DESC:FIELD OF THE INVENTION
[0001] The present disclosure pertains to the field of moisturizer. Particularly the present disclosure relates to a moisturizer composition comprising parabiotic for microbiome balance and skin barrier improvement and formulation and process for preparation thereof.

BACKGROUND OF THE INVENTION
[0002] The background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
[0003] Skin a fragile structure is probably one of the most important organs of the body. Skin is responsible for maintaining body integrity and keeping microbes, chemicals, and allergens from penetrating the skin. Skin is made up of layers, each of which performs important functions in protecting the body. The outermost layer, called the stratum corneum consists of tough skin cells called corneocytes that are bound together by mortar-like lipids, which forms a skin barrier. Inside these skin cells keratin, natural moisturizers and a lipid layer are present. The skin barrier helps retain the water inside the body as well as healthy microbiome.
[0004] Skin houses microbiome that is skin microbiota an ecosystem of bacteria on the skin's surface. Skin microbiome works to guard against pathogens that could affect skin and overall health. When skin microbiome is balanced, skin looks and feels healthy. However, when skin microbiome is unbalanced, there's more harmful bacteria than helpful bacteria, leading to issues like dryness and itching.
[0005] Weakening of the skin barrier allows the water inside body to escape and evaporate, leaving the skin and body dehydrated and disturbing skin microbiome.
[0006] Weakening of skin barrier can be contributed by the external and internal conditions that can include dry environment; allergens, irritants, and pollutants; too much of sun exposure; exposure to harsh chemicals; alkaline detergents and soaps; over-exfoliation or over-washing; cosmetics; steroids; psychological distress; genetic factors; and age. As a result, skin looks dry, dull and possibly scaly. This can lead to chemicals penetrating more readily and potentially cause inflammation, which manifests as skin sensitivity, sever irritation, allergic reaction and eczema as well disturbs and destroys skin microbiome.
[0007] Maintaining skin’s barrier is therefore important and good hydration is vital for the same. Hydration not only can help maintain the skin barrier but also makes skin resilient, flexible, look radiant and balance microbiome.
[0008] There are certain preparations known in the art comprising probiotics such as disclosed in the published PCT application no. WO2020002429A1, which discloses microorganism or mixture comprising or consisting of two microorganisms for use in the treatment and/or prevention of skin conditions by topical application, wherein the microorganism(s) is/are selected from the group consisting of Lactobacillus plantarum HEAL 19 (DSM 15313) and Lactobacillus plantarum HEAL 99 (DSM 15316).
[0009] Though said publication claims the use of such microorganism in skin condition like atopic dermatitis (AD), however, the composition does not completely inhibit the growth of Staphylococcus aureus, a causative agent of AD. Besides, the publication discloses compositions containing chemicals like hydroxyacetophenone, phenoxyethanol, dimethicone, sodium EDTA which may be cause allergic reactions, or side effects like rash, itching, irritation, etc. and wherein hydroxyacetophenone is considered hazardous as well as is found to have low solubility, even sodium EDTA used in the composition is found to have low skin absorption.
[00010] There are compositions available, for example as disclosed in the above said PCT application and others, however they contain harsh chemicals. Another, shortcomings of such composition are that they do not remain stable with aromatic characteristic to allow long term use to achieve positive action. Further, they do not provide the desired skin barrier to provide the soothing effect as well as do not adequately check atopic dermatitis, especially caused by Staphylococcus aureus.
[00011] Thus, there remains a need to provide a moisturizing composition that can help maintain natural moisturizing factors to help skin hydrate, maintain the microbiome balance, improve skin barrier to provide soothing effect and remain stable with respect to at least aroma.

OBJECTS OF THE INVENTION
[00012] An object of the present disclosure is to provide a moisturizing composition that can help maintain or improve one or more of skin barrier and microbiome balance.
[00013] Another object of the present disclosure is to provide a moisturizing composition comprising parabiotic, moisturizing agents, and cosmeceutically acceptable excipients.
[00014] One more object of the present disclosure is to provide a moisturizing composition that can help maintain or improve one or more of skin barrier and microbiome balance, and remain stable with respect to aroma characteristics, the composition comprises parabiotic, moisturizing agents, and cosmeceutically acceptable excipients.
[00015] Yet another object of the present disclosure is to provide a formulation comprising the moisturizing composition containing parabiotic, moisturizing agents, and cosmeceutically acceptable excipients and process for preparing the.

SUMMARY OF THE INVENTION
[00016] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in Detailed Description section. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.
[00017] In general aspects the present disclosure provides a moisturizing composition.
[00018] In aspects of the present disclosure there is provided a moisturizing composition that can help maintain or improve one or more of skin barrier and microbiome balance.
[00019] In one aspect, the present disclosure provides a moisturizing composition that can help maintain or improve skin barrier, maintain the microbiome balance and remain stable with respect to aroma characteristics.
[00020] In an aspect, the present disclosure provides a moisturizing composition comprising parabiotic, moisturizing agents, and cosmeceutically acceptable excipients to help maintain or improve skin barrier and maintain the microbiome balance.
[00021] In one aspect, the present disclosure provides a moisturizing composition comprising parabiotic, moisturizing agents, essential oil and cosmeceutically acceptable excipients to help maintain or improve skin barrier, maintain the microbiome balance and remain stable with respect to aroma characteristics.
[00022] In one aspect, the parabiotic can be Lactobacillus ferment.
[00023] In one aspect, the moisturizing agent comprises moisturizing component-1, moisturizing component-2 and moisturizing component-3. The moisturizing component-1 can be selected from but not limiting to shea butter, ceramide III, and cholesterol. The moisturizing component-2 can be D panthenol, and moisturizing component-3 can be hydrolyzed jojoba esters.
[00024] In one aspect, the cosmeceutically acceptable excipients can include adjuvant.
[00025] In one aspect, the cosmeceutically acceptable excipients can be selected from but not limiting to emollient, humectant, emulsifier, soothing agent, preservative, viscosity modifier, anti-oxidant, buffer, stabilizer, colouring agent, vehicle, and the like.
[00026] In one aspect, the present disclosure provides a moisturizing composition comprising a soothing agent containing Lactobacillus ferment; lavender oil; moisturizing component-1; moisturizing component-2; moisturizing component-3; emollients; humectant; anti-oxidants; emulsifiers; viscosity modifiers; preservatives; buffer; and vehicle.
[00027] In another aspect, the moisturizing composition is formulated into a suitable formulation for example a topical formulation.
[00028] In an aspect, the present disclosure provides a stable emulsion formulation comprising the composition of the present disclosure. The topical formulation can be a lotion.
[00029] In an aspect, the present disclosure provides a process of preparing a stable moisturizing emulsion formulation, the process comprising the steps of:
a. providing a phase-I by mixing a moisturizing component-1, emollients, anti-oxidants, and emulsifiers at a temperature of about 65 oC to about 85 oC;
b. providing a phase-II by mixing viscosity modifiers with a vehicle at a temperature of about 60 oC to about 80 oC;
c. mixing phase-I and phase-II by adding phase-I to phase-II at a temperature of about 60 oC to about 80 oC and allowing to cool to a temperature of about 25 oC to about 45 oC;
d. mixing a moisturizing component-2 with a vehicle and adding to the mixture of phase-I and phase-II obtained in step (c);
e. mixing a moisturizing component-3, a vehicle, and preservatives with the mixture obtained in step (d);
f. mixing a soothing agent containing Lactobacillus ferment with humectant and mixing with the mixture obtaining in step (e);
g. mixing lavender oil and stabilizer with the mixture obtained in step (f); and
h. adjusting the pH to about 5-6 of the mixture obtained in step (g) by adding a buffer and mixing homogenously to provide the moisturizing lotion.
[00030] These and other features, aspects, and advantages of the present subject matter will be better understood with reference to the following description and appended claims. This summary is provided to introduce a selection of concepts in a simplified form. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[00031] The following drawings form part of the present specification and are included to further illustrate aspects of the present disclosure. The disclosure may be better understood by reference to the drawings in combination with the detailed description of the specific embodiments presented herein.
[00032] FIG. 1 is a graph depicting baseline and post baseline value of SCORAD ("SCORing Atopic Dermatitis") Index, after application of the Moisturizing Emulsion Formulation of Example 1 in accordance with an exemplary embodiment of the present disclosure.
[00033] FIG. 2 is a graph depicting baseline and post baseline values for Eczema Area and Severity Index (EASI), after application of the Moisturizing Emulsion Formulation of Example 1 in accordance with an exemplary embodiment of the present disclosure.
[00034] FIG. 3 is a graph depicting baseline and post baseline values for final score of Eczema Area and Severity Index (EASI), after application of the Moisturizing Emulsion Formulation of Example 1 in accordance with an exemplary embodiment of the present disclosure.
[00035] FIG. 4 is a graph depicting baseline and post baseline data of Staphylococcus Aureus (S. aureus) growth after the application of the Moisturizing Emulsion Formulation of Example 1 in accordance with an exemplary embodiment of the present disclosure.
[00036] FIG. 5 is a graph depicting baseline and post baseline values - Visual Analogue Scale (VAS) showing pruritus severity reduction at postbaseline visits after the application of the Moisturizing Emulsion Formulation of Example 1 in accordance with an exemplary embodiment of the present disclosure.
[00037] FIGs. 6a-6b are graphs depicting baseline and post baseline values – of MoistureMeterEpiD affected area and unaffected area respectively after the application of the Moisturizing Emulsion Formulation of Example 1 in accordance with an exemplary embodiment of the present disclosure.
[00038] FIGs. 7a-7b are graphs depicting Vapometer measurements from baseline and post baseline of Transepidermal water loss (TEWL) values – of affected area and unaffected area respectively after the application of the Moisturizing Emulsion Formulation of Example 1 in accordance with an exemplary embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE INVENTION
[00039] The following is a detailed description of embodiments of the disclosure. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.
[00040] All publications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.
[00041] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
[00042] In some embodiments, numbers have been used for quantifying weights, percentages, ratios, and so forth, to describe and claim certain embodiments of the invention and are to be understood as being modified in some instances by the term “about.” Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.
[00043] Various terms as used herein are shown below. To the extent a term used in a claim is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.
[00044] As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.
[00045] Unless the context requires otherwise, throughout the specification which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense that is as “including, but not limited to.”
[00046] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein.
[00047] All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. “such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.
[00048] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified.
[00049] The description that follows, and the embodiments described therein, is provided by way of illustration of an example, or examples, of particular embodiments of the principles and aspects of the present disclosure. These examples are provided for the purposes of explanation, and not of limitation, of those principles and of the disclosure.
[00050] It should also be appreciated that the present disclosure can be implemented in numerous ways, including as a system, a method or a device. In this specification, these implementations, or any other form that the invention may take, may be referred to as processes. In general, the order of the steps of the disclosed processes may be altered within the scope of the invention.
[00051] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.
[00052] The following discussion provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus, if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.
[00053] As used herein, the term ‘Lactobacillus ferment’ refers to a parabiotic i.e., lysed probiotic with intact cell walls of Lactobacillus species.
[00054] As used herein, the phrase “cosmeceutically acceptable excipient” refers to a constituent suitable and adapted to be used in cosmetic preparations, especially for topical application to the keratinous tissue, is compatible with the actives in the composition, and would not cause any unreasonable safety or toxicity concerns.
[00055] The present invention relates to a moisturizing composition. Specifically, the present invention relates to a moisturizing composition that can help maintain or improve one or more of skin barrier and microbiome balance.
[00056] In general, the present disclosure provides a moisturizing composition that can help maintain or improve skin barrier, maintain the microbiome balance and remain stable with respect to aroma characteristics.
[00057] In an embodiment the present disclosure provides a moisturizing composition comprising parabiotic, moisturizing agents, and cosmeceutically acceptable excipients to help maintain or improve skin barrier and maintain the microbiome balance.
[00058] In one embodiment the present disclosure provides a moisturizing composition comprising parabiotic, moisturizing agents, essential oil and cosmeceutically acceptable excipients to help maintain or improve skin barrier, maintain the microbiome balance and remain stable with respect to aroma characteristics.
[00059] In one embodiment, the parabiotic agent is Lactobacillus ferment.
[00060] In one embodiment, the Lactobacillus ferment is a lysate of the fermentation and/or enzymatic hydrolysis product containing intracellular and extracellular metabolites of Lactobacillus species.
[00061] In a preferred embodiment, the ferment may be made non-viable by mild heat treatment to exert the metabolites such as antimicrobial peptides (AMPs) responsible to induce anti-inflammatory response on the skin.
[00062] In an embodiment, the Lactobacillus ferment acts as a soothing agent.
[00063] In an embodiment, the Lactobacillus ferment is present in the range from about 0.25% to about 1% w/w basis of the composition.
[00064] In an embodiment, the Lactobacillus may be selected from Lactobacillus plantarum, Lactobacillus salivarius, Lactobacillus casei, and the like.
[00065] In one embodiment, the moisturizing agent comprises moisturizing component-1, moisturizing component-2 and moisturizing component-3. The moisturizing component-1 can be selected from but not limiting to shea butter, ceramide III, and cholesterol. The moisturizing component-2 can be D panthenol or the like. The moisturizing component-3 can be hydrolyzed jojoba esters or the like.
[00066] In one embodiment, the present disclosure provides a moisturizing composition comprising a soothing agent containing Lactobacillus ferment; lavender oil; moisturizing component-1 selected from shea butter, ceramide III, and cholesterol; moisturizing component-2 being D panthenol; moisturizing component-3 being hydrolyzed jojoba esters; and cosmeceutically acceptable excipients.
[00067] In one embodiment, the present disclosure provides a moisturizing composition comprising a soothing agent containing Lactobacillus ferment from about 0.25% to about 1% w/w; lavender oil from about 0.3% to about 1.5% w/w; moisturizing component-1 comprising shea butter, ceramide III, and cholesterol, the moisturizing component-1 present in the range from about 0.75% to about 5% w/w; moisturizing component-2 being D panthenol present in the range from about 0.01% to about 0.05% w/w; moisturizing component-3 being hydrolyzed jojoba esters present in the range from about 0.25% to about 1.5% w/w; and cosmeceutically acceptable excipients.
[00068] In an embodiment, the Lactobacillus ferment can be present in the composition at least about 0.25%, 0.5%, 0.75%, or 1% or integers in-between on w/w.
[00069] In an embodiment, the lavender oil can be present in the composition at least about 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 1.1%, 1.2%, 1.3%, or 1.5% or integers in-between on w/w.
[00070] In an embodiment, the moisturizing component-1 can be present in the composition at least about 0.75%, 1%, 2%, 3%, 4% or 5% or integers in-between on w/w.
[00071] In an embodiment, the moisturizing component-2 can be present in the composition at least about 0.01%, 0.02%, 0.03%, 0.04%, or 0.05% or integers in-between on w/w.
[00072] In an embodiment, the moisturizing component-3 can be present in the composition at least about 0.25%, 0.5%, 0.75%, 1% or 1.5% or integers in-between on w/w.
[00073] In one embodiment, the shea butter is the vegetable fat from the fruits of Butyrospermum Parkii.
[00074] In one embodiment, the shea butter can be present in the range from about 0.75% to about 2.5% or integers in-between on w/w basis of the composition.
[00075] In one embodiment, ceramide III can be present in the range from about 0.02% to about 0.08% on w/w basis of the composition.
[00076] In one embodiment, cholesterol can be present in the range from about 0.01% to about 0.05% or integers in-between on w/w basis of the composition.
[00077] In one embodiment, D-panthenol can be present in the range from about 0.1% to about 0.5% on w/w basis of the composition.
[00078] In one embodiment, hydrolyzed jojoba esters in the form of a solution with water can be present in the range from about 0.25% to about 1.5% or integers in-between on w/w basis of the composition.
[00079] In one embodiment, the cosmeceutically acceptable excipients can include adjuvant.
[00080] In one embodiment, the cosmeceutically acceptable excipients can be selected from but not limiting to emollient, humectant, emulsifier, soothing agent, skin hydrant, preservative, viscosity modifier, anti-oxidant, buffer, stabilizer, colouring agent, thickener, vehicle, and the like. However, a person of skill in the art would understand that any other excipient(s) well-known in the art may be selected without going beyond the scope of the present disclosure.
[00081] In one embodiment, the present disclosure provides a moisturizing composition comprising a soothing agent containing Lactobacillus ferment; lavender oil; moisturizing component-1; moisturizing component-2; moisturizing component-3; emollients; humectant; anti-oxidants; emulsifiers; viscosity modifiers; preservatives; buffer; and vehicle.
[00082] In an embodiment, the emollient may be selected from caprylic/capric triglyceride, Avena sativa oil and the like.
[00083] In one embodiment, caprylic/capric triglyceride can be present in the range from about 5% to about 15% or integers in-between on w/w basis of the composition.
[00084] In one embodiment, the oat oil is oil from kernel of Avena sativa.
[00085] In one embodiment, the oat oil can be present in the range from about 0.2% to about 1.5% or integers in-between on w/w basis of the composition.
[00086] In an embodiment, the humectant may be glycerine or the like.
[00087] In one embodiment, glycerine can be present in the range from about 3% to about 7% or integers in-between on w/w basis of the composition.
[00088] In an embodiment, the anti-oxidant can be selected from but not limiting to DL-A tocopheryl acetate, butylated hydroxy toluene, and the like.
[00089] In one embodiment, DL-A tocopheryl acetate can be present in the range from about 0.1% to about 0.5% or integers in-between on w/w basis of the composition.
[00090] In one embodiment, butylated hydroxy toluene can be present from about 0.05% to about 0.25% or integers in-between on w/w basis of the composition.
[00091] In an embodiment, the emulsifier can be selected from but not limiting to a blend of hydrogenated sunflower seed oil polyglyceryl-3 esters (and) hydrogenated sunflower seed oil glyceryl esters (and) cetearyl alcohol (and) sodium stearoyl lactylate; cetostearyl alcohol; and the like.
[00092] In one embodiment, a blend of hydrogenated sunflower seed oil polyglyceryl-3 esters (and) hydrogenated sunflower seed oil glyceryl esters (and) cetearyl alcohol (and) sodium stearoyl lactylate can be present in the range from about 3% to about 4.5% on w/w basis of the composition.
[00093] In one embodiment, cetostearyl alcohol can be present in the range from about 2% to about 5% or integers in-between on w/w basis of the composition.
[00094] In an embodiment, the preservative can be selected from but not limiting to phenoxyethanol and ethylhexylglycerin, or combination thereof.
[00095] In one embodiment, phenoxyethanol and ethylhexylglycerin in combination can be present in the range from about 0.25% to about 1.5% or integers in-between on w/w basis of the composition.
[00096] In an embodiment, the viscosity modifier can be selected from but not limiting to sodium acryloyldimethyl taurate copolymer, and hydroxyethyl acrylate, or combination thereof.
[00097] In one embodiment, sodium acryloyldimethyl taurate copolymer, and hydroxyethyl Acrylate in combination can be present in the range from about 0.1% to about 0.5% or integers in-between on w/w basis of the composition.
[00098] In an embodiment, the stabilizer can be selected from but not limiting to sucrose acetate isobutyrate or the like.
[00099] In one embodiment, sucrose acetate isobutyrate or any other stabilizer can be present from about 0.5% to about 1% or integers in-between on w/w basis of the composition.
[000100] In an embodiment, the buffer can be selected from but not limiting to citric acid or the like.
[000101] In one embodiment, citric acid or any other buffer can be present from in an amount sufficient to achieve the pH of the composition to about 5.5 to about 6 on w/w basis of the composition.
[000102] In an embodiment, the vehicle can be selected from water, suitable organic solvent, or the like.
[000103] In one embodiment, the vehicle may be present in quantity sufficient to form the final composition or formulation to 100%. The vehicle may be present in a range from about 60% to about 75% on w/w basis of the composition.
[000104] In some embodiments, the composition may comprise other actives, such as antimicrobial agent, anti-inflammatory agents, and the like. In some embodiments, the composition may comprise an additional antimicrobial agent such as antibacterial and/or antifungal agent(s).
[000105] In an embodiment, the composition may be formulated into a suitable topical formulation such as an emulsion, lotion, gel, cream or the like.
[000106] In an embodiment, the present disclosure provides a topical formulation comprising the composition provided in accordance with the present disclosure. In a preferred embodiment, the formulation may be a moisturizing emulsion formulation.
[000107] The composition of the present disclosure or the formulation comprising the same can help maintain or restores damaged and compromised skin barrier. It strengthens skin barrier function. The composition of the present disclosure maintains, and/or restores healthy state of the skin microbiome.
[000108] The composition is devoid of harsh chemicals including sulphates, parabens or phthalates. The composition is dermatologically safe, clinically safe and is hypoallergenic. Therefore, it is very well suited for sensitive skins.
[000109] In an embodiment, the present disclosure provides a process of preparing a stable moisturizing emulsion formulation, the process comprising the steps of:
a. providing a phase-I by mixing a moisturizing component-1, emollients, anti-oxidants, and emulsifiers at a temperature of about 65 oC to about 85 oC;
b. providing a phase-II by mixing viscosity modifiers with a vehicle at a temperature of about 60 oC to about 80 oC;
c. mixing phase-I and phase-II by adding phase-I to phase-II at a temperature of about 60 oC to about 80 oC and allowing to cool to a temperature of about 25 oC to about 45 oC;
d. mixing a moisturizing component-2 with a vehicle and adding to the mixture of phase-I and phase-II obtained in step €;
e. mixing a moisturizing component-3, a vehicle, and preservatives with the mixture obtained in step (d);
f. mixing a soothing agent containing Lactobacillus ferment with humectant and mixing with the mixture obtaining in step €;
g. mixing lavender oil and stabilizer with the mixture obtained in step (f); and
h. adjusting the pH to about 5-6 of the mixture obtained in step (g) by adding a buffer and mixing homogenously to provide the moisturizing lotion.
[000110] The composition is accordance with the present disclosure was unexpectedly found to maintain the stability of the formulation prepared therefrom in terms of the aroma characteristics. In particular the presence of essential oil that is lavender oil was surprisingly found to remain stable and not undergo degradation unlike any other essential oil or fragrance when included in the composition. Thus, the composition in accordance with the present invention comprising lavender oil unexpectedly provides moisturizing composition with pleasant stable aroma without degradation to allow long term usage of the composition to achieve the positive results. In addition, the composition of the present disclosure was unexpectedly found to control and inhibit growth of S. aureus and treat atopic dermatitis and at the same time can provide effective moisture barrier to provide a soothing effect.
[000111] While the foregoing describes various embodiments of the disclosure, other and further embodiments of the disclosure may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.

EXAMPLES
[000112] The disclosure will now be illustrated with the following example, which is intended to illustrate the working of disclosure as per one of the embodiments and not intended to take restrictively to imply any limitations on the scope of the present disclosure. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this disclosure belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice of the disclosed methods and compositions, the exemplary methods, devices and materials are described herein. It is to be understood that this disclosure is not limited to particular methods, and experimental conditions described, as such methods and conditions may vary.

Geographical Source of Biological Materials:
[000113] Shea Butter was procured from Suru Chemicals & Pharmaceuticals Pvt. Ltd., Mumbai, Maharashtra, India; Avena Sativa (Oat) oil was procured from Trisun Pharma Pvt. Ltd., Hyderabad, Telangana, India; Lactobacillus ferment was procured from Symrise Pvt. Ltd. Holzminden, Germany; lavender oil, was procured from S. Khushalchand International Pvt. Ltd., Mumbai, Maharashtra, India.

EXAMPLE 1
Moisturizing Emulsion Formulation comprising the Composition in accordance with the present disclosure
[000114] The Moisturizing emulsion formulation comprising the composition in accordance with the present disclosure was prepared suing the components and the process as described below:
Phase I
[000115] Phase I, an essentially oil phase comprising moisturizing component-1, emollients, anti-oxidants, and emulsifiers, was prepared by weighing or measuring constituents as per Table 1 and following the process below:
Table 1: Phase I constituents:
Constituents Example 1
Quantity (kg)
Caprylic-capric triglyceride 10.000
Polyglycerol-3 Sunflowerate, Sunflower Glycerides, Cetearyl Alcohol and Sodium Stearoyl Lactylate 3.700
Cetostearyl alcohol 3.000
Shea Butter 1.500
DL-a Tocopheryl Acetate 0.200
Avena Sativa (Oat) oil 1.000
Butylated Hydroxy toluene 0.100
Ceramide III 0.050
Cholesterol 0.016

[000116] In oil phase vessel, caprylic-capric triglyceride; polyglycerol-3 sunflowerate, sunflower glycerides; cetearyl alcohol, and sodium stearoyl lactylate; cetostearyl alcohol; shea butter; dl-a tocopheryl acetate; Avena sativa (oat) oil; ceramide III; cholesterol; and butylated hydroxy toluene were added and melted together by heating up to 75°C ± 5°C under continuous stirring to mix well and form a uniform slight hazy mixture.
Phase II
[000117] Phase II comprising viscosity modifiers with a vehicle was prepared by weighing or measuring constituents as per Table 2 and following the process below:
Table 2: Phase II constituents:
Constituents Example 1
Quantity (kg)
Purified Water 67.740
Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyethyl Acrylate 0.300

[000118] In main manufacturing vessel, purified water was added to which sodium acryloyldimethyl taurate copolymer was added as well as hydroxyethyl acrylate was added to this under stirring to get uniform lump free low viscous gel, which was heated up to 70°C ± 5°C, under continuous stirring.
Mixing of Phases
[000119] The oil phase that is Phase I was added to main manufacturing vessel containing Phase II under continuous fast stirring and homogenization for 5 mins at 70°C ± 5°C. The mixture was allowed to cool after 5 mins under medium speed stirring. A uniform white colored lotion formed, which was allowed to cool to 35°C± 5°C.
Mixing a moisturizing component-2
[000120] The moisturizing component-2 mixture with vehicle was prepared by weighing measuring the constituents as per Table 3 and following the process below:
Table 3: Moisturizing Component-2:
Constituents Example 1
Quantity (kg)
Purified Water 10.000
D-Panthenol 0.300

[000121] In another vessel, D-panthenol was dissolve in purified water under stirring to mix well and added to main manufacturing vessel under continuous medium stirring at 35°C ± 5°C.
Mixing a moisturizing component-3 and Preservatives
[000122] The moisturizing component-3 mixture with vehicle and preservatives was prepared by weighing and measuring the constituents as per Table 4 and following the process below:
Table 4: Moisturizing Component-3 and Preservatives:
Constituents Example 1
Quantity (kg)
Hydrolyzed Jojoba Esters (and) Water 0.500
Phenoxyethanol (and) Ethylhexylglycerin 0.500
[000123] One by one hydrolyzed jojoba esters, water, phenoxyethanol and ethylhexylglycerin were added to the main manufacturing vessel containing mixture obtained in previous steps, under continuous medium stirring.
Mixing a Soothing agent and Humectant
[000124] The soothing agent mixture with humectant was prepared by weighing and measuring the constituents as per Table 5 and following the process below:
Table 5: Soothing agent mixture and Humectant:
Constituents Example 1
Quantity (kg)
Lactobacillus ferment 0.500
Glycerine 5.000
[000125] In another vessel, Lactobacillus ferment, and glycerine were added to mix well. The mixture thus obtained was added to the main manufacturing vessel containing the mixture obtained in the previous step under continuous medium stirring at 35°C ± 5°C.
Mixing a lavender oil and stabilizer
[000126] The lavender oil mixture with a stabilizer was prepared by weighing and measuring the constituents as per Table 6 and following the process below:
Table 6: Lavender oil mixture and Stabilizer:
Constituents Example 1
Quantity (kg)
Lavender Oil 0.300
Sucrose Acetate Isobutyrate 0.500
[000127] Lavender oil and sucrose acetate isobutyrate the fragrance stabilizer were added to the main manufacturing vessel containing the mixture obtained in the previous step under continuous sitting to mix well and provide a homogenous mixture.
Adjusting the pH
[000128] The pH of the mixture obtained in the previous step was adjusted with citric acid as per the constituents in Table 7 and following the process below:
Table 7: Buffer:
Constituents Example 1
Quantity (kg)
Citric Acid Monohydrate 0.020
Purified water 0.500
[000129] The pH was adjusted with citric acid solution. (0.020 kg citric acid + 0.5 kg water), by adding slowly the citric acid solution in the main manufacturing vessel containing the mixture obtained in previous step to pH.5.7 ± 0.2
[000130] The final product obtained had a pH between 5.5 – 6.0. The final product obtained was a topical lotion as a homogenous emulsion with pleasant lavender oil fragrance.

Example 4
Comparative Examples 1A, 1B and 1C moisturizing emulsion formulations and comparison of their aroma characteristics with the Moisturizing Emulsion Formulation of Example 1 the present invention
[000131] Comparative moisturizing emulsion formulations as per Examples 1A, 1B and 1C having compositions as per Table 8 were prepared following the process of Example 1 using the compositions as per following Table 8.
Table 8: Compositions of moisturizing emulsion formulations of Examples 1A-1C:
Sr. No Name of Ingredients Comparative Example 1A
with vanilla oil 0.5% Comparative Example 1B
with rose oil 0.1% Comparative Example 1C with orange oil 0.3%
1 Purified water 72.850 73.8 74.05
2 Caprylic/capric triglyceride 10.000 10.000 10.000
3 Glycerine 5.000 5.000 5.000
4 Hydrogenated Sunflower Seed Oil Polyglyceryl-3 Esters (and) Hydrogenated Sunflower Seed Oil Glyceryl Esters (and) Cetearyl Alcohol (and) Sodium Stearoyl Lactylate 3.700 3.700 3.700
5 Cetostearyl Alcohol 3.000 3.000 3.000
6 Shea Butter 1.500 1.500 --
7 Oat oil pure 1.000 -- 1.000
8 Lactobacillus ferment -- 0.500 0.500
9 Hydrolyzed Jojoba Esters (and) Water 0.500 0.500 0.500
10 Phenoxyethanol (and) Ethylhexylglycerin 0.300 0.300 0.300
11 D-Panthenol 0.300 0.300 0.300
12 Sodium Acryloyldimethyl Taurate Copolymer,
Hydroxyethyl Acrylate 0.300 0.300 0.300
13 DL-A Tocopheryl Acetate 0.200 0.200 0.200
14 Perfume Vanilla oil 0.500 0.000 0.000
14 Perfume Rose oil 0.000 0.100 0.000
14 Perfume Orange oil 0.000 0.000 0.300
15 Fragrance stabilizer 0.500 0.500 0.500
16 BHT 0.100 0.100 0.100
17 Ceramide III 0.050 0.050 0.050
18 Cholesterol NF 0.016 0.016 0.016
19 Citric acid 0.020 0.020 0.020
100.036 100.086 100.036
[000132] The aroma characteristics of the formulations of Examples 2A-2C were compared with that of the Example 1 formulation having the composition as per the present invention containing lavender oil 0.3% and prepared as per the process in Example 1 in accordance with the present disclosure. The observations were noted as follows in Table 9:
Table 9: Comparative aroma characteristics of Moisturizing Emulsion Formulation of Comparative Examples 1A-1C with Example 1 the present invention:
Observation Aroma Characteristic
Vanilla oil Rose oil Orange oil Lavender Oil
Comparative Example 1A Degradation Degradation Degradation Degradation
Comparative Example 1B Degradation Degradation Degradation Degradation
Comparative Example 1C Degradation Degradation Degradation Degradation
Example 1 Significant reduction of smell No degradation but Significant reduction in fragrance No degradation but Significant reduction in fragrance Pleasant milky lavender smell subsisting

[000133] As can be seen from Table 9, the formulation comprising the composition and prepared in accordance with the present disclosure as per Example 1 had at a start as well as retained the pleasant lavender fragrance, whereas in case of vanilla, rose and orange oils, there was no degradation of fragrance, but aroma reduced significantly. Whereas the formulation with the comparative Examples 1A-1C though initially had typical aroma of the respective fragrances, they later gave the foul smell confirming the degradation of the fragrance constituents. This shows that unexpectedly addition of lavender oil in the presence of all the three ingredients namely Shea Butter, Oat oil pure, and Lactobacillus ferment as per Example 1 of the present disclosure surprisingly retained the pleasant characteristic aroma, which did not degrade and subsisted.

Example 5
Activity Studies
[000134] Various studies were conducted to evaluate the moisturizing effect, skin barrier improvement and other activities of the Moisturizing Emulsion Formulation as per Example 1.
Statistical Analysis
[000135] Demographic characteristics and results of the study has been summarized with descriptive statistics including Mean, Standard deviation (SD), Minimum, Maximum and Median for continuous variables and frequency and percentages for categorical variables.
[000136] For the continuous data descriptive statistics, change from baseline, Percentage change from baseline and to comparison between baseline visit and postbaseline visit p-value has been calculated using paired t-test. To evaluate categorical data, Frequency count and % along with p-value using Wilcoxon signed rank test has been provided.
[000137] All the statistical analysis were done by using R 4.2.1 software with a 5% level of significance.
[000138] For both data type Continuous, and Categorical variables graphical presentation has been done using Box plot and vertical bar charts respectively.
Subject Disposition
[000139] An overall summary of subject disposition was presented using frequency and percentage (wherever applicable) for subjects screened, screen failures, enrolled subjects, subjects who completed the study, and subjects who discontinued, along with the reason of discontinuation. The frequency and percentage of subjects in different analysis sets were also reported.
[000140] There were total 33 subjects who had enrolled, from these 7 subjects discontinue the study. Hence, total 26 subjects completed the study.
Table 10: Number of Subjects:
Disposition, n (%) Enrolled Subjects (N = 33)
Screen failure 0 (0.00)
Randomized subjects 33 (100.00)
Completed study subjects 26 (78.78)
Discontinued subjects
Lost to follow-up 7 (0.21)
7 (0.21)
Determination of Sample Size
[000141] In this study, 26 completed subjects (out of 33 enrolled) were considered for proof-of-concept study.
Data Sets Analyzed
[000142] A total of 33 subjects were enrolled in this study and 26 subjects have completed the study and data of all 26 subjects who completed the study were taken for statistical analysis.
Demographic and Other Baseline Characteristics
Table 11: Summary of Demographic Characteristics:
Parameter Statistic (N=26)
Gender n (%) Female 10 (38.5%)
Male 16 (61.5%)
Race n (%) Asian 26 (100.0%)
Age (Years) n 26
Mean (SD) 25.81 (20.21)
Median 19.00
Minimum, Maximum 2.00, 60.00
Height (cm) n 26
Mean (SD) 142.00 (27.58)
Median 148.50
Minimum, Maximum 79.00, 177.00
Weight (kg) n 26
Mean (SD) 40.46 (24.50)
Median 32.95
Minimum, Maximum 8.30, 83.30
SD = Standard deviation.
Interpretation:
[000143] In this study, there were 10 (38.5%) Females and 16 (61.5%) Males; age of the subjects ranged from 2 to 60 years with the average being 25 years.
I. Primary Efficacy Endpoints:
1. Assessment by SCORAD ("SCORing Atopic Dermatitis") Index
[000144] Atopic dermatitis severity reduction assessment by SCORAD ("SCORing Atopic Dermatitis") index, which is a clinical tool for assessing the severity (i.e., extent, intensity) of atopic dermatitis was carried out to evaluate the effect of the Moisturizing Emulsion Formulation of Example 1.
Table 12: Statistics of SCORAD Index - Percentage Change from Baseline, Post Baseline and Paired T-Test Result:
Parameter Statistics Visit 02 Visit 03
SCORAD Index n 26 26
Mean (SD) -36.86 (9.49) -56.69 (11.31)
Median -36.82 -60.02
Minimum, Maximum -52.25,
-23.61 -70.80,
-38.63
p-Value <0.01 <0.01
SD = Standard deviation.
% CFB = ((Postbaseline - Baseline)/Baseline) *100, visit 01 is considered as baseline
Baseline and Post Baseline Value of SCORAD Index
Interpretation:
[000145] As can be seen from the above Table 12- there was highly statistical significant difference observed in SCORAD Index from baseline visit to visit 02 and visit 03 after the application of the Moisturizing Emulsion Formulation of Example 1. Total atopic dermatitis severity on adult and child subject’s affected skin reduction by using SCORAD Index was 37% at visit 02 and 57% at visit 03. Hence, we can conclude that there is good improvement observed in terms of disease severity reduction at visit 3. From the graph (FIG. 1) we can visualize SCORAD Index reduction at postbaseline visits.
2. Eczema Area and Severity Index (EASI) Severity Score:
Table 13: Descriptive Statistics of Severity Score (EASI) - Percentage Change from Baseline, Post Baseline and Paired T-Test Result:
Parameter Statistics Visit 02 Visit 03
Severity Score of EASI n 26 26
Mean (SD) -32.44 (18.30) -51.91 (20.43)
Median -33.33 -59.82
Minimum, Maximum -85.71, 0.00 -71.43, 0.00
p-Value <0.01 <0.01
SD = Standard deviation.
% CFB = ((Postbaseline - Baseline)/Baseline) *100, visit 01 is considered as baseline
Interpretation:
[000146] As can be seen from the above Table 13 there was highly statistical significant difference observed in severity score (EASI) from baseline visit to visit 02 and visit 03 after application of the Moisturizing Emulsion Formulation of Example 1. Total severity score (EASI) reduction was 32% at visit 02 and 52% at visit 03. Hence, we can conclude that there is good improvement observed in terms of severity score (EASI) reduction at visit 3. From the graph (FIG. 2) we can visualize severity score (EASI) reduction at postbaseline visits.
3. Eczema Area and Severity Index (EASI) Final Score:

Table 14: Descriptive Statistics of Final EASI Score - Percentage Change from Baseline, Post Baseline and Paired T-Test Result:
Parameter Statistics Visit 02 Visit 03
EASI Score n 26 26
Mean (SD) -32.58 (17.95) -53.61 (18.99)
Median -33.33 -53.57
Minimum, Maximum -75.00,
0.00 -83.33,
0.00
p-Value <0.01 <0.01
SD = Standard deviation.
% CFB = ((Postbaseline - Baseline)/Baseline) *100, visit 01 is considered as baseline
Interpretation:
[000147] As can be seen from the above Table 14 there was highly statistical significant difference observed in final score (EASI) from baseline visit to visit 02 and visit 03 after application of the Moisturizing Emulsion Formulation of Example 1. Total final score (EASI) reduction is 33% at visit 02 and 54% at visit 03. Hence, we can conclude that there is good improvement observed in terms of EASI score reduction at visit 3. From the graph (FIG. 3) we can visualize severity of atopic eczema reduction at postbaseline visits.
II. Secondary Efficacy Endpoints:
1. Effect of Application of the Moisturizing Emulsion Formulation of Example 1 on growth of Staphylococcus Aureus
Table 15: Count and Percentage of Staphylococcus Aureus:
Parameter Response Visit-01 Visit-02 Visit-03
Staphylococcus Aureus
n (%) No Growth 15 (57.7%) 23 (88.5%) 26 (100.0%)
Mild 7 (26.9%) 0 (0.0%) 0 (0.0%)
Scanty 3 (11.5%) 3 (11.5%) 0 (0.0%)
Heavy growth 1 (3.8%) 0 (0.0%) 0 (0.0%)

Table 16: Percentage Change from Baseline and Wilcoxon Signed Rank Test Result - Staphylococcus Aureus:
Parameter Statistic Visit 02 Visit 03


Staphylococcus Aureus

N 26 26
Mean (SD) -12.50 (36.00) -24.04 (29.28)
Median 0.00 0.00
Minimum,
Maximum -75.00,
50.00 -75.00,
0.00
p-Value 0.0602 <0.01
SD = Standard deviation.
% CFB = ((Postbaseline - Baseline)/Baseline) *100, visit 01 is considered as baseline
Interpretation:
[000148] As can be seen from the above Tables 15-16 there was highly statistical significant difference observed in terms of Staphylococcus Aureus from baseline visit to visit 03 after the application of the Moisturizing Emulsion Formulation of Example 1. All the 26 subjects showed no growth in staphylococcus aureus at visit 03 after the application of the Moisturizing Emulsion Formulation of Example 1 as evident from FIG. 4.
3. Visual Analogue Scale
Table 17: Descriptive Statistics of Visual Analogue scale (VAS) - Percentage Change from Baseline and Paired T-Test Result:
Parameter Statistic Visit 02 Visit 03
Visual Analogue Scale n 26 26
Mean (SD) -54.17 (17.27) -69.30 (9.06)
Median -55.00 -66.67
Minimum, Maximum -75.00, 0.00 -83.33, -50.00
p-Value <0.01 <0.01
SD = Standard deviation.
% CFB = ((Postbaseline - Baseline)/Baseline) *100, visit 01 is considered as baseline.
Interpretation:
[000149] As can be seen from the above Table 17, there was highly statistical significant difference observed in visual analogue scale from baseline visit to visit 02 and visit 03 after the application of the Moisturizing Emulsion Formulation of Example 1. Total visual analogue scale reduction is 54% at visit 02 and 69% at visit 03. Hence, we can conclude that there is good improvement observed in terms of pruritus severity reduction at visit 3. From the graph (FIG. 5) we can visualize pruritus severity reduction at postbaseline visits.
4. MoistureMeterEpiD Affected and Unaffected Area
Table 18: Descriptive Statistics of MoistureMeterEpiD - Percentage Change from Baseline, Post Baseline and Paired T-Test Result:
Parameter Statistics Visit 02 Visit 03
MoistureMeterEpiD Affected n 26 26
Mean (SD) 43.90 (59.44) 78.20 (87.93)
Median 20.70 45.58
Minimum, Maximum 0.75, 245.95 13.32, 437.84
p-Value <0.01 <0.01
MoistureMeterEpiD Unaffected n 26 26
Mean (SD) -3.09 (12.02) -1.43 (13.84)
Median -2.62 -2.42
Minimum, Maximum -26.76, 24.81 -27.65, 31.19
p-Value 0.1388 0.361
SD = Standard deviation.
% CFB = ((Postbaseline - Baseline)/Baseline) *100, visit 01 is considered as baseline

Interpretation:
[000150] As can be seen from the above Table 18, for affected area, there was highly statistical significant difference observed in Moisture meter EpiD measurements from baseline visit to visit 02 and visit 03 after the application of the Moisturizing Emulsion Formulation of Example 1. The skin hydration at the epidermis and the upper dermis increased by 44% at visit 02 and 78% at visit 03. Hence, we can conclude that there is good improvement observed in affected areas in terms of skin hydration at visit 3. From the graph (FIG. 6a) we can visualize skin hydration increases of the affected areas at postbaseline visits after the application of the Moisturizing Emulsion Formulation of Example 1. For unaffected area (FIG. 6b), there was no statistical significant difference observed after the application of the Moisturizing Emulsion Formulation of Example 1 in terms of Moisture meter EpiD measurements.

5. Transepidermal water loss (TEWL) values by Vapometer measurement of Affected and Unaffected Area
Table 19: Descriptive Statistics of Transepidermal water loss (TEWL) values by Vapometer Measurements - Percentage Change from Baseline, Post Baseline and Paired T-Test Result:
Parameter Statistics Visit 02 Visit 03
Vapometer Affected n 26 26
Mean (SD) -26.40 (31.35) -44.19 (23.78)
Median -27.00 -44.53
Minimum, Maximum -71.50, 60.48 -79.69, 30.38
p-Value <0.01 <0.01
Vapometer Unaffected n 26 26
Mean (SD) -9.23 (65.19) -23.44 (54.73)
Median -19.43 -33.17
Minimum, Maximum -67.06, 191.67 -69.06, 219.30
p-Value 0.0102 <0.01
SD = Standard deviation.
% CFB = ((Postbaseline - Baseline)/Baseline) *100, visit 01 is considered as baseline
Interpretation:
[000151] As can be seen from the above Table 19, for affected area, there was highly statistical significant difference observed in Vapometer measurements from baseline visit to visit 02 and visit 03 after the application of the Moisturizing Emulsion Formulation of Example 1. Transepidermal water loss (TEWL) decreased by 26% at visit 02 and 44% at visit 03. Hence, we can conclude that there is good improvement observed in terms of TEWL at visit 3. From the graph (FIG. 7a) we can visualize TEWL decrease at postbaseline visits after the application of the Moisturizing Emulsion Formulation of Example 1.
[000152] As can be seen from the above Table 19, for unaffected area, there was highly statistical significant difference observed in Vapometer measurements from baseline visit to visit 02 and visit 03 after the application of the Moisturizing Emulsion Formulation of Example 1. Transepidermal water loss (TEWL) decreased by 9% at visit 02 and 23% at visit 03. Hence, we can conclude that product is effective in reducing TEWL on unaffected area also. From the graph (FIG. 7b) we can visualize TEWL decreases at postbaseline visits after the application of the Moisturizing Emulsion Formulation of Example 1.

Comparative Effects:
[000153] Following are the comparative effects of the composition of the present disclosure as per above Example 1 and effects thereof illustrated above in Example 5 as compared to the effect discloses in the PCT published application no. WO 2020/002429 A1 (referred to as ‘429 application hereinafter).
A. SCORAD Index Score:
[000154] Atopic dermatitis severity reduction assessment by SCORAD ("SCORing Atopic Dermatitis") index, is an important clinical tool for assessing the severity (i.e., extent, intensity) of atopic dermatitis. The SCORAD is widely used score for skin health especially in dry / eczema skin. The moisturizing emulsion formulation decreased the SCORAD value by 57% by 3rd visit (Table 12 and FIG. 1), however, this parameter is not even tested in the ‘429 application.
B. Effect on growth of Staphylococcus aureus:
[000155] Though said ‘429 application claims the use of HEAL 19 and 99 in skin condition like atopic dermatitis (AD), however, they do not completely inhibit the growth of Staphylococcus aureus, a causative agent of AD. As observed from Figure 7 of ‘429 application, as compared to the positive control, the HEAL 19 at different concentration is found to reduce in dose dependent manner over a period of 21 days but showed only 0.2 to 0.3 reduction in OD and no complete inhibition. Whereas, as can be seen from Table 15 and FIG. 4 the moisturizing emulsion formulation as per Example 1 completely inhibited the growth the S. aureus by 3rd visit, thereby proving the potential for effective treatment of AD.
C. TEWL values
[000156] Transepidermal water loss (TEWL) values by Vapometer measurement after the application of the moisturizing emulsion formulation of Example 1 showed as high as 44% reduction in water loss (about 20 points lesser in vapometer affected score) by 3rd visit, whereas, though the ‘429 application shows the dose dependant reduction in TEWL values, which is only 0 to -1.5 (Figure 16) and hence the same does not seem significant as compared to the TEWL values after the application of the moisturizing emulsion formulation of the present disclosure.
[000157] From the foregoing, it will be appreciated that, although specific embodiments of the invention have been described herein merely for purposes of illustration, various modifications may be made without deviating from the spirit and scope of the invention and should not be construed so as to limit the scope of the invention or the appended claims in any way.

ADVANTAGES OF INVENTION
[000158] The composition of the present disclosure or the formulation comprising the same can help maintain or restores damaged and compromised skin barrier. It strengthens skin barrier function. The composition of the present disclosure maintains, and/or restores healthy state of the skin microbiome.
[000159] The present disclosure provides a moisturizing composition that is paraben-free, phthalate-free and sulphate-free.
[000160] The composition comprising lavender oil with other ingredients, moisturizing formulation as well as process for preparation thereof unexpectedly contributes to retain subsisting pleasant stable aroma without degradation to allow long term usage for achieving the positive results in terms of treatment of AD, provide an effective moisture barrier effect and thereby soothing effect.
,CLAIMS:1. A moisturizing composition comprising a soothing agent containing Lactobacillus ferment from 0.25% to 1% w/w; lavender oil from 0.3% to 1.5%w/w; moisturizing component-1 selected from shea butter, ceramide III, and cholesterol, the moisturizing component-1 present from 0.75% to 5% w/w; moisturizing component-2 being D panthenol from 0.01% to 0.05% w/w; moisturizing component-3 being hydrolyzed jojoba esters from 0.25% to 1.5% w/w; and cosmeceutically acceptable excipients.
2. The composition as claimed in claim 1, wherein the Lactobacillus ferment is a lysate of the fermentation and enzymatic hydrolysis product containing intracellular and extracellular metabolites of Lactobacillus species selected from Lactobacillus plantarum, Lactobacillus salivarius, and Lactobacillus casei.
3. The composition as claimed in claim 1, wherein the cosmeceutically acceptable excipients is selected from emollient, humectant, emulsifier, soothing agent, skin hydrant, preservative, viscosity modifier, anti-oxidant, buffer, stabilizer, colouring agent, thickener, and vehicle.
4. The composition as claimed in claim 1, wherein the shea butter in the range from 0.75% to 2.5% w/w basis of the composition.
5. The composition as claimed in claim 1, wherein the cholesterol is in the range from 0.01% to 0.05% w/w basis of the composition.
6. The composition as claimed in claim 3, wherein the emollient is selected from caprylic/capric triglyceride and Avena sativa oil.
7. The composition as claimed in claim 6, wherein the caprylic/capric triglyceride is in the range from 5% to 15% and oat oil is in the range from 0.2% to 1.5% w/w basis of the composition.
8. The composition as claimed in claim 3, wherein the emulsifier is selected from a blend of hydrogenated sunflower seed oil polyglyceryl-3 esters (and) hydrogenated sunflower seed oil glyceryl esters (and) cetearyl alcohol (and) sodium stearoyl lactylate in the range from 3% to 5% w/w; and cetostearyl alcohol 2% to 5% w/w of the composition.
9. The composition as claimed in claim 3, wherein the preservative is selected from phenoxyethanol and ethylhexylglycerin present from 0.25% to 1.5% on w/w basis of the composition.
10. The composition as claimed in claim 3, wherein the viscosity modifier is selected from sodium acryloyldimethyl taurate copolymer, and hydroxyethyl acrylate present from 0.1% to 0.5% on w/w basis of the composition.
11. The composition as claimed in claim 3, wherein the stabilizer is sucrose acetate isobutyrate present from 0.5% to 1% on w/w basis of the composition.
12. The composition as claimed in claim 3, wherein the buffer is citric acid.
13. The composition as claimed in claim 3, wherein the vehicle is water present in quantity sufficient to make the final composition to 100%.
14. A process of preparing a stable moisturizing emulsion formulation, the process comprising the steps of:
a. providing a phase-I by mixing a moisturizing component-1, emollients, anti-oxidants, and emulsifiers at a temperature of 65 oC to 85 oC;
b. providing a phase-II by mixing viscosity modifiers with a vehicle at a temperature of 60 oC to 80 oC;
c. mixing phase-I and phase-II by adding phase-I to phase-II at a temperature of 60 oC to 80 oC and allowing to cool to a temperature of 25 oC to 45 oC;
d. mixing a moisturizing component-2 with a vehicle and adding to the mixture of phase-I and phase-II obtained in step (c);
e. mixing a moisturizing component-3, a vehicle, and preservatives with the mixture obtained in step (d);
f. mixing a soothing agent containing Lactobacillus ferment with humectant and mixing with the mixture obtaining in step (e);
g. mixing lavender oil and stabilizer with the mixture obtained in step (f); and
h. adjusting the pH to about 5-6 of the mixture obtained in step (g) by adding a buffer and mixing homogenously to provide the moisturizing lotion.