Formulation of natural oils for hair growth promotion and hair loss decrease

Abstract

The present invention relates to a hair oil composition comprising natural oils only, wherein the natural oils are selected from the group comprising seed oils, fruit oils, nut oils, and plant leaf oils, the composition comprising: a mixture of Kakadu plum oil, pumpkin seed oil, avocado fruit oil, caiaue oil, and rosemary oil, and at least one natural anti-androgen. Furthermore, the invention relates to use of said composition and to a method for treating hair loss diseases.

Description

FORMULATION OF NATURAL OILS FOR HAIR GROWTH PROMOTION AND HAIR LOSS DECREASETechnical Field

[0001] The present invention relates to hair oil compositions comprising natural oils only, such as selected from the group comprising seed oils, fruit oils, nut oils, and plant leaf oils. Furthermore, the invention relates to different applications of the hair oil compositions.Background Art

[0002] Hair loss, commonly referred to as alopecia, is a common occurrence in men and women. Androgenetic alopecia, or androgenic alopecia, both refer to the condition readily known as male pattern baldness or female pattern hair loss. Male pattern baldness is a common condition of hair loss in aging men. Each hair has a hair shaft, i.e. , the visible part of the hair protruding out of the skin, and a hair root. The hair root is in the skin and extends down to the deeper skin layers. The hair root is surrounded by the hair follicle, a layer of skin and connective tissue, which is also connected to a sebaceous gland. The hair follicle naturally cycles between growth phase (anagen phase) and rest phase (telogen phase). Hair growth rate and hair density decrease with age, and hair loss can occur if the hairs shed, and the hair follicle stem cells remain in the rest phase.

[0003] A wide range of methods for treating hair loss and hair thinning are available today. Platelet-rich plasma (PRP) injections is a treatment strategy wherein a concentrate of platelet-rich plasma protein derived from whole blood, centrifuged to remove red blood cells, is injected into the scalp via micro injections. Although PRP is considered a safe treatment method with minimal side effects, people with critical thrombocytopenia i.e., low blood platelet count, platelet dysfunction, or with a medical condition that could worsen or spread with injections such as an active infection, are not eligible for such treatment. Moreover, the treatment may be perceived as painful or highly uncomfortable. The effectiveness of stimulating tissue regeneration depends on factors such as the concentration of platelets injected during the procedure, and platelet function. Thus, the achieved effect from PRP is variable,potentially requiring several costly treatments and a long time before results are obtained. If successful, maintenance treatments will be required to sustain the effect.

[0004] Alternative treatment options are available, offering non-invasive strategies to reduce hair loss and promote hair growth. Minoxidil (Rogaine®) is available in serum or tablet form and has shown effect in men and women. Despite demonstrated effect, it may take up to 4-6 months of continuous usage before significant improvement of hair growth is noticeable and the product is most effective if the subject is under age 40 and hair loss has only recently started. Moreover, undesirable side effects such as skin irritation may result in discontinuation of the treatment. Other products advertising natural ingredients only, contains alcohol which has a drying effect on the skin, often causing skin itching and irritation (Bio-Pilixin®). A range of products are advertised online containing a mixture of natural oils and potentially synthetic ingredients, and typically directed to men (Primal - black jamaican castor oil & rosemary oil hair growth serum, 2022, Wolfmen Skin). The demand for complementary therapies which are perceived as more natural compared to conventional treatments for hair loss using chemicals is increasing.

[0005] There is hence a need for improved non-invasive strategies to reduce hair loss and promote hair growth.Summary of invention

[0006] In one aspect, the invention provides a hair oil composition comprising natural oils only, wherein the natural oils are selected from the group comprising seed oils, fruit oils, nut oils, and plant leaf oils, or combinations thereof, the composition comprising: a mixture of the oils Kakadu plum oil, pumpkin seed oil, avocado fruit oil, caiaue oil, and rosemary oil, and at least one natural anti-androgen.

[0007] In another aspect, the invention relates to use of the hair oil composition according to the first aspect for preventing hair loss and / or promoting hair growth, the use comprises a step of topical application of said composition on the area affected by hair loss.

[0008] In another aspect, the invention provides a hair oil composition for use in treatment of hair loss diseases.Description of figures

[0009] Figure 1 shows effect on new hair growth for a male test subject affected by androgenetic alopecia or male pattern baldness on his head crown for over 20 years, before start of treatment (A), after using the hair oil composition for 8 weeks (B), 12 weeks (C), and 20 weeks (D), ref. Example 2.

[0010] Figure 2 shows effect on hair fibre thickness and new hair growth for a male test subject with male pattern baldness, before start of treatment (A), and after 4 weeks of using the hair oil composition (B). Enlarged image of the bald spot prior to using the hair oil composition of the present invention (C) and the same area after 16 weeks (D). Enlarged image of the rightmost section of the bald spot prior to starting using the hair oil composition (E), and at 16 weeks of using the hair oil composition (F), ref. Example 2.

[0011] Figure 3 shows effect of use of the hair oil composition in a female test subject affected by chronic alopecia areata, before start of treatment (A), demonstrating new hair growth after 4 weeks (B), and after 8 weeks (C), ref. Example 2.

[0012] Figure 4 shows effect on hair growth in cohort-level data from cohort 1 and cohort 2 (n=14) at timepoints week 0, week 4, week 12, and week 20 measured by HairMetrix®. Data presented as absolute total hair count per cm2(A), mean change from baseline total hair count per cm2(B), and mean percent change from baseline total hair count per cm2, p-value based on two-tailed paired student’s t test. (C). Error bars are represented by ±SEM.

[0013] Figure 5 shows effect on hair growth in cohort-level data from cohorts 1-4 (n=30) at timepoints week 0, week 4, and week 12 measured by HairMetrix®. Data presented as absolute total hair count per cm2(A), mean change from baseline totalhair count per cm2(B), and mean percent change from baseline total hair count per cm2(C). p-values are based on two-tailed paired student’s t test, error bars are represented by ±SEM.Detailed description of the invention

[0014] The invention is directed to hair oil compositions, wherein the hair oil compositions comprise natural oils only. By natural oils only it is hereby referred to oils derived from naturally occurring oils selected from the group comprising seed oils, fruit oils, nut oils, and plant leaf oils. The applicant has developed a composition of natural oils comprising oils rich in nutrients such as fatty acids and vitamins, compounds which may interfere with hormonal pathways associated with hair loss, and compounds which improve blood circulation to the scalp. The natural oils comprised in the hair oil composition work in synergy to reduce hair loss, improve scalp health, support hair follicle health, and stimulate hair growth. The presence of natural antioxidants stabilizes the hair oil composition, enhancing its stability without the need for synthetic chemicals.

[0015] Hair loss, commonly referred to as alopecia, is a common occurrence in both men and women. Male pattern baldness, androgenetic alopecia, is a common condition of hair loss in aging men. The condition can also occur in women and is then commonly referred to as female pattern hair loss. Contributing causes to androgenic alopecia include androgenic sex hormones, particularly dihydrotestosterone (DHT), which cause hair follicles to miniaturize. Miniaturization of hair follicles leads to a shortened hair growth period, resulting in progressive hair thinning and hair loss. Another hair loss condition is alopecia areata, an autoimmune disease affecting hair follicles located typically on the head and face. Alopecia areata affects both men and women, and the hair loss pattern may vary depending on the disease subtype. The underlying disease mechanisms of alopecia areata remain to be elucidated.

[0016] The invention is directed to a hair oil composition, particularly a hair follicle revitalising composition. The hair oil composition consists of natural oils only. The natural oil sources are selected from natural oil sources, such as from vegetable oil sources. In one embodiment, the natural oil sources are selected from the groupcomprising seed oils, fruit oils, nut oils, and plant leaf oils, or combinations thereof. In one embodiment, the hair oil composition consists of a blend of natural oils only, selected from seed oils, fruit oils, nut oils, and plant leaf oils.

[0017] Furthermore, the natural oil sources may be selected from vegetable oil sources, such as from seed oils such as mamey sapote oil, Kakadu plum oil, harakeke seed oil, pumpkin seed oil, and sesame seed oil, fruit oils such as ungurahui oil, avocado fruit oil, amla fruit oil, nut oils such as caiaue oil, and plant leaf oils such as bhringraj oil, rosemary oil, and peppermint oil. Preferably, the hair oil composition comprises the natural oils Kakadu plum oil, pumpkin seed oil, avocado fruit oil, caiaue oil, and rosemary oil.

[0018] The main physical property of vegetable oils is the hydrophobicity of such oils, wherein the oil composition and structure will affect the properties and subsequent functions such as the ability to diffuse into the hair. For instance, unsaturated fatty acids, such as omega-3 and omega-6 fatty acids, enable maintenance of the lipid barrier of the scalp thus reducing dryness and flakiness. Saturated fatty acids may provide deep conditioning and help retain moisture in the hair shaft. In one embodiment, the natural oil source is a vegetable oil source comprising predominantly unsaturated fatty acids, such as monounsaturated fatty acids or polyunsaturated fatty acids. For example, monounsaturated fatty acids such as from avocado fruit oil, mamey sapote oil, ungurahui oil, or amla fruit oil and / or polyunsaturated fatty acids such as from harakeke seed oil, sesame seed oil, or pumpkin seed oil. In other embodiments, the natural oil source is a plant leaf oil, such as an essential oil. Preferably, the natural oil source is a vegetable oil source comprising saturated fatty acids, unsaturated fatty acids, or combinations thereof.

[0019] In one embodiment, one or several of the natural oil sources included in the hair oil composition comprise antioxidants. Antioxidants neutralize free radicals, can help protect the scalp and hair from environmental damage, including ultraviolet radiation and pollution. This protection may contribute to healthier hair follicles. Antioxidants may additionally have a role in reducing the rate of oxidation of the other vegetable oils, and e.g. of the fatty acids of these, of the hair oil composition. Antioxidants may further contribute to stabilize the composition of the present invention. Examples of antioxidants include, but are not limited to, Vitamin C orascorbic acid, ellagic acid, gallic acid. In preferred embodiments, the hair oil composition of the invention comprises at least one oil source with a high content of natural androgen antagonists or anti-androgens. Androgen antagonists are compounds that have the biological effect of preventing dihydrotestosterone (DHT) from mediating its biological effect by either inhibiting or suppressing DHT production or by inhibiting DHT binding to hormone receptors. The presence of anti-androgenic chemicals found in plants and herbs such as rosemary, provides an alternative to modem synthetic pharmaceuticals. It is also commonly believed that there are fewer adverse effects of such alternative therapies. Emerging data indicates that androgen, prolactin, and gonadotropin levels can be biochemically modulated by the active compounds of plant-derived anti-androgens. Accordingly, the hair oil composition comprises at least one natural anti-androgen source. Non-limiting examples of suitable natural anti-androgens include chemical compounds such as for example 5- alpha-reductase inhibitors, dihydrotestosterone hormone receptor blockers, phytosterols, flavonoids, and triterpenoids. Preferably, the at least one anti-androgen is selected from the group comprising 5-alpha-reductase inhibitors, dihydrotestosterone hormone receptor blockers, and phytosterols. In some embodiments, the composition may further comprise at least one of flavonoids and triterpenoids.

[0020] The at least one natural anti-androgen source may be selected from the group comprising pumpkin seed oil, avocado fruit oil, rosemary oil, amla oil, sesame seed oil, and harakeke seed oil. Preferably, the natural anti-androgen source is pumpkin seed oil, avocado fruit oil, and rosemary oil. The hair oil composition may further comprise at least one of amla oil, sesame seed oil, and harakeke seed oil.

[0021] The hair oil composition further comprises natural oils which may increase the blood circulation to the scalp and hair follicles. This may enhance nutrient and oxygen delivery and improve waste removal from hair follicles. Suitable oils for increasing the blood circulation to the scalp and hair follicles include natural plant leaf oils such as peppermint oil and rosemary oil, and seed oils such as Kakadu plum oil.

[0022] The hair oil composition comprises only natural oils, and the ingredients have been carefully selected by the applicant to provide a composition which promote hair growth by nourishing the scalp, improving blood circulation, and supporting folliclehealth. A further reason for providing the claimed composition, is that the applicant wants to provide a product containing only natural oils with no synthetic chemicals added which still achieves beneficial effects on hair growth. The applicant aims to provide a product that is safe and tolerable for consumers, reducing the risk of unwanted side effects commonly associated with products containing synthetic chemicals. By offering a natural composition, it is more likely that consumers will maintain regular use of the product, thereby sustaining its beneficial effects.

[0023] The hair oil composition comprises caiaue oil, also known as ojon oil (INCI: Elaeis Oleifera nut oil). Caiaue oil is rich in amino acids, natural antioxidants, and provitamin A, i.e. carotenoids. Caiaue oil is also rich in omega-9 oleic acid (monounsaturated fatty acid (MLIFA), C18:1 n-9), omega-6 linoleic acid (polyunsaturated fatty acid (PLIFA), C18:2, n-6) and other saturated fatty acids. The constituent parts of caiaue oil allow the oil to penetrate deeply into the hair shaft, and possibly into the scalp, providing nourishment directly to the hair follicles.

[0024] The hair oil composition comprises kakadu plum oil (INCI: Terminalia Fernandina seed oil). Kakadu plum oil contains a high concentration of ascorbic acid, i.e. vitamin C (Kakadu plum fruit contains 2300-3150 mg / 100g of fresh weight, i.e.2.3-3.2%). It is enriched for polyphenolic compounds, mainly ellagic acid and gallic acid, with potent antioxidant properties. Antioxidant, antibacterial, anti-inflammatory, anti-apoptotic and cytoprotective functions have been reported for Kakadu plum. Kakadu plum oil is thought to improve blood circulation to the scalp, ensuring sufficient blood supply of nutrients to the hair follicles.

[0025] The hair oil composition comprises avocado fruit oil (INCI: Persea Americana fruit oil). Avocado fruit oil contains B2 (Riboflavin), B3 (Niacin), B5 (Pantothenic acid) and B6 (Pyridoxine), as well as folate, magnesium, potassium and vitamins C, E and K. Water-soluble B vitamin, including riboflavin, biotin, folate, and vitamin B12 deficiencies have been associated with hair loss. The role of folate and vitamin B12 in nucleic acid production suggest that they might play a role in the highly proliferative hair follicle. Moreover, avocado fruit oil is suggested to have natural DHT blocker function.

[0026] The hair oil composition comprises pumpkin seed oil (INCI: Cucurbita pepo seed oil). Pumpkin seed oil predominantly comprises unsaturated fatty acids, such asPLIFAs including linoleic acid and MLIFAs including oleic acid. Pumpkin seed oil is rich in vitamin E, zinc, antioxidants, and phytosterols. It is also 5-alpha-reductase inhibitor.

[0027] The hair oil composition comprises rosemary oil, such as particularly rosemary leaf and flowering tops oil (INCI: Rosmarinus officinalis). When applied to the scalp, rosemary oil increases blood circulation and thus the delivery of oxygen and nutrients to hair follicles. Additionally, rosemary oil is a natural DHT inhibitor.

[0028] In some embodiments, the hair oil composition of the invention comprises a mixture of the oils Kakadu plum oil, pumpkin seed oil, avocado fruit oil, caiaue oil, and rosemary oil. In one embodiment, the concentration in the hair oil composition of Kakadu plum oil, pumpkin seed oil, avocado fruit oil, and caiaue oil respectively, is about the same, such as 10-15%, such as 12%. In one embodiment, the concentration in the composition of rosemary oil is less than 5%, such as less than 2%, such as less than 1 %. In one embodiment the hair oil composition comprises:Kakadu plum oil in a weight% of 5-20%, pumpkin seed oil in a weight% of 5-20%, avocado fruit oil in a weight% of 5-20%, caiaue oil in a weight% of 5-20%, and rosemary oil in a weight% of 0.5- 2.0%.In one embodiment the hair oil composition comprises Kakadu plum oil, pumpkin seed oil, avocado fruit oil, caiaue oil, and rosemary oil in an about 12:12:12:12:1 ratio.

[0029] In some embodiments, the hair oil composition of the invention comprises a variety of other natural oils, including natural oils rich in natural anti-androgens, vitamins, antioxidants, and / or nutrients of the natural oils. These natural oils may comprise saturated, monounsaturated and / or polyunsaturated fatty acids. In some embodiments, the composition further comprises one or more of the oils selected from the group of Mamey sapote oil, Harakeke seed oil, Ungurahui oil, Sesame seed oil, Amla fruit oil, Bhringraj oil, and Peppermint oil. In one embodiment, the hair oil composition comprises at least six of the following natural oils of Table 1 , more preferably at least 7 or 8 of the oils, and preferably all. In one embodiment, thecomposition comprises maximum 20 different natural oils, such as maximum 15 natural oils. Suitable weight% ranges of the preferred 12 natural oils of the composition are listed in Table 1.

[0030] Table 1 : Suitable weight% ranges of the preferred 12 natural oils of the hair oil composition.

[0031] In one embodiment, the hair oil composition comprises the preferred 12 natural oils listed in Table 1 , wherein Kakadu plum oil, pumpkin seed oil, avocado fruit oil, and caiaue oil are present in equal amounts, such as 12%, and the remaining natural oils are present in suitable weight% to a total of 100 weight% of the composition. Typically, as a consequence of their high potency, the concentration of certain components, such as essential oil components or plant leaf oils of the composition is less than 5%, such as 0.5-2 weight%. The amount of each oil component is selected to provide a hair oil composition comprising nourishing ingredients to the scalp and hair follicles, anti-androgenic components, andcomponents which improve the blood circulation thereby improving delivery of said compounds to the scalp and hair follicles.

[0032] The natural oils, i.e. the natural oil sources, comprised in the composition, are included as they are without having been exposed to any modifications, enrichments or chemical processes such as separation or fractionation, i.e. the natural oils are naturally occurring. The natural oils have typically been extracted from the natural vegetable oil sources, such as from seeds, fruits, nuts, and plant leaves, and are accordingly pure, organic oils. The composition consists of natural oils only, i.e. the natural oils amount to 100 wt% of the composition.

[0033] For preparation of the hair oil composition the natural oils are mixed together, e.g. by gentle blending together the oils, to provide the hair oil composition in the form of a clear, liquid, oily solution. By clear, it is referred to that the composition is substantially free from any impurities or unwanted substances. The composition may comprise minor particles derived from some of the oils, such as from the fruit oils.The hair oil composition may appear coloured, resulting from the natural pigments of the natural hair oils. The composition may have appearance of brown or green nuances, or a mixture thereof. When the composition has been prepared this is filled into suitable containers such as bottles, or containers suitable for one time use. Typically, the volume of suitable containers such as for multi-dose containers are in the range of 10-500 mL, such as 50 mL, or typically 25 mL as used in Example 2. The claimed hair oil composition provides a high concentration of nourishing components as a stable oily solution. Studies of the applicant confirm that the composition is stable over time (shelf life), typically of at least 24 months. In one embodiment, the hair oil composition is contained in a container, wherein each container contains the appropriate volume of product intended for one use.

[0034] The invention also relates to use of the hair oil composition according to the first aspect for preventing hair loss and / or promoting hair growth. The hair loss may be due to conditions such as non-scarring alopecias, alternatively to scarring alopecias. As used herein, the term “non-scarring alopecias” refers to hair loss due to changes in hair cycle, hair follicle size, hair breakage or a combination of these. In all conditions, the hair follicle is preserved. The term “scarring alopecias” refers to forms of hair loss wherein hair follicles are damaged or destroyed due to inflammation.Preferably, use of the hair oil composition is for preventing hair loss due to nonscarring alopecias, more preferably due to androgenic alopecia. Use of the hair oil composition may have effect on different hair types, non-limiting examples include scalp hair and face hair such as eyebrows, eyelashes, and beard.

[0035] Male pattern baldness, known as androgenetic alopecia, is a common condition in which hair loss occurs as men age. With increased binding of the sex hormone dihydrotestosterone (DHT) to the follicle of hair receptors, each successive anagen cycle shortens in length. In these individuals, follicles shrink and gradually produce shorter, thinner, more vellus-like hairs. Possible treatments may include slowing the conversion of testosterone to dihydrotestosterone in men with this condition. Various products in the form of shampoos, conditioners, and serums are also available on the market intended for boosting hair growth. However, such products are often required to be used in combination and over long time periods, and the effect obtained from such products is variable. Hence, such approach for combating hair loss and regain hair growth is often tedious and expensive. Consequently, such treatments are often discontinued and thus the hair loss reoccurs. Alternative treatment strategies include more invasive treatments such as PRP. The applicant initially developed the composition of the present invention as a supplementary treatment to PRP, which is commonly used in the treatment of alopecia, such as alopecia areata and androgenic alopecia. However, the applicant noticed surprising effects on hair growth in subjects solely using the composition of the invention without any other type of treatment. Accordingly, the composition of the invention may be used as a supplement, or preferably as an alternative to treatment with PRP injections.

[0036] One of the advantages of the hair oil composition is that it comprises only natural oils. The inclusion of only natural oils is to prevent unwanted side effects in the user, such as skin irritation, itching, and rashes. In a clinical trial conducted by the applicant (Refer to Example 3 for details), 30 participants applied the hair oil composition to the scalp every other day for 140 days (20 weeks). None of the 30 participants enrolled in the trial have reported any related side effects after using the hair oil for a period of 4 to 20 weeks. Moreover, before the clinical trial commenced, the hair oil composition according to the first aspect passed all required preclinicalsafety tests. Accordingly, the hair oil composition is safe to use and is a well-tolerated product for topical administration. Consequently, this reduces the likelihood of discontinued use as is often seen for alternative hair loss treatment solutions.

[0037] The invention further relates to a composition for use in treatment of hair loss diseases and alleviation of diseases related to negative effects on hair follicles, such as reduced hair follicle health including risk of hair loss. The use comprises a step of applying said composition on the skin of the area to be treated. In one embodiment, the hair oil composition of the invention is included in a formulation for dermal delivery, such as a serum, cream, or an oil formulation. In one embodiment, the invention provides the composition of the first aspect for use in treatment of hair loss diseases. Non-limiting examples of such hair loss diseases include autoimmune diseases, and hair loss diseases related to inflammatory conditions. In one embodiment, the invention relates to a composition for use in treatment of alopecia areata. The hair oil composition of the invention, as defined in the first aspect, may have one or more of the following health gains, providing: decreased inflammation, improved hair follicle nutrition supply, and regulation of hormonal changes. Thus, the invention provides a composition according to the first aspect, for use as medical composition for use in treatment of hair loss diseases.

[0038] In one embodiment, the present invention relates to use of the composition according to the first aspect of the invention for preventing hair loss and / or promoting hair growth, wherein the use comprises a step of applying said composition on the skin on the area affected by hair loss. In one embodiment, the hair oil composition of the invention is included in a formulation for dermal delivery, such as in a cosmetic product, such as a serum, cream, or an oil formulation. In one embodiment, the invention provides the composition of the first aspect for use as a cosmetic product.

[0039] When using the hair oil composition of the invention, the composition should be applied by topical administration directly on the affected area. The composition should be applied 1-5 times a week, such as 2-3 times a week. The composition should be massaged onto the scalp where hair thinning, or hair loss is seen. The composition should be left on the affected area for at least one hour, such as for 1-3 hours, typically at least two hours or for instance over the night. The use should be followed by washing of the hair, the scalp and / or the treated areas. The compositionshould be used regularly for as long as one wants to maintain the result. Hair loss will probably resume if the treatment or use is stopped. The amount of the composition used should be sufficient to cover the area affected, such as 5-20 or 20-50 drops per use, or 1 -5 mL, such as 1 -3 mL, typically 1.2-1 .5 mL.

[0040] The applicant has performed several studies, testing the composition according to the inventions with very favourable results (Example 2). Approximately 40 cases have been included in such studies and followed up at regular intervals to assess the effect of use of the composition. From the applicant’s studies, visible favourable results have been seen in men affected by male pattern baldness (Fig. 1 and Fig. 2) or androgenetic alopecia (Fig. 3) after only 3-4 weeks of use or treatment. In a male test subject affected by male pattern baldness, new hair growth was observed from previously resting or dormant hair follicles already after 8 weeks of using the hair oil composition (Fig. 1 A). It is surprising that such effect of new hair strands growing out of hair follicles which have been dormant for over 20 years is seen, because it is commonly reported in the literature that once hair follicles stop working i.e. enter dormancy and stop producing hair, they are commonly not able to re-enter the growing phase. Thus, the observed effect on hair growth in the subject after only a short period of using the hair oil composition is surprising. Another effect from using the hair oil composition appears to be thickening of hair fibres in already existing hair strands (Fig. 2B). After continued use of the composition, new hair strands growing out from previously dormant hair follicles are detectable (Fig. 2D and Fig. 2F).

[0041] In their studies, the applicant has also included female subjects affected by alopecia areata, also demonstrating improved hair growth after only 4 weeks (Fig. 3B) of using the composition of the present invention. With continued use of the composition other affected bald areas also improved with respect to increased hair growth after 8 weeks of regular topical administration (Fig. 3C).

[0042] To further assess the effectiveness and safety of the hair oil composition, the applicant has conducted a clinical trial of the hair oil composition according to the first aspect for use according to the second aspect. The clinical trial was designed as a single-arm, open-label, uncontrolled study involving 30 healthy male and female participants aged 18-60 with moderate hair loss. The duration of the clinical trial was140 days (20 weeks), wherein the participants topically applied the hair oil composition, as defined in Example 1 , to the scalp every other day. A primary endpoint included scalp hair density, assessed by automated image analysis as described herein (Example 3).

[0043] For the 14 participants of cohorts 1 and 2, the mean change in hair growth from baseline in total hair count per cm2was 11 .9, corresponding to a mean percent change from baseline of 9.8% (Table 3). Notably, not all participants had equal response to the hair oil composition. For instance, of cohorts 1-2, 8 participants out of 14 were responders. Consequently, inter-individual variability across the cohorts likely influences the magnitude of observed changes from baseline. Factors such as differences in the severities of hair loss among cohorts, could potentially affect the capacity to respond to the treatment. Despite this, use of the hair oil composition demonstrated a positive effect on hair growth. Particularly, use of the hair oil composition demonstrated effect on promoting growth of new hair.

[0044] The hair oil composition may further revitalise dormant hair follicles in both men and women. Another primary endpoint of the clinical trial was to measure the ratio of hair follicles in anagen phase (growth phase) and telogen phase (resting phase). In the responders of cohorts 1-2 (n=8), preliminary data show that the number of hairs / cm2in anagen phase increased by 18.4% on average at week 20 (Table 5). Accordingly, use of the hair oil composition demonstrated positive effect on hair growth cycle after 20 weeks. In line with the transient hair density decrease at week 4 (Example 3, Figure 4 A), the number of hairs / cm2in anagen phase had increased after 4 weeks of treatment, supporting the hair oil composition’s effect on hair growth stimulation.

[0045] Hence, the use of the hair oil composition may result in reduced hair loss and promote hair growth, such as manifested by one or more of increasing the number of hair strands by contributing to new hair strands growing out of previously dormant hair follicles, increasing the thickness of already existing hair fibres of a hair strand, increasing the number of hair strands per cm2, and increasing the hair strand length.

[0046] It is to be understood that every embodiment of the disclosure can optionally be combined with any one or more of the other embodiments described herein.Elements disclosed for one aspect also apply for other aspects, hence the details provided for the composition also apply for the method or use when relevant.

[0047] ExamplesExample 1: Preparation of hair follicle revitalising compositionThe following oils, purchased from plant oil suppliers, were provided: Kakadu plum seed oil (INCI: Terminalia ferdiandiana),Pumpkin seed oil (INCI: Curcurbita pepo),Avocado fruit oil (INCI: Persea americana),Caiaue nut oil (INCI: Elaeis oleifera),Rosemary leaf and flowering tops oil (INCI: Rosmarinus officinalis)Mamey sapote seed oil(INCI: Pouteria sapota),Harakeke seed oil (INCI: Phormium tenax),Ungurahui fruit oil (INCI: Oenocarpus bataua),Sesame seed oil (INCI: Sesamum Indicum),Amla fruit and seed oil (INCI: Emblica officinalis Fruit Extract and Phyllanthus Emblica Seed Oil),Bhringraj leaf oil (INCI: Eclipta alba Extract), andPeppermint leaf oil (INCI: Mentha Piperita Oil)In the example, each of the Kakadu plum oil, pumkin seed oil, avocado fruit oil and caiaue oil components were present in an amount of 12 wt%, rosemary oil in 1wt%, and the other oil components listed were present in an amount making the total weight% of the oil composition 100 wt%.The above listed natural oils where gently mixed together by stirring, providing a composition comprising the oils in the weight% as provided above. The obtained composition had a clear, viscous, oily appearance with a pleasant smell. The composition was filled into containers containing a volume of 25 mL.The applicant plans for preparing further compositions wherein the amount of each of the above-listed oils are adjusted according to the details of the disclosure.Example 2: Studies using the hair follicle revitalising compositionA range of studies have been conducted by the applicant using the hair follicle revitalising composition as detailed in Example 1. The studies are summarized below, and reference is made to the enclosed Figures.

[0048] A Caucasian male aged 71 , who has had bald area on his head crown for over 20 years (Fig. 1A). After applying the hair follicle revitalizing composition 2-3 times a week, effect in form of new hair growth was noticeable after 8 weeks (Fig. 1 B), 12 weeks (Fig. 1 C) and 20 weeks (Fig. 1 D). Approximately 25 drops of the composition have been topically administered onto the scalp and massaged into the skin for about two minutes, left on the skin for approximately two hours before washed off.

[0049] A Caucasian male aged 57 (Fig. 2A) has been applying the hair oil composition topically to his bald area two to four times per week. He has left the hair oil composition on the skin for a variable time, ranging from approximately two hours to overnight. After 4 weeks, individual hair strands of existing hair appear thicker (Fig. 2B). Enlarged bald area prior to starting using the hair oil composition of the present invention (Fig. 2C). After 16 weeks of using the hair oil composition, new hair is growing out from the hair follicles, the effect is predominant in the rightmost area of the bald spot (Fig. 2D). Enlarged image of the rightmost section of the bald spot prior to starting using the hair oil composition (Fig. 2E). Enlarged image of the rightmost section of the bald spot at 16 weeks of using the hair oil composition (Fig. 2F).

[0050] A Caucasian female, 53 years old, who developed Alopecia areata five years ago (Fig. 2A) experienced new hair growth predominantly on the top of her head after 4 weeks (Fig. 2B). Hair growth on the sides of her head improved after 8 weeks (Fig. 2C) of using the hair follicle revitalising composition.

[0051] Example 3: Demonstrated effect on increased hair density by use of the hair oil compositionThe applicant has conducted a clinical trial to assess the hair oil composition according to the first aspect, more specifically as defined in Example 1 . Herein, preliminary data from the clinical trial are presented. It is noted that the preliminary data presented herein do not represent final analyses but are provided to demonstrate preliminary findings substantiating the effect of the hair oil composition according to the first aspect for use according to other aspects described herein.The clinical trial design was a single-arm, open-label, uncontrolled study involving 30 active participants. Herein, 21 male and 9 female participants, considered to be healthy, aged 18-60, and having moderate hair loss. The duration of the study was 20 weeks (140 days). The 30 participants were distributed across four cohorts, namely cohorts 1-4. Starting at week 0, participants were applying the hair oil composition according to the first aspect to the scalp every other day.One of the primary endpoints of the clinical trial included automated measurement of hair density of the participants. The HairMetrix® fully automated real-time analysis method was used to measure the hair density of the participants at defined timepoints described below. To precisely measure the number of hairs per square centimetre (cm2) on the scalp, as a measure of hair density, magnified digital images of the scalp of each participant were taken at timepoints; week 0, week 4, week 12, and week 20. The magnified digital images were analysed by the HairMetrix® computer software (Table 2).Table 2: Absolute hair count per cm2at the cohort-level, derived from individual subject-level data within each respective cohort. Mean change from baseline and mean percent (%) change from baseline, both calculated based on individual subjectlevel data for each cohort.At the present time, data for the full duration of 20 weeks was available for only cohort 1 and cohort 2. Individual subject-level data within each cohort were used to determine absolute hair count per cm2, mean change from baseline in total hair count per cm2, and mean percent (%) change in total hair count from baseline.Table 3: Cohort 1 and 2 data (n=14) for week 0 to week 20.Notably, a small transient decrease from baseline in in the hair density of 3% was observed after 4 weeks of treatment. This is consistent with stimulation of new hair growth, starting with resting hair (telogen phase) being expelled from the hair follicle, before the start of a new growth phase (anagen phase).Table 4: Aggregated data from cohortl 1-4 for week 0 to week 12.

[0052] Example 4: Demonstrated effect on hair growth cycle by use of the hair oil compositionThe hair growth cycle was assessed in participants of the clinical trial (refer to Example 3 for details). The HairMetrix® fully automated real-time analysis method was used to measure the ratio of hair follicles in anagen phase (growth phase) and telogen phase (resting phase). Magnified digital images of the scalp were taken of participants of cohort 1 and cohort 2 (n=14) at timepoints week 0, week 4, week 12, and week 20. The magnified digital images were analysed by the HairMetrix® computer software. Preliminary data for the responders of cohort 1 and cohort 2 (n=8) is presented herein.Table 5: Change in number of hairs / cm2in anagen phase in participants in cohort 1 and cohort 2 (n=8).The number of hairs / cm2in anagen phase increased by 18.4% on average at week 20 (Table 5). In line with the transient hair density decrease at week 4 (Example 3), the number of hairs / cm2in anagen phase had increased after 4 weeks of treatment, supporting the hair oil composition’s effect on hair growth stimulation.

Claims

Claims1 . A hair oil composition comprising natural oils only, wherein the natural oils are selected from the group comprising seed oils, fruit oils, nut oils, and plant leaf oils, or combinations thereof, the composition comprising: a mixture of Kakadu plum oil, pumpkin seed oil, avocado fruit oil, caiaue oil, and rosemary oil, and at least one natural anti-androgen.

2. The hair oil composition of claim 1 , wherein the at least one natural anti-androgen is selected from the group of 5-alpha-reductase inhibitors, dihydrotestosterone hormone receptor blockers, and phytosterols.

3. The hair oil composition of any of the claims 1 -2 comprisingKakadu plum oil in a weight% of 5-20%, pumpkin seed oil in a weight% of 5-20%, avocado fruit oil in a weight% of 5-20%, caiaue oil in a weight% of 5-20%, and rosemary oil in a weight% of 0.5- 2.0%.

4. The hair oil composition of any of the claims 1-3, wherein the at least one natural anti-androgen is a component from one or more of the oils comprising pumpkin seed oil, avocado fruit oil, rosemary oil, amla oil, sesame seed oil, and harakeke seed oil.

5. The hair oil composition of any of the preceding claims, further comprising one or more of the oils selected from the group comprising ungurahui oil, mamey sapote oil, harakeke seed oil, amla fruit oil, bringraj oil, sesame seed oil, and peppermint oil.

6. The hair oil composition of any of the preceding claims comprising the following oils: Kakadu plum oil, pumpkin seed oil, avocado fruit oil, caiaue oil, rosemary oil, ungurahui oil, mamey sapote oil, harakeke seed oil, amla fruit oil, bringraj oil, sesame seed oil, and peppermint oil.

7. Use of a hair oil composition according to claims 1-6 for preventing hair loss and / or promoting hair growth, the use comprises a step of applying said composition on the area affected by hair loss.

8. Use of a hair oil composition according to claim 7, wherein the hair loss is due to a condition of non-scarring alopecia.

9. Use of a hair oil composition according to claim 8 wherein the non-scarring alopecia is androgenic alopecia.

10. A hair oil composition comprising natural oils only, wherein the natural oils are selected from the group comprising seed oils, fruit oils, nut oils, and plant leaf oils, or combinations thereof, the composition comprising: a mixture of Kakadu plum oil, pumpkin seed oil, avocado fruit oil, caiaue oil, and rosemary oil, and at least one anti-androgen for use in treatment of hair loss diseases, the use comprises a step of applying said composition on the skin of the area to be treated.11 . The hair oil composition according to claim 10 for use according to claim 10, wherein the hair loss disease is alopecia areata.

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