Method for providing cooling to skin with eczema

Abstract

There is provided a method of providing a cooling sensation to skin having eczema, the method comprising topically applying a composition comprising isododecane to skin having eczema.

Description

Technical Field

[0001] The present invention generally relates to compositions suitable for use on skin suffering from eczema. More particularly, the present invention relates to compositions comprising an alpha hydroxy acid, a volatile emollient and / or a processed oat ingredient. Background Art

[0002] Atopic dermatitis (also known as eczema) is a chronic, recurrent, itchy inflammation of the skin that can impair quality of life. Atopic dermatitis affects 10%-20% of children and 1%-3% of adults worldwide, with an increased prevalence in highly industrialized countries. Atopic dermatitis is characterized by impaired epidermal barrier, innate and adaptive immune disorders, and high susceptibility to bacterial colonization and infection. Therefore, lubricants (ointments and creams) and topical or oral corticosteroids (which act on the immune system by blocking the production of substances that trigger allergic and inflammatory effects) remain first-line treatments. Similarly, antihistamines may also be administered. If pruritus is unresponsive to standard treatment, antibiotics may be considered.

[0003] Emollients are effective in keeping the skin hydrated and repairing the skin barrier. However, the cosmetic acceptance of these types of preparations can be poor, which is reflected in lower compliance in patients with atopic dermatitis. Furthermore, this approach alone is often not enough. On the other hand, corticosteroids are powerful drugs but are known to cause side effects, some of which can be severe with long-term use. While antihistamines can be used to treat the itching associated with atopic dermatitis, they can cause drowsiness and may not help in all cases of atopic dermatitis. Finally, the use of antibiotics is controversial due to increasing bacterial resistance.

[0004] Additionally, the treatment would ideally address the visual appearance of skin with eczema, and / or otherwise provide other sensory benefits, such as a cooling sensation. However, conventional ingredients are often too harsh for use on the sensitive skin of individuals with eczema.

[0005]

[0006] Therefore, there exists a need for topical compositions suitable for use on eczematous skin that address one or more of the problems listed above. Summary of the invention

[0006] One aspect of the present invention relates to a composition suitable for use on skin suffering from eczema, the composition comprising:

[0007] a. α-hydroxy acid;

[0008] b. Volatile emollients; and

[0009] c. Processed oat ingredients.

[0010] In one or more embodiments, alpha-hydroxy acid is selected from glycolic acid, malic acid, tartaric acid, pyruvic acid, mandelic acid, lactic acid and combinations thereof. In some embodiments, alpha-hydroxy acid is present in an amount ranging from about 0.01% by weight to about 5% by weight according to the total weight of the composition. In one or more embodiments, volatile emollients are selected from cyclopentasiloxane, dimethicone, isoparaffin fraction (C9-C16), ethyl trisiloxane, trisiloxane and caprylyl polymethicone, isododecane and combinations thereof. In some embodiments, volatile emollients are present in an amount ranging from about 0.01% by weight to about 12% by weight according to the total weight of the composition. In one or more embodiments, processed oat ingredients are selected from oat extracts, colloidal oatmeal, oat oil, fermented oats, avenamide, β-glucan, modified oat grain materials and combinations thereof. In some embodiments, processed oat ingredients are present in an amount ranging from about 0.01% by weight to about 30% by weight according to the total weight of the composition. In one or more embodiments, the composition further comprises a dermatologically acceptable ingredient selected from a viscosity increasing agent, a humectant, a skin conditioning agent, an emulsifier, and combinations thereof. In some embodiments, the composition has a pH of about 4.5 to about 5.5. In one or more embodiments, the composition is in the form of a lotion, a gel, or a cream product.

[0011] Another aspect of the present invention relates to a composition suitable for use on skin suffering from eczema, the composition comprising:

[0012] a.Lactic acid;

[0013] b. isododecane; and

[0014] c. A processed oat ingredient, wherein the processed oat ingredient is selected from oat extract, colloidal oatmeal, oat oil and a combination thereof.

[0015] In one or more embodiments, the composition comprises:

[0016] a. from about 0.01 wt % to about 3 wt % lactic acid;

[0017] b. from about 0.01 wt % to about 4 wt % isododecane; and

[0018] c. From about 0.01% to about 6% by weight of a combination of oat extract, colloidal oatmeal, and oat oil.

[0019] Another aspect of the present invention relates to a method of treating eczema, comprising topically applying any of the compositions described herein to skin suffering from eczema. In one or more embodiments, the skin suffering from eczema includes mild to moderate eczema.

[0020] Another aspect of the present invention relates to a method for improving the appearance of skin suffering from eczema, the method comprising applying a composition comprising lactic acid topically to the skin suffering from eczema. In one or more embodiments, lactic acid is present in an amount in the range of about 0.01 wt % to about 5 wt % by the total weight of the composition. In some embodiments, the skin suffering from eczema includes mild to moderate eczema. In one or more embodiments, the composition is applied to the lesion area. In some embodiments, the composition is applied to the face or body. In one or more embodiments, the composition is applied once or twice a day. In some embodiments, the lesion area shows symptoms selected from the following: erythema, pruritus, exudation, scratches, lichenification, dryness, rough touch, abnormal skin tone, burning, stinging and combinations thereof. In one or more embodiments, the composition also comprises a volatile emollient. In some embodiments, the volatile emollient is selected from cyclopentasiloxane, dimethicone, isoparaffin fraction (C9-C16), ethyl trisiloxane, trisiloxane and caprylyl polymethicone, isododecane and combinations thereof. In one or more embodiments, the volatile emollient is present in an amount ranging from about 0.01% by weight to about 12% by weight by the total weight of the composition. In some embodiments, the composition further comprises a processed oat ingredient. In one or more embodiments, the processed oat ingredient is selected from oat extract, colloidal oatmeal, oat oil, fermented oats, avenamide, beta-glucan, modified oat grain material and a combination thereof. In some embodiments, the processed oat ingredient is present in an amount ranging from about 0.01% by weight to about 30% by weight by the total weight of the composition. In one or more embodiments, the composition further comprises a dermatologically acceptable ingredient selected from a thickener, an additional emollient, a wetting agent, a skin conditioner, an emulsifier and a combination thereof. In some embodiments, the composition is in the form of a lotion, a gel or a cream product.

[0021] Another aspect of the present invention relates to a method for providing a cooling sensation to skin suffering from eczema, the method comprising topically applying a composition comprising isododecane to skin suffering from eczema. In one or more embodiments, isododecane is present in the composition in an amount ranging from about 0.01% by weight to about 12% by weight based on the total weight of the composition. In some embodiments, the skin suffering from eczema includes mild to moderate eczema. In one or more embodiments, the composition is applied to the lesion area. In some embodiments, the composition is applied to the face or body. In one or more embodiments, the composition is applied once or twice a day. In some embodiments, the lesion area exhibits symptoms selected from the following: erythema, pruritus, exudation, scratches, lichenification, dryness, rough touch, abnormal skin tone, burning, stinging and combinations thereof. In one or more embodiments, the composition further comprises an alpha-hydroxy acid. In some embodiments, the alpha-hydroxy acid is present in an amount ranging from about 0.01% by weight to about 5% by weight based on the total weight of the composition. In one or more embodiments, the volatile emollient is selected from cyclopentasiloxane, dimethicone, isoparaffin fraction (C9-C16), ethyl trisiloxane, trisiloxane and caprylyl polymethicone, isododecane and combinations thereof. In some embodiments, the composition further comprises processed oat ingredients. In one or more embodiments, the processed oat ingredients are selected from oat extract, colloidal oatmeal, oat oil, fermented oats, avenamide, beta-glucan, modified oat grain materials and combinations thereof. In some embodiments, the processed oat ingredients are present in an amount ranging from about 0.01 wt % to about 30 wt % by the total weight of the composition. In one or more embodiments, the cool sensation lasts at least 5 minutes. In some embodiments, the composition is in the form of a lotion, gel or cream product. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 is the thermal image of the skin at baseline;

[0023] Figure 2 According to one or more embodiments of the present invention Figure 1 Thermal image of the same skin immediately after treatment with the control;

[0024] Figure 3 is a thermal image of the same skin as in the previous figure 5 minutes after treatment;

[0025] Figure 4 is a thermal image of the same skin as in the previous figure 10 minutes after treatment;

[0026] Figure 5 is a thermal image of the same skin as in the previous figure 15 minutes after treatment;

[0027] Figure 6 is a graph of qPCR copy numbers by group for Staphylococcus aureus;

[0028] Figure 7 is a graph of qPCR copy numbers by group for Staphylococcus epidermidis;

[0029] Figure 8 is a graph of the average qPCR copy number of Staphylococcus epidermidis:Staphylococcus aureus by group;

[0030] Fig. 9 is a graph of the relative abundance of Staphylococcus to other genera at the genus level;

[0031] Fig.10 is a graph of the species-level relative abundance of S. epidermidis , S. aureus , and S. hominis compared with other species;

[0032] Fig.11 is a graph of α-diversity: Chao1 richness at the genus level;

[0033] Fig.12 is α-diversity: a graph of Shannon diversity at the genus level;

[0034] Fig.13 is α-diversity: a graph of Simpson diversity at the genus level;

[0035] Fig.14 is a graph of α-diversity: species-level Chao1 richness;

[0036] Fig.15 is α-diversity: a graph of species-level Shannon diversity;

[0037] Fig.16 is α-diversity: a graph of species-level Simpson diversity;

[0038] Fig.17 is a graph of in vitro bacterial competition between colloidal oatmeal, oat extract, and glycerin; and

[0039] Fig.18 is a graph of in vitro bacterial competition for colloidal oatmeal, oat extract, oat oil, lactic acid, and combination treatments. DETAILED DESCRIPTION

[0040] It is believed that one skilled in the art can utilize the present invention to its fullest extent based on the description herein.The following specific embodiments are to be construed as merely illustrative, and not limitative of the remainder of the disclosure in any way whatsoever.

[0041] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs. In addition, all publications, patent applications, patents and other references mentioned herein are incorporated by reference.

[0042] Unless otherwise indicated, percentages used to express the amount of an ingredient are weight percentages (referred to as "weight %", "wt %", "weight %" or "% (W / W)"). Similarly, weight ratios used to express the relative proportions of ingredients are also determined using weight percentages (i.e., the weight ratio is calculated by dividing the weight percentage of one ingredient by the weight percentage of another ingredient). Unless otherwise stated, all ranges are inclusive, e.g., "4 to 9" includes the endpoints 4 and 9.

[0043] As used herein, "cosmetically acceptable" means that the ingredients described by the term are suitable for use in contact with tissue (eg, skin or hair) without undue toxicity, incompatibility, instability, irritation, allergic response, and the like.

[0044] As used herein, the term "safe and effective amount" means an amount sufficient to cause the desired effect but low enough to avoid serious side effects. The safe and effective amount of a compound, extract or composition will vary with factors such as the age, health and environmental exposure of the end user, the duration and nature of the treatment, the specific extract, ingredient or composition employed, and the specific carrier used.

[0045] As used herein, the term "about" means within 5 weight %, within 4 weight %, within 3 weight %, within 2.5 weight %, within 2 weight %, or within 1 weight % of the disclosed value.

[0046] One aspect of the present invention relates to a composition suitable for use on skin suffering from eczema, the composition comprising: (a) an alpha hydroxy acid; (b) a volatile emollient; and (c) a processed oat component. It has been surprisingly found that such a composition is able to improve the cosmetic appearance, skin barrier properties and hydration of skin suffering from eczema.

[0047] In particular, it has been surprisingly found that alpha-hydroxy acids, in particular lactic acid, are well tolerated by skin suffering from eczema. Therefore, another aspect of the invention relates to a method for improving the appearance of skin suffering from eczema, the method comprising applying a composition comprising lactic acid to skin suffering from eczema. As used herein, the term "improving the appearance of skin suffering from eczema" refers to improving one or more of the visual symptoms of skin suffering from eczema (e.g., dry papules, crusting and scaling, etc.), in particular skin color.

[0048] Additionally, it has been surprisingly found that volatile emollients, particularly isododecane, are sufficient to provide a cooling sensation that is mild enough to skin suffering from eczema. Accordingly, another aspect of the present invention relates to a method of providing a cooling sensation to skin suffering from eczema, the method comprising applying to skin suffering from eczema a composition comprising isododecane.

[0049] Alpha Hydroxy Acids

[0050] Alpha hydroxy acids are compounds containing carboxylic acids substituted with hydroxyl groups on adjacent carbon atoms. Examples of alpha hydroxy acids include, but are not limited to, glycolic acid, lactic acid, malic acid, tartaric acid, pyruvic acid, mandelic acid, or any combination of any of the foregoing. In some embodiments, the alpha hydroxy acid comprises lactic acid. The suitability of alpha hydroxy acids, particularly lactic acid, is surprising because such acids are generally considered to be too irritating for skin with eczema.

[0051] The alpha-hydroxy acid may be present in an amount ranging from about 0.01%, 0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, or 5% to about 1.0%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, or 5% by weight of the total composition. In one or more embodiments, the alpha-hydroxy acid is present in an amount ranging from about 0.01% to about 5% by weight based on the total weight of the composition. In some embodiments, the alpha-hydroxy acid is present in an amount ranging from about 0.1% to about 4% by weight based on the total weight of the composition. In one or more embodiments, the alpha hydroxy acid is present in an amount ranging from about 0.5 wt % to about 2 wt % by total weight of the composition. In some embodiments, the alpha hydroxy acid is present in an amount ranging from about 0.5 wt % to about 1.5 wt % by total weight of the composition. In one or more embodiments, the alpha hydroxy acid is present in an amount ranging from about 0.75 wt % to about 1.5 wt % by total weight of the composition. In some embodiments, the alpha hydroxy acid is present in an amount ranging from about 1 wt % to about 1.5 wt % by total weight of the composition.

[0052] In one or more embodiments, alpha-hydroxy acid includes lactic acid. Lactic acid can be present in the amount of the following range: about 0.01% by weight, 0.05% by weight, 0.1% by weight, 0.2% by weight, 0.3% by weight, 0.4% by weight, 0.5% by weight, 0.6% by weight, 0.7% by weight, 0.8% by weight, 0.9% by weight, 1.0% by weight, 1.5% by weight, 2% by weight, 2.5% by weight, 3% by weight, 3.5% by weight, 4% by weight, 4.5% by weight or 5% by weight of the total composition to about 1.0% by weight, 1.5% by weight, 2% by weight, 2.5% by weight, 3% by weight, 3.5% by weight, 4% by weight, 4.5% by weight or 5% by weight. In one or more embodiments, lactic acid is present in an amount in the range of about 0.01% by weight to about 5% by weight by the total weight of the composition. In some embodiments, lactic acid is present in an amount in the range of about 0.1% by weight to about 4% by weight by the total weight of the composition. In one or more embodiments, lactic acid is present in an amount ranging from about 0.5 wt % to about 2 wt % by the total weight of the composition. In some embodiments, lactic acid is present in an amount ranging from about 0.5 wt % to about 1.5 wt % by the total weight of the composition. In one or more embodiments, lactic acid is present in an amount ranging from about 0.75 wt % to about 1.5 wt % by the total weight of the composition. In some embodiments, lactic acid is present in an amount ranging from about 1 wt % to about 1.5 wt % by the total weight of the composition.

[0053] Volatile emollients

[0054] As used herein, "volatile emollient" refers to an emollient whose flash point is within 15 ° C of the skin temperature, and therefore does not persist on the skin after application. Volatile emollients can act as cooling agents to provide a cooling sensation to the user's skin and will evaporate easily. Although it is not desired to be bound by any particular theory, it is believed that volatile emollients provide a cooling sensation on the skin only due to the evaporation of ingredients from the skin. It is believed that when the time required for the evaporation of ingredients is longer, there is a higher cooling effect. According to one or more embodiments, the composition may include a volatile emollient, such as isododecane. Other examples of volatile emollients may include cyclopentasiloxane, dimethicone, isoparaffin fractions (C9-C16), ethyl trisiloxane, trisiloxane and caprylyl polymethicone. In some embodiments, the volatile emollient includes isododecane.

[0055] The volatile emollient can be present in the amount of the following range: about 0.01% by weight, 0.05% by weight, 0.1% by weight, 0.2% by weight, 0.3% by weight, 0.4% by weight, 0.5% by weight, 0.6% by weight, 0.7% by weight, 0.8% by weight, 0.9% by weight, 1.0% by weight, 1.5% by weight, 2% by weight, 2.5% by weight, 3% by weight, 3.5% by weight, 4% by weight, 4.5% by weight or 5% by weight to about 5% by weight, 5.5% by weight, 6% by weight, 6.5% by weight, 7% by weight, 8% by weight, 9% by weight, 10% by weight, 11% by weight or 12% by weight of the total composition. In one or more embodiments, the volatile emollient is present in an amount in the range of about 0.1% by weight to about 10% by weight of the total composition. In some embodiments, the volatile emollient is present in an amount in the range of about 0.1% by weight to about 5% by weight of the total composition. In one or more embodiments, the volatile emollient is present in an amount in the range of about 0.5 wt % to about 5 wt % by the total weight of the composition. In some embodiments, the volatile emollient is present in an amount in the range of about 0.5 wt % to about 4 wt % by the total weight of the composition. In one or more embodiments, the volatile emollient is present in an amount in the range of about 0.5 wt % to about 3 wt % by the total weight of the composition. In some embodiments, the volatile emollient is present in an amount in the range of about 1 wt % to about 3 wt % by the total weight of the composition. In one or more embodiments, the volatile emollient is present in an amount in the range of about 1.5 wt % to about 2.5 wt % by the total weight of the composition. In some embodiments, the volatile emollient is present in an amount in the range of about 1.75 wt % to about 2.25 wt % by the total weight of the composition. In one or more embodiments, the volatile emollient is present in an amount in the range of about 2 wt % by the total weight of the composition.

[0056] In one or more embodiments, volatile emollients include isododecane. Isododecane can be present in the amount of the following range: about 0.01% by weight, 0.05% by weight, 0.1% by weight, 0.2% by weight, 0.3% by weight, 0.4% by weight, 0.5% by weight, 0.6% by weight, 0.7% by weight, 0.8% by weight, 0.9% by weight, 1.0% by weight, 1.5% by weight, 2% by weight, 2.5% by weight, 3% by weight, 3.5% by weight, 4% by weight, 4.5% by weight or 5% by weight to about 5% by weight, 5.5% by weight, 6% by weight, 6.5% by weight, 7% by weight, 8% by weight, 9% by weight, 10% by weight, 11% by weight or 12% by weight of the total composition. In one or more embodiments, isododecane is present in the amount in the range of about 0.1% by weight to about 10% by weight by the total weight of the composition. In some embodiments, isododecane is present in an amount ranging from about 0.1% by weight to about 5% by weight by the total weight of the composition. In one or more embodiments, isododecane is present in an amount ranging from about 0.5% by weight to about 5% by weight by the total weight of the composition. In some embodiments, isododecane is present in an amount ranging from about 0.5% by weight to about 4% by weight by the total weight of the composition. In one or more embodiments, isododecane is present in an amount ranging from about 0.5% by weight to about 3% by weight by the total weight of the composition. In some embodiments, isododecane is present in an amount ranging from about 1% by weight to about 3% by weight by the total weight of the composition. In one or more embodiments, isododecane is present in an amount ranging from about 1.5% by weight to about 2.5% by weight by the total weight of the composition. In some embodiments, isododecane is present in an amount ranging from about 1.75% by weight to about 2.25% by weight by the total weight of the composition. In one or more embodiments, isododecane is present in an amount ranging from about 2% by weight by the total weight of the composition.

[0057] Processed oat ingredients

[0058] As used herein, the term "processed oat ingredients" refers to ingredients that are generally derived from a part of the oat plant (oat). The ingredient can be a processing (e.g., extraction, grinding, fermentation) of one or more parts of the oat plant (e.g., grains, leaves, stems, seeds), or a molecule found in the oat plant (e.g., β-glucan, flavonoids, avenamide, lipids, peptides, etc.). This definition is intended to cover processed oat ingredients derived from sources other than oats (e.g., from another plant or chemical synthesis) but otherwise related to oats. In one or more embodiments, the processed oat ingredients are selected from oat extracts, colloidal oat flour, oat flour, oat bran, oat protein, oat peptides, oat oil, fermented oats, avenamide, β-glucan, modified oat grain materials (e.g., chemically modified, enzymatically modified, microbially modified), and combinations thereof. As used herein, "colloidal oat flour" refers to a powder obtained by grinding and further processing whole oat grains that meets the standards of U.S. No. 1 or No. 2 oats. Colloidal oatmeal powder has a particle size distribution of no more than 3% of the total particles exceeding 150 microns, and no more than 20% of the total particles exceeding 75 microns. Examples of suitable colloidal oatmeal powders include, but are not limited to, "Tech-0" purchased from Beacon Corporation and colloidal oatmeal powder purchased from Quaker. In one or more embodiments, the processed oat ingredients include oat extract, colloidal oat powder, and oat oil. In some embodiments, the processed oat ingredients include oat extract. In one or more embodiments, the processed oat ingredients include colloidal oat powder. In some embodiments, the processed oat ingredients include oat oil. In some embodiments, the processed oat ingredients are selected from oat extract, colloidal oat powder, oat oil, and combinations thereof. In some embodiments, the processed oat ingredients include oat extract, colloidal oat powder, and oat oil. In one or more embodiments, the processed oat ingredients include avenamide. In some embodiments, the processed oat ingredients include fermented oats. In one or more embodiments, the processed oat component includes beta-glucan.

[0059] The processed oat component can be present in an amount ranging from about 0.01%, 0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, or 5% to about 5%, 5.5%, 6%, 6.5%, 7%, 8%, 9%, 10%, 11%, 12%, 15%, 20%, 25%, or 30% by weight of the total composition. In one or more embodiments, the processed oat component is present in an amount ranging from about 0.1% to about 10% by weight based on the total weight of the composition. In some embodiments, the processed oat component is present in an amount ranging from about 0.1% by weight to about 5% by weight by the total weight of the composition. In one or more embodiments, the processed oat component is present in an amount ranging from about 0.5% by weight to about 5% by weight by the total weight of the composition. In some embodiments, the processed oat component is present in an amount ranging from about 0.5% by weight to about 4% by weight by the total weight of the composition. In one or more embodiments, the processed oat component is present in an amount ranging from about 0.5% by weight to about 3% by weight by the total weight of the composition. In some embodiments, the processed oat component is present in an amount ranging from about 1% by weight to about 3% by weight by the total weight of the composition. In one or more embodiments, the processed oat component is present in an amount ranging from about 1% by weight to about 2% by weight by the total weight of the composition. In some embodiments, the processed oat component is present in an amount ranging from about 1% by weight to about 2% by weight by the total weight of the composition. In one or more embodiments, the processed oat component is present in an amount ranging from about 2% by weight by the total weight of the composition.

[0060] In one or more embodiments, the processed oat component comprises colloidal oatmeal powder, and the colloidal oatmeal powder is present in an amount of about 0.5% by weight to about 3% by weight by the total weight of the composition. In some embodiments, colloidal oatmeal powder is present in an amount of about 1% by weight to about 3% by weight by the total weight of the composition. In one or more embodiments, colloidal oatmeal powder is present in an amount of about 1% by weight to about 2% by weight by the total weight of the composition. In some embodiments, colloidal oatmeal powder is present in an amount of about 1% by weight to about 2% by weight by the total weight of the composition. In one or more embodiments, colloidal oatmeal powder is present in an amount of about 2% by weight by the total weight of the composition.

[0061] In some embodiments, the processed oat component includes oat extract, colloidal oat flour, and oat oil, and the total amount of these three components can be present in an amount ranging from about 0.01%, 0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, or 5% to about 5%, 5.5%, 6%, 6.5%, 7%, 8%, 9%, 10%, 11%, 12%, 15%, 20%, 25%, or 30% by weight of the total composition. In one or more embodiments, the total amount of oat extract, colloidal oat flour and oat oil is present in an amount in the range of about 0.1 wt % to about 10 wt % by the total weight of the composition. In some embodiments, the total amount of oat extract, colloidal oat flour and oat oil is present in an amount in the range of about 0.1 wt % to about 5 wt % by the total weight of the composition. In one or more embodiments, the total amount of oat extract, colloidal oat flour and oat oil is present in an amount in the range of about 0.5 wt % to about 5 wt % by the total weight of the composition. In some embodiments, the total amount of oat extract, colloidal oat flour and oat oil is present in an amount in the range of about 0.5 wt % to about 4 wt % by the total weight of the composition.

[0062] Other Ingredients

[0063] Any of the compositions described herein may also include any of a variety of additional other adjuncts conventionally used in health / personal care compositions (generally referred to as "personal care components"). These other personal care components non-exclusively include one or more pearlescent agents or sunscreens, conditioning agents, humectants, chelating agents, active substances, exfoliants, and additives that enhance the appearance, feel, and fragrance of the composition, such as colorants, fragrances, preservatives, pH adjusters, rheology modifiers, etc. Such adjuncts (when present) will be cosmetically / dermatologically acceptable and present in a safe and effective amount. In one or more embodiments, any composition described herein may also include one or more dermatologically acceptable ingredients selected from thickeners, humectants, skin conditioning agents, additional emollients (i.e., other than volatile emollients), emulsifiers, and combinations thereof.

[0064] Any of a variety of commercially available humectants is suitable for use in the present invention. A humectant is meant to be a compound (e.g., a hygroscopic compound) that is intended to increase the water content of the top layer of the skin. Examples of suitable humectants include those found in Chapter 35, pp. 399-415, in Humectants (edited by A. Barel, M. Paye, and H. Maibach, published in 2001 by Marcel Dekker (Inc New York, NY) (G Zocchi's Skin Feel Agents), and include, but are not limited to, glycerol, sorbitol, or trehalose (e.g., α, α-trehalose, β, β-trehalose, α, β-trehalose) or salts or esters thereof (e.g., trehalose 6-phosphate).

[0065] When present, the humectant can be present in an amount of about 1% to about 30%, about 1 to about 20%, about 2% to about 15%, about 5% to about 15%, about 10% to about 15%, about 12% to about 15%, about 13% to about 15%, or about 14% by weight of the total composition. In one or more embodiments, the humectant includes glycerin and is present in an amount of about 1% to about 30%, about 1 to about 20%, about 2% to about 15%, about 5% to about 15%, about 10% to about 15%, about 12% to about 15%, about 13% to about 15%, or about 14% by weight of the total composition.

[0066] Any of a variety of skin conditioning agents are suitable for use in the present invention. Examples include glycols (e.g., caprylyl glycol), cationic surfactants (e.g., cetyltrimonium chloride, stearamidopropyl dimethylamine, distearyldimonium chloride, laurylmethyl gluceth-10 hydroxypropyldimonium chloride); cationic polymers (e.g., cationically modified polysaccharides including polyquaternium-10, polyquaternium-24, polyquaternium-67, starch hydroxypropyltrimonium chloride, guar hydroxypropyltrimonium chloride, and hydroxypropylguar hydroxypropyltrimonium chloride), and (co)polymers derived from ethylenically unsaturated cationic monomers and optionally hydrophilic monomers. Cationic polymers, the hydrophilic monomers include polyquaternium-5, polyquaternium-6, polyquaternium-7, polyquaternium-11, polyquaternium-14, polyquaternium-15, polyquaternium-28, polyquaternium-39, polyquaternium-44, polyquaternium-76); silicones and silicone derivatives (e.g., polydimethylsiloxane and its derivatives, such as alkyl-, polyalkyleneoxy-, cationic-, anionic modified polydimethylsiloxane (co)polymers); and emollients (e.g., caprylic / capric triglyceride, petrolatum, di-PPG-2 myreth-10 adipic acid).

[0067] Additional emollients include compounds that help maintain the soft, smooth and pliable appearance of the skin (e.g., by remaining on the skin surface or in the stratum corneum to act as a lubricant). Examples of suitable emollients include those found in Handbook of Cosmetic Science and Technology (edited by A. Barel, M. Paye and H. Maibach, published by Marcel Dekker (New York, NY) in 2001, Chapter 35, pages 399-415 (Skin Feel Agent by G Zocchi), and include, but are not limited to, esters (e.g., isopropyl palmitate), petrolatum, hexyldecyl stearate, and vegetable, nut and plant oils and butters, such as avocado butter, candelilla wax; hydrogenated vegetable oils, macadamia nut oil, rice bran oil, grapeseed oil, palm oil, evening primrose oil, hydrogenated peanut oil, and avocado oil.

[0068] Compositions useful in the present invention may also include any of a variety of conventional thickeners. Examples of such thickeners include: carbomers (e.g., CARBOPOL ULTREZ 30 polymer), cetyl alcohol, electrolytes (e.g., sodium chloride, ammonium chloride, magnesium chloride); polysaccharides of natural origin (e.g., xanthan gum, dehydrogenated xanthan gum, guar gum, cassia gum, carrageenan, alginic acid and alginate gum (algin, calcium alginate, etc.), gellan gum, pectin, microcrystalline cellulose); derivatives of natural polysaccharides (e.g., hydroxyethyl cellulose, ethyl hydroxyethyl cellulose, cetyl hydroxyethyl cellulose, methyl cellulose, hydroxypropyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl guar gum, carboxymethyl hydroxypropyl guar gum, C18-22 hydroxyalkyl hydroxypropyl guar gum); alkali swellable emulsion (ASE) polymers (e.g., acrylate copolymers, available under the trade name AQUA SF-1 is commercially available from Noveon Consumer Specialties, Brecksville, Ohio, USA, and acrylate copolymers are available under the trade name Aculyn TM 33 is commercially available from Dow Personal Care, Spring House, Pennsylvania, USA; hydrophobically modified alkali swellable emulsion (HASE) polymers (e.g., acrylates / steareth-20 methacrylate copolymer, acrylates / steareth-20 methacrylate crosspolymer, and acrylates / cetoeth-20 itaconate copolymer); hydrophobically modified acid swellable emulsion polymers (e.g., acrylates / aminoacrylates / C10-30 alkyl PEG-20 itaconate copolymer and polyacrylate-1 crosspolymer); hydrophobically modified acrylate crosspolymers, such as those available under the trade name 1382 Acrylates C10-30 Alkyl Acrylate Crosspolymer commercially available from The Lubrizol Corporation, Brecksville, Ohio, USA; sodium polyacrylate (commercially available as COSMEDIA SP) and a hydrophobic non-ethoxylated micellar thickener such as glyceryl oleate, cocamide MIPA, lauryl lactate or sorbitan sesquioctanoate.

[0069] Compositions described herein may contain additional surfactants / emulsifiers, including anionic, cationic, nonionic and amphoteric surfactants. Suitable emulsifiers include emulsifiers derived from olives, such as olive esters. For example, a suitable emulsifier includes Olivem 1000 (sold by Hallstar), which is a combination of olive oil cetyl alcohol esters and olive oil sorbitan esters. Examples of suitable nonionic surfactants include, but are not limited to, fatty alcohol acid or amide ethoxylates, monoglyceride ethoxylates, sorbitan ester ethoxylates, alkyl polyglycosides and mixtures thereof. One suitable nonionic surfactant is a polyoxyethylene derivative of a polyol ester, wherein the polyoxyethylene derivative of the polyol ester (1) is derived from (a) a fatty acid containing from about 8 to about 22, and preferably from about 10 to about 14 carbon atoms, and (b) a polyol selected from sorbitol, sorbitan, glucose, α-methyl glucoside, polyglucose having an average of from about 1 to about 3 glucose residues per molecule, glycerol, pentaerythritol, and mixtures thereof; (2) contains an average of from about 10 to about 120, and preferably from about 20 to about 80 oxyethylene units; and (3) has an average of from about 1 to about 3 fatty acid residues per mole of the polyoxyethylene derivative of the polyol ester.

[0070] Examples of polyoxyethylene derivatives of polyol esters include, but are not limited to, PEG-80, sorbitan laurate, and polysorbate 20. PEG-80 sorbitan laurate (sorbitan laurate monoester ethoxylated with an average of about 80 moles of ethylene oxide) is commercially available from ICI Surfactants (Wilmington, Del.) under the trade designation "Atlas G-4280." Polysorbate 20 (laurate monoester of a mixture of sorbitol and sorbitan anhydride condensed with about 20 moles of ethylene oxide) is commercially available from ICI Surfactants (Wilmington, Del.) under the trade designation "Tween 20."

[0071] Another class of suitable nonionic surfactants includes long chain alkyl glucosides or polyglucosides, which are condensation products of (a) long chain alcohols containing from about 6 to about 22, and preferably from about 8 to about 14 carbon atoms, and (b) glucose or a glucose-containing polymer. The alkyl glucosides have from about 1 to about 6 glucose residues per molecule of the alkyl glucosides. A preferred glucoside is decyl glucoside, which is a condensation product of decyl alcohol and a glucose polymer and is commercially available from Henkel Corporation (Hoboken, NJ) under the trade name "Plantaren 2000".

[0072] The compositions of the present invention may also contain amphoteric surfactants. As used herein, the term "amphoteric" refers to: 1) molecules containing both acidic and basic sites, such as, for example, amino acids containing both amino (basic) and acid (e.g., carboxylic acid, acidic) functional groups; or 2) zwitterionic molecules having both positive and negative charges in the same molecule. The charge of the latter may depend on or be independent of the pH of the composition. The amphoteric surfactants disclosed herein do not contain counterions. Those skilled in the art will readily recognize that, under the pH conditions of the compositions of the present invention, the amphoteric surfactants are electrically neutral due to having balanced positive and negative charges, or they have counterions such as alkali metal counterions, alkaline earth counterions, or ammonium counterions. Examples of amphoteric surfactants suitable for use in the present invention include, but are not limited to, amphoteric carboxylates such as alkyl amphoacetates (mono or di); alkyl betaines; alkyl amidoalkyl betaines; alkyl amidoalkyl sulfobetaines; alkyl amphophosphates; phosphatidyl imidazolines such as phosphobetaines and pyrophosphobetaines; carboxyalkyl alkyl polyamines; alkyl iminodipropionates; alkyl amphoglycolates (mono or di); alkyl amphopropionates (mono or di); N-alkyl β-aminopropionic acids; alkyl polyaminocarboxylates; and mixtures thereof.

[0073] Cationic surfactants suitable for use in the present invention include alkyl quaternary ammonium salts (monoalkyl quaternary ammonium salts, dialkyl quaternary ammonium salts or trialkyl quaternary ammonium salts), benzyl quaternary ammonium salts, ester quaternary ammonium salts, ethoxylated quaternary ammonium salts, alkyl amines and mixtures thereof, wherein the alkyl group has from about 6 carbon atoms to about 30 carbon atoms, preferably from about 8 to 22 carbon atoms. These cationic surfactants can be used in the composition of the present invention in an amount of from about 0.01% to about 18%, or from about 0.05% to about 15%, or from about 0.1% to about 10%, based on the total weight of the composition.

[0074] Examples of suitable chelating agents include those that are capable of protecting and retaining the compositions of the present invention. The chelating agent may include ethylenediaminetetraacetic acid ("EDTA"), such as tetrasodium EDTA, available under the trade name "Versene 100XL" from The Dow Chemical Company of Midland, Michigan, and present in an amount of from about 0% (if not used) to about 0.5% or from about 0.05% to about 0.25%, based on the total weight of the composition.

[0075] Suitable preservatives include, for example, parabens, quaternary ammonium substances, phenoxyethanol, benzoates, sorbitol esters, DMDM ​​hydantoin, and are present in the composition in an amount of about 0% (if not used) to about 1%, or about 0.05% to about 0.5%, based on the total weight of the composition. Preservatives are preferably selected from potassium benzoate, potassium sorbate and combinations thereof. Preservatives can also be combined with other ingredients that provide a synergist effect. An example of such a synergist is caprylyl glyceryl ether, which is an emollient that can provide a synergistic effect to potassium benzoate and / or potassium sorbate. The ratio of preservative to caprylyl glyceryl ether can be about 0.3 to 0.9, preferably 0.6.

[0076] The pH of the composition can be adjusted using pH adjusting agents commonly used in the art. In one or more embodiments, the composition has a pH of about 4.5 to about 5.5. In some embodiments, the pH of the composition ranges from about 3, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8 or 3.9 to about 3.8, 3.9, 4, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9 or 5. In some embodiments, the pH of the composition ranges from about 3 to about 5, or from about 3.5 to about 4.5.

[0077] Exemplary embodiments

[0078] An exemplary composition suitable for use on skin suffering from eczema according to one or more embodiments comprises:

[0079] a.Lactic acid;

[0080] b. isododecane; and

[0081] c. A processed oat ingredient, wherein the processed oat ingredient is selected from oat extract, colloidal oatmeal, oat oil and a combination thereof.

[0082] In other embodiments, the composition comprises:

[0083] a. from about 0.01 wt % to about 3 wt % lactic acid;

[0084] b. from about 0.01 wt % to about 4 wt % isododecane; and

[0085] c. From about 0.01% to about 6% by weight of a combination of oat extract, colloidal oatmeal, and oat oil.

[0086] Product form and packaging

[0087] A variety of product forms and packaging may be applicable to any of the compositions described herein. As used herein, a "product" is optionally in the form of a finished package. In one embodiment, the package is a container, such as a plastic, metal or glass tube or can, that holds the composition. In one or more embodiments, the composition may be squeezed or pumped out of the container. The product may also contain additional packaging, such as a plastic or cardboard box for storing such containers. In one or more embodiments, the product comprises a composition of the present invention and contains instructions for instructing the user to apply the composition to the skin.

[0088] Any of the compositions that can be in the form of an emulsion, including but not limited to oil-in-water, water-in-oil, water-in-oil-in-water, and oil-in-water-in-silicone emulsions, can be used herein. These emulsions can cover a range of viscosities, for example, from about 100 cps to about 200,000 cps. Two types of viscosity measurements are mentioned in this application: A) "rheometer viscosity", which is measured at 25°C in a rheometer at 20 s -1 The viscosity of the rheometer is the steady state value measured at an applied shear rate of 1000 rpm and B) the "Brookfield viscosity" measured after 1 minute at 25°C in a 4 ounce jar using spindle RV#4 or RV#5 at 5 RPM or 10 RPM. Unless otherwise stated, the viscosity mentioned is the rheometer viscosity.

[0089] In one or more embodiments, the compositions described herein may be in the form of lotions, gels, or cream products. Lotions, gels, and cream products may advantageously have properties that allow the composition to flow and be applied to the skin. Such products are typically thin enough to allow volatile emollients to evaporate and provide a cooling effect. If too thick, as with ointments, sealants, or patches, the user may not feel the cooling effect.

[0090] In one or more embodiments, the compositions described herein are in the form of lotions. As used herein, the term "lotion" means a predominantly aqueous topical preparation having a light texture and a refreshing watery feel, with a viscosity of about 1,000 cPs to 4,000 cPs. In addition to a solvent, a lotion or serum typically includes at least one emollient. The lotion / serum may include about 1% to about 20% (e.g., about 5% to about 10%) of an emollient and about 50% to about 90% (e.g., about 60% to about 80%) of water.

[0091] In one or more embodiments, the composition described herein is in the form of a cream. As used herein, the term "cream" means a rich, mainly aqueous topical preparation having a viscosity of about 2,000 cPs to 8,000 cPs. Creams typically contain about 5% to about 50% (e.g., about 10% to about 20%) of an emollient and about 45% to about 85% (e.g., about 50% to about 75%) of water.

[0092] Lotions and creams can be formulated as emulsions. Typically such lotions contain 0.5% to about 5% emulsifier, while such creams will typically contain about 1% to about 20% (e.g., about 5% to about 10%) of an emollient; about 20% to about 80% (e.g., 30% to about 70%) of water; and about 1% to about 10% (e.g., about 2% to about 5%) of an emulsifier.

[0093] Oil-in-water and water-in-oil single-phase emulsion skin care formulations (such as lotions and creams) are well known in the art and can be used in the subject invention. Multiphase emulsion compositions, such as water-in-oil-in-water or oil-in-water-in-oil, can also be used in the subject invention. Generally speaking, such single emulsions or multiphase emulsions contain water, emollients and emulsifiers as main ingredients.

[0094] The compositions of the present invention may also be formulated as gels. As used herein, the term "gel" means a rich, predominantly aqueous topical preparation that contains a dispersed polymer and exhibits a yield value of about 0.1 Pa or more. The gel may contain a gelling agent. Such gels typically contain about 0.1% to 5% by weight of such a gelling agent.

[0095] The compositions of the present invention may also be formulated as solid formulations (eg, wipes). The compositions of the present invention may also be combined with and / or impregnated onto solid, semisolid or dissolvable substrates (eg, wipes, masks, pads, gloves or tapes).

[0096] The compositions described herein can be provided to consumers in containers (e.g., bottles, tubes, etc.). Individual packages enclosing measured portions of the composition can also be used. To dispense the composition from the bottle, a pump, a squeezable valve, or a removable screw cap can be used.

[0097] method

[0098] Various methods described herein involve topically applying one or more of the compositions described to skin affected by eczema. As described above, the compositions can be used to treat skin suffering from eczema, to improve the appearance of skin suffering from eczema, and / or to provide a cooling sensation to skin suffering from eczema.

[0099] Any suitable method of topically applying the compositions described herein to skin in need can be used. As used herein, "topical application" means applying or wiping directly on the outer skin by hand or an applicator (such as a wipe, roller, or sprayer). For example, the composition can be applied to the skin in need by applying it directly from the package to the skin in need by hand, or can be transferred from a substrate such as a wipe or a mask, or a combination of two or more thereof. In other embodiments, the composition can be applied via a dropper, a tube, a roller, a sprayer, or added to a bathtub or otherwise added to water for application to the skin, etc. Such topical application can be for any skin on the body that needs treatment, such as the skin of the face, lips, neck, chest, back, buttocks, arms, armpits, and / or legs.

[0100] Skin suffering from eczema may include mild to moderate eczema. Compositions as described herein may be applied to the lesion area on the skin suffering from eczema. The lesion area may be an area showing symptoms selected from the following: erythema, pruritus, exudation, scratches, lichenification, dryness, rough touch, abnormal skin tone, burning, stinging and combinations thereof. In some embodiments, the composition is applied to the face or body. The composition may be applied to the skin as needed, or otherwise used at a frequency desired by the user. In one or more embodiments, the composition is applied once or twice a day.

[0101] Example

[0102] Example 1: Preparation of the composition

[0103] The test composition was prepared by first adding water to the container. The colloidal oatmeal was then stirred into the water with continuous mixing, followed by the lactic acid and carbomer, ensuring a uniform mixture after the addition of each ingredient. The mixture was heated to 75°C-80°C while adding caprylyl glycol until uniform. Half of the glycerin and sodium polyacrylate were premixed together until uniform and then added to the main container at 75°C-80°C. Next, each of the following materials was added to the container while continuously mixing and maintaining the temperature at 75°C-80°C: olive oil cetyl alcohol ester, olive oil sorbitan ester (Olivem1000), cetyl alcohol, candelilla wax, hydrogenated vegetable oil, vegetable oil (Cegesoft VP), avocado butter, isopropyl palmitate, isododecane, and oat kernel oil. Continuous mixing was continued until the batch was uniform, and then the temperature was cooled to 68°C-75°C for a minimum of 5 minutes. The temperature was then allowed to begin cooling while the other half of the glycerin was added. Once the batch has cooled to 40°C or below, add the following materials with continuous mixing until uniform: water, glycerin, oat kernel extract (Dragocalm), 1,2-hexanediol, caprylyl glycol, and tropolone (Symdiol 68T). Once the mixture has cooled to 35°C or below, test the pH and adjust to 4.8 with 50% w / w aqueous sodium hydroxide solution. Finally, homogenize the mixture and transfer to a container for storage. See Table 1 below for the final composition.

[0104] Table 1

[0105]

[0106] 1.100% Isododecane

[0107] 2.100% glycerol

[0108] 3.100% Oat Kernel Oil

[0109] 4.0.55% oat kernel extract, 49.625% glycerol, 49.625% water, 0.2% potassium sorbate

[0110] 5.100% Colloidal Oatmeal Powder

[0111] 6.90% lactic acid, 10% water

[0112] 7.100% Isopropyl Palmitate

[0113] 8.3% candelilla wax, 10% hydrogenated vegetable oil; 87% vegetable oil

[0114] 9.100% Caprylyl Glycol

[0115] 10.49.5% 1,2-hexanediol, 49.5% octyl glycol, 1% tropolone

[0116] 11. 100% Avocado Butter

[0117] 12.100% Carbomer

[0118] 13.100% Cetyl Alcohol

[0119] 14.60% Cetyl Olive Oil Esters, 40% Sorbitan Olive Oil Esters

[0120] 15.89% sodium polyacrylate, 11% water

[0121] 16.100% Sodium Hydroxide

[0122] Example 2: Clinical study

[0123] A single-center, single-arm clinical trial was conducted to evaluate the efficacy and perceived benefit of the test composition on pruritus, as well as tolerability, when applied to target eczema lesions in subjects with mild to moderate eczema. The study was conducted by the principal investigator, who is a board-certified dermatologist.

[0124] The study included a variety of demographics, including age, sex, ethnicity, race, skin type, and skin color. Exclusion criteria included having skin conditions that could interfere with study results, such as severe eczema, psoriasis, rosacea, rash, multiple and / or severe scratching, etc.; using Class I-III topical corticosteroids or systemic medications that can have direct or indirect effects on eczema; or having known allergies or adverse reactions to common skin care ingredients. Inclusion criteria included subjects with mild to moderate eczema severity grade (Rajka and Langeland Severity Index) at Visit 1, at least one target eczema lesion area at Visit 1, with a score of 5-12 on the Atopic Dermatitis Severity Index (ADSI), and mild or moderate erythema. Thirty-five subjects completed study participation.

[0125] The subjects were also instructed to wash and remove all topical products on the eczema lesion area at least 2-3 hours before each visit evaluation. During the study, the subjects applied the test composition to the selected target lesions at least twice a day (once in the morning and once in the evening) according to the instructions. After completing the baseline evaluation, the subjects performed the first application of the test composition in situ on the target lesions.

[0126] Clinical evaluation was performed at Visit 1 (baseline), Visit 2 (Day 3), Visit 3 (Week 1 / Day 7) and Visit 4 (Week 2 / Day 14). The principal investigator (PI) evaluated the effectiveness of the test composition by grading the various endpoints discussed in the eczema lesions of the subject using the Atopic Dermatitis Severity Index (ADSI). The ADSI score reported is the sum of each score. In addition, the dryness, tactile roughness and skin tone of the target lesions of the subject compared with the normal overall skin tone were evaluated. Finally, the PI assessed the tolerance of the target lesions of the subject to overall stimulation, and required each subject to rate the degree of burning / stinging sensation on the target eczema lesions. The scoring criteria are shown in Table 2-6.

[0127] Table 2

[0128]

[0129] Table 3

[0130]

[0131]

[0132] Table 4

[0133]

[0134] Table 5

[0135]

[0136] Table 6

[0137]

[0138] The average scores for each assessment are reported in Table XX below.

[0139] Table 7

[0140]

[0141] *All measures showed statistically significant improvements compared to baseline at all time points (p<0.05)

[0142] The overall results of the study shown in Table 7 indicate that the test composition is effective in improving the cosmetic appearance, skin barrier properties and skin hydration of target eczema lesions when used by subjects with mild to moderate eczema over the course of 2 weeks. The performance of the test composition in this study is surprising for a composition containing lactic acid. Dermatologists generally do not recommend the use of lactic acid on eczematous skin because this ingredient is irritating. However, the high tolerance of the test composition comprising lactic acid to eczematous skin, particularly to burning / stinging, itching and irritation as shown herein, is particularly surprising.

[0143] Example 3: Final Product Questionnaire

[0144] After 2 weeks of product use as described in Example 2, patients completed a final self-evaluation questionnaire regarding product performance perception. The results of the product measurements are shown in Table 8. Subjects rated the statements using Strongly Agree, Agree, Neutral, Disagree, and Strongly Disagree.

[0145] Table 8

[0146]

[0147]

[0148] A statistically significantly greater proportion of subjects selected favorable responses (strongly agree and agree) compared to unfavorable responses to the statements (strongly disagree and disagree), as listed in Table 8. Cooling, itching relief, dryness relief with these positive levels of agreement is surprising. In particular, 91% of the subjects agreed or completely agreed with the statement that the tested product provided cooling relief. This is surprising because isododecane is not a known cooling agent and the formulation is well tolerated by patients with eczema. Also considering the results shown in Example 5 below, the cooling effect of isododecane is particularly surprising because it did not provide a cooling effect at the same rate in subjects without eczema as in subjects with eczema. This suggests that isododecane is promising as a mild cooling agent suitable for patients with eczema.

[0149] Example 4 Thermal Imaging Cooling Study

[0150] The test composition and deionized water prepared as described above were applied by the subjects to the palmar side of the forearm. The cooling effect of the test composition was compared with the deionized water as a control. The skin surface temperature at baseline, immediately after application, 5 minutes after application, 10 minutes after application, and 15 minutes after application was captured using a FLIR thermal imaging camera (Teledyne FLIR, Thousand Oaks, California, USA). The temperature range displayed was adjusted to accommodate the baseline skin surface temperature of the subject.

[0151] For each subject, two circular sites of approximately 1" diameter were marked on the forearm of their choice. There was approximately 3" spacing between the two sites. The subjects were allowed to acclimate to ambient temperature for 15 minutes before baseline thermal images were taken.

[0152] The subjects were then instructed to apply the treatment and control to the designated sites as they would normally use personal care products. The subjects were allowed to apply and rub the product to an area larger than the marked site, but were instructed to avoid overlapping the product on their skin. The experiment was repeated for 5 subjects.

[0153] Figures 1 to 5 In the figure, representative thermal images of the gray scale at baseline, immediately after application, 5, 10 and 15 minutes after application are shown respectively. The point marked as 1 is the control, and the point marked as 2 is the test composition. The light gray circular spots marked by 1 and 2 show a cooling effect at 5-10 minutes, but at 15 minutes only spot 2 (test composition) continues to show a cooling effect. The duration of the cooling effect of the test composition and the control varies, and generally the test composition has a longer cooling duration than the control.

[0154] Example 5: Clinical Study of Topical Cream and Gel Cream Using Isododecane in Individuals Without Eczema (contrast)

[0155] As shown in Table 9, a topical gel cream composition (Example 5-1) having the following ingredients was prepared.

[0156] Table 9 :

[0157] Element weight% Purified water Moderate Colloidal Oatmeal 1.00 <![CDATA[Carbomer (Carbomer Ultrez 10 Polymer) 1 > 0.40 Citric Acid Anhydrous USP 0.60 Lidocaine USP 4.00 glycerin 14.00 <![CDATA[Sodium polyacrylate 2 > 0.75 <![CDATA[Isopropyl palmitate 3 > 5.00 <![CDATA[Olive cetyl esters; Olive dehydrated sorbitol esters 4 > 0.50 <![CDATA[Cetyl alcohol 5 > 1.00 <![CDATA[Candelilla wax; hydrogenated vegetable oil; vegetable oil 6 > 2.00 <![CDATA[Isododecane 7 > 4.00 Ginger Root Extract 0.20 <![CDATA[Decylene Glycol 8 > 0.26 <![CDATA[1,2 - hexanediol; caprylyl glycol; tropolone 9 > 0.50 <![CDATA[Chlorphenesin 10 > 0.30

[0158] 1: Commercially available as Ultrez 10 polymer from Lubrizol Corporation

[0159] 2: Yes SP is commercially available from UL Prospector Corporation

[0160] 3: Commercially available as Radia 7732 from Oleon Corporation

[0161] 4: Olivem 1000 is commercially available from Hallstar BPC Corporation

[0162] 5: Vegarol 1698 is commercially available from UL Prospector Corporation

[0163] 6: Commercially available as Cegesoft VP from UL Prospector Corporation

[0164] 7: Permethyl 99A is commercially available from Presperse Corporation

[0165] 8: Hydrolite CG is commercially available from Symrise Corporation

[0166] 9: Symdiol 68T is commercially available from Symrise Corporation

[0167] 10: Germazide C is commercially available from BASF Corporation

[0168] The following mixing steps can be used to prepare Example 5-1:

[0169] a) Add purified water to a suitable container and add colloidal oatmeal while mixing

[0170] b) Add citric acid and lidocaine USP while mixing and mix until dissolved

[0171] c) Add Carbomer while mixing slowly until all lumps are dissolved

[0172] d) Heat the mixture to 75°C-80°C

[0173] e) Add caprylyl glycol and chlorphenesin while mixing and mix until uniform

[0174] f) Then slowly add sodium polyacrylate while mixing at 75℃-80℃ until uniform

[0175] g) Then add the oil phase ingredients (7% glycerin, isopropyl palmitate, cetyl olive oil esters; sorbitan olive oil esters and cetyl alcohol) while mixing

[0176] h) Mix the mixture for 10 minutes and then homogenize at 5000 RPM for 3 minutes

[0177] i) The mixture was cooled to 25°C, and 7% glycerol and isododecane were added and mixed.

[0178] j) Add ginger root extract, 1,2-hexanediol; caprylyl glycol; tropolone and mix until homogeneous.

[0179] k) At 35°C or below, adjust the pH to 6.5 using sodium hydroxide solution or citric acid solution and mix.

[0180] l) Make up the batch to 95%-100% of the theoretical batch weight with water.

[0181] As shown in Table 10, a topical cream composition (Example 5-2) having the following ingredients was prepared.

[0182] Table 10 :

[0183]

[0184]

[0185] 1: Commercially available as Ultrez 10 polymer from Lubrizol Corporation

[0186] 2: Yes SP is commercially available from UL Prospector Corporation

[0187] 3: Commercially available as Radia 7732 from Oleon Corporation

[0188] 4: Olivem 1000 is commercially available from Hallstar BPC Corporation

[0189] 5: Vegarol 1698 is commercially available from UL Prospector Corporation

[0190] 6: Cegesoft BP is commercially available from UL Prospector Corporation

[0191] 7: Permethyl 99A is commercially available from Presperse Corporation

[0192] 8: Commercially available as Carbopol Aqua SF-1 polymer from Lubrizol Corporation

[0193] 9: Hydrolite CG is commercially available from Symrise Corporation

[0194] 10: Available commercially as Symdiol 68T from Symrise Corporation

[0195] 11: Germazide C is commercially available from BASF Corporation. The following mixing steps can be used to prepare the cream of this example:

[0196] a) Add purified water to a suitable container and add colloidal oatmeal while mixing

[0197] b) Add citric acid and lidocaine USP while mixing and mix until dissolved

[0198] c) Add Carbomer while mixing slowly until all lumps are dissolved

[0199] d) Heat the mixture to 75°C-80°C

[0200] e) Add caprylyl glycol and chlorphenesin while mixing and mix until uniform

[0201] f) Then slowly add sodium polyacrylate while mixing at 75℃-80℃ until uniform

[0202] g) Then add the oil phase ingredients (7% glycerin, isopropyl palmitate, cetyl olive oil esters; sorbitan olive oil esters and cetyl alcohol) while mixing

[0203] h) Mix the mixture for 10 minutes and then homogenize at 5000 RPM for 3 minutes

[0204] i) The mixture was cooled to 25°C and isododecane was added and mixed.

[0205] j) Add fragrance, 1,2-hexanediol; caprylyl glycol; tropolone and mix until uniform.

[0206] k) At 35°C or below, adjust the pH to 6.5 using sodium hydroxide solution or citric acid solution and mix.

[0207] l) In a separate container add 5% glycerin and acrylate copolymer and mix until homogeneous to produce acrylate copolymer premix.

[0208] m) Add the acrylate copolymer premix to the mixture from step 11 and mix until uniform.

[0209] Human Use Studies

[0210] Study plan and objectives :

[0211] A human use test (abbreviated as "HUT") was conducted in which 253 consumers (also referred to as "subjects", "patients" or "users") self-applied the formulations in Examples 5-1 and 5-2 (also referred to as "formulations" or "products" in this example) as needed for a period of two weeks. These consumers were between 30 and 55 years old, they regularly or occasionally experienced minor aches and pains in muscles or joints, and they had a range of skin tones and types, some of whom reported having sensitive skin, dry skin and / or eczema.

[0212] Consumers were instructed to use the product within the first two days of receipt and then at least once a week as needed over the next two weeks. Consumers were further instructed to abstain from other pain relief treatments during the two-week period. Consumers provided feedback via an online survey at three time points: 1) after first use, 2) after one week of use, and 3) after two weeks of use.

[0213] Example 5-1 may be referred to as a "calming gel cream" incorporating, for example, ginger, and Example 5-2 may be referred to as a "calming cream" incorporating a suitable calming fragrance, such as lavender.

[0214] The purpose of human use studies is to provide support for potential consumer perception claims centered on the consumer's experience with the product. For example, one purpose is to understand the consumer's experience with a product regarding absorption, concealment, and skin feel.

[0215] Regarding feel, consumers provide feedback on whether the product feels mild and whether the product makes their skin feel moisturized and / or smooth.

[0216] A "test statement" may be a question or a statement of agreement or disagreement answered by the consumer at least once during the duration of the HUT. According to one embodiment, the following test statements may relate to the consumer's experience with product absorption: fast absorption, immediate absorption into the skin, non-greasy and / or does not make the skin shiny. According to one embodiment, the following test statements may relate to the consumer's experience with "hiddenness": light texture, no irritating taste / smell, no unpleasant taste / smell, non-sticky, non-greasy, does not make the skin shiny, has a pleasant taste. According to one embodiment, the following test statements may relate to the consumer's experience with the feel of the product: light texture, non-sticky, non-greasy, immediately moisturizing, makes the skin feel smooth, immediately cool, feel immediately effective and / or immediately numb. Test statements of immediate cooling, immediate effect and / or immediate numbness may indicate pain relief.

[0217] Results Summary :

[0218] The main data is presented in Table 11 and shows the responses described by the consumers, collated as the percentage of users who agreed with the test statements. The overall results and the results for each of Example 5-1 and Example 5-2 are shown.

[0219] Table 11: Results of human use studies

[0220]

[0221] *Not applicable: Formulated without fragrance.

[0222] As can be seen above, the percentage of subjects reporting a cooling effect was 61% for 5-1 and 64% for 5-2. As mentioned above, this study included subjects who did not suffer from eczema. Therefore, the presence of isododecane does not necessarily provide a cooling effect felt at the same rate as in patients with eczema, even when present in amounts as high as 4% and 8%, which is much higher than the 2% present in the formulation of Example 1.

[0223] Example 6: Microbiome Clinical Research

[0224] The clinical study was conducted according to the method described in Example 2. Surface skin microbiomes were collected from the target lesions of each subject at Visit 1 (baseline), Visit 2 (Day 3), Visit 3 (Day 7), and Visit 4 (Day 14). Swab sampling was performed in a 4 cm × 4 cm skin area on the identified target lesions. A sterile swab was immersed in an aliquot of 0.85% sterile saline and the excess liquid was squeezed out by pressing it against the inner wall of the saline tube. While rotating the swab between the thumb and index finger, the side of the swab was wiped across the entire defined area for 60 seconds. More specifically, for each subject, the rotating swab was wiped back and forth in a cross-wise manner in a defined area in the same manner to maintain consistency. The head of each swab was placed in a sterile microcentrifuge tube and aseptically cut off from the handle before closing the lid. The tube was labeled with the protocol ID, subject ID, and visit number. Post-baseline swab sampling was performed at the same location as the baseline.

[0225] On each day of subject sampling, a control swab was collected after the subject swab was collected. A sterile swab was dipped into an aliquot of 0.85% sterile saline and excess liquid was squeezed out by pressing it against the inner wall of the saline tube. Without the polyester tip touching any surface, the head of the swab was placed in a sterile microcentrifuge tube and aseptically cut from the handle before closing the cap. The tube was labeled with the protocol number, date, and "Micro Control" (or equivalent).

[0226] Swabs from each subject and control swabs were frozen at -20°C until shipped on dry ice to an external laboratory designated by the sponsor (CosmosID, Germantown, MD) for DNA extraction and analysis to determine the effects of IP on the skin microbiome. A total of 154 16S samples were used in the analysis. All plots were generated using the 16SOUT assay from the CosmosID Center and adjusted for 16S qPCR abundance, where control abundance was subtracted from all other samples.

[0227] Taxonomic comparative statistical analyses were performed by an external laboratory and included qPCR abundance, relative abundance, alpha diversity, and beta diversity. qPCR abundance is the average abundance of each group and the scaled abundance of each sample. Relative abundance is the average abundance of the highest bacterial species in each group. Alpha diversity is the number and abundance of taxa and the dissimilarity of each group. Beta diversity is the degree of dissimilarity of the entire microbial community and indicates whether the groups are significantly different.

[0228] S. aureus and S. epidermidis were determined by sample and by group. The mean abundance of each group and the scaled abundance of each sample were calculated. Stacked bar plots were generated using matrices filtered at the phylum, genus, and species levels from CosmosID. ​​Stacked bar plots of each group were generated using the R package ggpubr.

[0229] The copy numbers of Staphylococcus aureus and Staphylococcus epidermidis by group are shown in Figure 6 and Figure 7 , while the ratio of the mean S. epidermidis to the mean S. aureus copy number by group is shown in Figure 8 There was no significant change in S. qPCR copy number between baseline and day 14. However, the S. epidermidis qPCR copy number increased significantly between baseline and day 14. Thus, the ratio of S. epidermidis to S. aureus increased between baseline and day 14. These results show that the test composition unexpectedly increased the number of symbiotic S. epidermidis in the sample.

[0230] The relative abundance at the genus level and the relative abundance at the species level are shown in Fig. 9 and Fig.10 There was a visible increase in the genus Staphylococcus relative to other genera between baseline and day 14. At the species level, Staphylococcus epidermidis increased between baseline and day 14, and Staphylococcus aureus decreased slightly between baseline and day 14, also relative to the levels of other species present. Increases were observed in other commensals, including an unexpected increase in the relative abundance of Staphylococcus hominis between baseline and day 14.

[0231] Alpha diversity box plots were calculated based on the genus and species level abundance score matrices from the CosmosID analysis. Chao, Simpson, and Shannon alpha-diversity measures were calculated in R using the R package Vegan. Wilcoxon Rank-Sum tests were performed between groups using the R package ggsignif. Box plots with superimposed significance markers in p-value format were generated using the R package ggplot2. All alpha diversity indices (Chao1, Simpson, and Shannon) increased significantly between baseline and day 14, both at the genus and species level. Fig.11 and Fig.14 ; Shannon, Fig.12 and Fig.15 ; Simpson, Fig.13 and Fig.16 ) showed a significant decrease. The alpha diversity between day 7 and day 14 showed a potential increasing trend: a significant increase was observed between day 7 and day 14 in both the species-level Shannon diversity and Simpson diversity analyses. In general, increasing diversity is considered to be preferred, and therefore the increase is surprising given the very positive clinical results of the above examples.

[0232] Beta diversity principal coordinate analysis was calculated based on matrices filtered at the phylum, genus, and species levels from CosmosID. ​​Bray-Curtis diversity was calculated in R using the R package Vegan with the function vegdist, and the PCoA table was generated using the function pcoa of ape. The PERMANOVA test for each distance matrix was generated using the function adonis2 of vegan. The R package ggpubr was used to visualize the graph. The PERMANOVA results are shown in Table 12 below, and the paired PERMANOVA results are shown in Table 13 below. Significant changes in beta diversity were observed between baseline and day 14, indicating that there were significant differences in the microbial community.

[0233] Table 12: PERMANOVA

[0234] pair Df SumsofSqs R2 F. Model p-value Signif group 3 4.510374 0.08050339 3.881454 0.001 *** Residual 133 51.516758 0.91949661 NA NA NA total 136 56.027132 1.00000000 NA NA NA

[0235] ***: p <= 0.001

[0236] Table 13: Pairwise PERMANOVA

[0237] pair Df SumsofSqs R2 F. Model p-value Signif Baseline vs. Day 3 1 0.5145805 0.01904598 1.300857 0.164 NS Baseline vs. Day 7 1 2.5221164 0.08899577 6.642903 0.001 *** Baseline vs. Day 4 2 2.3654925 0.07872146 2.947958 0.001 ***

[0238] ***: p <= 0.001

[0239] Example 7: In vitro bacterial competition assay

[0240] In vitro bacterial competition assay evaluated the co-cultivation of Staphylococcus epidermidis (ATCC 12228, skin health-related strain) and Staphylococcus aureus (ATCC 6538, human lesion isolate) in the presence of test materials. Percentages are w / v% in liquid culture medium (nutrient broth, Culture Media and Supplies). In order to simulate the microenvironment of the skin surface, an aerobic co-cultivation system of Staphylococcus epidermidis and Staphylococcus aureus was established. In the presence of the test materials specified in Table 14 below, 50 μL of Staphylococcus epidermidis and 50 μL of Staphylococcus aureus (1:1 ratio) were inoculated (50 μL each, about 5.0×10 6 CFU / mL) into nutrient broth.

[0241] Table 14

[0242]

[0243] 1.100% Colloidal Oatmeal Powder

[0244] 2.0.55% oat kernel extract, 49.625% glycerol, 49.625% water, 0.2% potassium sorbate

[0245] 3.100% glycerol

[0246] 4.100% Oat Kernel Oil

[0247] 5.90% lactic acid, 10% water

[0248] 6. Adjust pH to 4.5 with 10% NaOH

[0249] The test groups were incubated aerobically for 24 hours (n=3 per test group). After 24 hours, each test group was plated on agar and incubated for 24 hours with shaking at 200 rpm. After incubation, colonies were counted and CFU / mL was calculated. Staphylococcus epidermidis and Staphylococcus aureus colonies were distinguished on agar (tryptic soy agar + 5% sheep blood, BD Diagnostics) based on representative morphology.

[0250] Fig.17 Depicted are the results of bacterial competition assays for colloidal oatmeal, oat extract, and glycerol (a component in oat extract). 2% oatmeal significantly promoted the growth of Staphylococcus epidermidis compared to untreated. When cultured in the presence of 2% oatmeal, the levels of Staphylococcus epidermidis were significantly greater than those of Staphylococcus aureus.

[0251] Fig.18The results of bacterial competition assays for oat extract, oat flour, oat oil, lactic acid and combinations as described in Table 15 are shown. Compared with untreated, 2% oat flour and 0.5% oat oil each significantly promoted the growth of Staphylococcus epidermidis and Staphylococcus aureus, and the promotion of Staphylococcus epidermidis growth was stronger than that of Staphylococcus aureus. Compared with untreated, 1% oat extract + 2% oat flour significantly promoted the growth of Staphylococcus epidermidis and Staphylococcus aureus, and the promotion of Staphylococcus epidermidis growth was stronger than that of Staphylococcus aureus. Compared with untreated, 2% colloidal oat flour + 1% oat extract + 0.5% oat oil also significantly promoted the growth of Staphylococcus epidermidis and Staphylococcus aureus, and the promotion of Staphylococcus epidermidis growth was stronger than that of Staphylococcus aureus.

[0252] Table 15

[0253]

[0254] The resulting prebiotic activity of the oat flour in Example 6 (significant increase in commensal Staphylococcus epidermidis) is consistent with the bacterial growth rate assay results presented in Example 7. Interestingly, the presence of lactic acid inhibited Staphylococcus epidermidis, a low population of which is associated with atopic dermatitis. These results occurred for lactic acid alone as well as in combination with the three oat components, which showed that the three oat components increased Staphylococcus epidermidis. Therefore, such results are surprising in view of the very positive clinical results of the above examples.

Claims

1. A method of providing a cooling sensation to skin suffering from eczema, the method comprising topically applying a composition comprising isododecane to the skin suffering from eczema.

2. The method of claim 1, wherein the isododecane is present in the composition in an amount ranging from about 0.01 wt % to about 12 wt % based on the total weight of the composition.

3. The method of claim 1 or 2, wherein the skin suffering from eczema comprises mild to moderate eczema.

4. The method according to any one of claims 1 to 3, wherein the composition is applied to the lesion area.

5. The method of any one of claims 1 to 4, wherein the composition is applied to the face or body.

6. The method according to any one of claims 1-5, wherein the composition is administered once or twice daily.

7. The method according to any one of claims 1-6, wherein the lesion area exhibits symptoms selected from the group consisting of erythema, pruritus, exudation, scratching, lichenification, dryness, roughness to touch, abnormal skin tone, burning, stinging, and combinations thereof.

8. The method of any one of claims 1-7, wherein the composition further comprises an alpha-hydroxy acid.

9. The method of any one of claims 1-8, wherein the alpha-hydroxy acid is present in an amount ranging from about 0.01 wt. % to about 5 wt. % based on the total weight of the composition.

10. The method of any one of claims 1-9, wherein the volatile emollient is selected from cyclopentasiloxane, dimethicone, isoparaffin fractions (C9-C16), ethyl trisiloxane, trisiloxane and caprylyl methicone, isododecane, and combinations thereof.

11. The method of any one of claims 1-10, wherein the composition further comprises a processed oat component.

12. The method according to any one of claims 1 to 11, wherein the processed oat component is selected from the group consisting of oat extract, colloidal oat flour, oat oil, fermented oats, avenamide, β-glucan, modified oat grain material, and combinations thereof.

13. The method of any one of claims 1-12, wherein the processed oat component is present in an amount ranging from about 0.01 wt. % to about 30 wt. % based on the total weight of the composition.

14. The method of any one of claims 1-13, wherein the cooling sensation lasts for at least 5 minutes.

15. The method of any one of claims 1-14, wherein the composition is in the form of a lotion, gel or cream product.

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