Vehicle for the application of bacteria to the skin, scalp and hair

Abstract

Topical methods and compositions for applying bacteria to the skin, scalp, and hair are described. These topical compositions include bacteria in a suitable base vehicle, such as honey, for application to the skin, scalp, and hair. The base vehicle may include additional components, such as plant-derived products, micronutrients, emollients, plant-derived emulsifiers, and antioxidants, among others. The topical compositions can be used to treat and / or prevent skin, scalp, and hair conditions such as dry skin, dry scalp, dandruff, psoriasis, cradle cap, seborrheic dermatitis, and / or eczema.

Description

[0001] The present application relates to a hair tonic composition for use in the treatment of seborrheic dermatitis or atopic dermatitis of the scalp or hair. In particular a hair tonic composition comprising heat-killed Lactobacillus acidophilus at a concentration of 106 colony forming units / gram of the hair tonic composition, heat-killed Lactobacillus plantarum at a concentration of 106 colony forming units / gram of the hair tonic composition, 2% (w / w) of Vitamin B12, about 4% (w / w) of Turmeric, 51% of base inactive ingredients, and 43% (w / w) of honey, wherein the concentration of the bacteria added to the composition is determined prior to killing the bacteria.BACKGROUND

[0002] The present invention relates to therapeutic compositions for use in introducing bacteria to the skin, scalp, and hair. Specifically, the invention relates to topical compositions that include honey and may be utilized as vehicles for introducing bacteria to the skin, scalp, and hair. In addition to honey, the disclosed topical compositions may include plant-based lipids, micro-nutrients, emollients and plant-sourced emulsifiers, and anti-oxidants, among other components.

[0003] The health and character of the skin is an area of concern for a large portion of the population. Beyond the barrier functions the skin provides, it is also responsible for conveying sense information, and - very literally - presenting its wearer to the world. Healthy skin may therefore support one or more of these functions, potentially preventing physical or psychological injury. The skin is a living organ, and should be treated as such. The present invention provides a vehicle to take advantage of this reality, among other things. Billions of dollars are spent every year by people who wish to improve the appearance of their skin, either through their diet, cosmetics, or by some other means.

[0004] Presently, many products aimed at improving the health and structure of the skin exist. However, these products are characterized by several limitations. First, and most importantly, these products may not be characterized as being "skin microbiome friendly." The skin is a living part of an intricate web of human cells and microorganisms, and the products presently available are not entirely supportive or compatible with the skin microbiome and pH. Of the multitude of current topical preparations, none are in biological parity with their purported target. Evidence continues to accumulate that nurturing the skin pH and its biome can be beneficial to the skin's condition.

[0005] WO 2012 / 118535 A1 discloses anti-biofilm compositions comprising honey and probiotic organisms including Lactobacillus, Bifidobacterium and Streptococcus strains. Said compositions are also formulated for topical administration and used in the treatment of skin conditions such as dermatitis, acne and eczema. KR 2016 / 0049812 A1 relates to a cosmetic skin composition useful for promoting ceramide biosynthesis, comprising honey and propolis with kimchi lactic acid bacteria. US 2014 / 037688 A1 provides anti-biofilm compositions comprising anti-microbial honey and non-lactic acid as well as lactic acid producing bacteria. Stocker et al., 2004, relates to a topical vitamin B12 composition and a therapeutic approach in atopic dermatitis-evaluation of efficacy and tolerability in a randomized placebo-controlled multicentre clinical trial. Mcloone et al., 2016 relates to a topical composition comprising honey as a therapeutic agent for disorders of the skin. Vaughn et al., 2016, relates to the effects of turmeric (Curcuma longa) on skin health: A Systematic Review of the Clinical Evidence.

[0006] An additional limitation of current topical preparations is their dependence on pharmaceutical agents, synthetic detergents, and the use of skin-irritating preservatives, biocides and solvents. While useful in preparing mass-market skincare products, the inclusion of skin irritating or compromising chemicals in a preparation aimed at improving skin quality represents a contradiction. For example, in order to treat moderate to severe cases of eczema or psoriasis, the current standard of care revolves around the use of corticosteroids, immunosuppressants, ultraviolet radiation, and similar measures. These treatments are not only often expensive, but carry large side-effect profiles, and substantial risk to their recipients. Even in the case of healthy individuals aiming to improve the cosmetic character or general health of their skin, the ingredients in many preparations are at odds with the user's goals.

[0007] There is therefore a need for improvement over the shortcomings of skincare products, in the form of a shelf-stable, nutrient-rich solution, which delivers bacteria to the skin. The present invention consists of a vehicle and associated bacterial preparation, aimed at viable application of said bacteria to the skin, scalp, and hair.SUMMARY

[0008] Disclosed is a hair tonic composition for use in the treatment of seborrheic dermatitis or atopic dermatitis of the scalp or hair, wherein the hair tonic composition comprises heat-killed Lactobacillus acidophilus at a concentration of 106 colony forming units / gram of the hair tonic composition, heat-killed Lactobacillus plantarum at a concentration of 106 colony forming units / gram of the hair tonic composition, 2% (w / w) of Vitamin B12, about 4% (w / w) of Turmeric, 51% of base inactive ingredients, and 43% (w / w) of honey; wherein the concentration of the bacteria added to the composition is determined prior to killing the bacteria, preferably wherein the honey is selected from Manuka honey, raw honey, refined honey, and a combination thereof.DETAILED DESCRIPTION

[0009] The present invention is described herein using several definitions, as set forth below and throughout the application.

[0010] Unless otherwise specified or indicated by context, the terms "a", "an", and "the" mean "one or more." For example, "a component" should be interpreted to mean "one or more components. "

[0011] As used herein, "about," "approximately," "substantially," and "significantly" will be understood by persons of ordinary skill in the art and will vary to some extent on the context in which they are used. If there are uses of these terms which are not clear to persons of ordinary skill in the art given the context in which they are used, "about" and "approximately" will mean plus or minus:S:10% of the particular term and" substantially" and "significantly" will mean plus or minus >10% of the particular term.

[0012] As used herein, the terms "include" and "including" have the same meaning as the terms "comprise" and "comprising" in that these latter terms are "open" transitional terms that do not limit claims only to the recited elements succeeding these transitional terms. The term "consisting of," while encompassed by the term "comprising," should be interpreted as a "closed" transitional term that limits claims only to the recited elements succeeding this transitional term. The term "consisting essentially of," while encompassed by the term "comprising," should be interpreted as a "partially closed" transitional term which permits additional elements succeeding this transitional term, but only if those additional elements do not materially affect the basic and novel characteristics of the claim.

[0013] As used herein, a "subject in need thereof' may include a subject in need of skin, scalp, or hair care and / or treatment. A subject in need thereof may include, but is not limited to, a subject having or at risk for developing one or more of dry skin, dry scalp, dandruff, psoriasis, cradle cap, seborrheic dermatitis, and / or eczema.

[0014] As used herein, the term "subject" may be used interchangeable with the terms "patient" and "individual." A subject may include a human and / or a non-human animal (e.g., a companion animal such as a dog or a cat).Vehicle for Applying Bacteria to Skin, Scalp, and Hair

[0015] Disclosed is a topical composition for applying bacteria to theskin, scalp, and / or hair. Accordingly, in the topical composition the bacteria are formulated in a suitable base vehicle comprising honey for applying bacteria to the skin, scalp, and hair as a topical composition. The topical compositions of the present disclosure preferably are formulated to be supportive and compatible with the skin microbiome and pH.

[0016] In particular, the base vehicle may include honey as produced by honey bees including, but not limited to, honey produced by any species of the genus Apis such as A mellifera, A. cerana, A. florea, A. andreniformis, A koschevnikovi, and A dorsata. The base vehicle may include honey produced by honey bees and collected pollen and nectar from any flowering plant, in particular, honey produced from the pollen and nectar of Leptospermum scoparium and its relatives and / or the Manuka tree or its relatives (i.e., Manuka honey). Suitable honey for the disclosed topical compositions may include raw honey or processed honey. In some embodiments of the present disclosure, honey used in the disclosed compositions has been heat-treated (e.g., via pasteurization) and / or irradiated.

[0017] The disclosed topical compositions include a suitable concentration of honey, for example, to prepare a composition for treating and / or preventing skin conditions and / or scalp conditions. In some embodiments of the present disclosure, the honey may be present in the disclosed compositions at a concentration of at least about 1%, 2%, 3%, 5%, 7%, 10%, 15%, 20%,25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70% (w / w) or higher, or within a range bounded by any of these values (e.g. about 15-60% (w / w) or 20-50% (w / w)).

[0018] The topical compositions according to the present disclosure include bacteria which may be live bacteria and / or killed bacterial. Killed bacteria for the disclosed compositions may be killed by methods known in the art, including but not limited to heat-treatment, irradiations, and / or chemical treatment. In some embodiments of the present disclosure, the bacteria are present in the topical composition at a concentration of at least about 10 4< , 10 5< , 10 6< , 10 7< , 10 8< colony forming units (CFU) / gram (g) topical composition or higher, or within a concentration range bounded by any of these values (e.g., 10 4< -10 8< CFU / g). Where the bacteria are killed bacteria, the concentration of the bacteria added to the composition may be determined prior to killing the bacteria. In other embodiments of the present disclosure, the bacteria are present at a concentration of at least about 10 -8< , 10 -7< , 10 -6< , 10 -5< , 10 -4< g bacteria / g composition or higher, or within a concentration range bounded by any of these values (e.g., 10 -7< - 10 -5< g bacteria / g composition). In other embodiments of the present disclosure, the bacteria are present at a concentration of at least about 1%, 2%, 3%, 5%, 7%, 10%, 15%, 20% (w / w) or higher or within a range bounded by any of these values (e.g., at a concentration of 3-10% (w / w)).

[0019] In some embodiments of the present disclosure, bacteria for the disclosed topical compositions may include bacteria suitable for use in a topical formulation for treating and / or preventing skin conditions and / or scalp conditions. Suitable bacteria for the disclosed compositions may include, but are not limited to bacteria of the genera Lactobacillus, Bifidobacterium, or Streptococcus, especially Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus delbruecki, Lactobacillus paracasei, Lactobacillus salivarius, Lactobacillus casei, Bifidobacterium lactis, Bifidobacterium longum, Bifidobacterium breve, and Streptococcus thermophiles.

[0020] Optionally, the topical compositions of the present disclosure may include additional bacterial species or non-bacterial species that natural occur in honey (e.g. yeasts), products of fermentation (e.g. lactic acid and / or ethanol), peroxides and any other metabolic byproducts of the bacteria listed above, or of those organisms contained in honey, and additional carriers, buffers, emulsifiers, and anti-oxidants.

[0021] Additional components for the topical compositions of the present disclosure may include, but are not limited to plant-based products. In some embodiments of the present disclosure, the one or more plant- based products are present in the topical composition at a concentration of at least about 5%, 10%, 20%, 30%, 40%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90% or higher, or within a concentration range bounded by any of these values (e.g., 30-90% (w / w), or about 30-70% (w / w), or about 30-50% (w / w)).

[0022] Suitable plant-based products for the disclosed topical compositions may include plant-based lipid products. Plant-based lipid products may include plant-based butters (such as shea butter or cocoa butter), plant-based waxes (such as carnauba wax or beeswax), and plant-based oils (such as coconut oil, sunflower oil, or jojoba oil, or fractions thereof).

[0023] Suitable plant-based products for the disclosed topical compositions may include plant-based gels, lotions, or other extracts or components. In some embodiments of the present disclosure, the disclosed composition comprise a plant-based gel, lotion, or other extract or component from the Aloe vera plant or a plants producing similar substances as the Aloe vera plant.

[0024] Additional plant-based components for the disclosed topical compositions may include turmeric (e.g., Curcuma longa), turmeric-derived products, or components that are present in turmeric. In some embodiments of the present disclosure, the disclosed compositions include turmeric powder and / or components that are present in turmeric such as curcuminoids and essential oils. The disclosed compositions may include components selected from but not limited to curcumin, demethoxycurcumin, and bisdemethoxycurcumin. The disclosed compositions may include components selected from but not limited to turmerone, germacrone, atlantone, and zingiberene. In some embodiments of the present disclosure, the disclosed compositions comprise turmeric- derived products, or components that are present in turmeric at a concentration of at least about 0.5%, 1.0%, 1.5%, 2.0%, 2.5%, 3.0%, 3.5%, 4.0%, 4.5%, 5.0%, 5.5%, 6.0%, 6.5%, 7.0%, 7.5%, 8.0%, 8.5%, 9.0%, 9.5%, 10.0% or higher, or within a concentration range bounded by any of these values (e.g., about 0.5-10% (w / w) or about 2.0-6.0% (w / w)).

[0025] The topical compositions of the present disclosure may comprise curcuminoids or essential oils (e.g., curcuminoids and essential oils that are present in turmeric (such as curcumin, demethoxycurcumin, and bisdemethoxycurcumin; and turmerone, germacrone, atlantone, and zingiberene)). In some embodiments of the present disclosure, the curcuminoids and / or essential oils are present in the composition at a concentration of at least about 0.005%, 0.01%, 0.02%, 0.05%, 0.1%, 0.2%, 0.5% or higher, or within a concentration range bounded by any of these values (e.g., about 0.005-0.5% (w / w) or 0.05-0.5% (w / w)).

[0026] Additional plant-based components for the topical compositions according to the present disclosure may include, but are not limited to beta-glucans, olive polyphenols, ahi flower oil, carotenoids such as fucoxanthin, ceramides, and fatty acids such as omega-7 oil optionally obtained from sea buckthorn.

[0027] The topical compositions according to the present disclosure may comprise micronutrient components, including but limited to vitamins. Suitable vitamins may include, but are not limited to vitamin B 12 , vitamin E and / or vitamin B 3 . In some embodiments of the present disclosure, the micronutrient (e.g., vitamin B 12 , vitamin E and / or vitamin B 3 ) is present in the topical composition at a concentration of at least about 0.1%, 0.2%, 0.5%, 1.0%, 1.5%, 2.0%, 2.5%, 3.0%, 3.5%, 4.0%, 4.5%, 5.0%, 5.5%, 6.0% or higher, or within a concentration range bounded by any of these values (e.g., about 0.1-5% (w / w) or about 1-3% (w / w)).

[0028] The topical compositions according to the present disclosure may comprise a humectant. Suitable humectants may include, but are not limited to glycerin, or other fractions of triglyceride hydrolysis. In some embodiments of the present disclosure, the disclosed compositions comprise glycerin (or other fractions of triglyceride hydrolysis) at a concentration of about 1%, 2%, 3%, 5%, 10%, 15%, 20%, 25%, 30% or higher, or within a concentration range bounded by any of these values (e.g., 3-30% (w / w), or about 5-25% (w / w), or about 10-20% (w / w), or about 15% (w / w)).

[0029] The topical compositions according to the present disclosure may comprise emulsifiers. Suitable emulsifiers may include, but are not limited to, plant-based emulsifiers such as lecithin, especially from Helianthus annuus.

[0030] The topical compositions of the present disclosure may include anti-oxidants. Suitable anti-oxidants may include, but are not limited to, hydroxytyrosol.

[0031] Additional components for the topical compositions of the present disclosure may include, but are not limited to beta-glucans, olive polyphenols, ahi flower oil, carotenoids such as fucoxanthin, ceramides, and fatty acids such as omega-7 oil optionally obtained from sea buckthorn.

[0032] The disclosed topical compositions preferably are formulated to be supportive and compatible with the skin microbiome and pH. For example, preferably the disclosed topical compositions have a pH within a range of 6-8. Optionally, the disclosed topical compositions may include a buffering system.

[0033] The topical compositions of the present disclosure may be produced by methods known in the art including, but not limited to, the following description. This description is not meant to limit future or potential means of production, nor to exhaustively detail all methods currently in use or development.

[0034] A base vehicle comprising honey, shea butter, cocoa butter, and glycerin may be prepared as follows. To an amount of shea butter that consists of 50% of the final formulation by mass, there may be added an amount of softened cocoa butter equal to 25% of the final formulation by mass. After creating a homogenous cream via stirring or blending, an amount of glycerin and honey, equal to 12.5% and 5% of the final formulation by mass, respectively, may be added to the cocoa and shea butter mixture.

[0035] A blend containing bacteria from the genera Lactobacillus, Bifidobacterium, or Streptococcus, especially as listed above among, may be dissolved in a solution of distilled water, along with sunflower lecithin, that together are equal to 2.5% of the final formulation by mass. This water-based mixture then may be added to the base vehicle above.

[0036] Lastly, sunflower oil and fractioned coconut oil, each in an amount equal to 2.5% of the final formulation by weight, may together be dissolved in the base vehicle above and mixed on low power until integrated to yield a cream-like solution. The resulting product should be refrigerated for 12 to 24 hours. Depending on the crystal structure of the cocoa butter used, applying heat and controlling re-solidification conditions may be necessary to optimize consistency. Preparation may be best conducted slightly above average room temperature, depending on environment and ingredient feedstock. The vehicle and bacterial preparations detailed herein may be adapted for application to other body systems, including for different purposes entirely.EXAMPLES

[0037] The following Example is illustrative.Example 1

[0038] Twenty (20) subjects were enrolled to assess a skin cream product and a hair tonic product for comfort and safety. The compositions of the skin cream product and the hair tonic product are as follows: Table 1.ComponentSkin Cream ProductHair Tonic ProductHoney3g (-5% (w / w))41g (-47% (w / w))Shea Butter30g (-46% (w / w))4g (-5% (w / w))Cocoa Butter15g (-23% (w / w))-Glycerin9g (-14% (w / w))15g (-17% (w / w))Coconut Oil1.5g (-2% (w / w))6g (- 7% (w / w))Sunflower Oil1.5g (-2% (w / w))-Vitamin B120.5g (-1% (w / w))1g (-1 % (w / w))Vitamin E0.5g (-1 % (w / w))0.5g (-0.5% (w / w))Sunflower Lecithin-3g (-3% (w / w))Water-14g (-16% (w / w))Lactobacillus spp.4.5g (- 7% (w / w))3g (-3% (w / w))

[0039] The average age of the subjects was 39 (range 10-72) with 10 men and 10 women. Tiuee male and three female subjects also had both skin eczema and dry scalp.

[0040] AU subjects were instructed to use the skin cream product and the hair tonic product once a day for ten days. The skin cream was to be applied in a thin fayer to arms and legs in the morning after a shower. TI1e hair tonic was to be applied to the scalp once a day for seven days. Prior to taking a shower in the morning, a palm-size amount of tbe hair tonic vvas to be massaged into the scalp, left in place for about five minutes, and then rinsed in the shower,

[0041] A brief questionnaire was conducted on ail the subjects after the study. All subjects reported using the product as instructed. No subjects reported any adverse reactions. A questionnaire scale of 1 to 4 was used, with 1 being poor and 4 being excellent. The results are noted in the Table 2. Table 2.ParameterSkin Cream ProductHair Tonic ProductEase of Application4.03.95Adverse Reactions00Feel on Skin / Scalp3.93.9

[0042] One of the subjects found the skin cream slightly greasy and gave a rating of 3. Two of the subjects found the hair tonic to be slightly sticky and gave a rating of 3. The 6 subjects who had skin eczema and dry scalp all reported a subjective improvement in the quality of their skin.Example 2

[0043] A hair tonic and a skin cream were prepared with the following components: Hair Tonic. Vitamin B12: 2%; Turmeric: 4%; Honey: 43%; Base (inactive ingredients): 51%; Bacteria (Heat-killed Lactobacillus Acidophilus): 1 million colony forming units per gram of product; and Bacteria (Heat-killed Lactobacillus Plantarum): 1 million colony forming units per gram of product.

[0044] Skin Cream. Vitamin B 12 2%; Turmeric: 4%; Honey: 30%; Base (inactive ingredients): 64%; Bacteria (Heat-killed Lactobacillus Acidophilus): 1 million colony forming units per gram of product; and Bacteria (Heat-killed Lactobacillus Plantarum): 1 million colony forming units per gram of product.

[0045] Twenty (20) adult and seventeen (17) pediatric subjects with seborrheic dermatitis were enrolled to study the hair tonic, and twenty (20) adult and twenty (20) pediatric subjects with atopic dermatitis were enrolled to study the skin cream. All subjects were instructed to use the skin cream product and the hair tonic product once a day for ten days. The skin cream was to be applied in a thin layer to arms and legs in the morning after a shower. The hair tonic was to be applied to the scalp once a day for ten days. Prior to taking a shower in the morning, a palm-size amount of the hair tonic was to be massaged into the scalp, left in place for about five minutes, and then rinsed in the shower.

[0046] A brief questionnaire was conducted on all the subjects after the study. All subjects reported using the product as instructed. No subjects reported any adverse reactions. A questionnaire scale of 1 to 4 was used, with 1 being poor and 4 being excellent. The results are presented in Table 3: Table 3.ParameterSkin Cream ProductHair Tonic ProductEase of Application4.03.95Adverse Reactions00Feel on Skin / Scalp3.93.9Improvement of dermatitis4.04.0 REFERENCES

[0047] Stocker M et al.: "Topical vitamin B12-a new therapeutic approach in atopic dermatitis-evaluation of efficacy and tolerability in a randomized placebo-controlled multicentre clinical trial", BRITISH JOURNAL OF DERMATOLOGY, JOHN WILEY, HOBOKEN, USA, vol. 150, no. 5, 30 April 2004 (2004-04-30), pages 977-983. Pauline Meloone et al.: "Honey: A Therapeutic Agent for Disorders of the Skin", Central Asian Journal of Global Health, vol. 5, no. 1, 4 August 2016 (2016-08-04). Vaughn Alexandra R. et al.: "Effects of Turmeric (Curcuma longa) on Skin Health: A Systematic Review of the Clinical Evidence : Effects of Curcuma longa on Skin Health", Physiotherapy Research, vol. 30, no. 8, 23 May 2016 (2016-05-23), pages 1243-1264.

Claims

1. A hair tonic composition for use in the treatment of seborrheic dermatitis or atopic dermatitis of the scalp or hair, wherein the hair tonic composition comprises heat-killed Lactobacillus acidophilus at a concentration of 106 colony forming units / gram of the hair tonic composition, heat-killed Lactobacillus plantarum at a concentration of 106 colony forming units / gram of the hair tonic composition, 2% (w / w) of Vitamin B12, about 4% (w / w) of Turmeric, 51% of base inactive ingredients, and 43% (w / w) of honey; wherein the concentration of the bacteria added to the composition is determined prior to killing the bacteria.

2. The hair tonic composition for use of claim 1, wherein the honey is selected from Manuka honey, raw honey, refined honey, and a combination thereof.