Compositions suitable for use on skin affected by eczema

Abstract

1. A composition suitable for skin affected by eczema, comprising: a. an alpha hydroxy acid; b. a volatile emollient; and c. a processed oat component. 2. A composition suitable for skin affected by eczema, comprising: a. lactic acid; b. isododecane; and c. a processed oat component selected from the group consisting of oat extract, colloidal oatmeal, oat oil, and combinations thereof. 3. The composition for use in treating eczema.

Description

[Technical Field]

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

[0002] Atopic dermatitis, also known as eczema, is a chronic, recurrent, pruritic inflammation of the skin that can impair quality of life. It affects 10–20% of children and 1–3% of adults worldwide, with increasing prevalence in highly industrialized countries. Atopic dermatitis is characterized by an impaired epidermal barrier, dysregulation of innate and adaptive immunity, and a 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 reactions, remain first-line treatments. Antihistamines can also be administered. If pruritus is unresponsive to standard treatments, antibiotics may be considered.

[0003] Lubricants are effective in keeping the skin hydrated and repairing the skin barrier. However, the cosmetic acceptability of these types of preparations may be poor, which is reflected in the low compliance of patients with atopic dermatitis. Furthermore, this approach is often insufficient by itself. On the other hand, although corticosteroids are powerful drugs, some of them are well known to induce side effects that can be severe when used for a long period of time. Antihistamines can be used to treat the itching associated with atopic dermatitis, but they can cause drowsiness and may not be useful in all cases of atopic dermatitis. Finally, the use of antibiotics is controversial due to the increasing incidence of bacterial resistance.

[0004] Additionally, the treatment ideally addresses the appearance of eczema-affected skin and / or otherwise provides 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. Summary of the Invention [Problem to be solved by the invention]

[0005] Therefore, there is a need for a topical composition that is suitable for use on eczema skin and that can address one or more of the above concerns. [Means for solving the problem]

[0006] One aspect of the present invention is a composition suitable for skin affected by eczema, comprising: a. alpha hydroxy acid; b. a volatile emollient; c. a processed oat ingredient.

[0007] In one or more embodiments, the alpha hydroxy acid is selected from the group consisting of glycolic acid, malic acid, tartaric acid, uric acid, mandelic acid, lactic acid, and combinations thereof. In some 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 one or more embodiments, the volatile emollient is selected from the group consisting of cyclopentasiloxane, dimethicone, isoparaffinic fractions (C9-C16), ethyltrisiloxane, trisiloxane and caprylyl methicone, isododecane, and combinations thereof. In some embodiments, the volatile emollient is present in an amount ranging from about 0.01% to about 12% by weight, based on the total weight of the composition. In one or more embodiments, the processed oat ingredient is selected from the group consisting of oat extract, colloidal oatmeal, oat oil, fermented oats, avenanthramides, β-glucan, modified oat kernel material, and combinations thereof. In some embodiments, the processed oat ingredient is present in an amount ranging from about 0.01% to about 30% by weight, based on the total weight of the composition. In one or more embodiments, the composition further comprises a dermatologically acceptable ingredient selected from the group consisting of thickeners, moisturizers, skin conditioners, emulsifiers, 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, gel, or cream product.

[0008] Another aspect of the present invention is a composition suitable for skin affected by eczema, comprising: Lactic acid and b. Isododecane, c. a processed oat ingredient selected from the group consisting of oat extract, colloidal oatmeal, oat oil, and combinations thereof.

[0009] In one or more embodiments, the composition comprises: a. about 0.01% by weight to about 3% by weight of lactic acid; b. about 0.01% by weight to about 4% by weight of isododecane; c. about 0.01% to about 6% by weight of a combination of oat extract, colloidal oatmeal, and oat oil.

[0010] Another aspect of the present invention relates to a method of treating eczema, comprising topically applying any of the compositions described herein to skin affected by eczema, hi one or more embodiments, the skin affected by eczema comprises mild to moderate eczema.

[0011] Another aspect of the present invention relates to a method for improving the appearance of skin affected by eczema, comprising topically applying to the skin affected by eczema a composition comprising lactic acid. In one or more embodiments, the lactic 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 skin affected by eczema comprises mild to moderate eczema. In one or more embodiments, the composition is applied to the affected 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 daily. In some embodiments, the affected area exhibits symptoms selected from the group consisting of erythema, itching, oozing, peeling, lichenification, dryness, roughness to the touch, abnormal skin tone, burning, stinging, and combinations thereof. In one or more embodiments, the composition further comprises a volatile emollient. In some embodiments, the volatile emollient is selected from the group consisting of cyclopentasiloxane, dimethicone, isoparaffin fractions (C9-C16), ethyltrisiloxane, trisiloxane and caprylyl methicone, isododecane, and combinations thereof. In one or more embodiments, the volatile emollient is present in an amount ranging from about 0.01% to about 12% by weight, based on 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 the group consisting of oat extract, colloidal oatmeal, oat oil, fermented oats, avenanthramides, β-glucan, modified oat kernel material, and combinations thereof. In some embodiments, the processed oat ingredient is present in an amount ranging from about 0.01% to about 30% by weight, based on the total weight of the composition. In one or more embodiments, the composition further comprises a dermatologically acceptable ingredient selected from the group consisting of thickeners, additional emollients, moisturizers, skin conditioners, emulsifiers, and combinations thereof. In some embodiments, the composition is in the form of a lotion, gel, or cream product.

[0012] Another aspect of the present invention relates to a method for providing a cooling sensation to skin affected by eczema, comprising topically applying a composition comprising isododecane to the skin affected by eczema. In one or more embodiments, the isododecane is present in the composition in an amount ranging from about 0.01% to about 12% by weight, based on the total weight of the composition. In some embodiments, the skin affected by eczema has mild to moderate eczema. In one or more embodiments, the composition is applied to the affected 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 daily. In some embodiments, the affected area exhibits symptoms selected from the group consisting of erythema, itching, oozing, peeling, lichenification, dryness, roughness to the touch, abnormal skin tone, a burning sensation, a stinging sensation, 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% to about 5% by weight, based on the total weight of the composition. In one or more embodiments, the volatile emollient is selected from the group consisting of cyclopentasiloxane, dimethicone, isoparaffin fractions (C9-C16), ethyltrisiloxane, trisiloxane and caprylyl methicone, isododecane, and combinations thereof. In some embodiments, the composition further comprises a processed oat component. In one or more embodiments, the processed oat component is selected from the group consisting of oat extract, colloidal oatmeal, oat oil, fermented oats, avenanthramides, β-glucan, modified oat kernel material, and combinations thereof. In some embodiments, the processed oat component is present in an amount ranging from about 0.01% to about 30% by weight, based on the total weight of the composition. In one or more embodiments, the cooling sensation lasts for at least 5 minutes. In some embodiments, the composition is in the form of a lotion, gel, or cream product. [Brief explanation of the drawings]

[0013] [Figure 1] 1 is a thermal image of the skin at baseline. [Figure 2]2 is a thermal image of the same skin as in FIG. 1 immediately after treatment with a control, and in accordance with one or more embodiments of the present invention. [Figure 3] Thermal image of the same skin as in the previous figure 5 minutes after treatment. [Figure 4] Thermal image of the same skin as in the previous figure 10 minutes after treatment. [Figure 5] Thermal image of the same skin as in the previous figure 15 minutes after treatment. [Figure 6] 13 is a chart of qPCR copy numbers by cohort for S. aureus. [Figure 7] 13 is a chart of qPCR copy numbers by cohort for S. epidermidis. [Figure 8] 10 is a chart of mean qPCR copy numbers by cohort for S. epidermidis and S. aureus. [Figure 9] 1 is a chart of the genus-level relative abundance of Staphylococcus relative to other genera. [Figure 10] Figure 10: Chart of species-level relative abundance of Staphylococcus epidermidis, Staphylococcus aureus, and Staphylococcus hominis relative to other genera. [Figure 11] α-Diversity: Chart of Chao1 richness at the genus level. [Figure 12] Alpha-diversity: A chart of Shannon diversity at the genus level. [Figure 13] Alpha-diversity: A chart of Simpson diversity at the genus level. [Figure 14] α-Diversity: A chart of species-level Chao1 abundance. [Figure 15] α-diversity: A chart of species-level Shannon diversity. [Figure 16] α-diversity: A chart of species-level Simpson diversity. [Figure 17] 1 is a chart of in vitro bacterial competition of colloidal oat flour, oat extract, and glycerin. [Figure 18]1 is a chart of in vitro bacterial competition of colloidal oat flour, oat extract, oat oil, lactic acid, and combination treatments. DETAILED DESCRIPTION OF THE INVENTION

[0014] It is believed that one skilled in the art can, based on the description herein, utilize the present invention to its fullest extent. The following specific embodiments are to be construed as merely illustrative, and not limitative of the following disclosure in any way.

[0015] 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 this invention belongs. Furthermore, all publications, patent applications, patents, and other references mentioned herein are incorporated by reference.

[0016] Unless otherwise specified, percentages used to express amounts of ingredients are weight percent (also referred to as "weight %, "wt %, "% by weight", or "% (W / W)"). Similarly, weight ratios used to express relative proportions of ingredients are also determined using weight percent (i.e., the weight ratio is calculated by dividing the weight percent of one ingredient by the weight percent of another ingredient). Unless otherwise specified, all ranges are inclusive of their endpoints; for example, "4 to 9" includes the endpoints 4 and 9.

[0017] As used herein, "cosmetically acceptable" means that the ingredient it describes is suitable for use in contact with tissue (e.g., skin or hair) without undue toxicity, incompatibility, instability, irritation, allergic reaction, etc.

[0018] As used herein, the term "safe and effective amount" means an amount sufficient to induce the desired effect, but small enough to avoid serious side effects. A safe and effective amount of a compound, extract, or composition will vary depending, for example, on the age, health, and environmental exposure of the end user, the duration and nature of the treatment, the particular extract, ingredient, or composition used, the particular carrier employed, and similar factors.

[0019] As used herein, the term "about" refers to within 5%, within 4%, within 3%, within 2.5%, within 2%, or within 1% by weight of the disclosed value.

[0020] One aspect of the present invention relates to a composition suitable for eczema-affected skin, the composition comprising: (a) an alpha hydroxy acid; (b) a volatile emollient; and (c) a processed oat component. Surprisingly, it has been discovered that such a composition can improve the cosmetic appearance, skin barrier properties, and hydration of eczema-affected skin.

[0021] In particular, it has been surprisingly discovered that alpha hydroxy acid, especially lactic acid, is well tolerated by eczema-affected skin.Therefore, another aspect of the present invention relates to a method for improving the appearance of eczema-affected skin, comprising applying a composition comprising lactic acid to eczema-affected skin.As used herein, the term "improving the appearance of eczema-affected skin" refers to improving one or more of the visual symptoms of eczema-affected skin (for example, dry bumps, crusted scales, etc.), particularly skin tone.

[0022] Furthermore, it has surprisingly been discovered that volatile emollients, particularly isododecane, are sufficient to provide a sufficiently mild cooling sensation to skin affected by eczema. Accordingly, another aspect of the present invention relates to a method of providing a cooling sensation to skin affected by eczema, comprising applying to the skin affected by eczema a composition comprising isododecane.

[0023] Alpha hydroxy acids 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, uric acid, mandelic acid, or any combination 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 too harsh for eczema-affected skin.

[0024] 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% by weight 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% to about 2% 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 0.5% to about 1.5% by weight, based on the total weight of the composition. In one or more embodiments, the alpha hydroxy acid is present in an amount of about 0.75% to about 1.5% by weight, based on the total weight of the composition. In some embodiments, the alpha hydroxy acid is present in an amount of about 1% to about 1.5% by weight, based on the total weight of the composition.

[0025] In one or more embodiments, the alpha hydroxy acid comprises lactic acid. Lactic 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% by weight 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, lactic 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, lactic 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, lactic acid is present in an amount ranging from about 0.5% to about 2% by weight, based on the total weight of the composition. In some embodiments, lactic acid is present in an amount ranging from about 0.5% to about 1.5% by weight based on the total weight of the composition. In one or more embodiments, lactic acid is present in an amount ranging from about 0.75% to about 1.5% by weight based on the total weight of the composition. In some embodiments, lactic acid is present in an amount ranging from about 1% to about 1.5% by weight based on the total weight of the composition.

[0026] Volatile emollients As used herein, "volatile emollient" refers to an emollient that has a flash point within 15°C of the skin temperature and therefore does not remain on the skin after application. Volatile emollients can act as a cooling agent, imparting a cooling sensation to the user's skin, and are easily evaporated. While not wishing to be bound by any particular theory, it is believed that volatile emollients impart a cooling sensation to the skin solely due to the evaporation of ingredients from the skin. The longer it takes for an ingredient to evaporate, the greater the 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), ethyltrisiloxane, trisiloxane, and caprylyl methicone. In some embodiments, the volatile emollient includes isododecane.

[0027] The volatile emollient 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 5, 5.5, 6, 6.5, 7, 8, 9, 10, 11, or 12% by weight of the total composition. In one or more embodiments, the volatile emollient 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 volatile emollient is present in an amount ranging from about 0.1% to about 5% by weight, based on the total weight of the composition. In one or more embodiments, the volatile emollient is present in an amount ranging from about 0.5% to about 5% by weight, based on the total weight of the composition. In some embodiments, the volatile emollient is present in an amount ranging from about 0.5% to about 4% by weight, based on the total weight of the composition. In one or more embodiments, the volatile emollient is present in an amount ranging from about 0.5% to about 3% by weight, based on the total weight of the composition. In some embodiments, the volatile emollient is present in an amount ranging from about 1% to about 3% by weight, based on the total weight of the composition. In one or more embodiments, the volatile emollient is present in an amount ranging from about 1.5% to about 2.5% by weight, based on the total weight of the composition. In some embodiments, the volatile emollient is present in an amount ranging from about 1.75% to about 2.25% by weight, based on the total weight of the composition. In one or more embodiments, the volatile emollient is present in an amount of about 2% by weight, based on the total weight of the composition.

[0028] In one or more embodiments, the volatile emollient comprises isododecane. The isododecane 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 5, 5.5, 6, 6.5, 7, 8, 9, 10, 11, or 12% by weight of the total composition. In one or more embodiments, the isododecane 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 isododecane is present in an amount ranging from about 0.1% to about 5% by weight, based on the total weight of the composition. In one or more embodiments, the isododecane is present in an amount ranging from about 0.5% to about 5% by weight, based on the total weight of the composition. In some embodiments, isododecane is present in an amount ranging from about 0.5% to about 4% by weight, based on the total weight of the composition. In one or more embodiments, isododecane is present in an amount ranging from about 0.5% to about 3% by weight, based on the total weight of the composition. In some embodiments, isododecane is present in an amount ranging from about 1% to about 3% by weight, based on the total weight of the composition. In one or more embodiments, isododecane is present in an amount ranging from about 1.5% to about 2.5% by weight, based on the total weight of the composition. In some embodiments, isododecane is present in an amount ranging from about 1.75% to about 2.25% by weight, based on the total weight of the composition. In one or more embodiments, isododecane is present in an amount of about 2% by weight, based on the total weight of the composition.

[0029] Processed Oat Ingredients As used herein, the term "processed oat ingredient" refers to an ingredient typically derived from a part of the oat plant (Avena sativa). The ingredient may be the processing (e.g., extraction, milling, fermentation) of one or more parts of the oat plant (e.g., kernel, leaves, stems, seeds) or may be a molecule (e.g., β-glucan, flavonoids, avenanthramides, lipids, peptides, etc.) found in the oat plant. This definition is intended to encompass processed oat ingredients derived from sources other than oat (e.g., derived from another plant or chemically synthesized), but otherwise related to oat. In one or more embodiments, the processed oat ingredient is selected from the group consisting of oat extract, colloidal oatmeal, oat flour, oat bran, oat protein, oat peptides, oat oil, fermented oats, avenanthramides, β-glucan, modified oat kernel material (e.g., chemically, enzymatically, microbially modified), and combinations thereof. As used herein, "colloidal oatmeal" refers to a powder obtained from the grinding and further processing of whole grain oats that meet U.S. standards for first or second oats. The colloidal oatmeal has the following particle size distribution: no more than 3 percent of the total particles exceed 150 micrometers in size, and no more than 20 percent of the total particles exceed 75 micrometers in size. Examples of suitable colloidal oatmeal include, but are not limited to, "Tech-0" available from Beacon Corporation and colloidal oatmeal available from Quaker. In one or more embodiments, the processed oat ingredient comprises oat extract, colloidal oatmeal, and oat oil. In some embodiments, the processed oat ingredient comprises oat extract. In one or more embodiments, the processed oat ingredient comprises colloidal oatmeal. In some embodiments, the processed oat ingredient comprises oat oil. In some embodiments, the processed oat ingredient is selected from the group consisting of oat extract, colloidal oatmeal, oat oil, and combinations thereof. In some embodiments, the processed oat ingredient includes oat extract, colloidal oatmeal, and oat oil.In one or more embodiments, the processed oat ingredient comprises avenanthramide. In some embodiments, the processed oat ingredient comprises fermented oats. In one or more embodiments, the processed oat ingredient comprises β-glucan.

[0030] The processed oat ingredient 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 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 ingredient 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 ingredient is present in an amount ranging from about 0.1% to about 5% by weight, based on the total weight of the composition. In one or more embodiments, the processed oat ingredient is present in an amount ranging from about 0.5% to about 5% by weight, based on the total weight of the composition. In some embodiments, the processed oat ingredient is present in an amount ranging from about 0.5% to about 4% by weight, based on the total weight of the composition. In one or more embodiments, the processed oat ingredient is present in an amount ranging from about 0.5% to about 3% by weight, based on the total weight of the composition. In some embodiments, the processed oat ingredient is present in an amount ranging from about 1% to about 3% by weight, based on the total weight of the composition. In one or more embodiments, the processed oat ingredient is present in an amount ranging from about 1% to about 2% by weight, based on the total weight of the composition. In some aspects, the processed oat ingredient is present in an amount of about 1% by weight, based on the total weight of the composition. In one or more embodiments, the processed oat ingredient is present in an amount of about 2% by weight, based on the total weight of the composition.

[0031] In one or more embodiments, the processed oat ingredient comprises colloidal oatmeal, and the colloidal oatmeal is present in an amount of about 0.5% to about 3% by weight, based on the total weight of the composition. In some embodiments, the colloidal oatmeal is present in an amount of about 1% to about 3% by weight, based on the total weight of the composition. In one or more embodiments, the colloidal oatmeal is present in an amount of about 1% to about 2% by weight, based on the total weight of the composition. In some embodiments, the colloidal oatmeal is present in an amount of about 1% by weight, based on the total weight of the composition. In one or more embodiments, the colloidal oatmeal is present in an amount of about 2% by weight, based on the total weight of the composition.

[0032] In some embodiments, the processed oat component comprises oat extract, colloidal oatmeal, and oat oil, and the total amount of the three components 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 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 oatmeal, and oat oil is from about 0.1% to about 10% by weight of the total composition. In some embodiments, the total amount of oat extract, colloidal oatmeal, and oat oil is from about 0.1% to about 5% by weight of the total composition. In one or more embodiments, the total amount of oat extract, colloidal oatmeal, and oat oil is about 0.5% to about 5% by weight of the total composition, hi some embodiments, the total amount of oat extract, colloidal oatmeal, and oat oil is about 0.5% to about 4% by weight of the total composition.

[0033] Other ingredients Any of the compositions described herein may further comprise any of a variety of additional other adjunct ingredients conventionally used in health care / personal care compositions (commonly referred to as "personal care components"). These other personal care components non-exclusively include one or more pearlizing or opacifying agents, conditioners, moisturizers, chelating agents, actives, exfoliants, and additives that enhance the appearance, feel, and scent of the composition, such as colorants, fragrances, preservatives, pH adjusters, and rheology modifiers. Such adjunct ingredients, when present, are cosmetically / dermatologically acceptable and are present in safe and effective amounts. In one or more embodiments, any of the compositions described herein may further comprise one or more dermatologically acceptable ingredients selected from the group consisting of thickeners, moisturizers, skin conditioners, additional emollients (i.e., other than volatile emollients), emulsifiers, and combinations thereof.

[0034] Any variety of commercially available moisturizers are suitable for use in the present invention.Moisturizer refers to a compound (for example, hygroscopic compound) that is intended to increase the moisture content of the uppermost layer of skin.Examples of suitable moisturizers include those found in Chapter 35, pages 399-415 (Skin Feel Agents, by G Zocchi) of Handbook of Cosmetic Science and Technology (edited by A. Barel, M. Paye and H. Maibach, 2001, published by Marcel Dekker, Inc., New York, NY), including but not limited to glycerin, sorbitol or trehalose (for example, α,α-trehalose, β,β-trehalose, α,β-trehalose), or their salt or ester (for example, trehalose-6-phosphate).

[0035] When present, the humectant may 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 comprises glycerin and may 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 composition.

[0036] Any of a variety of skin conditioners are suitable for use in the present invention. Examples include glycols (e.g., caprylyl glycol), cationic surfactants (e.g., cetrimonium chloride, stearamidopropyl dimethylamine, distearyldimonium chloride, laurylmethyl gluceth-10 hydroxypropyldimonium chloride), cationic polymers (e.g., Polyquaternium-10, Polyquaternium-24, Polyquaternium-67, cationic modified polysaccharides including starch hydroxypropyltrimonium chloride, guar hydroxypropyltrimonium chloride, and hydroxypropyl guar hydroxypropyltrimonium chloride, as well as Polyquaternium-5, Polyquaternium-67, and the like). Polyquaternium-6, Polyquaternium-7, Polyquaternium-11, Polyquaternium-14, Polyquaternium-15, Polyquaternium-28, Polyquaternium-39, Polyquaternium-44, and Polyquaternium-76 (cationic polymers derived from the (co)polymerization of ethylenically unsaturated cationic monomers and optional hydrophilic monomers), silicones and silicone derivatives (e.g., dimethicone and its derivatives, such as alkyl-, polyalkyleneoxy-, cationic-, and anionic-modified dimethicone (co)polymers), and emollients (e.g., caprylic / capric triglyceride, petrolatum, di-PPG-2, Myreth-10 adipate).

[0037] Additional emollients include compounds that help maintain the soft, smooth, and supple appearance of skin (for example, by remaining on the surface or stratum corneum of the skin to act as a lubricant).Suitable examples of emollients include those found in Chapter 35, pages 399-415 (Skin Feel Agents, by G Zocchi) of Handbook of Cosmetic Science and Technology (edited by A. Barel, M. Paye, and H. Maibach, published in 2001 by Marcel Dekker, Inc., New York, NY), including but not limited to esters (for example, isopropyl palmitate), petrolatum, hexyldecyl stearate, and vegetable, nut, and plant oils and butters (hydrogenated vegetable oil, vegetable oil, macadamia nut oil, rice bran oil, grape seed oil, palm oil, primrose oil, hydrogenated peanut oil, and avocado oil) such as Butyrospermum parkii (shea) butter, Euphorbia chelifera (candelilla) wax.

[0038] Compositions useful in the present invention may also include any of a variety of conventional thickening agents. Examples of such thickening agents include carbomers (e.g., CARBOPOL ULTREZ 30 polymer), cetyl alcohol, electrolytes (e.g., sodium chloride, ammonium chloride, magnesium chloride), naturally occurring polysaccharides (e.g., xanthan gum, dehydroxanthan gum, guar (e.g., Chamopsis tetragono (guar) gum, cassia gum, Chondrus crispus (carrageenan) gum, alginic acid and alginate gums (e.g., algin, calcium alginate), 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 methylcellulose, hydroxypropyl guar, carboxymethyl hydroxypropyl guar, C18-22 hydroxyalkyl hydroxypropyl guar), alkali-swellable emulsion (ASE) polymers (e.g., available under the trade name Carbopol® AQUA from Noveon Consumer Specialties, Brecksville, Ohio). SF-1 available from Dow Personal Care, Spring House, Pa.; hydrophobically-modified alkali-swellable emulsion (HASE) polymers (e.g., acrylates / steareth-20 methacrylate copolymer, acrylates / steareth-20 methacrylate crosspolymer, and acrylates / ceteth-20 itaconate copolymer); hydrophobically-modified acid-swellable emulsion polymers (e.g., acrylates / aminoacrylate / C10-30 alkyl PEG-20 itaconate copolymer and polyacrylate-1 crosspolymer), Lubrizol Corp.Examples of suitable thickeners include hydrophobically modified acrylate crosspolymers, such as Acrylates C10-30 Alkyl Acrylate Crosspolymer available under the trade name Carbopol® 1382 from Cosmetics, Brecksville, Ohio; sodium polyacrylate (available as COSMEDIA SP); and hydrophobic non-ethoxylated micellar thickeners (e.g., glyceryl oleate, cocamide MIPA, lactyl lauryl lactate, or sorbitan sesquicaprylate).

[0039] The compositions described herein may contain additional surfactants / emulsifiers, including anionic, cationic, nonionic, and amphoteric surfactants. Suitable emulsifiers include olive-derived emulsifiers, such as olive olivate. For example, one suitable emulsifier is Olivem 1000 (sold by Hallstar), which is a combination of cetearyl olivate and sorbitan olivate. Suitable examples of nonionic surfactants include, but are not limited to, fatty alcohol acid or amide ethoxylates, monoglyceride ethoxylates, sorbitan ester ethoxylate alkyl polyglycosides, and mixtures thereof. One suitable nonionic surfactant is a polyoxyethylene derivative of a polyol ester, the polyoxyethylene derivative of the polyol ester being (1) derived from (a) a fatty acid containing from about 8 to about 22, preferably from about 10 to about 14, carbon atoms, and (b) a polyol selected from sorbitol, sorbitan, glucose, α-methylglucoside, polyglucose having an average of from about 1 to about 3 glucose residues per molecule, glycerin, pentaerythritol, and mixtures thereof; (2) containing an average of from about 10 to about 120, preferably from about 20 to about 80 oxyethylene units; and (3) having an average of from about 1 to about 3 fatty acid residues per mole of the polyoxyethylene derivative of the polyol ester.

[0040] Examples of such preferred polyoxyethylene derivatives of polyol esters include, but are not limited to, PEG-80 sorbitan laurate and polysorbate 20. PEG-80 sorbitan laurate, a sorbitan monoester of lauric acid ethoxylated with an average of about 80 moles of ethylene oxide, is commercially available from ICI Surfactants (Wilmington, Del.) under the trade name "Atlas G-4280." Polysorbate 20, a lauric acid monoester of a mixture of sorbitol and sorbitol anhydrides condensed with about 20 moles of ethylene oxide, is commercially available from ICI Surfactants (Wilmington, Del.) under the trade name "Tween 20."

[0041] Another class of suitable nonionic surfactants comprises long-chain alkyl glucosides or polyglucosides, which are the condensation products of (a) long-chain alcohols containing from about 6 to about 22, preferably from about 8 to about 14, carbon atoms with (b) glucose or glucose-containing polymers. Alkyl polyglucosides have from about 1 to about 6 glucose residues per alkyl glucoside molecule. A preferred glucoside is decyl glucoside, which is the condensation product of decyl alcohol with a glucose polymer and is commercially available from Henkel Corporation (Hoboken, NJ) under the trade name "Plantaren 2000."

[0042] The compositions of the present invention may also contain amphoteric surfactants. As used herein, the term "amphoteric" refers to 1) a molecule containing both acidic and basic sites, such as an amino acid containing both amino (basic) and acid (e.g., carboxylic acid, acidic) functional groups, or 2) a zwitterionic molecule that possesses both positive and negative charges within the same molecule. The latter charge may be either dependent on or independent of the pH of the composition. Amphoteric surfactants are disclosed herein without counterions. Those skilled in the art will readily recognize that under the pH conditions of the compositions of the present invention, amphoteric surfactants are either electrically neutral due to having balanced positive and negative charges, or have counterions such as alkali metal, alkaline earth, or ammonium counterions. Examples of amphoteric surfactants suitable for use in the present invention include, but are not limited to, amphocarboxylates such as alkylamphoacetates (mono or di), alkylbetaines, alkylamidoalkylbetaines, alkylamidoalkylsultaines, alkylamphophosphates, phosphorylated imidazolines such as phosphobetaines and pyrophosphobetaines, carboxyalkylalkylpolyamines, alkylimino-dipropionates, alkylamphoglycinates (mono or di), alkylamphopropionates (mono or di), N-alkyl β-aminopropionic acids, alkylpolyaminocarboxylates, and mixtures thereof.

[0043] Classes of cationic surfactants suitable for use in the present invention include alkyl quaternaries (mono-, di-, and tri-), benzyl quaternaries, ester quaternaries, ethoxylated quaternaries, alkyl amines, and mixtures thereof, where the alkyl group has from about 6 carbon atoms to about 30 carbon atoms, with from about 8 to about 22 carbon atoms being preferred. These cationic surfactants may be used in the compositions of the present invention in amounts 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.

[0044] Examples of suitable chelating agents include those capable of protecting and preserving the compositions of the present invention, such as ethylenediamine tetracetic acid (EDTA), for example, tetrasodium EDTA commercially available under the trade name "Versene 100XL" from Dow Chemical Company (Midland, Mich.), present in an amount of from about 0 (unused) to about 0.5 percent, or from about 0.05 percent to about 0.25 percent, by weight of the total composition.

[0045] Suitable preservatives include, for example, parabens, quaternary ammonium species, phenoxyethanol, benzoates, sorbates, and DMDM ​​hydantoin, and are present in the composition in an amount of about 0 (if unused) to about 1 percent, or about 0.05 percent to about 0.5 percent, based on the total weight of the composition. The preservative is preferably selected from the group consisting of potassium benzoate, potassium sorbate, and combinations thereof. The preservative may also be combined with other ingredients that provide a booster effect. One example of such a booster is caprylyl glyceryl ether, an emollient that can provide a booster effect to potassium benzoate and / or potassium sorbate. The ratio of preservative to caprylyl glyceryl ether may be about 0.3 to 0.9, preferably 0.6.

[0046] The pH of the composition can be adjusted using pH adjusters 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 is in the range of 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 is in the range of about 3 to about 5, or about 3.5 to about 4.5.

[0047] Exemplary Embodiments One exemplary composition suitable for eczema-affected skin, according to one or more embodiments, comprises: Lactic acid and b. Isododecane, c. a processed oat ingredient selected from the group consisting of oat extract, colloidal oatmeal, oat oil, and combinations thereof.

[0048] In a further embodiment, the composition comprises: a. about 0.01% by weight to about 3% by weight of lactic acid; b. about 0.01% by weight to about 4% by weight of isododecane; c. about 0.01% to about 6% by weight of a combination of oat extract, colloidal oatmeal, and oat oil.

[0049] Product Form and Packaging Various product forms and packaging may be suitable for any of the compositions described herein. As used herein, "product" is optionally a finished packaged form. In one embodiment, the package is a container, such as a plastic, metal, or glass tube or jar, that contains the composition. In one or more embodiments, the composition may be squeezed or pumped from the container. The product may further include additional packaging, such as a plastic or cardboard box for storing such a container. In one or more embodiments, the product includes the composition of the present invention and includes instructions for the user to apply the composition to the skin.

[0050] Any of the compositions useful herein are 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. These emulsions may cover a wide range of viscosities, for example, from about 100 cps to about 200,000 cps. In this application, two types of viscosity measurements are taken: A) at 25°C in a rheometer at 20 s -1 and B) "Brookfield viscosity" measured at 5 or 10 RPM after 1 minute at 25° C. in a 4 oz. jar using spindle RV#4 or RV#5. Unless otherwise specified, the viscosity referenced is the rheometer viscosity.

[0051] In one or more embodiments, the compositions described herein can be in the form of lotion, gel, or cream product.Lotion, gel, and cream products can advantageously have the properties that allow the composition to be fluid and spread on the skin.Such products are generally thin enough to allow the volatile emollient to evaporate and provide a cooling effect.If the product is too thick, such as an ointment, ointment, or patch, the user may not be able to perceive the cooling effect.

[0052] In one or more embodiments, the compositions described herein are in the form of a lotion. As used herein, the term "lotion" refers to a primarily water-containing topical formulation with a viscosity of about 1,000 cPs to 4,000 cPs, a light texture, and a fresh, watery feel. A lotion or serum typically contains at least one emollient in addition to a solvent. A lotion / serum may contain 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.

[0053] In one or more embodiments, the compositions described herein are in the form of a cream. As used herein, the term "cream" refers to a topical formulation containing a thick, predominantly water-based formulation 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.

[0054] Lotions and creams can be formulated as emulsions. Such lotions typically contain 0.5% to about 5% emulsifier, and such creams typically contain about 1% to about 20% (e.g., about 5% to about 10%) emollient, about 20% to about 80% (e.g., about 30% to about 70%) water, and about 1% to about 10% (e.g., about 2% to about 5%) emulsifier.

[0055] Single-phase emulsion skin care preparations, such as lotions and creams, of the oil-in-water and water-in-oil types, are well known in the art and are useful in the present invention. Multiphase emulsion compositions, such as water-in-oil-in-water or oil-in-water-in-oil types, are also useful in the present invention. Generally, such single-phase or multiphase emulsions contain water, emollients, and emulsifiers as essential ingredients.

[0056] The compositions of the present invention can also be formulated as gels. As used herein, the term "gel" refers to a topical formulation containing a dispersed polymer and primarily water, with a thick texture and a yield value of about 0.1 Pa or greater. Gels may contain a gelling agent. Such gels typically contain about 0.1% to 5% by weight of such a gelling agent.

[0057] The compositions of the present invention can also be formulated into solid preparations (e.g., wipes). The compositions of the present invention may be combined with and / or impregnated into solid, semi-solid, or soluble substrates (e.g., wipes, masks, pads, gloves, or strips).

[0058] The compositions described herein can be provided to the consumer in a container, such as a bottle, tube, etc. Individual packets containing measured portions of the composition can also be used. A pump, squeezable valve, or removable screw cap can be used to dispense the composition from the bottle.

[0059] method The 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 affected by eczema, improve the appearance of skin affected by eczema, and / or provide a cooling sensation to skin affected by eczema.

[0060] Any suitable method for topically applying the compositions described herein to skin in need may be used. As used herein, "topically applying" means applying or blending directly onto the skin using an applicator, such as a hand, wipe, roller, or spray. For example, the composition may be applied directly to the skin in need from a package, applied by hand to the skin in need, or transferred from a substrate such as a wipe or mask, or a combination of two or more of these. In other embodiments, the composition may be applied via a dropper, tube, roller, or spray, or may be added to water that is to be used in a bath or otherwise applied to the skin. Such topical application may be to any skin in need of treatment on the body, for example, the face, lips, neck, chest, back, buttocks, arms, underarms, and / or legs.

[0061] Skin affected by eczema may include mild to moderate eczema. The compositions described herein may be applied to affected areas on skin affected by eczema. The affected areas may exhibit symptoms selected from the group consisting of erythema, itching, weeping, peeling, lichenification, dryness, roughness to the 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 as frequently as otherwise desired by the user. In one or more embodiments, the composition is applied once or twice daily. [Example]

[0062] Example 1: Preparation of the composition The test compositions were prepared by first adding water to a container. Then, colloidal oat flour was stirred into the water with continuous mixing, followed by lactic acid and carbomer, ensuring a homogeneous mixture after each addition. The mixture was heated to 75-80°C while caprylyl glycol was added until uniform. Meanwhile, half of the glycerin and sodium polyacrylate were premixed until homogeneous and then added to the main container at 75-80°C. Next, with continuous mixing and maintaining the temperature at 75-80°C, each of the following ingredients was added to the container: cetyl-olivate, sorbitan-olivate (Olivem 1000), cetyl alcohol, Euphorbia chelifera (candelilla) wax, hydrogenated vegetable oil, vegetable oil (Cegesoft VP), Butyrospermum parkii (shea) butter, isopropyl palmitate, isododecane, and oat kernel oil. Continuous mixing was continued until the batch was uniform, and then the temperature was cooled to 68-75°C for a minimum of 5 minutes. Cooling was then initiated while adding the remaining half of the glycerin. After the batch had cooled to below 40°C, the following ingredients were added with continuous mixing until uniform: water, glycerin, oat kernel extract (Dragocalm), 1,2 hexanediol, caprylyl glycol, and tropolone (Symdiol 68T). After the mixture had cooled to below 35°C, the pH was tested and adjusted to 4.8 with 50% w / w sodium hydroxide in water. Finally, the mixture was homogenized and transferred to a storage container. See Table 1 below for the final composition.

[0063] [Table 1] 1. 100% Isododecane 2. 100% glycerin 3. 100% oat kernel oil 4. 0.55% oat kernel extract, 49.625% glycerin, 49.625% water, 0.2% potassium sorbate 5. 100% Colloidal Oatmeal 6. 90% lactic acid, 10% water 7. 100% Isopropyl Palmitate 8. 3% Euphorbia chelifera (Candelilla) wax, 10% hydrogenated vegetable oil, 87% vegetable oil 9. 100% Caprylyl Glycol 10. 49.5% 1,2-Hexanediol, 49.5% Caprylyl Glycol, 1% Tropolone 11. 100% Butyrospermum Parkii (Shea) Butter 12. 100% Carbomer 13. 100% Cetyl Alcohol 14. 60% cetyl-olivate, 40% sorbitan-olivate 15. 89% sodium polyacrylate, 11% water 16. 100% sodium hydroxide

[0064] Example 2: Clinical Trials A single-center, monadic clinical trial was conducted to evaluate the efficacy and perceived benefit of the test composition on pruritus and tolerability when used on eczema target lesions in subjects with mild to moderate eczema. The study was conducted by a board-certified dermatologist investigator.

[0065] The study included a variety of demographics, including age, sex, ethnicity, race, skin type, and skin tone. Exclusion criteria included those with skin conditions that could interfere with the results of the study, such as severe eczema, psoriasis, rosacea, rash, extensive and / or severe surface peeling, use of Class I-III topical corticosteroids or systemic medications that may have a direct or indirect effect on eczema, or known allergies or adverse reactions to common skin care ingredients. Inclusion criteria included subjects with a mild-to-moderate eczema severity rating (Rajka and Langeland Severity Index) at Visit 1, at least one target eczema lesion area with a mild or moderate Atopic Dermatitis Severity Index (ADSI) score of 5-12 at Visit 1, and erythema. Thirty-five subjects completed the study.

[0066] Subjects were also instructed to wash and remove all topical products on the eczema lesion area at least 2-3 hours before each assessment visit. During the study, subjects applied the test composition to selected target lesions at least twice daily (once in the morning and once in the evening) as instructed. Subjects performed their first on-site application of the test composition to the target lesions after completing the baseline assessment.

[0067] Clinical evaluations were conducted 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) assessed the efficacy of the test composition by grading various endpoints considered in the subject's eczema lesions using the Atopic Dermatitis Severity Index (ADSI). The reported ADSI score was the sum of the individual scores. Additionally, the subject's target lesions were assessed for lesion dryness, roughness to the touch, and skin tone compared to normal overall skin tone. Finally, the PI assessed the subject's target lesion tolerance to overall irritation and asked each subject to rate the degree of burning / stinging sensation for the target eczema lesion. See Tables 2-6 for scoring criteria.

[0068] [Table 2]

[0069] [Table 3]

[0070] [Table 4]

[0071] [Table 5]

[0072] [Table 6]

[0073] The mean scores for each assessment are reported in Table XX below.

[0074] [Table 7] *Statistically significant improvements (p<0.05) in all measures at all time points compared to baseline

[0075] The overall results from the study, shown in Table 7, indicate that the test composition was effective in improving the cosmetic appearance, skin barrier properties, and skin hydration of target eczema lesions when used for two weeks by subjects with mild to moderate eczema. The performance of the test composition in this study was surprising for a composition containing lactic acid. Dermatologists generally would not recommend lactic acid for use on eczema skin due to the irritating nature of the ingredient. However, as shown herein, the high tolerability of the test composition containing lactic acid on eczema skin, particularly with respect to burning / stinging pain, itching, and irritation, is particularly surprising.

[0076] Example 3: Final Product Questionnaire After two weeks of product use as described in Example 2, patients completed a final self-assessment questionnaire regarding their perception of product performance. The results of the product criteria are shown in Table 8. Subjects rated statements using completely agree, agree, neutral, disagree, and completely disagree.

[0077] [Table 8]

[0078] As listed in Table 8, a statistically significantly greater proportion of subjects selected favorable responses (strongly agree and agree) to the statements compared with unfavorable responses (strongly disagree and disagree). These levels of positive agreement for cooling, itch-relieving, and moisturizing relief are surprising. In particular, 91% of subjects agreed or completely agreed with the statement that the test product provided cooling relief. This is surprising given that the formulation was well tolerated by individuals with eczema, even though isododecane is not a known cooling agent. Furthermore, given the results shown in Example 5 below, the cooling effect of isosodecane is particularly surprising given that it does not provide cooling effects at the same rate in individuals with eczema compared to individuals without eczema. This indicates the promise of isododecane as a mild cooling agent suitable for individuals with eczema.

[0079] Example 4 Thermal Image Cooling Test The test composition prepared as described above and DI water were separately self-applied by subjects to the volar forearm. The cooling effect of the test composition was compared with DI water as a control. A FLIR thermal camera (Teledyne FLIR, Thousand Oaks, CA) was used to capture skin surface temperatures at baseline, immediately after application, 5 minutes after application, 10 minutes after application, and 15 minutes after application. The displayed temperature range was adjusted to accommodate the subject's baseline skin surface temperature.

[0080] For each subject, two circular sites approximately 1 inch in diameter were marked on the subject's chosen forearm. The two sites had approximately 3 inches between them. After allowing the subject to acclimate to the ambient temperature for 15 minutes, their baseline thermal image was taken.

[0081] Subjects were then instructed to apply both the treatment and control to the designated areas as they normally would with personal care products. Subjects were allowed to spread the product over larger areas than the marked areas, but were instructed to avoid overlapping the product on their skin. The experiment was repeated on five subjects.

[0082] Representative grayscale thermal images are shown in Figures 1-5 for baseline, immediately after application, and 5, 10, and 15 minutes after application, respectively. The spot labeled 1 was the control, and the spot labeled 2 was the test composition. The light gray circular spots marked 1 and 2 show a cooling effect at 5-10 minutes, but at 15 minutes, only spot 2, the test composition, continues to show a cooling effect. There was variation in the duration of the cooling effect for both the test composition and the control, and generally, the test composition had longer-lasting cooling than the control.

[0083] Example 5: Clinical Study of Topical and Gel Creams with Isododecane in Individuals Without Eczema (Comparative) A topical gel cream composition (Example 5-1) was made having the following ingredients, as shown in Table 9.

[0084] [Table 9] 1: Commercially available as Ultrez 10 polymer from Lubrizol Corporation 2: Available commercially as Cosmedia® SP from UL Prospector Corporation 3: Commercially available as Radia 7732 from Oleon Corporation 4: Marketed by Hallstar BPC Corporation as Olivem 1000 5: Commercially available as Vegarol 1698 from UL Prospector Corporation 6:Commercially available as Cegesoft VP from UL Prospector Corporation 7: Commercially available as Permethyl 99A from Presperse Corporation 8: Marketed by Symrise Corporation as Hydrolite CG 9: Commercially available as Symdiol 68T from Symrise Corporation 10: Commercially available as Germazide C from BASF Corporation

[0085] The following mixing procedure can be used to prepare Example 5-1: a) Add purified water to a suitable container and add colloidal oat flour while mixing. b) Add citric acid and lidocaine USP while mixing and mix until dissolved. c) Add the carbomer while mixing slowly until the lumps are dissolved. d) Heat the mixture to 75-80°C. e) Add caprylyl glycol and chlorphenesin with mixing and mix until uniform. f) Next, slowly add the sodium polyacrylate while mixing at 75-80°C until uniform. g) The oil phase ingredients are then added with mixing (7% glycerin, isopropyl palmitate, cetearyl-olivate, sorbitan-olivate, and cetyl alcohol). h) The mixture is mixed for 10 minutes and then homogenized at 5000 RPM for 3 minutes. i) Cool the mixture to 25°C and add and mix an additional 7% of glycerin and isododecane j) Add ginger root extract, 1,2-hexanediol, caprylyl glycol, tropolone and mix until homogeneous. k) Adjust the pH to 6.5 using sodium hydroxide solution or citric acid solution at 35°C or below and mix. l) Bring the batch to a volume of 95-100% of the theoretical batch weight with water.

[0086] A topical cream composition (Example 5-2) was made having the following ingredients, as shown in Table 10.

[0087] [Table 10] 1: Commercially available as Ultrez 10 polymer from Lubrizol Corporation 2: Available commercially as Cosmedia® SP from UL Prospector Corporation 3: Commercially available as Radia 7732 from Oleon Corporation 4: Marketed by Hallstar BPC Corporation as Olivem 1000 5: Commercially available as Vegarol 1698 from UL Prospector Corporation 6: Commercially available as Cegesoft BP from UL Prospector Corporation 7: Commercially available as Permethyl 99A from Presperse Corporation 8: Commercially available as Carbopol Aqua SF-1 polymer from Lubrizol Corporation 9: Marketed by Symrise Corporation as Hydrolite CG 10: Commercially available as Symdiol68T from Symrise Corporation 11: Commercially available as Germazide C from BASF Corporation

[0088] The following mixing procedure can be used to prepare the cream of this example: a) Add purified water to a suitable container and add colloidal oat flour while mixing. b) Add citric acid and lidocaine USP while mixing and mix until dissolved. c) Add the carbomer while mixing slowly until the lumps are dissolved. d) Heat the mixture to 75-80°C. e) Add caprylyl glycol and chlorphenesin with mixing and mix until uniform. f) Next, slowly add the sodium polyacrylate while mixing at 75-80°C until uniform. g) The oil phase ingredients are then added with mixing (7% glycerin, isopropyl palmitate, cetearyl-olivate, sorbitan-olivate, and cetyl alcohol). h) The mixture is mixed for 10 minutes and then homogenized at 5000 RPM for 3 minutes. i) Cool the mixture to 25°C and add isododecane and mix j) Add fragrance, 1,2-hexanediol, caprylyl glycol, and tropolone and mix until homogeneous. k) At 35°C or below, adjust the pH to 6.5 using sodium hydroxide solution or citric acid solution and mix. l) In a separate container, add 5% of glycerin and acrylate copolymer and mix until uniform to form an acrylate copolymer premix. m) Add the acrylate copolymer premix to the mixture from step 11 and mix until homogenous.

[0089] Human Use Testing Study Protocol and Objectives: A home use study (abbreviated as "HUT") was conducted in which 253 consumers (also referred to as "subjects," "patients," or "users") self-administered the formulations of Examples 5-1 and 5-2 (also referred to in this example as "formulations" or "products") as needed over a two-week period. These consumers were 30 to 55 years old, experienced minor muscle or joint aches and pains all the time or occasionally, and had a range of skin tones and types, with a subset having self-reported sensitive skin, dry skin, and / or eczema.

[0090] Consumers were instructed to use the product within the first two days of receiving it and then at least once a week as needed for the next two weeks. Consumers were also instructed to refrain from using other pain relief measures for two weeks. Consumers provided feedback via an online survey at three time points: 1) after initial use, 2) after one week of use, and 3) after two weeks of use.

[0091] Example 5-1 can be referred to as a "calming gel cream" incorporating, for example, ginger, and Example 5-2 can be referred to as a "calming cream" incorporating a suitable calming fragrance, for example, lavender.

[0092] The objective of the human use study was to generate support for potential consumer perceptual claims centered around the consumer's experience with the product. For example, the objective was to understand consumer experience with the product's absorption, discreetness, and feel on the skin.

[0093] With regard to feel, consumers provided feedback on whether the product was perceived as gentle and whether the product left their skin feeling moisturized and / or smooth.

[0094] A "test statement" can be a question answered or a statement that is agreed or disagreed with at least once during the HUT by the consumer. According to one embodiment, the following test statements can relate to the consumer's experience with product absorption: fast absorption, quickly absorbed into the skin, not greasy, and / or not leaving a shine on the skin. According to one embodiment, the following test statements can relate to the consumer's experience with "discreetness": lightweight, no harsh odor / odor, no unpleasant odor / odor, not sticky, not greasy, not leaving a shine, pleasant smell. According to one embodiment, the following test statements can relate to the consumer's experience with product feel: lightweight, not sticky, not greasy, quickly moisturizing, leaving a smooth feeling on the skin, fast cooling, fast acting, and / or fast numbing. The test statements of fast cooling, fast acting, and / or fast numbing can indicate pain relief.

[0095] Summary of results Topline data is presented in Table 11, showing responses described by consumers, compiled as the percentage of users who agreed with the test statements. Total results are presented, as well as results for each of Example 5-1 and Example 5-2.

[0096] [Table 11] * Not applicable: the formulation did not contain fragrance.

[0097] As can be seen above, the percentage of subjects reporting a cooling effect is 61% for 5-1 and 64% for 5-2. As noted above, this study included subjects without eczema. Thus, the presence of isododecane, even when present in amounts as high as 4% and 8%, much higher than the 2% present in the formulation of Example 1, does not necessarily provide the same perceived cooling effect as those with eczema.

[0098] Example 6: Microbiome Clinical Trial The clinical trial was conducted according to the method described in Example 2. Skin surface microbiome samples were collected from each subject's target lesion at Visit 1 (baseline), Visit 2 (Day 3), Visit 3 (Day 7), and Visit 4 (Day 14). Swabs were performed within a 4 cm x 4 cm area of ​​skin on the defined target lesion. A sterile swab was immersed in an aliquot of 0.85% sterile saline, and excess liquid was squeezed out by pressing it against the inner wall of a saline tube. The side of the swab was rubbed across the defined area while rotating between the thumb and index finger for 60 seconds. More specifically, to maintain consistency, the rotated swab was rubbed back and forth across the defined area in the same manner for each subject. The head of each swab was placed in a sterile microcentrifuge tube and aseptically cut from the handle before closing the lid. The tube was labeled with the protocol ID, subject ID, and visit number. Post-baseline swabs were performed in the same location as baseline swabs.

[0099] After subject swabs were collected, control swabs were taken for each day the subject was sampled. A sterile swab was dipped into an aliquot of 0.85% sterile saline and excess liquid was squeezed out by pressing it against the inside wall of a saline tube. Without allowing the polyester tip to touch any surface, the head of the swab was placed into a sterile microcentrifuge tube and aseptically cut from the handle before closing the lid. The tube was labeled with the protocol number, date, and "Micro Control" (or equivalent identification).

[0100] Swabs from each subject and control swabs were frozen at -20°C until transported on dry ice to a sponsor-designated external laboratory (CosmosID Inc., Germantown, MD) for DNA extraction and analysis to determine the effect of IP on skin microbiota. In total, 154 16S samples were utilized for analysis. All figures were generated using 16S OUT analysis from the CosmosID Hub and adjusted by 16S qPCR abundance minus control abundance from all other samples.

[0101] Taxonomic comparative statistical analyses, including qPCR abundance, relative abundance, α-diversity, and β-diversity, were performed by an external laboratory. qPCR abundance is the mean abundance per group and the scaled abundance for each sample. Relative abundance is the mean abundance of the top bacterial species per group. α-diversity is the number and abundance of taxa and the difference between groups. β-diversity is the dissimilarity of the entire microbial community and indicates whether cohorts are significantly different.

[0102] S. aureus and S. epidermidis were determined by sample and cohort. Mean abundance per group and scaled abundance for each sample were calculated. Stacked bar plots were created using filtered matrices at the phylum, genus, and species levels from CosmosID. ​​Stacked bar plots for each group were created using the R package ggpubr.

[0103] The copy numbers of S. aureus and S. epidermidis by cohort are shown in Figures 6 and 7, respectively, and the mean S. epidermidis to S. aureus copy number ratio by cohort is shown in Figure 8. There was no significant change in the qPCR copy number of Staphylococcus between baseline and day 14. However, there was a significant increase in the qPCR copy number of S. epidermidis between baseline and day 14. As a result, the ratio of S. epidermidis to S. aureus increased between baseline and day 14. These results indicate that the test composition unexpectedly enriched the samples for commensal S. epidermidis.

[0104] Genus-level relative abundance and species-level relative abundance are shown in Figures 9 and 10, respectively. There was a visible increase in the genus Staphylococcus between baseline and day 14 compared to other genera. At the species level, there was also an increase in Staphylococcus epidermidis between baseline and day 14 and a slight increase in Staphylococcus aureus between baseline and day 14 compared to other species present. Increases were also observed in other commensal organisms, including an unexpected increase in the relative abundance of Staphylococcus hominis between baseline and day 14.

[0105] Alpha-diversity box plots were calculated from the genus- and species-level abundance score matrices from the CosmosID analysis, respectively. Chao, Simpson, and Shannon alpha-diversity metrics 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 overlaid significance in the form of p-values ​​were created using the R package ggplot2. There was a significant decrease across all alpha-diversity indices between baseline and day 14 at both the genus and species levels (Chao1 (Figures 11 and 14), Shannon (Figures 12 and 15), Simpson (Figures 13 and 16)). Alpha-diversity between days 7 and 14 showed a trend as a potential increase: a significant increase between days 7 and 14 in the species-level Shannon diversity and Simpson diversity analyses.

[0106] In general, increased diversity is considered desirable, and therefore it is surprising to see an increase, given the very positive clinical results of the above examples.

[0107] Principal coordinate analysis of beta diversity was calculated from 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 PCoA tables were generated using the function pcoa in ape. PERMANOVA tests for each distance matrix were generated using the function adonis2 in vegan. Plots were visualized using the R package ggpubr. PERMANOVA results are shown in Table 12, and pairwise PERMANOVA results are shown in Table 13 below. Significant changes in beta diversity were observed between baseline and day 14, indicating significantly different microbial communities.

[0108] [Table 12] *** :p<=0.001

[0109] [Table 13] *** :p<=0.001

[0110] Example 7 In vitro bacterial competition assay The in vitro bacterial competition assay evaluated Staphylococcus epidermidis (ATCC 12228, a skin health-associated strain) and Staphylococcus aureus (ATCC 6538, a human lesion isolate) co-cultures in the presence of test materials. Percentages are w / v% in liquid medium (nutrient broth, Culture Media and Supplies Inc.). To mimic the microenvironment of the skin surface, an aerobic co-culture system of Staphylococcus epidermidis and Staphylococcus aureus was established. 50 μL of Staphylococcus epidermidis and 50 μL of Staphylococcus aureus (1:1 ratio) were inoculated into nutrient broth (approximately 5.0 × 10 cells each) in the presence of the test materials specified in Table 14 below. 6 CFU / mL in 50 μL).

[0111] [Table 14] 1. 100% Colloidal Oatmeal 2. 0.55% oat kernel extract, 49.625% glycerin, 49.625% water, 0.2% potassium sorbate 3. 100% glycerin 4. 100% oat kernel oil 5. 90% lactic acid, 10% water 6. Adjust pH to 4.5 with 10% NaOH

[0112] Test groups were incubated aerobically for 24 hours (n=3 per test group). After 24 hours, each test group was plated onto agar plates and incubated aerobically for 24 hours with shaking at 200 rpm. After incubation, colonies were counted and CFU / mL calculated. S. epidermidis and S. aureus colonies were differentiated on agar (tryptic soy agar + 5% sheep blood, BD Diagnostics) based on typical morphology.

[0113] 17 shows the results of a bacterial competition assay for colloidal oat flour, oat extract, and glycerin (a component of oat extract). 2% oat flour significantly promoted the growth of Staphylococcus epidermidis when compared to untreated. The levels of Staphylococcus epidermidis were significantly greater than the levels of Staphylococcus aureus when cultured in the presence of 2% oat flour.

[0114] Figure 18 shows bacterial competition assays of oat extract, oat flour, oat oil, lactic acid, and the combinations listed in Table 15. 2% oat flour and 0.5% oat oil each significantly promoted the growth of Staphylococcus aureus and Staphylococcus epidermidis compared to untreated. 1% oat extract + 2% oat flour significantly promoted the growth of Staphylococcus aureus and Staphylococcus epidermidis compared to untreated. 2% colloidal oat flour + 1% oat extract + 0.5% oat oil also significantly promoted the growth of Staphylococcus epidermidis against Staphylococcus aureus and compared to untreated.

[0115] [Table 15]

[0116] The obtained prebiotic activity of the oat flour of Example 6 (significantly enhanced commensal Staphylococcus epidermidis) is consistent with the results of the bacterial growth rate assay shown in Example 7. Interestingly, the presence of lactic acid inhibits Staphylococcus epidermidis, whose low populations are associated with atopic dermatitis. These results are seen for lactic acid both alone and in combination with the three oat components, indicating enhancement of Staphylococcus epidermidis. Such results are therefore surprising in view of the very positive clinical results of the above examples.

[0117] [Embodiment] (1) A composition suitable for skin affected by eczema, comprising: a. alpha hydroxy acid; b. a volatile emollient; c. a processed oat ingredient. (2) The composition of claim 1, wherein the alpha hydroxy acid is selected from the group consisting of glycolic acid, malic acid, tartaric acid, pyuric acid, mandelic acid, lactic acid, and combinations thereof. (3) The composition of any one of claims 1 to 2, wherein 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. (4) The composition of any one of the preceding claims, wherein the volatile emollient is selected from the group consisting of cyclopentasiloxane, dimethicone, isoparaffin fractions (C9-C16), ethyltrisiloxane, trisiloxane and caprylyl methicone, isododecane, and combinations thereof. (5) The composition of any one of the preceding claims, wherein the volatile emollient is present in an amount ranging from about 0.01% to about 12% by weight, based on the total weight of the composition.

[0118] (6) The composition of any one of the preceding claims, wherein the processed oat ingredient is selected from the group consisting of oat extract, colloidal oatmeal, oat oil, fermented oats, avenanthramides, beta-glucans, modified oat kernel material, and combinations thereof. (7) The composition of any one of claims 1 to 6, wherein the processed oat component is present in an amount ranging from about 0.01% to about 30% by weight, based on the total weight of the composition. (8) The composition of any one of the preceding embodiments, further comprising a dermatologically acceptable ingredient selected from the group consisting of a viscosity increasing agent, a moisturizing agent, a skin conditioner, an emulsifier, and combinations thereof. (9) The composition according to any one of the preceding embodiments, wherein the composition has a pH of about 4.5 to about 5.5. (10) The composition according to any one of the preceding claims, wherein the composition is in the form of a lotion, gel, or cream product.

[0119] (11) A method for treating eczema, comprising topically applying the composition of any one of embodiments 1 to 10 to skin affected by eczema. (12) A composition suitable for skin affected by eczema, comprising: Lactic acid and b. Isododecane, c. a processed oat ingredient selected from the group consisting of oat extract, colloidal oatmeal, oat oil, and combinations thereof. (13) The composition a. about 0.01% by weight to about 3% by weight of lactic acid; b. about 0.01% by weight to about 4% by weight of isododecane; c. about 0.01% to about 6% by weight of a combination of oat extract, colloidal oatmeal, and oat oil. (14) A method for treating eczema, comprising applying a composition according to any one of embodiments 12 to 13 to skin affected by eczema. (15) The method of embodiment 14, wherein the eczema-affected skin comprises mild to moderate eczema.

Claims

1. A composition suitable for skin affected by eczema, comprising: a. an alpha hydroxy acid; b. a volatile emollient; c. a processed oat ingredient.

2. 10. The composition of claim 1, wherein the alpha hydroxy acid is selected from the group consisting of glycolic acid, malic acid, tartaric acid, uric acid, mandelic acid, lactic acid, and combinations thereof.

3. The composition of claim 1, wherein 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.

4. 10. The composition of claim 1, wherein the volatile emollient is selected from the group consisting of cyclopentasiloxane, dimethicone, isoparaffinic fractions (C9-C16), ethyltrisiloxane, trisiloxane and caprylyl methicone, isododecane, and combinations thereof.

5. The composition of claim 1, wherein the volatile emollient is present in an amount ranging from about 0.01% to about 12% by weight, based on the total weight of the composition.

6. 10. The composition of claim 1, wherein the processed oat ingredient is selected from the group consisting of oat extract, colloidal oatmeal, oat oil, fermented oats, avenanthramides, beta-glucan, modified oat kernel material, and combinations thereof.

7. 10. The composition of claim 1, wherein the processed oat ingredient is present in an amount ranging from about 0.01% to about 30% by weight, based on the total weight of the composition.

8. 10. The composition of claim 1, further comprising a dermatologically acceptable ingredient selected from the group consisting of viscosity increasing agents, moisturizing agents, skin conditioners, emulsifiers, and combinations thereof.

9. The composition of claim 1, wherein the composition has a pH of about 4.5 to about 5.

5.

10. The composition of claim 1 , wherein the composition is in the form of a lotion, gel, or cream product.

11. A method for treating eczema, comprising topically applying a composition according to any one of claims 1 to 10 to skin affected by eczema.

12. A composition suitable for skin affected by eczema, comprising: a. lactic acid; b. Isododecane; c. a processed oat ingredient selected from the group consisting of oat extract, colloidal oatmeal, oat oil, and combinations thereof.

13. The composition comprises: a. about 0.01% to about 3% by weight of lactic acid; b. about 0.01% to about 4% by weight of isododecane; c. about 0.01% to about 6% by weight of a combination of oat extract, colloidal oatmeal, and oat oil.

14. A method for treating eczema, comprising applying a composition according to any one of claims 12 to 13 to skin affected by eczema.

15. 15. The method of claim 14, wherein the eczema-affected skin comprises mild to moderate eczema.

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