and in particular, deficiencies in such vitamins can lead to hair loss and / or skin conditions (e.g., scaly red rashes).

[0107] In some embodiments, the CBD-containing composition as disclosed above may further comprise a pH adjuster, such as citric acid monohydrate, component (xvii) and optionally one or more of components (x-xvi, xviii).

[0108] Suitable concentration ranges for the pH adjuster may include, for example, 0.1-2.0%, 0.2-1.0%, 0.25-0.5%, or about 0.4% pH adjuster, such as citric acid monohydrate. In some embodiments, the concentration may be less than 0.1%. In some embodiments, the concentration may be greater than 2.0%.

[0109] Apart from providing a pH adjusting / stabilizing effect, citric acid (or its salts, e.g., ammonium, potassium, and / or sodium salts) may provide one or more additional benefits, such as an antioxidant effect, an antimicrobial effect, a thickening effect, and / or a chelating effect (including any combination thereof). In some embodiments, citric acid / citrates provide an antioxidant effect. In some embodiments, citric acid / citrates provide an antimicrobial effect. In some embodiments, citric acid / citrates may provide a thickening effect to the serum. In some embodiments, citric acid / citrates may have a chelating effect, such as by complexing metal ions.

[0110] In some embodiments, the CBD-containing composition as disclosed above may further comprise a thickening agent, such as xanthan gum, component (xviii) and optionally one or more of components (x-xvii).

[0111] Suitable concentration ranges for thickening agents, such as xanthan gum, may include, for example, 0.1-2.0 wt.%, 0.15-1.0 wt.%, 0.15-0.4 wt.%, or about 0.25 wt.% thickening agent. In some embodiments, the concentration may be less than 0.1%. In some embodiments, the concentration may be greater than 2.0%.

[0112] Generally, thickeners can provide a viscosity enhancing effect. Additionally, such materials (e.g., xanthan gum) may function as one or more of a binding agent, an emulsion stabilizer, a skin conditioner, a surfactant, and an emulsifier (including any combination thereof).

[0113] In summary, in some embodiments of the CBD-containing composition according to the first aspect, one or more ingredients may be provided in the following concentrations (wt %) to provide a CBD-containing topical composition according to the first aspect: i. 0.001-2.0%, 0.05-0.5%, 0.075-0.2%, or about 0.1% CBD; ii. 10-60%, 30-55%, 40-50%, or about 30% alcohol, e.g., EtOH; iii. 30-70%, 35-60%, 40-55%, or about 45% water, and / or up to 100% water; iv. 0.5-6.0%, 1.0-5.0%, 2.0-4.0%, or about 3% Redensyl; v. 0.5-5.0%, 1.0-4.0%, 1.5-2.5%, or about 2% C3-C8 diol; vi. 0.1-2.0%, or 0.2-1.0%, 0.4-0.8%, about 0.57% Capixyl; vii. 0.1-2.0%, 0.2-1.0%, 0.4-0.8%, or about 0.6% menthol; viii. 0.01-2.0%, 0.1-1.5%, 0.85-1.15%, or about 0.95% of a skin healing compound; ix. 0.01-2.0%, 0.02-0.5%, 0.04-0.07%, or about 0.05% caffeine; x. 1.0-20%, 2-10%, 4-6%, or about 5.0% propylene glycol; xi. 1. 0-20%, 2-15%, 5-8%, or about 6.5% glycerin; xii. 0.05-2.0%, 0.1-1.0%, 0.7-1.2%, or 0.9% isopropyl palmitate; xiii. 0.1-2.0%, 0.15-1.0%, 0.2-0.4%, or about 0.28% triethanolamine; xiv. 0.0001-1.0%, 0.0005-0.1%, 0.001-0.003%, or about 0.002% arginine; xv. 0.5-5.0%, 1.0-4.0%, 2.5-3.0%, or about 2.7% panthenol; xvi. 0.1-2.0%, 0.2-1.5%, 0.8-1.2%, or about 1.0% of vitamins; xvii. 0.1-2.0%, 0.2-1.0%, 0.25-0.5%, or about 0.4% of a pH adjuster; xviii. 0.1-2.0%, 0.15-1.0%, 0.15-0.4%, or about 0.25% of a thickening agent. As described herein, often such compositions are formulated at about neutral and / or slightly acidic pH (eg, pH 5-7.5 or 5.5-6.5).

[0114] In some embodiments, at least 3, 4, 5, 6, 7, or 8 of components (i)-(ix) are provided in concentrations as disclosed above.

[0115] In some embodiments, at least 10, 11, 12, 13, 14, 15, 16, or 17 of components (i)-(xviii) are provided in concentrations as disclosed above.

[0116] In some embodiments, the CBD-containing composition is formulated to provide a defined pH. In general, a neutral, near neutral, and / or slightly acidic pH is considered to be advantageous, such as to mimic the pH of the skin or scalp. In some embodiments, the CBD-containing composition can be formulated at a pH of 5-7, 5-6, 5.5-6.5, or about 6. In some embodiments, the pH is about 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, or 7.0. In some embodiments, the pH can be about 5.2-5.8, 5.6-5.7, or about 5.5. In some embodiments, the pH is below 5.0. In some embodiments, the pH is above 7.0.

[0117] Providing a defined pH can be achieved using methods known in the art, including the addition of one or more acids, bases, salts of the acids and / or bases, and / or buffers (including any combination thereof). In some embodiments, citric acid, particularly citric acid monohydrate, is used in this context. In some embodiments, other pharma- ceutically acceptable acids or bases (including salts thereof) can be used. In some embodiments, triethanolamine and / or citrate / citric acid are used to provide and / or maintain the desired pH.

[0118] In general, the presence of oils and / or fats is undesirable in CBD-containing compositions according to the invention, particularly in the context of topical compositions to be applied to the hair and / or scalp of a subject. Without wishing to be bound by any theory, such fats and / or oils may contribute negatively, such as in terms of customer / patient satisfaction, such as by resulting in an oily scalp and / or hair. Thus, in some embodiments, the CBD-containing compositions as disclosed herein contain less than 1.0% or less than 0.1% oils and / or fats.

[0119] In particular, when the absence of oil and / or fat is desired, common sources of CBD, such as CBD-containing oils, are undesirable. Thus, in some embodiments, CBD is provided in essentially pure form, for example, in crystalline or powder form, and / or with a purity of more than 95%, 98%, 99%, or 99% or more. Without wishing to be bound by any theory, it is believed that the use of crystalline CBD can further contribute positively, such as requiring less CBD to obtain a similar effect, compared to CBD crude preparations. This is surprising, since according to common belief, the additional cannabinoids present in such CBD crude preparations would provide a synergistic effect.

[0120] In conclusion, in some embodiments, the CBD-containing composition does not contain one or more additional cannabinoids, such as one or more hallucinogenic and / or non-hallucinogenic cannabinoids. In some embodiments, the additional cannabinoids are not present in an amount greater than 10%, 5%, 2%, 1%, 0.5% or even 0.1% by weight relative to the CBD. In some embodiments, the composition does not contain one or more additional cannabinoids, such as one or more hallucinogenic and / or non-hallucinogenic cannabinoids, and / or the additional cannabinoids are present in an amount less than 10%, 5%, 2%, 1%, 0.5% or 0.1% by weight relative to the CBD.

[0121] However, in some embodiments, one or more additional cannabinoids may be present.

[0122] In some embodiments, the CBD-containing composition according to the first aspect may further comprise one or more cannabinoids of the following types: THC (tetrahydrocannabinol), THCA (tetrahydrocannabinolic acid), CBDA (cannabidiol acid), CBN (cannabinol), CBG (cannabigerol), CBC (cannabigerol), CBD (cannabinoid), CBN (cannabinol), CBG (cannabigerol), CBC (cannabinoid), CBD ... The composition may comprise one or more cannabinoids selected from the following: chromene, CBL (cannabicyclol), CBV (cannabivarin), THCC (tetrahydrocannabiolkol), THCV (tetrahydrocannabivarin), THCP (tetrahydrocannabiphorol), CBDV (cannabidivarin), CBCV (cannabichromevarin), CBGV (cannabigerovarin), CBGM (cannabigerol monomethyl ether), CBE (cannabielsoin), CBT (cannabicitran). Such additional cannabinoids may comprise hallucinogenic and / or non-hallucinogenic cannabinoids. In general, non-hallucinogenic cannabinoids are preferred to avoid undesirable side effects during use or treatment with compositions comprising such compounds, especially when present in physiologically active amounts.

[0123] It is believed that the presence of one or more additional cannabinoids can provide a synergistic effect. In some embodiments, the additional cannabinoids may be selected from CBDV, CBDA, CBG, CBN, THC, and CBC.

[0124] In some embodiments, the additional cannabinoid may be provided in a ratio of CBD:additional cannabinoid >100:1, 100:1 to 50:1, 50:1 to 25:1.25:1.10:1, 10:1, 10:1 to 5:1, 5:1 to 2:1, 2:1 to 1:1, 1:1 to 1:2, 1:2 to 1:5, or <1:5. In some embodiments, the CBD:additional cannabinoid ratio is about 10:1, 9:1, 8:1, 7:1, 6:1, 5:1, 4:1, 3:1, 2:1, 1.5:1, 1.25:1, 1:1, 1:1.25, 1:1.5, 1:2, 1:3, 1:4, or 1:5.

[0125] In some embodiments, the CBD is at least 98%, 99%, 99.5%, or 99.9% pure. In some embodiments, the CBD contains less than 1.5% of any other cannabinoids. In some embodiments, the CBD contains less than 1.5% of any other cannabinoids and less than 1.0% or less than 0.1% THC. In some embodiments, the CBD contains less than 0.1% by weight THC and / or any other hallucinogenic cannabinoids.

[0126] Regarding suitable topical formulations of the CBD-containing composition according to the first aspect, in some embodiments, the composition can be formulated as a hair serum. Without wishing to be bound by any theory, it is believed that a composition such as a serum according to the present invention can result in activation of key areas and / or cells (e.g., stem cells) in the hair follicle / root. Thus, the serum is formulated to allow ingredients to penetrate into / towards the hair follicle and / or root.

[0127] In a further embodiment, a CBD-containing hair serum, typically formulated at a pH of 5 to 7.5, e.g., 5.5 to 6.5, may contain the following (concentrations and / or ranges given in % by weight):

[0128] Embodiment A: i.0.001-2.0% CBD, ii. 10-60% alcohol, e.g., EtOH, and iii.30-70% water.

[0129] Embodiment B: i.0.001-2.0% CBD, ii. 10-60% alcohol, e.g. EtOH; iii. 30-70% water, and optionally one or more of the following: iv. 0.5-6.0% Redensyl, v.0.5-5.0% C3-C8 diols, vi. 0.1 to 2.0% Capixyl, and vii. 0.1-2.0% menthol.

[0130] Embodiment C: i.0.001-2.0% CBD, ii. 10-60% alcohol, e.g. EtOH; iii. 30-70% water, and optionally one or more of the following: iv. 0.5-6.0% Redensyl, v.0.5-5.0% C3-C8 diols, vi. 0.1-2.0% Capixyl, vii. 0.1 to 2.0% menthol, viii. 0.01-2.0% of a skin healing compound, such as hyaluronic acid / hyaluronate, and / or ix. 0.01-2.0% caffeine.

[0131] Embodiment D: i.0.001-2.0% CBD, ii. 10-60% alcohol, e.g. EtOH; iii. 30-70% water; iv. 0.5-6.0% Redensyl, v.0.5-5.0% C3-C8 diols, vi. 0.1-2.0% Capixyl, vii. 0.1 to 2.0% menthol, viii. 0.1-2.0% skin healing compounds, such as hyaluronic acid / hyaluronates, and / or ix. 0.01 to 2.0% caffeine, where either (iv), (vi), or (iv) + (vi) are optional.

[0132] Embodiment E: i.0.001-2.0% CBD, ii. 10-60% alcohol, e.g. EtOH; iii. 30-70% water; iv. 0.5-6.0% Redensyl, v.0.5-5.0% C3-C8 diols, vi. 0.1-2.0% Capixyl, vii. 0.1-2.0% menthol, and optionally one or more of the following: viii. 0.1-2.0% skin healing compounds, such as hyaluronic acid / hyaluronates; ix. 0.01 to 2.0% caffeine, x.1.0-20% propylene glycol, xi. 1. 0-20% glycerin, xii. 0.05-2.0% of a skin conditioner, emollient, and / or binder, such as isopropyl palmitate; xiii. 0.1 to 2.0% triethanolamine, xiv. 0.0001 to 1.0% arginine, xv. 0.5-5.0% panthenol, xvi. 0.1-2.0% vitamins, xvii. 0.1 to 2.0% pH adjuster, xviii. 0.1-2.0% thickener.

[0133] Embodiment F: i.0.001-2.0% CBD, ii. 10-60% alcohol, e.g. EtOH; iii. 30-70% water; iv. 0.5-6.0% Redensyl, v.0.5-5.0% C3-C8 diols, vi. 0.1-2.0% Capixyl, vii. 0.1-2.0% menthol; viii. 0.1-2.0% skin healing compounds, such as hyaluronic acid / hyaluronates; ix. 0.01 to 2.0% caffeine, x.1.0-20% propylene glycol, xi. 1. 0-20% glycerin, xii. 0.05-2.0% of a skin conditioner, emollient, and / or binder, such as isopropyl palmitate; xiii. 0.1 to 2.0% triethanolamine, xiv. 0.0001 to 1.0% arginine, xv. 0.5-5.0% panthenol, xvi. 0.1-2.0% vitamins, xvii. 0.1 to 2.0% pH adjuster, xviii. 0.1-2.0% thickener.

[0134] In some embodiments, the skin-healing compound (viii) is hyaluronic acid / hyaluronate.

[0135] In some embodiments, the skin conditioning, emollient, and / or binding agent (xii) is isopropyl palmitate.

[0136] In some embodiments, components viii and xii are hyaluronic acid / hyaluronate and isopropyl palmitate, respectively.

[0137] Some of the ingredients may be optional as disclosed herein. In some embodiments, one or more ingredients may be provided in higher or lower concentrations.

[0138] Further suitable concentrations and / or concentration ranges may be those disclosed herein.

[0139] With respect to the CBD used in preparing or formulating a CBD-containing topical formulation, in some embodiments, the CBD used to provide the topical composition is crystalline.

[0140] In some embodiments, the CBD used to provide the topical administration composition as disclosed above is characterized by certain features such as crystal structure and / or higher order structure. According to the inventors' observations (see, for example, Example 12), CBD having a needle-like crystal structure (=Crystal Structure A, see Figure 1) surprisingly and unexpectedly appears to be significantly more potent than CBD having a different crystal structure, a non-needle-like structure (also referred to herein as "tufted" or "clustered") (=Crystal Structure B, see Figure 2).

[0141] In some embodiments, the CBD, when crystalline, has or is capable of forming a needle-like crystal structure. In some embodiments, CBD of crystal structure A (or capable of forming needle-like crystals) is at least 1.5, 2, 3, 4, 5, 7.5, 10, 15, or 20 times more potent on a weight / weight basis than CBD of crystal structure B (or capable of forming cluster / tassel crystals).

[0142] A CBD of crystal structure A, or capable of forming needle-like crystals, is referred to herein as "type A CBD," and a CBD of crystal structure B, or capable of forming "tufted" or "clustered" crystals, is referred to as "type B CBD." In some embodiments, the CBD is "type A CBD." In many cases, "type A CBD" is preferred over "type B CBD."

[0143] If CBD needs to be in an active form, it may be in one or more of these particular conformations that it is active when administered to a subject, such as in a topical formulation. Lack of activity or efficacy may also result from reduced uptake and / or poor skin penetration.

[0144] Without wishing to be bound by any theory, it is believed that the difference in crystal structure may be due to different molecular structures, such as different conformations. For example, this may be due to the subject's body's inability to recognize the "wrong" CBD conformation, etc. It is hypothesized that the difference in CBD crystal structure is due to different extraction processes. In particular, the CBD disclosed in FIG. 1 was provided by an extraction process (see, e.g., Example 12) that includes extraction with isopropanol, distillation, and crystallization with heptane, while the CBD disclosed in FIG. 2 was provided by supercritical CO2 extraction.

[0145] In general, crystalline CBD may be provided by methods and techniques known in the art, such as the methods disclosed in US10413845 and / or US10414709.

[0146] In other words, crystalline CBD: - Isopropanol or other alcohol used to smear hemp or marijuana extraction to produce an extract rich in cannabinoids, THC, CBD, and terpenes; - The solvent portion of the extract evaporation to produce a substantially solvent-free extract; - subjecting said substantially solvent-free extract to Distillation and isolating CBD from the extract. - CBD is distilled and isolated Crystallization and optionally using a suitable organic solvent, such as an alkane (e.g., heptane), to produce crystallized and isolated CBD and one or more recrystallizations, typically followed by: - By vacuum drying, etc. Remove the solvent and removing volatile residues. The method may be provided from hemp or cannabis (Cannabis sativa) by a method consisting essentially of:

[0147] Thus, in some embodiments, the CBD crystals used in the formulation of the topical composition are needle-shaped crystals, such as the crystals shown in Figure 1. Similarly, in some embodiments, the CBD crystals used in the formulation of the topical composition are not clustered or bunched, such as crystals similar to those shown in Figure 2.

[0148] In some embodiments, the CBD crystals used in formulating the topical composition are not provided by an extraction method that includes supercritical CO2 extraction.

[0149] In some embodiments, the CBD crystals used in the formulation of the topical composition are provided by a method comprising extraction with a C3-C4 alcohol, such as isopropanol, and one or more crystallization steps with a C6-C8 alkane, such as heptane. In some embodiments, the C3-C4 alcohol is isopropanol. In some embodiments, the C6-C8 alkane is heptane. In some embodiments, the C3-C4 alcohol is isopropanol and the C6-C8 alkane is heptane. It is believed that this combination provides CBD crystals of satisfactory quality, such as the absence or reduction of inhibitors and / or the desired conformation of CBD.

[0150] In some embodiments, a suitable CBD product can be obtained when CBD crystals are provided by a process that includes critical CO2 extraction and one or more crystallization steps with a C6-C8 alkane, such as heptane.

[0151] As shown in Table 1, it can be seen that the cannabinoid profiles of CBD types A and B can be rather similar.

[0152] [Table 1]

[0153] However, it is also assumed that differences in crystal structure may be related to and caused by different extraction processes. Different crystal structures may also show different concentrations of "CBD inhibitors" and / or different concentrations of "CBD enhancers". In some embodiments, terpenes, such as natural terpenes, particularly those found in plants such as Cannabis sativa, act as CBD inhibitors, which is undesirable.

[0154] Thus, in some embodiments, CBD of crystal structure B, also known as "CBD type B", can be converted to CBD of crystal structure A, also known as "CBD type A" (and / or CBD capable of forming crystal structure A) by an organic extraction and / or recrystallization step. In such embodiments, the change in crystal structure is assumed to be related to the presence of inhibitors, which are significantly reduced in the additional extraction and / or crystallization step. Alternatively, the organic extraction step may change the conformation of CBD, making it more active again. In some embodiments, CBD type B can be converted to CBD type A by recrystallization with heptane.

[0155] In some embodiments, the CBD of crystal structure B is www.pharma-hemp.com and / or CBD crystals provided via supercritical CO2 extraction, such as those provided following extraction protocols similar to those of the manufacturers listed above.

[0156] In some embodiments, the presence of terpenes and / or terpenoids, particularly Cannabis sativa terpenes, in a CBD-containing topical composition as disclosed herein results in one or more undesirable effects, such as reduced efficiency or potency, lack or reduced ability to recognize CBD, the need for higher concentrations of CBD formulations to achieve similar effects, and / or an increase in non-CBD cannabinoids in the formulation. In some embodiments, the composition contains 0.0001% or less by weight, 0.001% or less by weight, 0.01% or less by weight, or 0.1% or less by weight of terpenes, particularly Cannabis sativa terpenes.

[0157] In some embodiments, the crystalline CBD does not contain significant amounts of terpenes, such as less than 0.1%, less than 0.05%, less than 0.02%, less than 0.01%, less than 0.005%, less than 0.002%, or less than 0.001% by weight of terpenes.

[0158] It is also assumed that other plant components such as terpenoids may act as inhibitors. In some embodiments, the presence of terpenoids, such as Cannabis sativa terpenoids, may be undesirable. In some embodiments, the crystalline CBD does not contain significant amounts of terpenoids, such as less than 0.1% by weight, less than 0.05% by weight, less than 0.02% by weight, less than 0.01% by weight, less than 0.005% by weight, less than 0.002% by weight, less than 0.001% by weight of terpenoids.

[0159] In some embodiments, the use of CBD having or capable of being provided as a crystal of crystal structure A as shown in FIG. 1 in a CBD-containing topical composition as disclosed herein provides positive effects such as one or more of increased efficacy, potentially reducing the total amount of CBD in the formulation, reducing the amount of topical formulation required by the subject to achieve the same effect, improved recognition and / or uptake of CBD by the subject's body, and / or reduced non-CBD cannabinoids and / or other impurities in the formulation.

[0160] Generally, the CBD-containing composition can be formulated for daily use, such as once or twice per day, preferably once per day for ease of use.

[0161] Generally, the composition according to the first aspect may be provided using methods and procedures known in the art. In some embodiments, the composition according to the first aspect may be provided as set forth in the third aspect.

[0162] Second Aspect In the present invention, the present invention relates to a composition for oral intake, such as a supplement, comprising one or more vitamins, zinc, selenium, and one or more amino acids. In some embodiments, such a composition may comprise, for example, a. A vitamin, such as one or more B vitamins, e.g., - Vitamin B5 (pantothenic acid), - Vitamin B6, - Vitamin B7, and / or - Vitamin B12 (including any combination of these) One or more of the following: b. Zinc, e.g., provided as zinc gluconate; c. Selenium, e.g., L-selenomethionine, and d. An amino acid, such as one or more S-containing amino acids, such as - L-Methionine, - L-cysteine, and / or - L-Cystine (including any combination of these) may also include

[0163] Such compositions for oral ingestion (also referred to herein as "supplements," and thus the two terms may be interchangeable) may be formulated using techniques known in the art and may include accepted excipients, etc. Thus, in some embodiments, the supplements may be formulated as oral dosage forms such as pills, tablets, or capsules, and / or may optionally include one or more excipients, anticoagulants, and / or flow agents.

[0164] In some embodiments, the supplement can be formulated as a capsule. In some embodiments, the capsule can optionally include an anti-caking agent and / or a flow agent, such as rice bran extract. Generally, when formulated as a capsule, the capsule will include a capsule shell, and thus, in some embodiments, the supplement can include a capsule shell. In some embodiments, the capsule can further include a coloring agent. More details on the formulation as a capsule and the like are provided below.

[0165] Supplements as disclosed herein can be formulated, for example, such that the oral dosage form (e.g., pill, tablet, or capsule) has a weight of 0.2-2.0 g, 0-4-1.5 g, 0.6-1.0 g, or about 0.72 g. In some embodiments, the weight can be less than 0.2 g. In some embodiments, the weight can be greater than 2.0 g.

[0166] Furthermore, the supplement according to the second aspect can be formulated for a prescribed number of doses per day, such as 1, 2, 3 or more. Generally, a smaller number of doses per day, such as 1 or 2, is preferred. In some embodiments, the oral dosage form is formulated for a single dose per day. In some embodiments, the oral dosage form is a capsule formulated for a single dose per day.

[0167] Set out below are suitable concentration ranges for various compounds / ingredients / components of such supplements formulated as capsules or the like.

[0168] In some embodiments, the supplement includes one or more of the following: 0.5-10% vitamins (such as one or more B vitamins), 0.1-2.0% zinc (e.g., provided as zinc gluconate), 0.001-2.0% selenium (such as L-selenomethionine), and 25-90% amino acids (such as one or more S-containing amino acids).

[0169] In some embodiments, the supplement includes 0.5-10% vitamins (such as one or more B vitamins), 0.1-2.0% zinc (e.g., provided as zinc gluconate), 0.001-2.0 selenium (such as L-selenomethionine), and 25-90% amino acids (such as one or more S-containing amino acids).

[0170] In some embodiments, the supplement contains 0.5-10% vitamins, such as one or more B vitamins and / or other vitamins. In some embodiments, the vitamin concentration can be less than 0.5%. In some embodiments, the concentration can be greater than 10%.

[0171] In general, B vitamins are believed to have a positive effect on hair growth, skin and / or nails, as further exemplified below.

[0172] Suitable ranges for the individual B vitamins may include, for example, 0.5-5.0% by weight, 0.8-3.0% by weight, or 1.0-1.5% by weight, or about 1.3% by weight of vitamin B5 (also known as pantothenic acid). In some embodiments, the concentration of vitamin B5 may be less than 0.5%. In some embodiments, the concentration of vitamin B5 may be greater than 5%.

[0173] Like other B vitamins, vitamin B5 is thought to nourish hair follicles so they function properly. It strengthens and improves hair follicle function, and healthy hair follicles are thought to be important for hair growth. Vitamin B5 appears to be essential for hair growth and health, and a deficiency of vitamin B5 can lead to undernutrition of hair follicles, which can result in reduced hair growth and even hair loss.

[0174] Suitable ranges for the individual B vitamins may include, for example, 0.01-2.0%, 0.1-1.5%, 0.2-0.4%, or about 0.28% by weight of vitamin B6. In some embodiments, the concentration of vitamin B6 may be less than 0.01%. In some embodiments, the concentration of vitamin B6 may be greater than 2%.

[0175] Vitamin B6 is believed to increase blood (e.g., oxygenated blood) flow to the scalp and / or hair follicles, supporting hair growth and / or hair revitalization. Vitamin B6 is also believed to contribute to optimal hair growth.

[0176] Suitable ranges for the individual B vitamins may include, for example, 0.1-2.0%, 0.15-1.0%, 0.20-0.5%, or about 0.35% by weight of vitamin B7 (also known as biotin). In some embodiments, the concentration of vitamin B7 may be less than 0.1%. In some embodiments, the concentration of vitamin B7 may be greater than 2%.

[0177] It is believed that vitamin B7 can stimulate the production of keratin in hair and / or other keratin-containing tissues, increasing the rate of hair follicle growth.

[0178] Suitable ranges for the individual B vitamins may include, for example, 0.00005-2.0%, 0.0001-1.0%, 0.0002-0.0004%, or about 0.0003% by weight of vitamin B12 (also known as cobalamin). In some embodiments, the concentration of vitamin B12 may be less than 0.00005%. In some embodiments, the concentration of vitamin B12 may be greater than 2%.

[0179] Vitamin B12 appears to be very essential for hair growth and a deficiency of B12 can cause hair loss.

[0180] In some embodiments, zinc (e.g., provided as zinc gluconate) is provided at a concentration of 0.1-2.0%, 0.2-1.0%, 0.4-0.7%, or about 0.55% by weight. In some embodiments, the zinc / zinc gluconate concentration can be less than 0.1%. In some embodiments, the zinc / zinc gluconate concentration can be greater than 0.55%.

[0181] Zinc is thought to play an important role in the growth and repair of hair tissue. It also helps keep the sebaceous glands around the hair follicle working properly. Hair loss is a common symptom of zinc deficiency.

[0182] Suitable ranges for selenium (e.g., provided as L-selenomethionine) may include 0.001-2.0%, 0.005-1.0%, 0.0075-0.015%, or about 0.01% selenium / selenomethionine. In some embodiments, the concentration of selenium / selenomethionine may be less than 0.001%. In some embodiments, the concentration of vitamin B12 may be greater than 2%.

[0183] Selenium is a trace mineral that plays many important roles in the body, including aiding in hair growth.

[0184] A suitable range of amino acids may include 25-90% amino acids. In some embodiments, the concentration of amino acids may be less than 25%. In some embodiments, the concentration of amino acids may be greater than 90%.

[0185] In some embodiments, the amino acids may include one or more essential amino acids, such as one or more selected from phenylalanine, valine, threonine, tryptophan, methionine, leucine, isoleucine, lysine, and histidine.

[0186] Often, the amino acids in the supplement include at least one, two, or three S-containing amino acids, such as one or more of L-methionine, L-cysteine, and / or L-cystine.

[0187] Suitable ranges of L-methionine may include 5-30%, 10-25%, 14-18%, or about 16.7% L-methionine. In some embodiments, the concentration of L-methionine may be less than 5%. In some embodiments, the concentration of L-methionine may be greater than 30%.

[0188] L-methionine may promote healthy skin, hair, and nails. It may also be involved in the body's natural detoxification processes by protecting cells from pollutants and slowing cellular aging. It is also important for the absorption and bioavailability of selenium and zinc.

[0189] Suitable ranges for L-cysteine ​​include 10-50%, 15-40%, 20-30%, or about 25% L-cysteine. In some embodiments, the concentration of L-cysteine ​​can be less than 10%. In some embodiments, the concentration of L-cysteine ​​can be greater than 50%.

[0190] L-cysteine ​​is believed to be the primary amino acid that stimulates hair growth. A diet low in cysteine ​​and / or health issues resulting in a deficiency in the body's absorption of cysteine ​​are believed to be common causes of hair loss.

[0191] Suitable ranges for L-cystine may include 10-50%, 20-40%, 26-32%, or about 28% L-cystine. In some embodiments, the concentration of L-cystine may be less than 10%. In some embodiments, the concentration of L-cystine may be greater than 50%.

[0192] L-cystine is an oxidized cysteine ​​dimer in keratin, the hair building block and source of hair and nails. L-cystine is the major protein component of keratin, the major hair protein, which is thought to contain approximately 17.5% L-cystine.

[0193] In some embodiments, a supplement is provided that includes at least one, two, three, or four B vitamins, optionally wherein said at least one, two, three, or four B vitamins are provided in the following concentrations: - 0.5-5.0%, 0.8-3.0%, or 1.0-1.5%, or about 1.3% by weight of vitamin B5, - 0.01-2.0%, 0.1-1.5%, 0.2-0.4% or about 0.28% by weight of vitamin B6, - 0.1-2.0%, 0.15-1.0%, 0.20-0.5% or about 0.35% by weight of vitamin B7, and / or - 0.00005-2.0%, 0.0001-1.0%, 0.0002-0.0004%, or about 0.0003% by weight of vitamin B12, and - One or more of the following: zinc, selenium, and / or amino acids.

[0194] In some embodiments, a supplement is provided that includes 0.1-2.0%, 0.2-1.0%, 0.4-0.7%, or about 0.55% zinc, e.g., zinc gluconate, and one or more vitamins, selenium, and / or amino acids.

[0195] In some embodiments, a supplement is provided that includes 0.001-2.0%, 0.005-1.0%, 0.0075-0.015%, or about 0.01% selenium, e.g., L-selenomethionine, and one or more of a vitamin, zinc, and / or an amino acid.

[0196] In some embodiments, a supplement is provided that includes at least one, two, or three S-containing amino acids, wherein the at least one, two, or three S-containing amino acids are provided in the following concentrations: - 5-30%, 10-25%, 14-18% or about 16.7% by weight of L-methionine, - 10-50%, 15-40%, 20-30% or about 25% by weight of L-cysteine, and / or 10-50%, 20-40%, 26-32%, or about 28% by weight of L-cystine, and - One or more of the following vitamins: zinc, and / or selenium.

[0197] As disclosed herein, the supplements can be formulated as capsules. Such capsules may typically contain 5-60% capsule-related ingredients, such as capsule shell-related materials and / or colorants. Additionally, the capsules may contain one or more additional agents and / or ingredients, such as one or more flow agents and / or anti-caking agents, such as rice bran extract. In some embodiments, the capsules may contain one or more of 5-30% by weight rice bran extract, 5-30% by weight capsule shell, and / or 0.1-2% by weight colorants.

[0198] Compositions for oral ingestion, such as those set forth herein above, are balanced in terms of the concentration of active ingredients, the intended effect, and their applicability for intended daily use as a supplement (e.g., a supplement formulated as a capsule). In some embodiments, the hair supplement can be formulated as a single oral dose, e.g., 0.5-1.0 g per day, or one capsule of about 0.72 g. In some cases, depending on the number and amount of additional ingredients, the daily dose may include multiple oral dosage forms / capsules (e.g., 2, 3, or more). Examples of various suitable oral dosage forms and their weights are disclosed elsewhere.

[0199] In some embodiments, the composition is formulated as an oral dosage form (e.g., capsule), and is 1, 2, or 3 of the above oral dosage forms (e.g., capsules) at 720 mg / day. In some embodiments, 1 capsule per day provides the required daily dosage. In some embodiments, 2 capsules per day provides the required daily dosage. In some embodiments, 3 capsules per day provides the required daily dosage. In some embodiments, more than 3 capsules per day provides the required daily dosage.

[0200] In some embodiments, the composition is formulated as an oral dosage form, such as about 0.5 to 1.0 or 0.72 capsules, and the daily dosage for a subject, such as an adolescent, adult, or elderly, is 1 or 2 oral dosage forms / day. In some preferred embodiments, the number of oral doses per day is 1. Generally, this is considered to be advantageous for the subject. However, in some cases, for example, it may be advantageous to distribute the daily dosage across two or more capsules, tablets, pills, etc.

[0201] As disclosed herein, in some embodiments, the supplement can be formulated for oral ingestion, e.g., as a tablet, pill, or capsule. Such formulations may include acceptable excipients, such as 1-80%, 2-70%, 3-60%, 4-50%, 5-30%, 8-20%, 10-15%, or about 12% by weight. An example of such an excipient is rice bran extract. In some embodiments, the excipient may be present in a concentration of at least 5%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, or 80% by weight or more. In some embodiments, suitable ranges for rice bran extract may include 5-30%, 6-20%, 8-14%, or about 11% rice bran extract. In some embodiments, the concentration of rice bran extract may be less than 5%. In some embodiments, the concentration of rice bran extract can be greater than 30%.

[0202] When formulated as a capsule, the composition may include a capsule shell, such as a conventional capsule shell. The shell may include, for example, 4-50%, 5-30%, 10-25%, 15-20%, or about 17% by weight of capsule shell. In some embodiments, the capsule shell may include a polishing agent, such as hydroxypropyl methylcellulose, and / or a coloring agent, such as TiO2. In some embodiments, suitable ranges of capsule shell components may be 5-30%, 8-35%, 15-20%, or about 17% by weight. In some embodiments, the concentration of capsule shell may be less than 5%. In some embodiments, the concentration of capsule shell may be greater than 30%.

[0203] Additionally, oral dosage forms such as capsules may contain colorants. Suitable ranges for colorants such as TiO2 may be, for example, 0.1-2%, 0.15-1%, 0.2-0.4%, or about 0.3%. In some embodiments, the concentration of the colorant may be less than 0.1%. In some embodiments, the concentration of the colorant may be greater than 2%.

[0204] Generally, in the embodiments presented herein, the percentages are given for compositions that may include excipients and / or capsule shells. Those skilled in the art can derive other dosage amounts, such as for oral dosage forms that do not include said excipients and / or capsule shells, without undue burden.

[0205] In some embodiments, the composition is formulated as a supplement for daily intake, such as 1-5, e.g., 1, 2, or 3 pills, tablets, capsules, etc., per day. Often, daily intake is in the morning in combination with breakfast and / or fluid intake (e.g., 100 ml of fluid, e.g., water, milk, tea, or coffee). Alternatively, other times, such as lunch or dinner, can be selected.

[0206] In some embodiments, the composition is formulated for oral ingestion, such as an oral dosage form formulated as a tablet, pill, or capsule having a weight of about 0.1-2.0 g, 0.4-1.5 g, 0.5-1.0 g, or about 0.72 g. In some embodiments, the weight of the daily dosage form is about 0.5 g, 0.6 g, 0.7 g, 0.8 g, 0.9 g, 1.0 g, 1.2 g, 1.4 g, 1.6 g, 1.8 g, or 2.0 g. In some embodiments, the weight can be less than 0.5 g, 0.5-0.6 g, 0.6-0.7 g, 0.7-0.8 g, 0.8-0.9 g, 0.9-1.0 g, 1.0-2.0 g, or (iv) more than 2.0 g. In some embodiments, the supplement is formulated as a capsule having a weight of about 0.6 to 0.8 g, e.g., about 0.6 g, 0.625 g, 0.65 g, 0.675 g, 0.7 g, 0.71 g, 0.72 g, 0.73 g, 0.74 g, 0.75 g, 0.8 g, 0.9 g, or 1.0 g.

[0207] The ingredients / components / ingredients of the composition may be provided in a variety of forms ranging from essentially pure forms to more complex extracts.

[0208] In some embodiments, a supplement is provided that includes (by weight) the following: ci.0.5-10% of vitamins, such as one or more B vitamins, e.g. - 0.5-5.0%, 0.8-3.0%, or 1.0-1.5%, or about 1.3% vitamin B5; - 0.01-2.0%, 0.1-1.5%, 0.2-0.4%, or about 0.28% vitamin B6; - 0.1-2.0%, 0.15-1.0%, 0.20-0.5%, or about 0.35% vitamin B7, and / or - 0.00005 to 2.0%, 0.0001 to 1.0%, 0.0002 to 0.0004%, or about 0.0003% vitamin B12 (including any combination thereof); cii. 0.1-2.0%, 0.2-1.0%, 0.4-0.7%, or about 0.55% zinc, e.g., zinc gluconate; ciii. 0.001-2.0%, 0.005-1.0%, 0.0075-0.015%, or about 0.01% selenium, e.g., L-selenomethionine; and civ. 25-90% of amino acids, including one or more S-containing amino acids, e.g. - 5-30%, 10-25%, 14-18%, or about 16.7% L-methionine; - 10-50%, 15-40%, 20-30%, or about 25% L-cysteine, and / or - 10-50%, 20-40%, 26-32%, or about 28% L-Cystine (including any combination of these), and optionally cv. 5-60% of capsule-related ingredients, such as one or more of the following: - 5-30%, 6-20%, 8-14%, or about 11% rice bran extract - 5-30%, 8-35%, 15-20%, or about 17% capsule shells, and - optionally 0.1-2%, 0.15-1%, 0.2-0.4%, or about 0.3% of a colorant, such as TiO2.

[0209] In some embodiments, a supplement is provided that includes (by weight) the following: ci.0.5-10% of vitamins, such as one or more B vitamins, e.g. - 0.5-5.0% Vitamin B5, - 0.01-2.0% Vitamin B6, - 0.1-2.0% Vitamin B7, and / or - Vitamin B12 from 0.00005 to 2.0 (including any combination of these); cii. 0.1-2.0% zinc, e.g. zinc gluconate; ciii. 0.001 to 2.0% selenium, e.g., L-selenomethionine, and civ. 25-90% of amino acids, including one or more S-containing amino acids, e.g. - 5-30% L-methionine, - 10-50% L-cysteine, and / or - 10-50% L-Cystine (including any combination of these), and optionally cv. 5-60% of capsule-related ingredients, such as one or more of the following: - 5-30% rice bran extract - 5-30% capsule shells, and optionally - 0.1-2% colorant, e.g. TiO2.

[0210] In some embodiments, a supplement is provided that includes (by weight) the following: cvi. 0.5-10% of vitamins, such as one or more B vitamins, e.g. - 0.5-5.0%, 0.8-3.0%, or 1.0-1.5%, or about 1.3% vitamin B5; - 0.01-2.0%, 0.1-1.5%, 0.2-0.4%, or about 0.28% vitamin B6; - 0.1-2.0%, 0.15-1.0%, 0.20-0.5%, or about 0.35% vitamin B7, and / or - 0.00005 to 2.0%, 0.0001 to 1.0%, 0.0002 to 0.0004%, or about 0.0003% vitamin B12 (including any combination thereof); cvii. 0.1-2.0%, 0.2-1.0%, 0.4-0.7%, or about 0.55% zinc, e.g., zinc gluconate; cviii. 0.001-2.0%, 0.005-1.0%, 0.0075-0.015%, or about 0.01% selenium, e.g., L-selenomethionine; and cix. 25-90% of amino acids, such as one or more S-containing amino acids, e.g. - 5-30%, 10-25%, 14-18%, or about 16.7% L-methionine; - 10-50%, 15-40%, 20-30%, or about 25% L-cysteine, and / or - 10-50%, 20-40%, 26-32%, or about 28% L-Cystine (including any combination of these), and optionally cx. 5-60% of capsule-related ingredients, such as one or more of the following: - 5-30%, 6-20%, 8-14%, or about 11% rice bran extract - 5-30%, 8-35%, 15-20%, or about 17% capsule shells, and - optionally 0.1-2%, 0.15-1%, 0.2-0.4%, or about 0.3% of a colorant, such as TiO2.

[0211] In some embodiments, a supplement is provided that includes (by weight) the following: cvi.: - 0.5-5.0% Vitamin B5, - 0.1-2.0% Vitamin B6, - 0.1-2.0% Vitamin B7, and - Vitamin B12, from 0.00005 to 2.0 cvii. 0.1-2.0% zinc, e.g. zinc gluconate; cviii. 0.001-2.0% selenium, e.g., L-selenomethionine, and cix.: - 5-30% L-methionine, - 10-50% L-cysteine, and - 10-50% L-cystine, and optionally cx.: - 5-30% rice bran extract, - 5-30% capsule shells, and optionally - 0.1-2% colorant, e.g. TiO2.

[0212] Third aspect In accordance with the present invention, there is provided a method of providing a composition, such as a topical composition (e.g. a hair serum) according to the first aspect, said method comprising the acts (or steps) of: - Providing a mixture of alcohol and water by adding alcohol directly to water; - providing the desired ingredients in their respective amounts; - mixing and / or dissolving the above ingredients in the alcohol / water mixture, and optionally - Adjusting the pH, for example to 5-6, for example 5.5, using, for example, an organic acid and / or its salt, for example citric acid, for example citric acid monohydrate.

[0213] In some embodiments, mixing is provided using a rotor-stator homogenizer. Such devices include a rapidly spinning inner rotor and a fixed outer sheath (stator) to homogenize the sample by mechanical tearing, shear fluid forces, and / or cavitation.

[0214] In some embodiments, the viscosity of the composition is adjusted by adding one or more thickening agents, such as xanthan gum.

[0215] In some embodiments, the topical composition is formulated to a liquid to semi-liquid viscosity.

[0216] In some embodiments, the CBD is "Type A CBD." In many cases, the use of "Type A CBD" is preferred over "Type B CBD."

[0217] Fourth aspect In the third aspect, the present invention relates to a composition obtained or obtainable according to the method as provided herein.

[0218] Fifth aspect In the present invention, the present invention relates to a topically administered composition for use in treating a condition related to the hair, scalp, skin and / or nails of a subject, said treatment comprising topically applying a composition as disclosed herein, such as a CBD-containing composition according to the first or fourth aspect, to one or more of the skin, hair, scalp, nails and / or nail bed of the subject.

[0219] In some embodiments, the topical composition is formulated for application to the scalp.

[0220] In some embodiments, the topical composition is formulated as a hair serum.

[0221] In some embodiments, the hair serum is formulated for daily use, such as once or twice a day, preferably once a day. The above use or application will require about 4ml of hair serum per application. In some embodiments, the hair serum is formulated as about 1-10ml, 2-6ml, 3-5ml, or about 4ml per application. In some embodiments, the volume is 2ml, 3ml, 4ml, 5ml, 6ml, 7ml, 8ml, 9ml, 10ml, or more than 10ml per application. This can be achieved, for example, by adjusting the amount of solvent, such as alcohol / ethanol and water.

[0222] In general, the concentration of the components / ingredients of the hair serum disclosed herein is based on 4ml per application. In some embodiments, the dosage volume can be less than 4ml per application. In some embodiments, the dosage volume can be more than 4ml per application. In general, the use and / or application of a topical composition such as hair gel includes applying the composition to a dry, clean scalp, such as in stripes, such as about 1cm apart, focusing on the areas where thinning is most noticeable, preferably followed by some massage to aid in the application, uptake, and / or penetration of the active ingredients. Some formulations will be applied in volumes such as about 4ml per application.

[0223] In some embodiments, treatment of hair, scalp, skin, and / or nail-related conditions with a topically administered composition, such as a hair serum, may include the ingestion of a supplement, such as a supplement comprising one or more of a vitamin, an amino acid, zinc, and / or selenium. In some embodiments, the supplement comprises a vitamin, an amino acid, zinc, and / or selenium.

[0224] Thus, in some embodiments, the treatment of conditions related to hair, scalp, skin and / or nails comprises the use of a topical application as disclosed herein, such as the first or fourth aspect, in combination with the ingestion / use of an orally ingestible composition as disclosed herein, such as the second or sixth aspect of the invention.

[0225] Sixth Aspect In the present invention, the present invention relates to a composition for oral ingestion, such as a supplement, for use in treating a condition related to hair, skin, scalp and / or nails in a subject, said treatment comprising ingestion of a supplement as disclosed herein, such as in the second aspect.

[0226] In some embodiments, the treatment may also include topical application of a cannabinoid-containing composition to the hair, skin, scalp, and / or nails. In some embodiments, the cannabinoid in the topically administered composition is or comprises a physiologically active amount of CBD.

[0227] In some embodiments, the CBD-containing composition is a topically administered composition as disclosed herein, such as the first or fourth aspect.

[0228] In some embodiments, the CBD-containing composition is a hair serum.

[0229] Thus, in some embodiments, the treatment of conditions related to hair, scalp, skin and / or nails comprises the ingestion / use of an orally ingestible composition as disclosed herein, such as the second aspect, in combination with the use of a topical application as disclosed herein, such as the first, fourth or fifth aspect of the invention.

[0230] Seventh aspect In the present invention, the present invention relates to a method of treating a condition associated with hair, skin, scalp, and / or nails, said method comprising topically applying a composition, such as a topically administered composition as disclosed herein, such as the first, fourth, or fifth aspect, to one or more of the skin, hair, scalp, nails, nail bed of a subject, such as a human or animal.

[0231] In some embodiments, the treatment may include taking an oral dosage form, such as a supplement, which in some embodiments is a composition as disclosed herein, such as the second or sixth aspect.

[0232] In some embodiments, the treatment may include both treatment with a topically administered composition and ingestion of an oral dosage form.

[0233] In some embodiments, the subject suffers from a symptom, condition, or disease associated with and / or manifested by alpha-keratin-containing tissue, including one or more of the following: (i) weak nails, cracked nails, broken nails; (ii) weak hair, hair breakage, reduced hair stylability, split ends, reduced hair strength, reduced hair volume, hair loss, thinning hair (e.g., one or more of receding hairline, scalp baldness, thinning hair over the entire scalp), alopecia, alopecia areata, traction alopecia, telogen effluvium, anagen effluvium, baldness, male pattern baldness, female pattern baldness, hereditary baldness, and / or hereditary thinning hair; and / or (iii) dandruff, seborrheic dermatitis, psoriasis, itching, burning sensation, dryness, greasiness, rash. In some embodiments, the subject suffers from one or more of the conditions (i). In some embodiments, the subject suffers from one or more of the conditions (ii). In some embodiments, the subject suffers from one or more conditions (iii). In some embodiments, the subject suffers from a combination of one or more conditions (i) and one or more conditions (ii). In some embodiments, the subject suffers from a combination of one or more conditions (i) and one or more conditions (iii). In some embodiments, the subject suffers from a combination of one or more conditions (i) and one or more conditions (iii). In some embodiments, the subject suffers from a combination of one or more conditions (ii) and one or more conditions (iii). In some embodiments, the subject suffers from a combination of one or more conditions (i), one or more conditions (ii), and one or more conditions (iii).

[0234] In some embodiments, the subject is a male suffering from one or more of androgenetic alopecia, telogen effluvium, anagen effluvium, and / or traction alopecia.

[0235] In some embodiments, the subject is a female suffering from one or more of androgenetic alopecia, telogen effluvium, anagen effluvium, and / or traction alopecia.

[0236] In some embodiments, the topical composition is formulated as a hair serum.

[0237] In some embodiments, the treatment includes taking an oral dosage form, such as a supplement. Such a supplement may include one or more of vitamins, amino acids, zinc, and / or selenium. In some embodiments, the supplement includes vitamins, amino acids, zinc, and / or selenium.

[0238] Eighth aspect In the present invention, the present invention relates to a method of treating a condition associated with hair, skin, scalp, and / or nails, said method comprising the ingestion of an oral dosage form, such as a supplement as disclosed herein, such as the second or sixth aspect. Such treatment may further comprise applying a topical composition, such as a cannabinoid-containing composition, such as a CBD-containing composition as disclosed herein, such as the first, fourth, or fifth aspect, to said hair, skin, scalp, and / or nails. In some embodiments, the CBD-containing composition may be a hair serum.

[0239] Ninth aspect In the present invention, the present invention relates to one or more compositions and / or methods as disclosed herein, such as a CBD-containing composition for treatment according to the fifth aspect, an oral dosage form for treatment according to the sixth aspect, and / or a method according to the seventh or eighth aspect, wherein said treatment relates to alpha-keratin-containing tissue, such as one or more of hair treatment, skin treatment, and / or nail treatment. A more detailed list of symptoms / conditions / diseases that can be treated by the present invention is given elsewhere.

[0240] In summary, in some embodiments, the treatment relates to one or more of a hair treatment, a skin treatment, and / or a nail treatment.

[0241] In some embodiments, the hair treatment comprises a treatment for hair loss and / or thinning. In some embodiments, the treatment alleviates, reduces, stops, inhibits thinning and / or hair loss, and / or restores lost or weakened hair. In some embodiments, the hair loss or thinning is caused by or associated with one or more of androgenetic alopecia, telogen effluvium, anagen effluvium, and / or traction alopecia. In some embodiments, the subject is male or female.

[0242] In some embodiments, the treatment comprises a dosing regimen comprising applying 1-10 ml, 2-8 ml, 3-5 ml, or about 4 ml of a topically administered composition as disclosed herein, such as the first, fourth, or fifth aspect, to / onto / the scalp per application per day.

[0243] In some embodiments, the topical composition, such as a hair serum, is applied to the scalp in stripes, such as at intervals of 1 cm, massaging to aid penetration and optionally concentrating on areas where hair thinning is most noticeable.

[0244] In some embodiments, the topically administered composition, such as a hair serum, is used in a treatment that includes one or more cycles of 2-10 days, 3-7 days, 4-6 days, or 5 consecutive days of treatment followed by 1-7 days, 2-4 days, 2 days, or 3 days of no treatment.

[0245] In some embodiments, the topical composition, such as a hair serum, is used in a treatment that includes multiple cycles over a period of at least 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks, 16 weeks, 20 weeks or more.

[0246] In some embodiments, particularly with respect to treatments related to hereditary hair thinning and / or hereditary baldness, the treatment may include a treatment period of about 2 months followed by a period of 1-2 months off treatment. In some embodiments, the treatment may include treatment cycles as disclosed above, such as 8-10 cycles of 5 days of treatment followed by 1 or 2 months off treatment.

[0247] In the case of combination therapy, i.e., topically administered composition + supplement, in some embodiments, intake of the supplement is not stopped during periods of non-treatment / application of the topically administered composition, in some embodiments, both application of the topically administered composition and intake of the supplement are stopped during non-treatment periods.

[0248] In summary, treatments involving topically administered compositions and / or supplements as disclosed herein can result in one or more of the following: - Increased hair volume, - Reducing hair loss or eliminating hair loss, - Reduction of baldness, - Providing reduction or elimination of male and female pattern baldness; - Hair becomes thicker and stronger, - Thicker, healthier hair, - Improved overall hair condition, - making the hair appear more attractive or beautiful; - Increased hair shine, - Hair becomes softer, - Enhancing the vitality of one or more of the following: hair, skin and nails; - Improved hair styling, - Protects and / or reduces split ends, - Improved scalp condition, - Reducing or eliminating scalp itching, - Reducing or eliminating dry scalp, - Reduction or elimination of scalp rashes, - Reduce or eliminate scalp redness, - Reduce or eliminate dandruff, - Not cause irritation and / or stripping of sensitive skin on the scalp; for example, it is believed that high alcohol concentrations may irritate / disrupt / destabilize delicate skin / scalp. - Reducing or eliminating an oily feeling on the scalp, - A feeling of coolness in the head, - Elimination or reduction of burning sensation, - Improved scalp vitality, and / or - Improved scalp condition, - Improved nail strength, - Reduce or eliminate split nails, - Improve the appearance of your nails, - Improved appearance of the skin, - Improved nail and / or skin health, - Increased nail strength.

[0249] Tenth aspect In accordance with the present invention, the present invention relates to a container comprising a composition according to any one of the above aspects.

[0250] In some embodiments, the container provides protection from visible and / or UV light.

[0251] In some embodiments, the container comprises a topically administered composition as disclosed herein. In some embodiments, the topically administered composition is formulated as a hair serum.

[0252] In some embodiments, the container has a volume sufficient for one cycle of treatment, such as about 20 ml of hair serum.

[0253] In some embodiments, the container includes dosing and / or measuring means to provide an appropriate aliquot for one treatment (eg, an aliquot having a volume of about 4 ml).

[0254] In some embodiments, the container comprises a supplement as disclosed herein.

[0255] Eleventh aspectIn accordance with the tenth aspect, the present invention relates to a kit comprising one or more containers according to the tenth aspect, instructions for use, and optionally packaging. In some embodiments, the instructions for use may include the following information: "Apply the serum to dry, clean scalp in a single strip (1 cm apart), concentrating on the areas where thinning is most noticeable. Gently massage to aid penetration."

[0256] Thus, in some embodiments, the kit may include one or more containers containing the topically administered composition and one container containing the supplement.

[0257] Twelfth aspect In the present invention, the present invention relates to a CBD-containing composition, such as a topical composition, in which the CBD used in said formulation is crystalline. In some embodiments, the composition is a topical composition as disclosed herein and / or in the third and / or fourth aspects. In some embodiments, the CBD is or can form type A (needle-shaped crystals), such as disclosed in the first aspect and / or examples.

[0258] Thirteenth aspect In accordance with the present invention, the present invention relates to a dosing regimen comprising administering an orally administered supplement as disclosed herein in combination with a topical composition, in particular a CBD-containing topical composition as disclosed herein. In some embodiments, the CBD is "type A".

[0259] Hereinafter, the present invention will be described in more detail and specifically with reference to examples, but these examples are not intended to limit the present invention. EXAMPLES

[0260] In the context of the present invention, particularly here, "ingredients (%) in raw material" can also be understood as purity.

[0261] Example 1 - Provision of hair beauty serum A CBD-containing composition according to the invention can be provided using methods and / or expertise conventional in the art, for example as disclosed herein, such as in the third aspect of the invention and / or in particular in the examples below.

[0262] Example 2 - Hair Serum Formulation A hair serum formulation can be provided according to Example 1.

[0263] Adjust the pH to 5.5 using citric acid.

[0264] Percentages are by weight.

[0265] Generally, unless otherwise stated, crystalline CBD is supplied by Enecta.

[0266] [Table 2]

[0267] [Table 3]

[0268] [Table 4]

[0269] Example 3 - Provision of supplements (mini, complete, placebo) The supplements according to the invention are provided using routine methods and expertise in the art.

[0270] All supplements are formulated as capsules of approximately 720 mg with rice bran extract (up to 100% by weight) as the excipient and a capsule shell (approximately 17% by weight) containing hydroxypropyl methylcellulose as a glazing agent and TiO2 as a colorant. Maltodextrin is used in the placebo formulation.

[0271] Example 4 Supplement Formulation Supplement formulations are provided according to Example 3. Supplements 1-3 are formulated as a single dose / capsule per day, with one capsule providing the required daily dose of ingredients. Percentages are by weight.

[0272] [Table 5]

[0273] [Table 6]

[0274] [Table 7]

[0275] Example 5 - Application of hair serum Generally, hair serums are applied in the evening, aiming to use about 4 ml per application. Serums are usually applied to clean, dry scalp in strips spaced about 1 cm apart, concentrating on areas where thinning is most noticeable. Some gentle massaging may be used to aid distribution, penetration, and / or uptake of the active ingredients.

[0276] Example 6 - Taking supplements Generally, the supplement is taken in the morning, preferably in combination with breakfast and / or an intake of about 100 ml or more of fluid.

[0277] Example 7 - Combination Treatment (Supplement + Hair Serum) The combination treatment included taking the supplement in the morning and applying a hair serum in the evening according to Examples 6 and 5, respectively.

[0278] Example 8 - Study Setup Inclusion criteria for hair serum, hair supplement, and hair serum + hair supplement: 60 subjects, 50% female, 50% male, ages 25-55, all hair types Subjects with a Hamilton-Norwood score of 3, 3V, or 4 (for men) - Subjects with Ludwig scores of I2, I3, and I4 (for women)

[0279] Exclusion Criteria: -Subjects using any treatment in the test area During the study, women who are pregnant or breastfeeding, or who are planning to become pregnant Subjects with lesions in the test area (e.g., severe acne, scars) History of drug or sun sensitivity, recurrent skin diseases, or recent sunburn Use of local or systemic treatments in the past few weeks that may interfere with the evaluation of the tolerance of each test product (Regarding the exam area) Subjects who are enrolled in other exams during the exam period Subjects who are deemed by the investigator to be non-compliant with the protocol -Subjects who have used any anti-hair loss and hair growth enhancing products / supplements within one month prior to the study

[0280] The test results are shown in Table AJ of Examples 9-11 below.

[0281] Example 9 - Hair Serum Results

[0282] [Table 8]

[0283] [Table 9]

[0284] [Table 10]

[0285] Example 10 - Supplements

[0286] [Table 11]

[0287] [Table 12]

[0288] [Table 13]

[0289] Example 11 - Combination Therapy

[0290] [Table 14]

[0291] [Table 15]

[0292] [Table 16]

[0293] Example 12 - Providing CBD by alcohol extraction, distillation, and crystallization Crystalline CBD can be provided by methods and techniques known in the art, such as those disclosed in US10413845 and / or US10414709.

[0294] Briefly, crystalline CBD can be provided from hemp or cannabis (Cannabis sativa) by a method consisting essentially of: Hemp or cannabis is treated with a solvent selected from the group consisting of propanol, isopropanol, butanol, pentanol, hexanol, heptanol, and octanol. extractionto obtain an extract from extracted hemp or cannabis consisting essentially of tetrahydrocannabinol, terpenes, or cannabidiol; A part of the solvent of the above extract evaporation to produce an extract containing CBD and substantially free of solvent; The substantially solvent-free extract Distillation and isolating said CBD. The distilled and isolated CBD Crystallization to obtain crystallized and isolated CBD.

[0295] In many cases, crystallized and isolated CBD can be used as needed. Vacuum drying This is to remove volatile residues, especially the solvent used in the crystallization or recrystallization.

[0296] In particular, a method involving extraction with isopropanol and crystallization with heptane (with one or more optional recrystallization steps), followed by vacuum drying, can provide CBD of crystalline structure A, i.e., needle-like crystals. Moreover, such CBD can be very low in undesirable compounds such as terpenes.

[0297] GC chromatography or other analytical methods known in the art can be used to monitor the process, such as to ensure high yield and / or purity of the desired product.

[0298] As for the raw material, hemp, which contains 2-3% CBD or similar, is dried, crushed, and then extracted with isopropanol, such as food-grade isopropanol.

[0299] Guidance for choosing appropriate reactions based on the boiling points or ranges of various compounds can be found, for example, here: www.nwsci.com / customer / docs / SKUDocs / RMR / Technical%20Data Extractions 03.28.18.pdf is found in.

[0300] The CBD of crystal structure A is, for example, www.enecta.com and / or following extraction and / or purification protocols similar to those of the manufacturers listed above.

[0301] Example 13 - Comparison of hair serum compositions formulated with various crystalline CBD Two hair serum compositions are prepared according to Example 2, with the only difference being that the crystalline CBD used in the formulations is either Type A (needle-shaped crystals, FIG. 1) or Type B (tufts / clusters, FIG. 2).

[0302] Type A crystalline CBD is supplied by Enecta, while Type B CBD is supplied by Pharma Hemp.

[0303] Upon testing both hair serum compositions, it can be surprisingly and unexpectedly found and / or concluded that type A CBD is significantly more active than type B CBD.

Claims

1. i. Cannabidiol (CBD), ii. an alcohol, such as one or more low molecular weight alcohols, such as one or more C2-C4 alcohols, such as one or more of ethanol, propanol, butanol, isobutanol, and / or any combination thereof; iii. water, iv. Redensyl, which contains dihydroquercetin-glucoside, gallic acid epigallocatechin glucoside, glycine, zinc chloride, metabisulfite, and glycerin; v. C3-C8 diols, such as 1,5-pentanediol; vi. Capixyl, which contains butylene glycol, dextran, acetyl tetrapeptide-3, and red clover flower extract; and vii. Menthol The composition is formulated as a hair beauty serum for the scalp.

2. 2. The composition of claim 1, wherein the CBD used to provide the composition is crystalline, and the CBD crystals are needle-shaped crystals.

3. The CBD crystals are dissolved in isopropanol or other ３ -C ４ Extraction with alcohol and C such as heptane ６ -C ８ 3. The composition according to claim 1 or 2, which is provided by a process comprising one or more steps of crystallization with alcohol and / or vacuum drying.

4. The CBD used to provide the composition is provided in essentially pure form, e.g., in crystalline or powder form, and / or with a purity of at least 95%, 98%, 99%, 99.5%, or 99.9% or more; Optionally, the composition comprises one or more further cannabinoids, such as one or more hallucinogenic and / or non-hallucinogenic cannabinoids, such as one or more cannabinoids of the CBG type, CBC type, CBD type other than CBD, THC type, CBN type, CBE type, iso-THC type, CBL type, CBT type (including any combination thereof), THC (tetrahydrocannabinol), THCA (tetrahydrocannabinolic acid), CBDA (cannabidiolic acid), CBN (cannabinol), CBG (cannabigerol), CBD (cannabin ... It may or may not contain one or more cannabinoids selected from BC (cannabichromene), CBL (cannabicyclol), CBV (cannabivarin), THCC (tetrahydrocannabiolcol), THCV (tetrahydrocannabivarin), THCP (tetrahydrocannabiphorol), CBDV (cannabidivarin), CBCV (cannabichromevarin), CBGV (cannabigerovarin), CBGM (cannabigerol monomethyl ether), CBE (cannabielsoin), and CBT (cannabicitran); 3. A composition as claimed in claim 1 or 2, optionally wherein the further cannabinoid is provided in a physiologically active amount, and / or the further cannabinoid is present in an amount of less than 10%, less than 5%, less than 2%, less than 1%, less than 0.5%, or less than 0.1% by weight relative to the CBD, and / or wherein the ratio of CBD: further cannabinoid is >100:1, 100:1 to 50:1, 50:1 to 25:1, 25:1 to 10:1, 10:1, 10:1 to 5:1, 5:1 to 2:1, 2:1 to 1:1, 1:1 to 1:2, 1:2 to 1:5, or < 1:

5.

5. 3. The composition of claim 1 or 2, comprising less than 1.0% or less than 0.1% oil or fat.

6. The composition of claim 1, wherein the C 3 -C 8 diol is a pentanediol.

7. viii. Skin healing compounds, such as hyaluronic acid / hyaluronates; ix. caffeine, x. propylene glycol, xi. glycerin, xii. skin conditioning agents, emollients, and / or binding agents, such as isopropyl palmitate; xiii. triethanolamine, xiv. arginine, xv. Panthenol, xvi. Vitamins, such as vitamin B, e.g. vitamin B7 (biotin); xvii. a pH adjuster, such as citric acid monohydrate, and / or xviii. Thickeners, such as xanthan gum The composition of claim 1 or 2, further comprising one or more of:

8. The following (weight%): i. 0.001-2.0%, 0.05-0.5%, 0.075-0.2%, or about 0.1% CBD; ii. 10-60%, 30-55%, 40-50%, or about 30% alcohol, e.g., EtOH; iii. 30-70%, 35-60%, 40-55%, or about 45% water; iv. 0.5-6.0%, 1.0-5.0%, 2.0-4.0%, or about 3% Redensyl; v. 0.5-5.0%, 1.0-4.0%, 1.5-2.5%, or about 2% of a C3-C8 diol; vi. 0.1-2.0%, 0.2-1.0%, 0.4-0.8%, or about 0.57% Capixyl; vii. 0.1-2.0%, 0.2-1.0%, 0.4-0.8%, or about 0.6% menthol; viii. 0.01-2.0%, 0.1-1.5%, 0.85-1.15%, or about 0.95% of a skin healing compound, such as hyaluronic acid / hyaluronate; ix. 0.01-2.0%, 0.02-0.5%, 0.04-0.07%, or about 0.05% caffeine; x. 1.0-20%, 2-10%, 4-6%, or about 5.0% propylene glycol; xi. 1.0-20%, 2-15%, 5-8%, or about 6.5% glycerin; xii. 0.05-2.0%, 0.1-1.0%, 0.7-1.2%, or 0.9% of a humectant, emollient, and / or binder, such as isopropyl palmitate; xiii. 0.1-2.0%, 0.15-1.0%, 0.2-0.4%, or about 0.28% triethanolamine; xiv. 0.0001-1.0%, 0.0005-0.1%, 0.001-0.003%, or about 0.002% arginine; xv. 0.5-5.0%, 1.0-4.0%, 2.5-3.0%, or about 2.7% panthenol; xvi. 0.1-2.0%, 0.2-1.5%, 0.8-1.2%, or about 1.0% of a vitamin; xvii. 0.1-2.0%, 0.2-1.0%, 0.25-0.5%, or about 0.4% of a pH adjuster, and / or xviii. 0.1-2.0%, 0.15-1.0%, 0.15-0.4%, or about 0.25% of a thickening agent The composition of claim 1 or 2 comprising:

9. A method for providing a scalp hair beauty serum composition according to claim 1, comprising: a. providing a mixture of alcohol and water by adding alcohol directly to water; b. providing the desired ingredients in their respective amounts; c. mixing and / or dissolving the ingredients in the alcohol / water mixture, and optionally d. A process comprising adjusting the pH, for example to 5-6, for example 5.5, optionally said adjusting the pH comprises using an organic acid or a salt thereof, for example citric acid, in particular citric acid monohydrate.

10. 10. A composition obtained or obtainable according to the method of claim 9.

11. A topically administered composition as described in any one of claims 1, 2 and 10 for use in treating a condition related to the hair or scalp of a subject, said treatment comprising topically applying said composition to one or more of the hair and scalp of a subject, such as a human or animal.

12. The topical composition of claim 11, formulated as a scalp hair serum for use in treating hair loss or thinning, wherein the hair loss or thinning is Androgenetic alopecia, Telogen effluvium, Anagen effluvium, and / or traction alopecia A topically administered composition resulting from or associated with one or more of the following:

13. The treatment further comprises ingestion of a supplement for use in treating a hair, scalp related condition in the subject, e.g., a supplement comprising vitamins, amino acids, zinc, and selenium, e.g., a supplement formulated as an oral dosage form and optionally comprising one or more excipients, e.g., a supplement formulated as a capsule and optionally comprising an anticoagulant and / or flow agent, e.g., rice bran extract, and / or a capsule shell; The above supplements include, for example: i. a vitamin, such as one or more B vitamins, e.g., a) Vitamin B5 (pantothenic acid), b) Vitamin B6, c) Vitamin B7, and / or d) Vitamin B12 (including any combination thereof); ii. Zinc, e.g. zinc gluconate; iii. Selenium, e.g., L-selenomethionine, and iv. an amino acid, such as one or more S-containing amino acids, such as: e) L-methionine, f) L-cysteine, and / or g) L-cystine (including any combination thereof); Optionally, the supplement is formulated as an oral dosage form (e.g., a pill, tablet, or capsule) having a weight of 0.2-2.0 g, 0-4-1.5 g, 0.6-1.0 g, or about 0.72 g; 13. The scalp hair beauty serum of claim 12, wherein the oral dosage form is optionally formulated for a single administration per day.

14. One or more components at the following concentrations (by weight): i. 0.5-10% of a vitamin, such as one or more B vitamins, e.g., a) 0.5-5.0%, 0.8-3.0%, or 1.0-1.5%, or about 1.3% vitamin B5; b) 0.01-2.0%, 0.1-1.5%, 0.2-0.4%, or about 0.28% vitamin B6; c) 0.1-2.0%, 0.15-1.0%, 0.20-0.5%, or about 0.35% vitamin B7; and / or d) 0.00005-2.0%, 0.0001-1.0%, 0.0002-0.0004%, or about 0.0003% Vitamin B12 (including any combination thereof); ii. 0.1-2.0%, 0.2-1.0%, 0.4-0.7%, or about 0.55% zinc, e.g., zinc gluconate; iii. 0.001-2.0%, 0.005-1.0%, 0.0075-0.015%, or about 0.01% selenium, e.g., L-selenomethionine; and iv. 25-90% amino acids, such as one or more S-containing amino acids, e.g. e) 5-30%, 10-25%, 14-18%, or about 16.7% L-methionine; f) 10-50%, 15-40%, 20-30%, or about 25% L-cysteine, and / or g) 10-50%, 20-40%, 26-32%, or about 28% L-cystine (including any combination thereof); and optionally v. 5-60% capsule-related ingredients, such as one or more of the following: h) 5-30%, 6-20%, 8-14%, or about 11% rice bran extract; j) 5-30%, 8-35%, 15-20%, or about 17% of a capsule shell; and j) optionally 0.1-2%, 0.15-1%, 0.2-0.4%, or about 0.3% of a colorant, such as TiO ２ The hair beauty serum for the scalp according to claim 13, provided by:

15. The scalp hair beauty serum is applied to the scalp in an amount of 1 to 10 ml, 2 to 8 ml, 3 to 5 ml, or about 4 ml per day, for example in stripes spaced 1 cm apart, with massage to aid penetration, and / or the treatment comprises one or more cycles of 2-10 days, 3-7 days, 4-6 days, or 5 consecutive days of treatment followed by a period of 1-7 days, 2-4 days, 2 days, or 3 days of no treatment; 12. The scalp hair beauty serum according to claim 11, wherein the treatment optionally comprises a treatment period of about 2 months followed by a non-treatment period of 1 to 2 months, and in the case of treatment related to hereditary hair loss and / or hereditary baldness, comprises 8 to 10 treatment cycles consisting of 5 days of treatment + 2 days of non-treatment.

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