Methods of using a skincare composition

Abstract

Provided are methods of treating skin using skincare compositions comprising (a) an emollient; (b) an occlusive; (c) a humectant; (d) a processed oat ingredient; (e) a rheological modifier; and (f) water.

Description

[0001] METHODS OF USING A SKINCARE COMPOSITION

[0002] FIELD

[0003] The present invention generally relates to compositions for suitable for use on skin afflicted with atopic dermatitis. More specifically, the present invention relates to methods of using skincare compositions on skin afflicted with atopic dermatitis.

[0004] BACKGROUND

[0005] Atopic dermatitis, also known as eczema, is a chronic relapsing pruritic inflammation of the skin that can compromise quality of life. Atopic dermatitis 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. Because it has a complex pathogenesis, atopic dermatitis can also present several types of therapeutic management according to its characteristics and severity. Basic therapy involves appropriate mild skin hygiene and daily use of moisturizers to maintain and restore the integrity of the skin barrier and increase the water content of the stratum comeum. Topical or oral corticosteroids, which act on the immune system by blocking the production of substances that trigger allergic and inflammatory actions, remain the first-line treatments. Similarly, antihistamine can also be administrated. If pruritus does not respond to standard treatments, antibiotics might be considered.

[0006] Moisturizers are effective in keeping the skin hydrated and repairing the skin barrier. However, the cosmetic acceptance of these types of formulations may be poor which is reflected in a lower compliance among the atopic dermatitis patients. Moreover, this approach is often not sufficient by itself. Corticosteroids on the other hand are powerful medications but are known to induce side effects, some of which might be severe in case of long term usage. While antihistamine can be used to treat itch associated with atopic dermatitis, they can cause sleepiness and may not help in all cases of atopic dermatitis. Finally, the use of antibiotics is controversial due to the raising occurrence of bacterial resistance. Additionally, a treatment will ideally address the visual appearance of skin afflicted with eczema, and / or otherwise provide other benefits perceived by the user. However, traditional ingredients are often too harsh for use on the sensitive skin of individuals with eczema.

[0007] Accordingly, there exists a need for topical compositions which are suitable for use on eczematic skin and can address one or more of the concerns above.

[0008] SUMMARY

[0009] One aspect of the invention pertains to a method of treating eczema, the method comprising topically applying to skin afflicted with eczema a composition comprising: a. an emollient; b. an occlusive; c. a humectant; d. a processed oat ingredient; and e. a rheological modifier; and f. water.

[0010] In one or more embodiments, treating eczema comprises a method of reducing Global SCORAD. In some embodiments, treating eczema comprises a method of reducing the severity of eczema as measured by the POEM questionnaire. In one or more embodiments, treating eczema comprises a method of increasing skin hydration. In some embodiments, treating eczema comprises a method of reducing S. aureus in the skin microbiome. In one or more embodiments, treating eczema comprises a method of increasing S. epidermidis in the skin microbiome. In some embodiments, treating eczema comprises a method of increasing the quality of life of a person having eczema. In one or more embodiments, the rheological modifier comprises hydroxypropyl starch phosphate. In some embodiments, the rheological modifier is present in an amount of from about 0.25% to about 2.5%. In one or more embodiments, the emollient is selected from the group consisting of esters; silicone-con taining compounds; plant, nut, and vegetable oils and butters; and combinations thereof. In some embodiments, the emollient is selected from the group consisting of isopropyl palmitate, dimethicone, helianthus annus seed oil, and combinations thereof. In one or more embodiments, the occlusive comprises petrolatum. In some embodiments, the occlusive is present in an amount ranging from about 1 to about 8 wt.% by total weight of the composition. In one or more embodiments, the humectant comprises glycerin.

[0011] Another aspect of the invention pertains to a method of treating eczema, the method comprising topically applying to skin afflicted with eczema a composition comprising: a. about 2 to about 10 wt. % of an emollient is selected from the group consisting of isopropyl palmitate, dimethicone, helianthus annus seed oil, and combinations thereof; b. about 1 to about 8 wt. % of an occlusive comprising petrolatum; c. about 0.5 to about 20 wt. % of a humectant comprising glycerin; d. about 0.1 to about 3 wt. % of a processed oat ingredient; and e. about 0.1 to about 3 wt. % of a rheological modifier comprising hydroxypropyl starch phosphate.

[0012] In some embodiments, treating eczema comprises a method of reducing Global SCORAD. In one or more embodiments, treating eczema comprises a method of reducing the severity of eczema as measured by the POEM questionnaire. In some embodiments, treating eczema comprises a method of increasing skin hydration. In one or more embodiments, treating eczema comprises a method of reducing S. aureus in the skin microbiome. In some embodiments, treating eczema comprises a method of increasing S. epidermidis in the skin microbiome. In one or more embodiments, treating eczema comprises a method of increasing the quality of life of a person having eczema.

[0013] Another aspect of the invention pertains to a method of treating skin, the method comprising topically applying to skin a composition comprising: a. an emollient; b. an occlusive; c. a humectant; d. a processed oat ingredient; and e. a rheological modifier; and f. water.

[0014] In one or more embodiments, the skin is skin afflicted with eczema. In some embodiments, the skin is skin adjacent to an area of skin afflicted with eczema. In one or more embodiments, the skin is skin that is not afflicted with eczema. In some embodiments, treating eczema comprises a method of increasing skin hydration. In one or more embodiments, treating eczema comprises a method of reducing S. aureus in the skin microbiome. In some embodiments, treating eczema comprises a method of increasing S. epidermidis in the skin microbiome. In one or more embodiments, the composition comprises: a. about 2 to about 10 wt. % of an emollient is selected from the group consisting of isopropyl palmitate, dimethicone, helianthus annus seed oil, and combinations thereof; b. about 1 to about 8 wt. % of an occlusive comprising petrolatum; c. about 0.5 to about 20 wt. % of a humectant comprising glycerin; d. about 0.1 to about 3 wt. % of a processed oat ingredient; and e. about 0.1 to about 3 wt. % of a rheological modifier comprising hydroxypropyl starch phosphate.

[0015] BRIEF DESCRIPTION OF FIGURES

[0016] FIG. 1 is a graph showing the global results of a SCORAD assessment before, during and after treatment with a composition in accordance with one or more embodiments of the invention;

[0017] FIG. 2 is a graph showing the SCORAD assessment of subjective symptoms before, during and after treatment with a composition in accordance with one or more embodiments of the invention; FIG. 3 is a graph showing the SCORAD assessment of lesion severity before, during and after treatment with a composition in accordance with one or more embodiments of the invention;

[0018] FIG. 4 is a graph showing the SCORAD assessment of total surface lesion before, during and after treatment with a composition in accordance with one or more embodiments of the invention;

[0019] FIG. 5 is a graph showing a POEM questionnaire assessment before, during and after treatment with a composition in accordance with one or more embodiments of the invention;

[0020] FIG. 6 is a graph showing a skin hydration assessment on skin having eczema characteristics before, during and after treatment with a composition in accordance with one or more embodiments of the invention;

[0021] FIG. 7 is a graph showing a skin hydration assessment on an area of skin adjacent to skin having eczema characteristics before, during and after treatment with a composition in accordance with one or more embodiments of the invention;

[0022] FIG. 8 is a graph showing a skin hydration assessment on skin having eczema characteristics compared to adjacent skin without eczema characteristics before, during and after treatment with a composition in accordance with one or more embodiments of the invention;

[0023] FIG. 9 is a graph showing a skin barrier assessment on skin having eczema characteristics before, during and after treatment with a composition in accordance with one or more embodiments of the invention;

[0024] FIG. 10 is a graph showing a skin barrier assessment on an area of skin adjacent to skin having eczema characteristics before, during and after treatment with a composition in accordance with one or more embodiments of the invention; and

[0025] FIG. 11 is a graph showing microbiome diversity on skin having eczema characteristics and an area of skin adjacent to skin having eczema characteristics before and after treatment with a composition in accordance with one or more embodiments of the invention. DETAILED DESCRIPTION

[0026] 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 remainder of the disclosure in any way whatsoever.

[0027] Unless defined otherwise, 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. Also, all publications, patent applications, patents, and other references mentioned herein are incorporated by reference.

[0028] Unless otherwise indicated, percentages used to express amounts of ingredients are percentage by weight (referred to as “weight %,” “wt%”, “% by weight” or “% (WAV)”) by total weight of the composition. Similarly, weight ratios used to express relative proportions of ingredients are also determined using percentage by weight (i.e., weight ratios are calculated by dividing the percentage by weight of one ingredient by another). Unless stated otherwise, all ranges are inclusive of the endpoints, e.g., “from 4 to 9” includes the endpoints 4 and 9.

[0029] As used herein, “cosmetically acceptable” means that the ingredients the term describes are suitable for use in contact with tissues (e.g., the skin or hair) without undue toxicity, incompatibility, instability, irritation, allergic response, or the like.

[0030] As used herein, the term “safe and effective amount” means an amount sufficient to induce the desired effect, but low enough to avoid serious side effects. The safe and effective amount of the compound, extract, or composition will vary with, e.g., the age, health and environmental exposure of the end user, the duration and nature of the treatment, the specific extract, ingredient, or composition employed, the particular carrier utilized, and like factors.

[0031] As used herein, the term “about” refers to within 5% weight, within 4% weight, within 3% weight, within 2.5% weight, within 2% weight, or within 1% weight of a disclosed value.

[0032] One aspect of the invention pertains to a skincare composition comprising: a. an emollient; b. an occlusive; c. a humectant; d. a processed oat ingredient; and e. a rheological modifier; and f. water.

[0033] It has been surprisingly discovered that such compositions provide deep and prolonged hydration, as shown by clinical studies. Indeed, the studies show that these compositions are actually capable of improving the quality of life of those afflicted with eczema, as well as alter the balance of the skin microbiome to reduce the incidence of bacteria associated with eczema and increase the incidence of bacteria associated with healthier skin.

[0034] Emollient

[0035] Emollients include compounds that help to 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 Chapter 35, pages 399-415 (Skin Feel Agents, by G Zocchi) in Handbook of Cosmetic Science and Technology (edited by A. Barel, M. Paye and H. Maibach, Published in 2001 by Marcel Dekker, Inc New York, N.Y.), and include, but are not limited to, esters; silicone-containing compounds; plant, nut, and vegetable oils and butters; and combinations thereof. In one or more embodiments, the emollient is selected from the group consisting of isopropyl palmitate, dimethicone, helianthus annus seed oil, and combinations thereof.

[0036] The total amount of emollients may be present in amounts 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 wt.% of the total composition. In one or more embodiments, the emollient is present in an amount ranging from about 1 wt.% to about 11 wt.% by total weight of the composition. In some embodiments, the emollient is present in an amount ranging from about 2 wt.% to about 10 wt.% by total weight of the composition. In one or more embodiments, the emollient is present in an amount ranging from about 5 wt.% to about 10 wt.% by total weight of the composition. In some embodiments, the emollient is present in an amount ranging from about 6 wt.% to about 9 wt.% by total weight of the composition. Occlusive

[0037] Occlusives are hydrophobic substances that promote water retention by forming a barrier on the skin that will prevent moisture loss. Oftentimes, occlusive agents are, by their very nature, oleaginous having a greasy texture and are difficult to spread. Some examples of occlusive agents include petrolatum, lanolin, and mineral oil. In one or more embodiments, the occlusive comprises petrolatum.

[0038] In one or more embodiments, the occlusive is present in an amount ranging from about 1 to about 8 wt.% by total weight of the composition, or from about 1.5 to about 6 wt.%, or from about 2 to about 5 wt.%, or from about 3 to about 5 wt.%, or about 4 wt.%.

[0039] Humectant

[0040] What is meant by a humectant is a compound intended to increase the water content of the top layers of skin (e.g., hygroscopic compounds). Examples of suitable humectants include those found in Chapter 35, pages 399-415 (Skin Feel Agents, by G Zocchi) in 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) and include, but are not limited to, glycerin, sorbitol or trehalose (e.g., a, a- trehalose, P,P-trehalose, a,P-trehalose) or a salt or ester thereof (e.g., trehalose 6-phosphate). In one or more embodiments, the humectant comprises glycerin.

[0041] When present, the humectant may be present in an amount of from 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 is present in an amount of from 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 11% to about 14%, about 11 % to about 13%, or about 12% by weight % of the total composition.

[0042] Processed Oat Ingredient

[0043] As used herein, the term “processed oat ingredient” refers to an ingredient that is typically derived from a part of the oat plant (Avena sativa). Said ingredient can be either a processing (e.g., an extract, milling, fermenting) of one or more parts of the oat plant (e.g., grain, leaf, stem, seed)or can be a molecule found in the oat plant (e.g., beta-glucan, flavonoids, avenanthramides, lipids, peptides, etc.). The definition is intended to cover processed oat ingredients which are derived from other sources other than oat (e.g., from another plant or chemically synthesized), but are otherwise associated with 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 peptide, oat oil, fermented oat, avenanthramides, beta-glucan, modified oat grain material (e.g., chemically, enzymatically-, microorganism-modified), and combinations thereof. As used herein, “colloidal oatmeal” means the powder resulting from the grinding and further processing of whole oat grain meeting United States Standards for Number 1 or Number 2 oats. The colloidal oatmeal has a particle size distribution as follows: not more than 3 percent of the total particles exceed 150 micrometers in size and not more than 20 percent of the total particles exceed 75 micrometers in size. Examples of suitable colloidal oatmeals include, but are not limited to, “Tech-0” available from the Beacon Corporation and colloidal oatmeals 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 comprises oat extract, colloidal oatmeal, and oat oil. In one or more embodiments, the processed oat ingredient comprises avenanthramides. In some embodiments, the processed oat ingredient comprises fermented oat. In one or more embodiments, the processed oat ingredient comprises beta-glucan.

[0044] The processed oat ingredient(s) may be present in amounts 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 wt.% of the total composition. In one or more embodiments, the processed oat ingredient(s) is present in an amount ranging from about 0.1 wt.% to about 10 wt.% by total weight of the composition. In some embodiments, the processed oat ingredient(s) is present in an amount ranging from about 0.1 wt.% to about 5 wt.% by total weight of the composition. In one or more embodiments, the processed oat ingredient(s) is present in an amount ranging from about 0.5 wt.% to about 5 wt.% by total weight of the composition. In some embodiments, the processed oat ingredient(s) is present in an amount ranging from about 0.5 wt.% to about 4 wt.% by total weight of the composition. In one or more embodiments, the processed oat ingredient(s) is present in an amount ranging from about 0.5 wt.% to about 3 wt.% by total weight of the composition. In some embodiments, the processed oat ingredient(s) is present in an amount ranging from about 1 wt.% to about 3 wt.% by total weight of the composition. In one or more embodiments, the processed oat ingredient(s) is present in an amount of about 1 wt.% to about 2 wt.% by total weight of the composition. In some embodiments, the processed oat ingredient(s) is present in an amount of about 1 wt.% by total weight of the composition. In one or more embodiments, the processed oat ingredient(s) is present in an amount of about 2 wt.% by total weight of the composition.

[0045] 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 wt.% to about 3 wt.% by total weight of the composition. In some embodiments, the colloidal oatmeal is present in an amount of about 1 wt.% to about 3 wt.% by total weight of the composition. In one or more embodiments, the colloidal oatmeal is present in an amount of about 1 wt.% to about 2 wt.% by total weight of the composition. In some embodiments, the colloidal oatmeal is present in an amount of about 1 wt.% by total weight of the composition. In one or more embodiments, the colloidal oatmeal is present in an amount of about 2 wt.% by total weight of the composition.

[0046] Rheological Modifier

[0047] Rheological modifiers according to the present invention are those which can increase viscosity but allow the composition to remain pourable. Pourability may be evaluated by strain sweep and flow curves, as described below. In one or more embodiments, the rheological modifier comprises a nonionic starch-based rheological modifier In further embodiments, the rheological modifier comprises hydroxypropyl starch phosphate, available as STRUCTURE® XL from Nouryon.

[0048] The rheological modifier may present in an amount of from about 0.25 wt.% to about 2.5 wt.%, from about 0.5 wt.% to about 2 wt.%, from about 0.75 wt.% to about 1.5 wt.%, from about 0.75 wt.% to about 1.25 wt.%, or about 1 wt.%. Carrier

[0049] Any suitable carrier may be used in the compositions. In some embodiments, the carrier is a cosmetically-acceptable carrier. As will be recognized by those of skill in the art, cosmetically acceptable carriers comprise carriers that are suitable for use in contact with the body, in particular the skin, without undue toxicity, incompatibility, instability, irritation, allergic response, and the like. A safe and effective amount of carrier is from about 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 98% to about 85, 90, 95, 98, 99, 99.1, 99.5 or 99.9% by weight of the composition.

[0050] The carrier can be in a wide variety of forms. For example, carriers in the form of emulsions, including, but not limited to, oil-in-water, water-in-oil, water-in-oil-in-water, and oil-in-water-in- silicone emulsions, are useful herein. These emulsions can cover a broad range of viscosities, e.g., from about 100 cps to about 200,000 cps using a Brookfield RVT viscometer.

[0051] The following are non-limiting examples of carriers. Other carriers can be formulated by those of ordinary skill in the art. In one embodiment, the carrier contains water. In a further embodiment, the carrier may also contain one or more aqueous or organic solvents. Examples of organic solvents include, but are not limited to: dimethyl isosorbide; isopropyl myristate; surfactants of cationic, anionic and nonionic nature; vegetable oils; mineral oils; waxes; gums; synthetic and natural gelling agents; alkanols; glycols; and polyols. Examples of glycols include, but are not limited to, glycerin, propylene glycol, butylene glycol, pentalene glycol, hexylene glycol, polyethylene glycol, polypropylene glycol, diethylene glycol, triethylene glycol, capryl glycol, glycerol, butanediol and hexanetriol, and copolymers or mixtures thereof. Examples of alkanols include, but are not limited to, those having from about 2 carbon atoms to about 12 carbon atoms (e.g., from about 2 carbon atoms to about 4 carbon atoms), such as isopropanol and ethanol. Examples of polyols include, but are not limited to, those having from about 2 carbon atoms to about 15 carbon atoms (e.g., from about 2 carbon atoms to about 10 carbon atoms) such as propylene glycol. The organic solvents may be present in the carrier in an amount, based upon the total weight of the carrier, of from about 1 percent to about 99.99 percent (e.g., from about 20 percent to about 50 percent). Water may be present in the carrier (prior to use) in an amount, based upon the total weight of the carrier, of from about 5 percent to about 95 percent (e.g., from about 50 percent to about 90 percent). Solutions may contain any suitable amounts of solvent, including from about 40 to about 99.99%. Some solutions contain from about 50 to about 99.9%, from about 60 to about 99%, from about 70 to about 99%, from about 80 to about 99%, or from about 90 to 99% of solvent.

[0052] A type of product that may be formulated from a solution is a cream. A cream typically contains from about 5% to about 50% (e.g., from about 10% to about 20%) of an emollient(s) and from about 45% to about 85% e.g., from about 50% to about 75%) of water.

[0053] Yet another type of product that may be formulated from a solution is an ointment. An ointment may contain a simple base of animal, vegetable, or synthetic oils or semi-solid 10 hydrocarbons. An ointment may contain from about 2% to about 10% of an emollient(s) plus from about 0.1% to about 2% of a thickening agent(s).

[0054] The compositions useful in the present invention can also be formulated as emulsions. If the carrier is an emulsion, from about 1% to about 10% (e.g., from about 2% to about 5%) of the carrier contains an emulsifier(s). Emulsifiers may be nonionic, anionic or cationic.

[0055] As used herein, the term “cream” means a predominantly water-containing topical preparation of rich texture having a viscosity of from about 35000 CPs to about 140000 CPs, (as measured by Brookfield RVT, with the following conditions: spindle T-C, 5 rpm, 1 min, 25°C) and tend to be thicker than lotions. Creams can be formulated as emulsions. Typically such lotions contain from 0.5% to about 5% of an emulsifier(s), while such creams would typically contain from about 1% to about 10% (e.g., from about 2% to about 5%) of an emulsifier(s). In one or more embodiments, the compositions described herein are in the form of a cream. A cream typically contains from about 5% to about 50% (e.g., from about 10% to about 20%) of an emollient(s) and from about 45% to about 85% (e.g., from about 50% to about 75%) of water. The skincare composition of claim 1, wherein the composition has a strain sweep of about y<> 0.01000 to about 0.06000.

[0056] Single emulsion skin care preparations, such as lotions and creams, of the oil-in-water type, and water-in-oil type are well-known in the art and are useful in the subject invention. Multiphase emulsion compositions, such as the water-in-oil-in-water type or the oil-in-water-in-oil type, are also useful in the subject invention. In general, such single or multiphase emulsions contain water, emollients, and emulsifiers as essential ingredients.

[0057] A variety of product forms and packaging may be suitable for any of the compositions described herein. As used herein, a “product” is optionally in finished packaged form. In one embodiment, the package is a container such as a plastic, metal or glass tube or jar containing the composition. The product may further contain additional packaging such as a plastic or cardboard box for storing such container. In one or more embodiments, the product includes a composition of the invention and contains instructions directing the user to apply the composition to the skin.

[0058] Methods of Manufacturing

[0059] As discussed above, even though the compositions described herein are sufficiently thick to constitute a cream that is suitable for skin afflicted with eczema, they remain pourable enough to be easily manufactured. Accordingly, another aspect of the invention pertains to a method of manufacturing or processing one or more of the compositions described herein, the method comprising pouring the skincare composition. Such pouring can be done after the composition is produced and ready to be put into packaging for delivery to users. In one or more embodiments, the skincare composition is poured into ajar.

[0060] Methods of Using

[0061] Various methods described herein pertain to topically applying one or more of the compositions described to skin, including skin affected by eczema. As described above, the compositions may be used for treating skin afflicted with eczema, for improving the appearance of skin afflicted with eczema, and / or other benefits to those having skin afflicted with eczema.

[0062] Any suitable method of topically applying the compositions described herein to the skin in need may be used. As used herein, “topically applying” means directly laying on or spreading on outer skin, by use of the hands or an applicator such as a wipe, roller, or spray. For example, the composition may be applied directly from a package to the skin in need, by hand to the skin in need, or may be transferred from a substrate such as a wipe or mask, or a combination of two or more thereof. In other embodiments, the composition may be applied via a dropper, tube, roller, spray, or added to a bath or otherwise to water to be applied to the skin, and the like. Such topical application may be to any skin in need of treatment on the body, for example skin of the face, lips, neck, chest, back, buttocks, arms, axilla, and / or legs.

[0063] The skin afflicted with eczema may comprise mild, moderate or severe eczema. The compositions described herein may be applied to a lesional area on the skin afflicted with eczema. The lesional area may be one exhibiting a symptom selected from the group consisting of erythema, pruritus, exudation, excoriation, lichenification, dryness, tactile roughness, abnormal skin tone, burning, stinging, and combinations thereof. In some embodiments, the composition is applied to the face or body. The compositions may be applied to the skin as needed, or otherwise how often the user desires. In one or more embodiments, the composition is applied once or twice per day.

[0064] Although the methods described herein are generally thought to help treat signs and / or symptoms of eczema, there are other methods considered under the term of “treating eczema”. Thus, in some embodiments, the methods include a method of reducing the signs and / or symptoms of eczema as measured by Global S CORAD. In one or more embodiments, the methods include a method of reducing the severity of eczema as measured by a POEM questionnaire.

[0065] In some embodiments, the methods include a method of increasing skin hydration. In one or more embodiments, the composition is applied to a lesional area on the skin of a person having eczema. In one or more embodiments, the composition is applied to an area adjacent to a lesional area on the skin of a person having eczema. In one or more embodiments, the composition is applied to skin adjacent to an area of skin afflicted with eczema. In some embodiments, the skin is skin that is not afflicted with eczema.

[0066] In one or more embodiments, the methods include a method of balancing the microbiome of skin, which can be skin with eczema or not. In particular, it has been surprisingly shown that one or more of the compositions described herein are capable of increasing the amount of S. epidermidis and / or reducing the amount of S. aureus on skin. This selectivity is highly desirable and could help balance the skin microbiome and improve atopic dermatitis conditions. In one or more embodiments, the composition is applied to a lesional area on the skin of a person having eczema. In one or more embodiments, the composition is applied to an area adjacent to a lesional area on the skin of a person having eczema. In one or more embodiments, the composition is applied to skin adjacent to an area of skin afflicted with eczema. In some embodiments, the skin is skin that is not afflicted with eczema.

[0067] In one or more embodiments, the methods include a method of increasing quality of life parameters of a person having eczema. It has been surprisingly shown that one or more of the compositions described herein are capable of alleviating a variety of the dermatological issues as perceived by people having eczema (e.g., redness, soothing the skin, flaking, itching). In particular, it is surprising that people having eczema felt that use of the composition actually improved their quality of life.

[0068] While the foregoing description represent exemplary embodiments of the present invention, it will be understood that various additions, modifications and substitutions may be made therein without departing from the spirit and scope of the present invention. In particular, it will be clear to those skilled in the art that the present invention may be embodied in other specific forms, structures, arrangements, proportions, and with other elements, materials, and components, without departing from the spirit or essential characteristics thereof. One skilled in the art will appreciate that the invention may be used with many modifications of structure, arrangement, proportions, materials, and components and otherwise, used in the practice of the invention, which are particularly adapted to specific environments and operative requirements without departing from the principles of the present invention. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims, and not limited to the foregoing description. It will be appreciated that in the claims, the term “comprises / comprising” does not exclude the presence of other elements or steps. In addition, singular references do not exclude a plurality. The terms “a”, “an”, “first”, “second”, etc., do not preclude a plurality.

[0069] EXAMPLES

[0070] EXAMPLE 1 : Composition ingredient selection and preparation

[0071] Across the industry, there is a trend for thicker format products in the use of thickeners (such as carbomer, xanthan gum and waxes such as cetyl alcohol, cetearyl alcohol) with a viscosity controller function, to achieve the appearance of a thick cream. A variety of thickeners were selected and tested, but as the percentage of these ingredients was increased, the final formulations had unpleasant sensory and instability properties.

[0072] Acrylate -based polymer gelling agents were also considered due to their viscoelastic properties and because they provide favorable shear effects. However, such acrylate-based polymers are swellable polymers that thicken through binding water by charge repulsion. Although cationic emulsifier has a salt (electrolyte) in the chain, so acrylates are also do not provide the requisite stability.

[0073] It was then discovered that an alternative rheological modifier ingredient, particularly hydroxypropyl starch phosphate, could contribute to obtain the rheology required and desired appearance for a jar product, without increasing the viscosity so much that it could impact the sensory (consumer experience) and processability attributes mentioned above. Such an ingredient was also compatible with the formulation's cationic emulsifier.

[0074] In view of the above, inventive composition (Ex. 1) and comparative composition (Ex. Cl) were prepared in the following manner using the amounts shown in the table below. In a main vessel, water, chelating agent, glycerin and Avena sativa (oat) kernel flour were added with stirring at room temperature. After the Avena sativa (oat) kernel flour was fully dispersed in solution the temperature was increased to 75 °C. The distearyldimonium chloride was added with stirring until completely dissolved, and the temperature was increased to 80 ° C and held for 20 minutes. Next, the cetyl alcohol, petrolatum, isopropyl palmitate, helianthus annuus (sunflower) seed oil, caprylic / capric triglyceride, dimethicone, caprylyl glycol, glyceryl stearate, synthetic beeswax, and tocopheryl acetate were added to the main vessel. Stirring continued for 20 min at 80 °C to provide the uniform emulsion. The hydroxypropyl starch phosphate was added and the emulsion was allowed to begin cooling down to 35 °C. When the temperature reached 60 °C the SymGlucan was added. A uniform emulsion resulted upon cooling to 35 °C. Any comparative compositions were prepared in a similar manner with the ingredients according to the Table below.

[0075] Table: Compositions

[0076] EXAMPLE 2: Clinical study: instrumental, clinical, microbiome and self-perception evaluations

[0077] This study was a single-center, open-label, non-randomized clinical trial aimed at evaluating the safety and efficacy of Ex. 1. Clinical efficacy was determined using SCORing Atopic Dermatitis (SCORAD) index; instrumental evaluation of skin hydration (through Corneometer®) and skin barrier (through Tewameter®) as well as microbiome sampling. Perceived efficacy was evaluated through subjective perception questionnaires: Patient Oriented Eczema Measure (POEM) questionnaire, a self-perception questionnaire based on formula perceived efficacy / sensorial aspects and a questionnaire based on quality of life parameters performed before and after a period of use under normal conditions. 30 subjects with mild to moderate atopic dermatitis and presenting with skin areas with atopic dermatitis characteristics (dryness / lesion), male and / or females age ranged from 18-65, having Fitzpatrick skin type I- VI and of any ethnicity were included in the study. Subjects were excluded from the study if they required systemic treatments, topical antimicrobial therapies, phototherapy or using antimicrobial / cosmetics for hygiene. Patients self- reporting type 1 or 2 diabetes or taking insulin / anti-diabetic medication, pregnant or planning to become pregnant were not eligible for the study.

[0078] The study consisted of three face-to-face visits over 21 days, the first visit was carried out on day 1 (TO), the second on day 5 (T5+ / -1), and the last on day 21(T21+ / -2). Composition was applied twice a day all over the body and face, massaging gently until absorbed by the skin, and paying special attention to the driest areas. Reapplied as needed.

[0079] SCORAD index assessment

[0080] SCORAD index assessment of atopic dermatitis was performed on day 1 (TO), day 5 (T5) and day 21 (T21), 27 out of the 30 subjects were considered with three subjects excluded due to SCORAD software issues during their visit. The SCORAD was developed to standardize the medical assessment of the extent and severity of AD. There are 3 components to the assessment: A = extent of lesion, B = severity of lesion, and C = subjective symptoms (pruritus and sleep loss). A global SCORAD score is calculated according to the formula: A / 5 + 7B / 2 + C. Mild AD corresponds to a score lower than 24; Moderate AD corresponds to a score between 25 to 50 and Severe AD corresponds to a score > 50. Assessments were performed by the dermatologist using the SCORAD software. Results for global SCORAD (FIG. 1), subjective symptoms (FIG. 2), severity of lesions (FIG. 3), and total surface lesion (FIG. 4), are shown and compared to baseline. Results (mean) were reported including standard error per time point. Statistics were performed using the Student’s t test.

[0081] A significant reduction of Global SCORAD, severity of the lesion and subjective symptoms was observed after 5 and 21 days of composition use. Also, a significant reduction of total surface of lesion was observed after 21 days of composition use, compared to baseline condition. 78% of subjects showed a reduction in lesion severity after 5 days and 85% of subjects showed reduction in lesion severity after 21 days. On average, global SCORAD decreased from moderate (25-50) to mild (<25) after 5 and 21 days. 100% of subjects showed a reduction in SCORAD after 5 (40% of rating reduction) and 21 days (62% of rating reduction). There was a 49% reduction in lesion area after 21 days and 70% of subjects showed reduction of lesion areas after 21 days. Regarding subjective symptoms (sleep loss and pruritus), a significant reduction was observed after 5 and 21 days of composition use and after 21 days of composition use compared to 5 days of use. There was 66% reduction in sleep loss and itching after 5 days and 90% after 21 days. Also, 93% of participants showed reduced sleep loss and itching after 5 and 21 days.

[0082] POEM questionnaire

[0083] POEM is an internationally known questionnaire used to monitor the severity of AD focused on the symptoms as experienced by the subject. The questionnaire comprises a total of 7 questions answered by subject once a week, with a 4-point scale, each point referring to the number of days the subject experienced each symptoms / situation. The score of the answers to the 7 questions were added up according to the scale and the classification of AD / eczema was performed, according to the following ranges: 0 to 2 = No eczema or almost no eczema; 3 to 7 = Mild eczema; 8 to 16 = Moderate eczema; 17 to 24 - Severe eczema; 25 to 28 = Very severe eczema. Results (mean) were reported including standard error per time point (FIG. 5). Comparisons were made to baseline using the Student’ s t test.

[0084] A significant reduction in the severity of atopic dermatitis / eczema was observed after 7, 14 and 21 days of composition use and after 14 and 21 days of composition use compared to 7 days of composition use. This result indicated a reduction in the severity of AD with prolonged use of the composition. There was a 74% reduction in eczema severity after 7 days and 88% after 14 and 21 days. AD severity decreased from “moderate eczema” to “no eczema” or “almost no eczema.” 100% of subjects had reduced eczema severity after 21 days, 97% after 14 days and 93% after 7 days.

[0085] Skin Hydration and Barrier

[0086] Skin hydration assessment using a Corneometer® CM825 (Courage-Khazaka Electronic GmbH, Cologne, Germany) was performed on day 1 (TO), day 5 (T5) and day 21 (T21). Assessments were made individually for area with AD characteristics (lesion / dry skin) (FIG. 6) and on adjacent area, without AD characteristics (FIG. 7) and compared T5 and T21 against TO (FIG. 8). Results (mean) were reported including standard error per time point. Statistics were performed using the Student’s t test. A significant improvement for skin hydration was observed for both lesioned and adjacent skin areas after 5 and 21 days of composition use. For lesioned skin a statistically significant increase of hydration was observed after 5 (44.3%) and 21 days (64.5%) of composition use compared to baseline. A significant increase of hydration was also observed after 21 days of composition use compared to 5 days of composition use, indicating a progressive improvement in hydration after continuous use. For the adjacent area, a statistically significant increase of hydration was observed after 5 (21.7%) and 21 days (25.1%) of composition use compared to baseline. Lesioned area had an increase in skin hydration significantly higher than the adjacent area after 21 days of composition use.

[0087] Skin barrier assessment was made by measuring transepidermal water loss (TEWL) using a Tewameter® TM300 (Courage-Khazaka Electronic GmbH, Cologne, Germany) and was performed on day 1 (TO), day 5 (T5) and day 21 (T21). Assessments were made individually for area with AD characteristics (lesion / dry skin) (FIG. 9) and on adjacent area, without AD characteristics (FIG. 10). Results (mean) were reported including standard error per time point. Statistics were performed using the Student’s t test.

[0088] No significant reduction for transepidermal water loss was observed for areas with and without Atopic Dermatitis (characteristics dryness / lesion) after 5 and 21 days of product use. However, a significant improvement in skin barrier was observed for area without AD (characteristics dryness / lesion) after 21 days of product use compared to 5 days of use. The skin of subjects affected by AD has specific characteristics regarding the damaged skin healing process and skin barrier repair. The studied patients presented lesions with distinct levels of severity (corroborated by initial values of SCORAD), and high variation on the lesioned and adjacent areas TEWL values, which, in turn, might have affected the intensity of the skin barrier repair impairment over time. Even after 21 days of investigational product use, 11% of patients still had moderate SCORAD values, therefore with apparent skin lesions that may have affected the mean TEWL values. On the other hand, clinical evaluation, expressed by the SCORAD and by the POEM had shown consistent results, endorsing the observation that the use of the composition is an important AD adjuvant treatment when part of self-care routine, reflecting on patients' quality of life and their well-being.

[0089] Skin Microbiome

[0090] Skin surface microbiome samples from each subject were collected from lesional and adjacent skin areas before (TO) and after 21 days of composition use. Samples were stored at 4°C and sent to the Gentros Company (San Paulo, Brazil for microbiota metagenomics analysis. The skin microbiome was evaluated by analyzing the alpha-diversity measured by the Shannon index and the assessment of the most abundant species.

[0091] In the lesional areas, the predominant genus was Staphylococcus. This genus harbors species such as S. aureus, which frequently is associated with AD, presenting a high prevalence on lesional skin (GEOGHEGAN JA et al, Trends in Microbiology, June 2018, Vol. 26, No. 6, 484-497). Within the Staphylococcus genus, both lesion and adjacent areas showed a predominance of the species S. aureus and S. epidermidis. S. aureus presence was reduced in half from baseline after using the composition for 21 days. (See Tables below 1-2). This result indicates that composition use for 21 days reduced the population of S. aureus, contributing to the balance of the skin microbiota. In terms of community level, the microbiome diversity (Alpha-diversity) was maintained after 21 days of use, demonstrating the composition was microbiome gentle (FIG. 11).

[0092] Table 1

[0093] Table 2

[0094]

[0095] Self-assessments

[0096] Patient’s self-assessments with respect to composition perceived efficacy for atopic dermatitis were performed on day 7 and day 21. Each variable was evaluated using a scale strongly agree, agree, neither agree nor disagree, disagree and strongly disagree. Quality of life assessments were performed before composition use, day 1, and after 7, 14, and 21 days of composition use under normal conditions. Before composition use, scale was: “affected very much”, “moderately affected”, “affected a little”, and “not affected” for day 1 assessment. After composition use, scale was: “helped a lot”, “helped moderately”, “helped a little”, and “didn’t help”, for day 7 and day 21 assessments. Results reported were the percentages of grouped responses (Top 2 box, positive responses) atopic dermatitis assessment (day 7) (Table 3), atopic dermatitis (day 21) (Table 4), quality of life assessment TO (Table 5), and quality of life assessment day 7, 14, and 21 (Table 6).

[0097] Table 3

[0098] Statement (D7); n=30 T2B

[0099] Relieves itching from the first application 66.7% (20)

[0100] Reduces flaking from the first application 80.0% (24)

[0101] Formula with creamy texture 90.0% (27)

[0102] It is easy to spread 93.3% (28)

[0103] It forms a moisturizing film on the skin 93.3% (28)

[0104] Fast absorption 76.7% (23)

[0105] Fast drying 66.7% (20)

[0106] Does not leave the skin oily 53.3% (16)

[0107] Does not leave the skin sticky 63.3% (19)

[0108] Relieves redness 90.0% (27)

[0109] Soothes the skin 96.7% (29)

[0110] Contributes to better night’ sleep from the first application 93.3% (28) Gentle application to the skin 86.7% (26) My skin feels hydrated longer 96.7% (29) Texture suitable for day-to-day use 86.7% (26)

[0111] Table 4

[0112] Statement (D21); n=30 T2B

[0113] Overall, how much did you like JAR Moisturizing Lotion for atopic dermatitis .c / care?* 93. / o (28)

[0114] Relieves itching 93.3% (28)

[0115] Reduces flaking 96.7% (29)

[0116] Made using the hydrant more pleasant and easier 90.0% (27)

[0117] Relieves redness 96.7% (29)

[0118] Soothes the skin 76.7% (23)

[0119] Effective in preventing crises of atopic dermatitis 76.7% (23)

[0120] I feel more confident in dealing with my atopic dermatitis routine 76.7% (23)

[0121] Helps me to better deal with my skin condition 63.3% (19)

[0122] I feel my skin more beautiful 93.3% (28)

[0123] Relieves the uncomfortable sensations of atopic dermatitis in just 1 step 96.7% (29)

[0124] Reconstructed skin sensation 90.0% (27)

[0125] I see my skin looking healthier day by day 96.7% (29)

[0126] Improved my quality of life 100.0% (30)

[0127] Sensation of relief for the skin 86.7% (26)

[0128] Patient’s self-perceived efficacy results showed that 90% or more agreed that composition relieved redness, soothed skin and contributed to better night sleep from the first application; 80% agreed that composition relieved flaking and 66.7% agreed that composition relieved itching, both from the first application. After 21 days of composition use, 96.7% of patients agreed that the composition relieved the uncomfortable sensations of AD in just one step and 100% agreed that the composition improved their quality of life. Besides clinically proven efficacy, subjects perceived the composition as pleasant to use, based on its sensory characteristics, which reinforced willingness to follow use recommendations for longer periods of time. From a self-perception perspective, patients agreed that the composition was easy to spread (93.3%) and had a texture suitable for day-to-day use (86.7%).

[0129] Table 5 How much have the symptoms and discomfort of atopic dermatitis NEGATIVELY impacted the following TO questions? Affected very

[0130] 1) Your daily activities like working, taking care of the

[0131] TO 63.3% (19) house, taking care of children, playing sports?

[0132] Before

[0133] 2) Your social interactions with people inside or outside product 80.0% (24) your house? use

[0134] 3) Your social interactions in public places like walks,

[0135] 80.0% (24) leisure, shopping, etc.?

[0136] 4) Your mood / irritability? 60.0% (18)

[0137] 5) Your self-esteem, embarrassment? 60.0% (18)

[0138] Table 6

[0139] How much has using the JAR T7 T14 T21 Moisturizing Lotion HELPED Helped a Helped a Helped a IMPROVE the questions below? lot / moderately lot / moderately lot / moderately

[0140] 1) Your daily activities like

[0141] T7, working, taking care of the house,90 0% (27) 90.0% (27) 93,3% (28) taking care of children, playing

[0142] T2|’ sports? . . 2) Your social interactions with roduct PeoPleinside or outside your 90.0% (27) 90.0% (27) 93.3% (28) house? use

[0143] 3) Your social interactions in public places like walks, leisure, 90.0% (27) 93.3% (28) 93.3% (28) shopping, etc.?

[0144] 4) Your mood / irritability? 93.3% (28) 100.0% (30) 100.0% (30)

[0145] 5) Your self-esteem, 100.0% (30) 100.0% (30) 93.3% (28) embarrassment !

[0146] Before use of the composition, subjects answered a questionnaire based on self-reported quality of life parameters for which 80% reported that symptoms and discomfort of atopic dermatitis negatively impacted their social interactions with people inside and outside home and 60% reported that AD affected their mood / irritability and self-esteem / embarrassment. After 21 days of composition use, 93.3% of patients reported that it helped to improve their social interactions with people inside or outside home, 100% reported improvement on mood / irritability and 93.3% expressed improved on self-esteem / embarrassment.

Claims

What is claimed is:

1. A method of treating eczema, the method comprising topically applying to skin afflicted with eczema a composition comprising: a. an emollient; b. an occlusive; c. a humectant; d. a processed oat ingredient; and e. a rheological modifier; and f. water.

2. The method of claim 1 , wherein treating eczema comprises a method of reducing Global SCORAD.

3. The method of claim 1, wherein treating eczema comprises a method of reducing the severity of eczema as measured by the POEM questionnaire.

4. The method of claim 1 , wherein treating eczema comprises a method of increasing skin hydration.

5. The method of claim 1, wherein treating eczema comprises a method of reducing S. aureus in the skin microbiome.

6. The method of claim 1 , wherein treating eczema comprises a method of increasing S. epidermidis in the skin microbiome.

7. The method of claim 1, wherein treating eczema comprises a method of increasing the quality of life of a person having eczema.

8. The skincare composition of claim 1, wherein the rheological modifier comprises hydroxypropyl starch phosphate.

9. The skincare composition of claim 1, wherein the rheological modifier is present in an amount of from about 0.25% to about 2.5%.

10. The skincare composition of claim 1, wherein the emollient is selected from the group consisting of esters; silicone-con taining compounds; plant, nut, and vegetable oils and butters; and combinations thereof.

11. The skincare composition of claim 1 , wherein the emollient is selected from the group consisting of isopropyl palmitate, dimethicone, helianthus annus seed oil, and combinations thereof.

12. The skincare composition of claim 1, wherein the occlusive comprises petrolatum.

13. The skincare composition of claim 1, wherein the occlusive is present in an amount ranging from about 1 to about 8 wt.% by total weight of the composition.

14. The skincare composition of claim 1, wherein the humectant comprises glycerin.

15. A method of treating eczema, the method comprising topically applying to skin afflicted with eczema a composition comprising: a. about 2 to about 10 wt. % of an emollient is selected from the group consisting of isopropyl palmitate, dimethicone, helianthus annus seed oil, and combinations thereof; b. about 1 to about 8 wt. % of an occlusive comprising petrolatum; c. about 0.5 to about 20 wt. % of a humectant comprising glycerin; d. about 0.1 to about 3 wt. % of a processed oat ingredient; and e. about 0.1 to about 3 wt. % of a rheological modifier comprising hydroxypropyl starch phosphate.

16. The method of claim 15, wherein treating eczema comprises a method of reducing Global SCORAD.

17. The method of claim 15, wherein treating eczema comprises a method of reducing the severity of eczema as measured by the POEM questionnaire.

18. The method of claim 15, wherein treating eczema comprises a method of increasing skin hydration.

19. The method of claim 15, wherein treating eczema comprises a method of reducing S. aureus in the skin microbiome.

20. The method of claim 15, wherein treating eczema comprises a method of increasing S. epidermidis in the skin microbiome.

21. The method of claim 15, wherein treating eczema comprises a method of increasing the quality of life of a person having eczema.

22. A method of treating skin, the method comprising topically applying to skin a composition comprising: a. an emollient; b. an occlusive; c. a humectant;d. a processed oat ingredient; and e. a rheological modifier; and f. water.

23. The method of claim 22, wherein the skin is skin afflicted with eczema.

24. The method of claim 22, wherein the skin is skin adjacent to an area of skin afflicted with eczema.

25. The method of claim 22, wherein the skin is skin that is not afflicted with eczema.

26. The method of claim 22, wherein treating eczema comprises a method of increasing skin hydration.

27. The method of claim 22, wherein treating eczema comprises a method of reducing S. aureus in the skin microbiome.

28. The method of claim 22, wherein treating eczema comprises a method of increasing S. epidermidis in the skin microbiome.

29. The method of claim 22, wherein the composition comprises: a. about 2 to about 10 wt. % of an emollient is selected from the group consisting of isopropyl palmitate, dimethicone, helianthus annus seed oil, and combinations thereof; b. about 1 to about 8 wt. % of an occlusive comprising petrolatum; c. about 0.5 to about 20 wt. % of a humectant comprising glycerin; d. about 0.1 to about 3 wt. % of a processed oat ingredient; and e. about 0.1 to about 3 wt. % of a rheological modifier comprising hydroxypropyl starch phosphate.

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