Novel composition for improving hair and scalp condition

Abstract

An anti-inflammatory and detoxifying composition comprising an Anetrea anisita extract for improving the condition of hair and scalp is provided.

Description

[Technical field]

[0001] [Status of related applications] This application claims priority to European Patent Application No. 22305603.7, filed April 22, 2022, the contents of which are incorporated by reference as if set forth in their entirety. [Background technology]

[0002] An unhealthy scalp shares several common symptoms, such as dandruff, itching, irritation, bumps on the scalp, oily hair and / or scalp, dull and unhealthy hair, or a combination thereof. Pityriasis capitis, commonly known as dandruff, is the most widespread and most underdiagnosed scalp disease in the entire world. A healthy stratum corneum of the scalp forms a protective barrier that protects against external stimuli. However, a weakened stratum corneum can promote the development of dandruff and dull and oily hair. Evidence of a destroyed stratum corneum includes subclinical inflammation and high sensitivity to local stimuli. Therefore, targeting inflammation of the stratum corneum can improve hair and scalp conditions, such as dandruff.

[0003] Synthetic anti-inflammatory drugs used in anti-dandruff treatments are generally aggressive and can be associated with significant side effects.For example, ketoconazole can cause additional skin inflammation, itching and skin irritation.Another commonly used drug, pyrithione zinc, can cause skin peeling and a tingling and / or burning sensation on the scalp.

[0004] Moreover, dandruff is a condition that requires long-term and regular treatment, so minimizing the risk of systemic adverse effects and the like is particularly important.

[0005] To meet such demands, the industry has expended considerable effort in exploring and developing new plant-derived therapeutic solutions that are generally less aggressive and safer than synthetic pharmaceuticals to prevent, treat or reduce inflammation and improve hair and scalp condition. Summary of the Invention [Problem to be solved by the invention]

[0006] The present invention provides novel compositions for preventing, treating or reducing inflammation, providing anti-inflammatory and cell regeneration, and methods of their use. More specifically, the present invention is directed to anti-inflammatory and anti-inflammatory compositions comprising Anetholea anisita extract and its unexpected cell type selective properties and advantageous uses in improving hair condition and scalp condition. [Means for solving the problem]

[0007] In one embodiment, the present invention is directed to a composition comprising an effective amount of Anetrea anisita extract, the composition preventing, treating or reducing inflammation, providing anti-inflammatory and cell regeneration, and improving the condition of hair and scalp.

[0008] In another embodiment, the present invention is directed to a composition comprising an effective amount of Anetrea anisita extract, wherein the composition prevents, treats or reduces inflammation in human hair papilla cells or human dermal fibroblast cells.

[0009] In another embodiment, the present invention is directed to a composition comprising an effective amount of an extract of Anetrea anisita, wherein the composition prevents, treats or reduces inflammation in human dermal papilla cells.

[0010] In another embodiment, the present invention is directed to a method of preventing, treating or reducing inflammation, providing anti-inflammatory and cell regeneration, or improving the condition of hair and scalp comprising applying an effective amount of an Anetrea anisita extract-containing composition to the scalp or skin of a subject in need thereof.

[0011] In another embodiment, the present invention is directed to a method for preventing, treating or reducing inflammation, providing anti-inflammatory and cell regeneration, or improving hair and scalp condition comprising applying an effective amount of an Anetrea anisita extract-containing composition to the scalp of a subject in need thereof.

[0012] In another embodiment, the present invention is directed to a method for improving hair or scalp condition, comprising applying an effective amount of an Anetrea anisita extract-containing composition to the scalp of a subject in need thereof.

[0013] In another embodiment, the present invention is directed to a consumer product comprising an effective amount of an extract of Anetrea anisita, wherein the extract of Anetrea anisita provides anti-inflammatory and anti-inflammatory properties.

[0014] In another embodiment, the present invention is directed to a hair and scalp care or skin care product comprising an effective amount of Anetrea anisita extract, which provides anti-inflammatory and anti-inflammatory properties.

[0015] In another embodiment, the present invention is directed to hair and scalp care products comprising an effective amount of Anetrea anisita extract, which provides anti-inflammatory and anti-inflammatory properties.

[0016] These and other embodiments of the invention will be apparent from a reading of the following specification. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] Anetrea anisita is a plant native to Australia and belongs to the Myrtaceae family. Due to its flavor and aroma, it is commercially produced and incorporated into Australian cuisine. Some compounds of Anetrea anisita also have health-promoting properties, such as antioxidant, estrogenic and / or antiestrogenic activity, anti-inflammatory, antibacterial, and prebiotic activity. However, such properties may differ depending on the respective cellular target, and therefore the action differs for each cell and tissue type. For example, in macrophages, Anetrea anisita extract has been shown to provide a dose-dependent inhibition of protein expression of COX-2 and, to a lesser extent, iNOS (Guo et al., Toxicology Reports (2014), 1: 385-390).

[0018] In the present invention, it has now been discovered for the first time that Anetrea anisita extract has a beneficial anti-inflammatory effect on human hair follicle papilla cells (HFDPC) and human dermal fibroblast (NHDF) cells. In particular, the anti-inflammatory effect on human hair follicle cells is surprisingly excellent. Special pro-resolution lipid mediators (SPMs) are a type of lipid mediators recently identified that suppress inflammatory processes in the skin, preventing the development of chronic inflammation and restoring tissue homeostasis. The inventors have confirmed for the first time the presence of SPMs in the scalp, and further demonstrated the anti-inflammatory effect of Anetrea anisita extract on the scalp. Anetrea anisita extract strengthens the scalp barrier, increases hair shine, reduces dandruff, and reduces the volume of sebaceous glands and the secretion of sebum. Thus, the present invention provides a cell type and tissue selective anti-inflammatory and anti-inflammatory composition comprising Anetrea anisita extract with unexpected and advantageous properties that improve the condition of the hair and scalp.

[0019] The term "hair condition and scalp condition" according to the present invention is understood to mean dandruff, scalp itching, scalp irritation, bumps on the scalp, greasy hair and / or scalp, dull and unhealthy hair, or combinations thereof.

[0020] The term "skin condition" according to the present invention is understood to mean skin inflammation, redness, sensitivity, irritation, itchiness, oily skin with or without acne tendency, imperfections, dull skin, or combinations thereof.

[0021] In the present application, the Anetrea anisita extract is an extract obtained from the aerial parts of the plant Anetrea anisita, such as the leaves, flowers, stems or combinations thereof, either fresh or dried. In one embodiment, the Anetrea anisita extract is an extract obtained from the leaves.

[0022] In another embodiment, the Anetrea anisita material is pretreated by a process such as freezing, drying, lyophilization, grinding or a combination thereof. In another embodiment, the pretreatment of the Anetrea anisita material includes a grinding process.

[0023] Suitable extraction methods to provide concentrated extracts are known to those skilled in the art and may include, for example, but are not limited to, decoction, steeping, maceration, percolation and percolation. In one embodiment, thermal extraction, such as decoction, is carried out in water or a hydroalcoholic mixture. In the present invention, decoction is understood to mean boiling plant material in water for a certain period of time to obtain a plant extract.

[0024] The extraction can be carried out with a polar solvent such as water, alcohol, ester, ketone or mixtures thereof. Alcohols include, for example, polyols such as, but not limited to, methanol, ethanol, n-propanol, isopropanol, and glycerol. Esters include, for example, but not limited to, propyl acetate, isopropyl acetate, butyl acetate, sec-butyl acetate, isobutyl acetate, and tert-butyl acetate. Ketones include, for example, but not limited to, acetone, cyclohexanone, and methyl ethyl ketone. In one embodiment, the solvent is water, alcohol, or an aqueous alcohol mixture such as a water / ethanol mixture, a water / methanol mixture, or a water / glycerol mixture. In another embodiment, the solvent is water.

[0025] In one embodiment, the Anetrea anisita extract is an aqueous extract. At the end of extraction, the aqueous Anetrea anisita extract is collected by removing solid residues using centrifugation and / or filtration.The aqueous extract can then be further formulated with (i) pH adjusters, stabilizers, or cosmetically acceptable vehicles or carriers; (ii) concentrated; and / or (iii) dried.

[0026] The Anetrea anisita extract of the present invention has a dry matter content of about 0.01% or more, preferably about 0.02% to about 50%, more preferably about 0.05% to about 10%, and even more preferably about 0.1% to about 5%. Percentages (%) are by weight unless otherwise specified.

[0027] The term "aqueous extract" is understood to mean an aqueous preparation of Anetrea anisita extract according to the present disclosure.

[0028] The terms "a" or "an" are understood to mean one or more.

[0029] The term "effective amount" is understood to mean the amount of Anetrea anisita extract used in which the Anetrea anisita extract prevents, treats or reduces inflammation of the scalp or skin, provides anti-inflammatory and cell regeneration of the scalp or skin, or improves hair and scalp conditions. More specifically, in the present invention, an effective amount of Anetrea anisita extract provides improvement in hair and scalp conditions such as dandruff, scalp itching, scalp irritation, bumps on the scalp, greasy hair and / or scalp, dull and unhealthy hair, or combinations thereof.

[0030] The effective amount may vary depending on many factors, such as the severity and duration of symptoms. Any amount and duration of treatment with Anetrea anisita extract that provides any degree of improvement in hair condition and scalp condition may be used.

[0031] In certain embodiments, the effective amount of Anetrea anisita extract ranges from about 0.01 to about 20% by weight, preferably from about 0.05 to about 10% by weight, and more preferably from about 0.1 to about 5% by weight.

[0032] The term "consumer composition" is understood to mean a composition containing Anetrea anisita extract, which prevents, treats, or reduces inflammation, provides anti-inflammatory and cell regeneration to the scalp or skin, or improves hair condition and scalp condition. The consumer composition of the present invention may contain Anetrea anisita extract in an amount of about 10 to about 50% by weight of the consumer composition, preferably about 20 to 40% by weight. Additional materials may be used with the consumer composition to encapsulate and / or deliver anti-inflammatory and anti-inflammatory effects. Some well-known materials include, for example, but are not limited to, polymers, oligomers, other non-polymers such as surfactants, emulsifiers, lipids such as fats, waxes, and phospholipids, organic oils, mineral oils, petrolatum, natural oils, perfume fixatives, fibers, starches, sugars, and solid surface materials such as zeolites and silicas. Some preferred polymers include polyacrylates, polyureas, polyurethanes, polyacrylamides, polyesters, polyethers, polyamides, poly(acrylate-co-acrylamide), starch, silica, gelatin and gum arabic, alginates, chitosan, polylactides, poly(melamine-formaldehyde), poly(urea-formaldehyde), or combinations thereof.

[0033] The term "consumer product" is understood to mean a product containing Anetrea anisita extract, which has anti-inflammatory and anti-inflammatory properties that prevent, treat or reduce inflammation, or provide anti-inflammatory and cell regeneration. Consumer products of the present invention include, for example, but are not limited to, bar soaps, liquid soaps, shower gels, bath foams, toners, lotions, creams, milks, serums, ointments, balms, salves, gels, cream gels, emulsions, foams, sprays, eye shadows, sticks, lipsticks, glosses, fams, deodorants, nourishing masks, exfoliating products, and hair or scalp care products. Hair or scalp care products of the present invention include, for example, but are not limited to, shampoos, hair rinses, conditioners, hair bleaches, hair colorants, hair dyes, and hair styling products.

[0034] The following is provided as a specific embodiment of the present invention. Other modifications of the present invention are easily apparent to those skilled in the art. Such modifications are understood to be within the scope of the present invention. Materials were purchased from Aldrich Chemical Company unless otherwise specified. All percentages used herein are mass percent unless otherwise specified, L is understood to mean liters, mL is understood to mean milliliters, g is understood to mean grams, ng is understood to mean nanograms, M is understood to mean moles, and μM is understood to mean micromoles. IFF used in the examples is understood to mean International Flavors & Fragrances Inc., New York, NY, USA. EXAMPLES

[0035] Example I: Preparation of Test Samples An aqueous Anetrea anisita extract was prepared by decoction from Anetrea anisita leaves according to methods known in the art, such as WO2018 / 073714A1, after which glycerol was added to the aqueous extract to provide a hydroalcoholic mixture with a mass ratio of glycerol to aqueous extract of 70:30. The obtained Anetrea anisita extract had a dry matter content of about 1%.

[0036] Example II: Inhibition of Interleukin-8 (IL-8) Production IL-8 is a potent neutrophil chemoattractant. Increased expression of IL-8 is associated with inflammatory processes. The effect of Anetrea anisita extract (prepared in Example I) on the production of IL-8 was evaluated in human hair papilla cells and human dermal fibroblasts. Here, IL-8 production was induced by the addition of IL-1α.

[0037] Cell Culture and Treatment: Human hair follicle papilla cells (HFDPC) (Promocell) and human dermal fibroblast (NHDF) cells (Promocell) were cultured according to standard procedures. Cells were treated with IL-1α (0.002ng / mL) and incubated for 24 hours in the presence of various concentrations of Anetrea anisita extract. Cells that were not treated with anything ("Untreated") or treated with IL-1α but without Anetrea anisita extract ("Control") served as control samples.

[0038] Cell viability measurement: After the end of the incubation, cell viability measurement was performed using CellTiter 96® AQueous MTS reagent powder (Promega) to determine the cytotoxic effect of Anetrea anisita extract, if applicable. No significant difference in cell viability was observed between samples treated with Anetrea anisita extract and control samples. Therefore, Anetrea anisita extract does not show cytotoxic effect on human hair papilla cells and human skin fibroblast cells.

[0039] IL-8 production: IL-8 levels were quantified using ELISA (Enzyme-Linked Immunosorbent Assay). Absorbance was measured and IL-8 level scores were reported as a percentage of absorbance values ​​of treated samples relative to control samples. The mean IL-8 score results are reported as follows:

[0040] [Table 1] All treated samples ("Anetolea anicita extract") showed significant differences (p<0.001) compared to the control sample ("Control").

[0041] Anetrea anisita extract significantly reduced IL-8 levels in both HFDPC and NHDF cells (p<0.001, Student's paired t-test). Furthermore, the inhibition of IL-8 production was surprisingly superior in HFDPC. Thus, the anti-inflammatory effect of Anetrea anisita extract is cell type selective. Such a finding is unexpected.

[0042] Example III: Inhibition of Reactive Oxygen Species (ROS) Production Reactive oxygen species (ROS) are produced by cells involved in host defense responses. ROS act as both signaling molecules and mediators of inflammation. The effect of Anetrea anisita extract (prepared in Example I) on ROS production was evaluated in human dermal papilla cells, and ROS production was induced by the addition of pyocyanin.

[0043] Cell Culture and Treatment: Human dermal papilla cells were cultured according to standard procedures. Cells were treated with Anetrea anisita extract (prepared in Example I) for 30 minutes, after which pyocyanin (Sigma-Aldrich Corp.) was added at 100 μM. Cells were incubated for an additional 2 hours. Cells without Anetrea anisita extract ("Control") served as a control sample.

[0044] ROS production: ROS production was measured using fluorescent staining followed by quantitative analysis. The scores of ROS production are expressed as a percentage of the fluorescence intensity of the control sample. The results of the average scores of ROS production are reported as follows:

[0045] [Table 2] All treated samples ("Anetolea anicita extract") showed significant differences (p<0.001) compared to the control sample ("Control").

[0046] Anetrea anisita extract significantly reduced ROS production in HFDPCs (p<0.001, Student's paired t-test).

[0047] Example IV: Reduction of Sebaceous Gland Volume in an In Vitro Study Sebaceous glands are responsible for sebum secretion. Excessive secretion of sebum can lead to inflammation. In the present invention, the effect of Anetrea anisita extract on the size of sebaceous glands was studied in vitro.

[0048] Scalp explants and treatments: Human scalp explants were established and maintained according to methods known to those skilled in the art, for example, WO2020 / 157428A1. On days 0, 2, 5 and 7, Anetrea anisita extract (2%, prepared in Example I) and placebo (glycerin) were applied topically to each scalp explant, respectively. On days 0 ("control") and 8, scalp explant samples of each treatment were taken and fixed by formol method.

[0049] Sebaceous gland volume: Sebaceous gland volume was measured using X-ray microtomography according to methods known to those skilled in the art (Bailly et al., Sci Rep. (2018), 8(1): 14003). The results of the average lobe volume per gland are reported below.

[0050] [Table 3] The treated sample ("Anetolea anicita extract") showed significant differences (p<0.01) compared to the control sample ("Control").

[0051] Anetrea anisita extract significantly reduced the volume / size of sebaceous glands in an in vitro study (p<0.01, Student's paired t-test).

[0052] Example V: Effects on the production of additional inflammation associated with proteins Prostaglandin E2 (PGE2) is a potent inflammatory mediator. Leukotriene B4 (LTB4) is a leukotriene involved in inflammation. The in vivo effect of Anetrea anisita extract (prepared in Example I) on the amount of IL-1α, IL-8, PGE2, LTB4 and special pro-resolving lipid mediators (SPMs) including lipoxin B4 (LXB4), resolvin D1 (RvD1) and resolvin D2 (RvD2) was evaluated.

[0053] Preparation of test samples: To evaluate the effectiveness of Anetrea anisita extract on the production of SPMs including IL-1α, IL-8, PGE2, LTB4, and lipoxin B4 (LXB4), resolvin D1 (RvD1) and resolvin D2 (RvD2), shampoos containing Anetrea anisita extract (prepared in Example I) were prepared at 2% based on the inventor's proprietary formula. In the control sample, a placebo of a mixture of glycerin and water in a weight ratio of 70:30 was used in place of Anetrea anisita extract.

[0054] Test procedure: 40 volunteers aged 18-40 years with oily hair and dandruff were divided into two groups of 20 people, a treatment group treated with shampoo containing Anetrea anisita extract every other day, or a control group treated with shampoo containing placebo every other day. Treatment continued for 28 days. On the 28th day, sebum was collected from the placebo group and the Anetrea anisita group.

[0055] Sebum samples and protein quantification: Sebum samples were taken from scalps treated with Anetrea anisita extract or placebo for 28 days. Samples were processed and the above mentioned proteins were quantified by methods known to those skilled in the art, for example, Le Faouder P. et al., J Chromatogr B Analyt Technol Biomed Life Sci. (2013), 922: 123-133. Protein quantity scores are reported as percentages of treated samples to control samples, respectively. Results are reported as follows:

[0056] [Table 4] Anetrea anisita extract significantly reduced the production of inflammatory proteins including IL-1α, IL-8, PGE2, and LTB4, but increased the production of SPMs including lipoxin B4 (LXB4), resolvin D1 (RvD1), and resolvin D2 (RvD2).

[0057] Example VI: Improvement of hair and scalp condition An unhealthy scalp may exhibit various abnormal biophysical properties such as scalp pH imbalance, increased transepidermal water loss (TEWL), increased sebum secretion, dandruff condition and loss of hair luster, etc. The effect of Anetrea anisita extract (prepared in Example I) on these biophysical properties of hair and scalp was evaluated.

[0058] The test samples and test procedures were the same as those described in Example V. Parameters were measured according to methods known to those skilled in the art and include (i) pH (Liu et al., J Cosmet Dermatol. (2022), 00: 1-10); (ii) transepidermal water loss (Khosrowpour et al., J Cosmet Dermatol. (2019) 18: 857-861); (iii) sebum content (Rajaiah Yogesh H. et al., J Cosmet Dermatol. (2021), 00: 1-10); (iv) presence of dandruff (Cavusoglu et al., Arch Dermatol Res. (2016) 308: 631-642); and (v) hair gloss (Li et al., Sci. Reports, (2017) 7: 18046). Measurements are reported as a percentage of the day 28 treated sample relative to the day 0 sample or the day 28 placebo sample, respectively.

[0059] Results for day 28 treated samples vs. day 0 treated samples are reported below.

[0060] [Table 5] The treated sample ("Anetolea anicita extract") showed significant differences (*p<0.05; **p<0.01; ***p<0.001; ****p<0.0001) when compared to the control sample ("Control").

[0061] The results for treated samples on day 28 vs. placebo samples on day 28 are reported below.

[0062] [Table 6] The treated sample ("Anetolea anicita extract") showed significant differences (*p<0.05; **p<0.01; ***p<0.001; ****p<0.0001) when compared to the placebo sample.

Claims

1. An anti-inflammatory and soothing composition containing an extract of Anetholea anisita.

2. The composition according to claim 1, wherein the Anetrea anisita extract is present in an amount of about 10 to about 50% by mass relative to the composition.

3. The composition according to claim 1, wherein the Anetrea anisita extract is present in an amount of about 20 to about 40% by mass relative to the composition.

4. The composition according to claim 1, which prevents, treats, or reduces inflammation of cells selected from the group consisting of human dermal papilla cells and human dermal fibroblasts.

5. The composition according to claim 4, wherein the cells are human dermal papilla cells.

6. The composition according to claim 4, wherein the cells are human dermal fibroblasts.

7. The composition according to claim 1, wherein the Anetrea anisita extract is an aqueous extract.

8. A composition according to claim 1 for use in a method for preventing, treating or reducing inflammation, providing anti-inflammatory and cell regeneration, or improving the condition of hair and scalp, wherein the method comprises the step of applying the anti-inflammatory and anti-inflammatory composition to the scalp or skin of a subject requiring it.

9. The composition according to claim 8, comprising the step of applying the composition to the scalp of a person requiring it.

10. The composition according to claim 8, wherein the Anetrea anisita extract is present in an amount of about 10 to about 50% by mass relative to the composition.

11. The composition according to claim 8, wherein the Anetrea anisita extract is present in an amount of about 20 to about 40% by mass relative to the composition.

12. The composition according to claim 8, which improves the condition of the hair or scalp.

13. The composition according to claim 8, which improves the condition of the skin.

14. A consumer product comprising an effective amount of Anetrea anisita extract, wherein the Anetrea anisita extract provides anti-inflammatory and soothing properties.

15. The consumer product according to claim 14, wherein the effective amount is about 0.01 to about 20% by mass of the consumer product.

16. The consumer product according to claim 14, wherein the effective amount is about 0.05 to about 10% by mass of the consumer product.

17. The consumer product according to claim 14, wherein the effective amount is about 0.1 to about 5% by mass of the consumer product.

18. A consumer product according to claim 14, selected from the group consisting of solid soap, liquid soap, shower gel, bath foam, lotion, cream, milk, serum, ointment, balm, salve, gel, cream gel, emulsion, foam, spray, eyeshadow, stick, lipstick, gloss, fem, deodorant, nourishing mask, exfoliating product, and hair or scalp care product.

19. The consumer product according to claim 18, wherein the care product for hair or scalp is selected from the group consisting of shampoo, hair rinse, conditioner, hair bleach, hair colorant, hair dye, and hair styling product.

20. A composition for the treatment or prevention of hair and scalp conditions selected from dandruff, itchy scalp, scalp irritation, scalp bumps, oily hair and / or scalp, and combinations thereof, comprising an extract of Anetholea anisita.

21. The composition according to claim 20, wherein the Anetrea anisita extract is an aqueous extract.

22. The composition according to claim 20, wherein the Anetrea anisita extract provides anti-inflammatory and soothing properties.

23. The composition according to any one of claims 20 to 22, wherein the composition is a hair or scalp care product selected from the group consisting of shampoo, hair rinse, conditioner, hair bleach, hair colorant, hair dye, and hair styling product.