Topical composition for treatment of diabetic's dry skin and itching

Abstract

A topical composition for treating diabetic skin conditions is disclosed, comprising a non-steroidal, non-comedogenic, and fragrance-free formulation. The composition includes a synergistic blend of emollients, humectants & occlusives for intense moisturization; emulsifying agents for stabilization; moisturizing agents for enhanced hydration; antioxidants for reducing oxidative stress; anti-inflammatory agents for alleviating inflammation; anti-itching agents for relieving the itching; skin conditioners for improved barrier function; Filaggrin improver and agents for stimulating collagen production. The composition provides relief from dry skin, itching, and redness associated with diabetic skin conditions.

Description

TITLE OF THE INVENTION:TOPICAL COMPOSITION FOR TREATMENT OF DIABETIC’S DRY SKIN AND ITCHING CROSS-REFERENCE TO RELATED APPLICATIONS AND PRIORITY The present application claims priority from Indian Patent Application number 202521015978 filed on Feb 24, 2025, incorporated herein by a reference.FIELD OF THE INVENTION

[0001] The present invention relates to topical composition for the treatment of Diabetic’s dry skin and itching. The process for preparation of the said topical composition is also provided herein.BACKGROUND OF THE INVENTION

[0002] Diabetic’s dry skin, also known as xerosis, is a prevalent issue for individuals with diabetes, caused by a combination of factors related to uncontrolled blood sugar levels. When blood glucose is poorly managed, it leads to dehydration, as high blood sugar levels cause the body to lose more fluids through increased urination. This dehydration affects the skin's ability to retain moisture, leading to dryness and itching. Additionally, diabetes can impair circulation, reducing blood flow to the skin, which further exacerbates the problem by limiting the nutrients and oxygen delivered to skin cells.

[0003] Common symptoms of diabetic dry skin include rough, flaky patches, itching, and a feeling of tightness or discomfort. In more severe cases, the skin may crack, leading to the development of sores or wounds that can become infected. Since elevated blood sugar can also slow the body's healing process, wounds and cracks may take longer to heal, increasing the risk of complications such as infections. The skin on the lower legs, feet, and elbows is most commonly affected, but dry skin can appear anywhere on the body.

[0004] To treat diabetic dry skin effectively, maintaining good blood sugar control is essential. Keeping blood glucose levels within the recommended range helps prevent dehydration and supports the skin’s overall health. Regular moisturizing is also critical; emollient-rich creams and lotions that contain ingredients such as shea butter, ceramides, or hyaluronic acid can help lock moisture into the skin and restore its natural barrier. It’s important to apply moisturizer immediately after bathing while the skin is still slightly damp to maximize hydration. Additionally,gentle, fragrance-free soaps should be used to avoid further irritation. Keeping the skin hydrated, avoiding long hot showers that can strip moisture from the skin, and using a humidifier in dry environments can also help improve skin condition. In some cases, a healthcare provider may recommend specific topical treatments such as corticosteroid creams for inflammation or specialized ointments for wound healing. For individuals with diabetic neuropathy, extra attention to the feet is necessary to prevent further complications.

[0005] Itching, or pruritus, is a common but often overlooked symptom in individuals with diabetes mellitus, particularly when blood sugar levels are poorly controlled. It can result from several diabetes-related complications, including diabetic neuropathy, where nerve damage causes an altered sensation, or diabetic dermopathy, which leads to dry, flaky skin. Persistent hyperglycemia can also impair circulation, reducing skin hydration and exacerbating dryness and itching. Additionally, fungal infections like candidiasis and bacterial infections are more prevalent in diabetes, contributing to localized or generalized itching. Proper glycemic control, regular skin moisturizing, and prompt treatment of infections can help alleviate itching and improve skin health in diabetic individuals.

[0006] By taking a holistic approach that includes good skincare practices, proper hydration, and regular monitoring of blood glucose levels, individuals with diabetes can reduce the risk of developing or worsening dry skin and its associated complications.

[0007] Chinese application CN116509963 discloses diabetic skin nutrition ointment and a preparation method thereof, the diabetic skin nutrition ointment consists of the following raw materials by weight: 80-110 parts ofDendrobium officinale, 60-90 parts of cinnamon, 40-55 parts of Poria cocos, 40-55 parts of purslane, 2-4 parts of ethylparaben, 45-55 parts of white vaseline, 120-130 parts of glycerin monostearate, 45-55 parts of liquid paraffin, 40-50 parts of stearic acid, 4-6 parts of triethanolamine, 70-80 parts of glycerin, and 1 part of water. According to the diabetes skin nutrition cream formula, all the medicines are compatible, the main effects of tonifying yin, moistening dryness and clearing heat are achieved, the methods of dredging vessels, nourishing blood, invigorating the spleen and promoting diuresis are considered, and diabetes (diabetes) skin lesions can be improved. The traditional Chinese medicine composition has health care and rehabilitation promotion effects on discomfort such as dry skin, itching, sore and swelling,hyperpigmentation, dyspepsia and the like caused by diabetes and diabetes due to deficiency of stomach in and dysfunction of spleen transportation.

[0008] Greek application GR20230100040 relates to a topically applied preparation acting against the dry skin of the lower extremities of diabetic patients while helping to stimulate blood microcirculation. The pharmaceutical form of said preparation is the following: cream (emulsion) with solvent (water and glycerin mixture) inside a tube. The production method of the formulation is as follows: preparation of the cream (emulsion) using the emulsification method and b) filling the tubes with a specified amount of the prepared cream (emulsion). The specificity of the preparation of the present invention lies a) in the original combination of active substances and b) in its clinically proven effectiveness.

[0009] US granted patent US6709663 discloses a topical delivery composition which employs a multivesicular emulsion in combination with a pharmaceutically / pharmacologically active agent is disclosed. The multivesicular emulsion is formed from a quaternary amine salt emulsifier such as behentrimonium methosulfate. The emulsion is multi- lamellar which is a series of concentric spheres or vesiculars of oil and water phase that can be seen microscopically. As a result, the active is time released over a sustained period rather than spike released as is common with most topicals.

[0010] Existing solutions typically focus on general moisturizing properties without targeting the underlying causes of skin issues in diabetic patients, such as impaired skin barrier function, filaggrin impairment, inflammation and itching. Many conventional products lack the necessary components to effectively restore skin hydration, reduce oxidative stress, and alleviate itching and inflammation. As a result, there is a significant need for a specialized dermatological composition that not only provides intense moisturization but also addresses the specific dermatological challenges faced by individuals with Diabetes Mellitus such as dry skin and itching.

[0011] The present invention therefore provides the novel multifaceted approach for treatment of skin related issues in diabetes in the present invention wherein the formulation not only provides occlusive, humectant, emollients in the right concentration but also improves filaggrin levels, has anti-oxidant and anti-itching effects, reduces cytokine mediated inflammatory reactions, soothes & protects the skin, improves skin barrier repair, improves tight junctions & helps to increase the ceramide & collagen level, provides moisturising & keratinising effects. Further the composition according to present invention offers intense moisturisation to the skin while providing relief fromdry skin, skin itching, redness and inflammation. Also, the present compositionis non-Steroidal, non-comedogenic and fragrance-free.SUMMARY OF THE INVENTION

[0012] This summary is provided to introduce a selection of concepts in a simplified form that is further described below in the 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.

[0013] According to the teachings of the present invention there is provided the spreadable composition for topical application.

[0014] In one aspect the present invention provides spreadable composition for topical application is essentially Non-Steroidal, Non-Comedogenic and Fragrance-free.

[0015] In another aspect the present invention provides topical composition comprising multiple components that works synergistically for providing relief from skin diseases such as dry skin, barrier disruption, itching and inflammation especially in Diabetes Mellitus.

[0016] In yet another aspect, the present invention provides the topical composition comprising multiple components selected from various categories comprising but not limiting to emollients, emulsifying agents, moisturizing agents, antioxidants, solvents, chelating agents, soothing agent, skin conditioner, humectant, anti-inflammatory agents, viscosity builders, anti-aging, Amino Acid complex, Filagrinol, antihistaminic agent, preservatives, occlusive, solvents and one or more cosmeceutically acceptable excipients.

[0017] In another aspect, the present invention provides the process for preparation of spreadable composition for topical application to provide relief from dry skin, skin itching, scaling & redness.

[0018] Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments.BRIEF DESCRIPTION OF THE DRAWINGSFigure 1: Changes in Mean MMSC readings (skin hydration)Figure 2: Changes in Mean VapoMeter readings (Trans epidermal Water Loss)DETAILED DESCRIPTION OF THE INVENTION

[0019] The present invention provides the spreadable composition characterized by high suitability for topical application.

[0020] Aspects of the present invention are best understood by reference to the description set forth herein. All the aspects described herein will be better appreciated and understood when considered in conjunction with the following descriptions. It should be understood, however, that the following descriptions, while indicating preferred aspects and numerous specific details thereof, are given by way of example only and should not be treated as limitations. Changes and modifications may be made within the scope herein without departing from the spirit and scope thereof, and the present invention herein includes all such modifications.

[0021] 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.

[0022] 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.

[0023] 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 specificexamples 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.

[0024] 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.

[0025] 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.

[0026] 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.”

[0027] 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.

[0028] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.

[0029] The term, "therapeutically effective amount" as used herein refers to an amount of a formulation or component, effective in producing the desired therapeutic response in a particular patient (subject) suffering from a disease or disorder.

[0030] As used herein the term "topical application" describes application onto a biological surface, e.g., an affected skin or membrane. Hence, the phrase "a composition for topical application" describes a composition that is applied, preferably by spreading, on, for example, skin, eye, ear, scalp, hair or membrane of a subject.

[0031] As used herein, the term "process" and the term "method" refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, thosemanners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

[0032] Moisturizing creams are designed to hydrate and protect the skin, typically comprising a combination of water and oil-based ingredients to restore the skin's moisture barrier. Their formulation often includes emollients like to soften and smoothen the skin, Humectants attract and retain water in the skin's outer layers. Occlusive agents form a barrier to lock in moisture. Additional ingredients may include vitamins for antioxidant benefits, soothing agents to reduce irritation, and preservatives to ensure product stability. Fragrances and coloring agents may be added for sensory appeal, though hypoallergenic and fragrance-free formulations are preferred for sensitive skin.

[0033] In one embodiment, the present invention provides the topical composition comprising occlusive agents, humectants, emollients and at least one other ingredients. The combined use of occlusives, humectants, and emollients is critical in formulating effective skincare products that provide comprehensive moisture management. Occlusive agents act as a protective barrier on the skin's surface, preventing transepidermal water loss (TEWL) and helping to retain natural moisture. Occlusives seals hydration within the skin. Humectants play a complementary role by attracting and binding water molecules from the environment or deeper layers of the skin to the outer layer, ensuring continuous hydration. Emollients are vital for filling gaps between skin cells, smoothing rough texture, and improving skin elasticity. The synergistic action of these three components restores and maintains the skin's natural moisture barrier, providing long-lasting hydration, protecting against environmental stressors, and enhancing the skin's overall health and appearance. Their balanced incorporation in a formulation is essential for optimizing efficacy and user satisfaction.

[0034] In another embodiment, the topical composition according to present invention comprises atleast one ingredient for the improvement of filaggrin levels. Filaggrin is a crucial protein in maintaining skin barrier integrity, is often altered in individuals with diabetes, contributing to compromised skin health. Filaggrin plays a pivotal role in aggregating keratin filaments, facilitating the formation of the skin's outermost protective layer, and generating natural moisturizing factors (NMF) through its breakdown. In diabetes, chronic hyperglycemia andoxidative stress can impair filaggrin synthesis and metabolism, leading to reduced NMF levels and a weakened skin barrier. This disruption results in increased transepidermal water loss (TEWL), skin dryness, and heightened susceptibility to irritants, infections, and inflammatory conditions. The altered filaggrin expression also contributes to pruritus and diabetic dermopathy, common dermatological complications in diabetes patients. Addressing filaggrin dysfunction through glycemic control and targeted skincare interventions can help restore the skin's protective function and improve overall dermatological health in individuals with diabetes.

[0035] In yet another embodiment, the topical composition according to present invention further comprises various antioxidants for the reduction of free radicals. In individuals with diabetes, chronic hyperglycemia leads to the excessive formation of advanced glycation end-products (AGEs) due to an increase in reactive oxygen species (ROS) and oxidative stress. AGEs are harmful compounds formed when proteins or lipids undergo non-enzymatic glycation in the presence of glucose. Elevated AGEs contribute to tissue damage, inflammation, and impaired skin barrier function by altering protein structure and function. The overproduction of ROS exacerbates this process, further damaging cellular components, including lipids, proteins, and DNA. Antioxidants play a critical role in mitigating these effects by neutralizing free radicals, thereby reducing oxidative stress and the subsequent formation of AGEs. Incorporating potent antioxidants such as vitamins C and E, polyphenols, or coenzyme Q10 in therapeutic formulations can help protect cellular integrity, enhance the skin’s natural defense mechanisms, and improve wound healing and overall skin health in diabetic individuals. This approach is vital for maintaining skin homeostasis and mitigating complications associated with diabetes-induced oxidative stress.

[0036] Pruritus and itching are prevalent symptoms in diabetes mellitus (DM) patients, primarily attributed to the dryness of the stratum corneum (SC), the outermost layer of the skin. The SC plays a vital role in maintaining skin hydration and barrier function, but chronic hyperglycemia in diabetes disrupts this balance by impairing lipid synthesis and reducing natural moisturizing factors (NMFs). This results in increased transepidermal water loss (TEWL) and subsequent skin dryness. The dehydrated SC triggers nerve endings in the skin, leading to sensations of itching and discomfort. Additionally, diabetes-related oxidative stress and microvascular complications further exacerbate these symptoms by compromising skin integrity and repair mechanisms. Effective management requires addressing the underlying skin dryness with targeted moisturizerscontaining humectants, emollients, and occlusives to restore hydration and strengthen the skin barrier, thereby alleviating pruritus and improving quality of life for DM patients. The present invention comprises the anti-itching components in the topical composition for relief from the prutritis and itching.

[0037] Cytokine-mediated inflammatory reactions play a significant role in the pathophysiology of diabetes mellitus (DM), contributing to both its onset and complications. Pro- inflammatory cytokines, such as tumor necrosis factor-alpha (TNF-a), interleukin-6 (IL-6), and interleukin- 1 beta (IL-ip), are often elevated in diabetes due to chronic hyperglycemia and oxidative stress. These cytokines promote systemic inflammation, impair insulin signaling, and exacerbate insulin resistance, creating a vicious cycle that worsens glycemic control. Furthermore, persistent inflammation contributes to endothelial dysfunction, a key factor in diabetes-related complications like cardiovascular disease, nephropathy, and retinopathy. Cytokine dysregulation also affects wound healing, leading to delayed recovery and increased risk of infections in diabetic patients. Indications of cytokine-mediated inflammation in diabetes include elevated markers such as C-reactive protein (CRP), hyperglycemia, impaired wound healing, microvascular complications, and increased susceptibility to infections. Therapeutic strategies targeting cytokine pathways, such as anti-inflammatory agents or lifestyle interventions like diet and exercise, can help mitigate these inflammatory effects and improve outcomes in diabetic patients. The present invention further comprises the components for reduction of cytokine mediated inflammatory reactions.

[0038] In yet another embodiment, the present invention provides the topical composition comprising one or more skin soothening and protectant agents.

[0039] In diabetes mellitus (DM) patients, skin health is often compromised due to lower levels of amino acids, which are essential for maintaining the skin's structure, hydration, and repair processes. Amino acids play a critical role in synthesizing key skin proteins like collagen and elastin, as well as in forming natural moisturizing factors (NMFs) that regulate skin hydration. Chronic hyperglycemia in DM disrupts amino acid metabolism, leading to reduced availability of these vital components in the skin. This deficiency impairs the skin’s barrier function, increases transepidermal water loss (TEWL), and contributes to dryness, pruritus, and delayed wound healing. Additionally, oxidative stress and advanced glycation end-products (AGEs) in diabetes further deplete amino acid levels, exacerbating skin damage and inflammation. Addressing thisdeficiency through targeted interventions, such as amino acid-enriched formulations or dietary supplementation, can help restore skin integrity, enhance hydration, and promote faster wound healing in diabetic patients. The present invention comprises atleast one amino acid in the topical composition.

[0040] In yet another embodiment, the present invention provides the topical composition comprising ceramides for improvement of skin barrier repair. Skin barrier repair is a critical concern in diabetic skin diseases, as individuals with diabetes are prone to impaired skin integrity due to factors such as hyperglycemia, oxidative stress, and inflammation. In diabetes, the skin barrier becomes weakened because of reduced levels of essential lipids, amino acids, and natural moisturizing factors (NMFs), which are necessary for maintaining the stratum corneum's structure and function. This dysfunction leads to increased transepidermal water loss (TEWL), dryness, and a higher susceptibility to infections and irritations. Additionally, diabetes-related complications, including diabetic neuropathy and poor circulation, further hinder the skin's ability to repair itself. Effective skin barrier repair in diabetic patients involves a multifaceted approach, including the use of emollients, humectants, and occlusive agents to restore moisture and protect the skin from external stressors. Additionally, controlling blood glucose levels and addressing underlying inflammatory conditions can significantly enhance the skin's healing response. Topical treatments containing lipids, growth factors, and antioxidants may also promote cellular regeneration and improve the overall function of the skin barrier, helping to prevent and manage diabetic skin complications.

[0041] Improving tight junctions, and increasing ceramide and collagen levels are crucial strategies in managing skin diseases in diabetic patients, as these factors play a key role in maintaining the skin's barrier function, hydration, and overall integrity. In diabetes, hyperglycemia and chronic inflammation disrupt the skin's structure, leading to weakened tight junctions between epidermal cells. Tight junctions, primarily composed of proteins like claudins and occludins, regulate the permeability of the skin barrier, preventing excessive water loss and the entry of harmful pathogens. In diabetes, the dysfunction of these junctions contributes to increased transepidermal water loss (TEWL) and greater vulnerability to infections and irritants. Enhancing the function of tight junctions can be achieved through targeted treatments that support the expression and stability of junction proteins, promoting better skin hydration and barrier protection.

[0042] Ceramide and collagen levels are typically lower in the skin of diabetic patients, further compromising the skin's structural integrity. Ceramides, which are a crucial component of the skin's lipid matrix, form a barrier to lock in moisture and protect against environmental damage. In diabetes, reduced ceramide production exacerbates skin dryness, inflammation, and impaired healing. Increasing ceramide levels through topical applications or dietary interventions can restore the skin's moisture balance and strengthen its barrier function. Collagen, the main structural protein in the dermis, provides elasticity and firmness to the skin. In diabetic skin, the synthesis of collagen is impaired due to high blood glucose levels and oxidative stress, leading to skin thinning, delayed wound healing, and an increased risk of developing diabetic dermopathy. Stimulating collagen production through the use of growth factors, peptides, or vitamin C can help improve the skin’s structural integrity, promote wound healing, and reduce the appearance of aging or damaged skin. Together, improving tight junction functionality and boosting ceramide and collagen levels can significantly enhance skin health and aid in the management of diabetic skin diseases, improving both cosmetic appearance and overall skin resilience.

[0043] In yet another embodiment, the present invention provides the composition comprising atleast one xylitol-based ingredients for improvement of tight junctions and increase in ceramide and collagen levels.

[0044] In yet another embodiment, the present invention provides the composition further comprising atleast one moisturizers and keratinizing agents. Moisturizers and keratinizing agents are essential in managing diabetic skin diseases, as they address the skin's unique challenges, including dryness, impaired barrier function, and delayed wound healing. In diabetes, hyperglycemia and chronic inflammation can lead to a compromised skin barrier, characterized by increased transepidermal water loss (TEWL) and skin dryness. Moisturizers, particularly those containing humectants like glycerin and hyaluronic acid, help restore hydration by attracting water to the skin's surface and locking it in. Emollients such as shea butter and oils further enhance skin smoothness and protect the skin from external irritants, providing relief from dryness and pruritus, common symptoms in diabetic patients. Regular use of moisturizers helps maintain skin elasticity, improve texture, and reduce the risk of infections by strengthening the skin's barrier function.

[0045] Keratinizing agents, such as retinoids and keratolytic agents like urea, are equally important in diabetic skin care. These agents promote the production of keratin, a key protein in the skin'souter layer, facilitating the renewal and repair of damaged or thickened skin. In diabetic patients, skin may become rough, thickened, or prone to hyperkeratosis due to disrupted keratinocyte function. Keratinizing agents help normalize the proliferation and differentiation of keratinocytes, promoting healthier skin turnover and improving the appearance of calluses, thickened patches, and other dermatological issues common in diabetes. The synergistic use of moisturizers and keratinizing agents addresses both the hydration and structural integrity of the skin, providing comprehensive care for diabetic skin diseases and enhancing overall skin health.

[0046] In yet another embodiment, the present invention provides the topical composition as an atleast one dosage form selected from but not limiting to cream, ointment, gel, lotion, foam, powder, paste, aerosol, patche, balm, spray, mousse, emollient, emulsion, serum, wipe and the like.

[0047] In a preferred embodiment, the present invention provides the topical composition for treatment of skin diseases in the diabetic patients, comprising:one or more emollients,one or more emulsifying agent,atleast one moisturising agentatleast one antioxidant,atleast one chelating agent,one or more soothing agent,atleast one skin conditionerone or more humectant,atleast one skin protectant,one or more anti-inflammatory,viscosity builder / s,atleast one agent for stimulating collagen production,one or more anti-aging,Amino Acid complex comprising atleast 10 amino acids,Filagrinol,atleast one antihistaminic and / or anti-itch agent,one or more preservatives,one or more occlusive,aqueous solvent,wherein any ingredient of the said composition can perform one or more functionalities and wherein said composition reduces itching, skin dryness, reduces transepidermal water loss and repairs damaged skin Barrier.

[0048] In a preferred embodiment, the present invention provides the topical composition for treatment of skin diseases in the diabetic patients, comprising:3-10% of one or more emollients,1-10% of one or more emulsifying agent,5-25% of atleast one moisturising agent0.1 -3% of atleast one antioxidant,0.01-0.5% of atleast one chelating agent,0.01-1% of one or more soothing agent,1-4% skin protectant, 0.5-5% of atleast one skin conditioner,0.5-10% of atleast one humectant,0.1 -1% of one or more anti-inflammatory,1-8% of viscosity builder / s,0.01-0.5% of atleast one agent for stimulating collagen production,0.1 -5% one or more anti-aging,0.1-5% of Amino Acid complex comprising atleast 10 amino acids,0.5-5% of Filagrinol,0.5 - 5% of one ore moreantihistaminic agent,0.5-5 % of one or more preservatives,0.5-5% of one or more occlusive,aqueous solvent,wherein any ingredient of the said composition can perform one or more functionalities and wherein said composition reduces itching, skin dryness, reduces transepidermal water loss and repairs damaged Skin Barrier.

[0049] The emollients according to present invention are selected from but not limiting to Coconut Oil, Shea Butter, Cocoa Butter, Argan Oil, Jojoba Oil, Cetyl Alcohol, Stearyl Alcohol, CetostearylAlcohol, Caprylic / Capric Triglyceride, Palmitic Acid, Oleic Acid, Isopropyl Palmitate, Cetearyl Ethylhexanoate, Octyl Palmitate, Dimethicone, Cyclopentasiloxane, Petrolatum, Mineral Oil, Squalane, Aloe Vera Oil, Evening Primrose Oil, Avocado Oil, Sunflower Seed Oil, Grape Seed Oil, Beeswax, Carnauba Wax, Lanolin, Urea and the like.

[0050] The emulsifying agent according to present invention are selected from but not limiting to Cetyl alcohol, Stearyl alcohol, Glyceryl stearate, Polysorbate 60, Polysorbate 80, Cetearyl alcohol, Ceteareth-20, Sorbitan monostearate, PEG- 100 stearate, Lecithin, Sodium lauryl sulfate, Carbomer, Stearic acid, Xanthan gum, Triethanolamine, Lanolin, Emulsifying Wax, Beeswax, PEG-40 hydrogenated castor oil, Glyceryl Stearate (and) PEG- 100 Stearate, Polyglyceryl-3 methylglucose distearate and the like.

[0051] The moisturising agent according to present invention are selected from but not limiting to Glycerin, Hyaluronic acid, Mango butter, Sodium Hyaluronate, Hydroxyethyl Urea, Urea, Lactic acid, Panthenol, Allantoin, Propylene glycol, Butylene glycol, Sodium PCA, Sorbitol, Aloe vera, Colloidal Oatmeal (Avena sativa Kernel Flour), Shea butter, Cocoa butter, Lanolin, Jojoba oil, Almond oil, Coconut oil, Olive oil, (Ceramide EOP, Ceramide NS, Ceramide NP, Ceramide AS, Ceramide AP, Cholesterol, Aquaxyl (Xylitylglucoside (and) Anhydroxylitol (and) Xylitol & Glucose & Water), Sodium Lactate (and) Sodium Gluconate) Hydrogenated Lecithin, Glyceryl Stearate, Dipropylene Glycol Squalane, Beeswax and the like.

[0052] The antioxidant according to present invention are selected from but not limiting to Vitamin C, Vitamin E, Coenzyme Q10, Butylated Hydroxytoluene, Resveratrol, Green Tea Extract, Niacinamide, Alpha Lipoic Acid, Ferulic Acid, Astaxanthin, Grape Seed Extract, Lycopene, Curcumin, Beta-Carotene, Glycyrrhiza Inflata Root Extract, Glutathione, Selenium, Polypodium Leucotomos Extract and the like.

[0053] The chelating agent according to present invention are selected from but not limiting to EDTA, Di Sodium EDTA, citric acid, phytic acid, gluconic acid, lactic acid, tartaric acid, malic acid, succinic acid, salicylic acid, dihydroxyethylglycine and the like.

[0054] The soothing agent according to present invention are selected from but not limiting to Aloe vera, chamomile extract, colloidal oatmeal, allantoin, calendula extract, panthenol, cucumber extract, bisabolol, licorice root extract, green tea extract, centella asiatica extract, shea butter,honey, rosewater, lavender oil, vitamin E, jojoba oil, glycerin, coconut oil, squalane, sunflower seed oil and the like.

[0055] The skin conditioner according to present invention are selected from but not limiting to glycerin, urea, hyaluronic acid, Cyclopentasiloxane, Phenyl Trimethicone, Dimethiconol, Cl 2- 15 Alkyl Benzoate, Dimethicone Crosspolymer, aloe vera, shea butter, lanolin, panthenol, squalane, dimethicone, niacinamide, ceramides, lactic acid, allantoin, jojoba oil, coconut oil, vitamin E, petrolatum, beeswax, almond oil, olive oil, argan oil, collagen, soybean oil, avocado oil, cocoa butter, propylene glycol, caprylic / capric triglycerides, macadamia oil, sodium PCA and the like.

[0056] The humectant according to present invention are selected from but not limiting to glycerin, propylene glycol, sorbitol, urea, hyaluronic acid, sodium PCA, honey, aloe vera, panthenol, sodium lactate, lactic acid, alpha-hydroxy acids (AHAs), xylitol, betaine, fructose, allantoin and the like.

[0057] The anti-inflammatory according to present invention are selected from but not limiting to Aloe vera, Tetrahydrocur cumin, chamomile extract, calendula extract, green tea extract, licorice root extract, oatmeal, allantoin, bisabolol, panthenol, centella asiatica extract, cucumber extract, shea butter, niacinamide, Glycyrrhiza Inflata Root Extract, honey, turmeric extract, rosemary extract, witch hazel extract, zinc oxide, ceramides, squalane and the like.

[0058] The viscosity builder according to present invention are selected from but not limiting to Carbomers, xanthan gum, hydroxyethylcellulose, Polyacrylate-13, Polyisobutene AND Polysorbate-20, hydroxypropyl methylcellulose, guar gum, sodium alginate, carrageenan, polyacrylamide, polyethylene glycol, cetyl alcohol, stearyl alcohol, behenyl alcohol, glyceryl stearate, cetearyl alcohol, ceteareth-20, acrylates / C 10-30 alkyl acrylate crosspolymer and the like.

[0059] The anti-aging agent according to present invention are selected from but not limiting to Retinol, Hyaluronic Acid, Vitamin C, Amino Acid Complex 17 (Lysine, Histidine, Arginine, Aspartic Acid, Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine, Glutamic acid, Arginine, Cystine, Proline, Serine, Tyrosine, Aspartic acid, Histidine), Niacinamide, Peptides, Coenzyme Q10, Alpha Hydroxy Acids (AHAs), Beta Hydroxy Acids (BHAs), Ceramides, Resveratrol, Bakuchiol, Green Tea Extract, Caffeine, Ferulic Acid, Glycolic Acid, Lactic Acid, Collagen, Zinc Oxide, Squalane, Aloe Vera Extract and the like.

[0060] The preservatives according to present invention are selected from but not limiting to Benzyl alcohol, Phenoxyethanol, Ethylhexylglycerin, Methylparaben, Propylparaben, Butylparaben, Sodium benzoate, Potassium sorbate, Ethylhexylglycerin AND Phenoxyethanol, Chlorphenesin, Caprylyl glycol, Disodium EDTA, Imidazolidinyl urea, Diazolidinyl urea, Phenylpropanol, Benzoic acid, Dehydroacetic acid and the like.

[0061] The occlusives according to present invention are selected from but not limiting to Petrolatum, Dimethicone, Cyclopentasiloxane, Cetearyl Alcohol, Lanolin, Beeswax, Caprylic / Capric Triglyceride, Paraffin, Mineral Oil, Stearyl Alcohol, Ozokerite, Castor Oil, Butyrospermum Parkii (Shea Butter), Hydrogenated Vegetable Oil, Avocado Oil, Cocoa Butter and the like.

[0062] In yet another embodiment, the present invention provides the moisturising topical formulation wherein the said invention is capable of providing the satisfactory moisturising level typically ranging from 40-70% of hydration. The topical composition provides intense moisturisation.

[0063] In yet another embodiment, the present invention provides good to excellent spreadability of the topical formulation according to present invention.

[0064] In yet another embodiment, the present invention provide the topical formulation having pH levels of between 5.0 and 6.0 which is suitable for natural skin pH.

[0065] In yet another embodiment, the present invention provides the topical formulation providing fast to moderate absorption of the ingredients through skin within 1-15 minutes.

[0066] In yet another embodiment, the Viscosity levels of topical formulation typically range from 5,000 to 50,000 centipoise (cP).

[0067] In yet another embodiment, the present invention provides the topical formulation with adequate emolliency, occlusivity, greasiness, stickiness, and smoothness.

[0068] In another preferred embodiment, the present invention provides the process for preparation of topical composition for the treatment of dry skin disorders caused due to diabetes. The process includes various steps such as:Step 1 : Preparation of oil phase with emollients, emulsifying agents, antioxidants, moisturising agent, emulsifying wax, at 75-80 °C and stirring,Step 2: Preparation of water phase by adding DM water, with chelating agent, and soothing agent, by mixing to obtain clear solution at 75-80 °CStep 3: Adding mixtures of step I and step II at 75-80 °C with proper stirring followed by homogenisation.Step 4: Adding skin conditioner and viscosity builder & stir with homogenisation for 10 to 15 mins,Step 5: In separate SS vessel Sprinkling moisturising Agent in DM (cold) water & soaking it for 10 - 15 mins. After soaking stir continuously until clear gel is obtained. Then add the mixture in main manufacturing vessel at 45 - 50°C.Step 6: In separate SS vessel taking Humectant and anti-inflammatory agent and heat upto 65 °C with proper mixing and add it in main manufacturing Vessel at 40 °C to 45 °C.Step 7: In separate SS vessel taking Humectant and Anti-oxidating, anti-inflammatory and antiallergic agent and mixing well properly & adding in main manufacturing Vessel at 40 °C to 45 °C. Step 8: In separate SS vessel taking DM Water and Moisturizer and mixing well properly & add it inm manufacturing Vessel at 40 °C to 45 °C.Step 9: In Main manufacturing vessel add Moisturising Agents that offers Intense Moisturisation, collagen production stimulants, Amino Acid Complex, Filagrinol and Preservatives at 45°C. Stirring continuously until uniform cream is obtained.Step 10: Checking the pH of the composition (Limit: 5.00 to 6.00). If required add pH adjuster, Step 11 : Making up the volume of cream by using balance quantity of DM Water under constant stirring.Clinical Trial evaluation of topical composition;

[0069] In a preferred embodiment, the topical composition according to present invention is subjected to a single group, monocentric study to evaluate efficacy and in use skin tolerance of a present product on diabetes patients with itchy dry skin.

[0070] In yet another embodiment, the topical composition is subjected to study of safety and efficacy of formulation through, skin hydration measurement of stratum corneum usingMoistureMeter, Trans epidermal water loss by VapoMeter, subject self evaluation and clinical evaluation for skin tolerance.

[0071] In another embodiment, the skin hydration measurement of stratum corneum was conducted using MoistureMeter SC. The MoistureMeter SC measures the hydration of the skin surface, stratum corneum. The skin is electrically layered structure. The electrical properties of these layers are related to their water content. The probe, the skin surface and the deeper skin layers form a structure similar to an electrical capacitor. The measured capacitance is proportional to the water content of the surface layer of the skin. The higher the reading, the higher the moisture content.

[0072] In yet another embodiment, the trans epidermal water loss was evaluated using VapoMeter. The VapoMeter is equipped with a closed cylindrical chamber that contains sensors for relative humidity and temperature. There is a linear increase of relative humidity (RH%) in the chamber shortly after placing the device in contact with the skin. The TEWL (Trans Epidermal Water Loss) is calculated from the increase in RH%. Values of ambient RH (%) and temperature (°C) are recorded before skin contact. The chamber is passively ventilated between measurements. Reduction in the VapoMeter readings indicates prevention of water loss from skin.

[0073] In yet another embodiment, a self-assessment questionnaire was administered to participants to understand their perception of efficacy of product.

[0074] In yet another embodiment, a self-assessment questionnaire was administered to capture reduction in itching on a scale as follows (0=None, l=Mild, 2=Moderate, 3=severe).

[0075] In yet another embodiment, a self-assessment questionnaire was administered to participants to understand their perception of overall improvement in the quality of life.

[0076] In yet another embodiment, safety Variable(s) were conducted by clinical evaluation for skin tolerance (1 hour, Day 28, Day 45). Clinical evaluation for reactions in skin was done clinically.

[0077] In yet another embodiment, self-assessment questionnaire for skin tolerance 1 hour, day 28, Day 45) a self-assessment questionnaire was administered to participants to capture skin tolerance (prickling, tingling and burning sensation).

[0078] In yet another embodiment, statistical analysis was carried out on version 30.0 of statistical software SPSS. Continuous variables was summarized by treatment group using summary statistics (number of observations, mean, standard deviation or median with range of minimum and maximum). Tests were carried out at 95% level of significance.Tests of significance : Student’t’test, Wilcoxan Sign Rank Test, Chi Square test.

[0079] In yet another embodiment, 34 participants were included in the study, and 31 participants completed the study. In this study, the age of the participants ranged from 30.00 - 60.00 years with average age being 46.32 years and there was 01 male and 30 females in the study.

[0080] The present disclosure is further described in light of the following experiments which are set forth for illustration purpose only and not to be construed for limiting the scope of the disclosure. The following experiments can be scaled up to industrial / commercial scale and the results obtained can be extrapolated to industrial scale.Example No. 01: Formulation of Topical Moisturising composition:Example No.03: Formulation of Topical Moisturising composition:Process for preparation;1) In Main Oil Phase Vessel, Ceto stearyl Alcohol, Glyceryl Stearate (and) PEG- 100 Stearate, Butylatedhydroxytoluene, Shea Butter, Vitamin E and Emulsifying Waxwas added in oil phase vessel together at temperature about 75°C to 80°C and stir for 20 min until it dissolves properly.2) In Water Phase SS Vessel, DM water in water phase vessel was added with Di sodium EDTA & Allantoin, mixed until clear solution obtained, at temperature about 75°C to 80°C.3) Mixture of step I was added into stage II mixture in Main manufacturing Vessel at 75°C to 78°C with proper stirring (at stirring rate 25 to 30 RPM) & started homogenizer for 30 min.4) In main manufacturing vessel Polyacrylate- 13 (and) Polyisobutene (and) Polysorbate-20 were added at 60°C and Stirred with homogenisation at 35 rpm continuously for 10 to 15 mins.5) In separate SS vessel Sprinkled Sodium Hyaluronate in DM (cold) water & started soaking for 10 - 15 mins. After soaking it was stirred continuously until clear gel was obtained. Then the mixture was added in main manufacturing vessel at 45 - 50°C.6) In separate SS vessel Propylene Glycol and Tetrahydrocurcumin were heat upto 65 °C mix well properly & added it in Main manufacturing Vessel at 40 °C to 45 °C .7) In separate SS vessel Propylene Glycol and Glycyrrhiza Inflata Root Extract were mixed well and added it in Main manufacturing Vessel at 40 °C to 45 °C .8) In separate SS vessel DM Water and Colloidal Oatmeal were mixed well properly and added in Main manufacturing Vessel at 40 °C to 45 °C.9) In Main manufacturing vessel Hydroxyethyl Urea, Aquaxyl, Purasal Moist XS, Resveratrol, Amino Acid Complex, Filagrinol & Phenoxyethanol (and) Ethylhexylglycerinwere added at 40 - 45°C. Stirred continuously until uniform cream is obtained.10) Checked the pH of the Cream (Limit: 5.00 to 6.00). If required Triethanolamine was added for pH adjustment.11) The volume of cream was made upto to intended final volume by using balance quantity of DM Water under constant stirring.12) The bulk was stirred for 30 minutes under vacuum (100 to 200 mm Hg)• Evaluation of finished composition based on clinical study results:1) Measurement of skin hydration values:

[0081] The skin hydration values were measured and the comparison of changes in mean MMSC readiings are shown in Table no. 1 and Figure no. 1.Table 1: Comparison of changes in mean MMSC readings (skin hydration)Interpretation: Significant increase in MMSC values indicates significant improvement in skin hydration)At baseline, mean MMSC reading was 9.71.After 5 mins of application, mean MMSC readings showed a significant increase of 43.7% from baseline (indicating significant increase in skin hydration).After 1 hour of application, mean MMSC readings showed a significant increase of 77.5% from baseline (indicating significant increase in skin hydration).After 28 Days of application, mean MMSC readings showed a significant increase of 19.7% from baseline (indicating significant increase in skin hydration).After 45 Days of application, mean MMSC readings showed a significant increase of 42.2% from baseline (indicating significant increase in skin hydration).2) Measurement of Trans epidermal water loss:

[0082] The transepidermal water loss was measured using Vapometer. The comparison of changes in Mean VapoMeter readings (Trans epidermal Water Loss) is shown in Table no. 2 and Figure no. 2.Table 2: Comparison of changes in Mean VapoMeter readings (Trans epidermal Water Loss)By Student ‘t’ Test * SignificantInterpretation: (Significant decrease in VapoMeter readings indicates significant reduction in transepidermal water loss from skin)At baseline, mean VapoMeter reading was 11.59.After 5 mins of application, mean VapoMeter readings showed a significant decrease of 8.6% from baseline (indicating significant reduction in transepidermal water loss).After 1 hour of application, mean VapoMeter readings showed a significant decrease of 15.7% from baseline (indicating significant reduction in transepidermal water loss). After 28 Days of application, mean VapoMeter readings showed a significant decrease of 18.7% from baseline (indicating significant reduction in transepidermal water loss).After 45 Days of application, mean VapoMeter readings showed a significant decrease of 27.9% from baseline (indicating significant reduction in transepidermal water loss). 3) Self-assessment for efficacy :

[0083] Different parameters of evaluation questionnaires were scored from 1 to 5. Where l=Strongly Disagree, 2=Disagree, 3=neither agree nor disagree, 4=Agree, 5=strongly agree. % of participants reporting top 2 scores (agree to strongly agree) was then calculated and reported.Table 3: Participants assessment question- After using the product skin has become hydrated.Interpretation :After 28 days of application, 100.0% of the participants agreed to strongly agreed that skin has become hydrated.After 45 days of application, 100.0% of the participants agreed to strongly agreed that skin has become hydrated.Table 4 : Participants assessment question- After using the product skin has become soft and smooth.Interpretation :After 28 days of application, 100.0% of the participants agreed to strongly agreed that skin has become soft and smooth.After 45 days of application, 100.0% of the participants agreed to strongly agreed that skin has become soft and smooth.Table 5: Participants assessment question- After using the product itching has reducedInterpretation :After 28 days of application, 100.0% of the participants agreed to strongly agreed that itching has reduced- After 45 days of application, 100.0% of the participants agreed to strongly agreed that itching has reduced.Table 6: Participants assessment question- Overall I liked the product.Interpretation :- After 28 days of application, 100.0% of the participants agreed to strongly agreed that they overall liked the product.After 45 days of application, 100.0% of the participants agreed to strongly agreed that they overall liked the product.4) Self-assessment for reduction in itching :Table 7 : Changes in mean score of itching based on participant feedbackBy Wilcoxon Sign Rank Test *SignificantInterpretation:

[0083] Reduction in mean itching score based on participant feedback indicates improvement in itching condition:At baseline, mean Itching was 2.10.After 1 hour of application, mean itching showed a significant fall of 100.0% from baseline.- After 28 Days of application, mean itching showed a significant fall of 75.2% from baseline.After 45 Days of application, mean itching showed a significant fall of 82.9% from baseline.5) Self-assessment for overall improvement in the Quality Of Life :

[0084] Different parameters of evaluation questionnaires were scored from 0 to 6 (i.e. 0=Never bothered to 6= Always bothered).Table 8: % of Participants reporting they have been bothered by Itching during the past week:By Chi Square Test * SignificantInterpretation :

[0085] % of participants who were bothered by itching were tracked over study duration. % of participants moving from category ‘bothered’ to ‘never bothered’ by itching, indicates improvement.At baseline, 100% of the participants were bothered by itching to some degree.After 28 Days of application, 74.2% of the participants were rarely, very rarely or never bothered by itching, which showed a significant change (improvement) from baseline. After 45 Days of application, 100% of the participants were rarely, very rarely or never bothered by itching, which showed a significant change (improvement) from baseline.Table 9: % of Participants reporting they have been bothered by the appearance of skin from scratching during past weekBy Chi Square Test * SignificantInterpretation:

[0086] % of participants who were bothered by the appearance of skin from scratching were tracked over study duration. % of participants moving from category ‘bothered’ to ‘never bothered’ by itching, indicates improvement.At baseline, 100% of the cases were bothered by the appearance of their skin from scratching.After 28 Days of application, 54.9% of the participants were rarely, very rarely or never bothered by the appearance of their skin from scratching which showed a significant change from baseline.After 45 Days of application, 100% of the participants were rarely, very rarely or never bothered by the appearance of their skin from scratching which showed a significant change from baseline.Table 10: % of Participants reporting they have been bothered by feeling depressed about itching during past weekBy Chi Square Test *SignificantInterpretation:

[0087] % of participants who were bothered by feeling depressed about itching was tracked over study duration. % of participants moving from category ‘bothered’ to ‘never bothered’ by itching, indicates improvement.At baseline, 100% of the cases were bothered by feeling depressed about their itching. After 28 Days of application, 77.4% of the of the participants were rarely, very rarely or never bothered by feeling depressed about their itching which showed a significant change from baseline.After 45 Days of application, 100% of the of the of the participants were never bothered by feeling depressed about their itching which showed a significant change from baseline.Table 11: % of Participants reporting they have been bothered by the effect of itching making it hard to work or enjoy during the past weekBy Chi Square Test * SignificantInterpretation :

[0088] % of participants who were bothered by the effect of itching making it hard to work or enjoy was tracked over study duration. % of participants moving from category ‘bothered’ to ‘never bothered’ by itching, indicates improvement.At baseline, 100% of the cases were bothered by the effect of itching making it hard to work or do what they enjoy.After 28 Days of application, 74.2% of the participants were rarely, very rarely or never bothered by the effect of itching making it hard to work or do what they enjoy which showed a significant change from baseline.After 45 Days of application, 100% of the participants were rarely, very rarely or never bothered by the effect of itching making it hard to work or do what they enjoy, which showed a significant change from baseline.6) Secondary Endpoint:i) Clinical evaluation for skin tolerance:

[0089] None of the participants had any skin intolerances when observed clinically, after using the product at 1 hr, Day 28 and Day 45.ii) Self-assessment questionnaire for skin tolerance:

[0090] None of the participants reported any skin intolerances (prickling, tingling or burning sensation) after using the product at 1 hr, Day 28 and Day 45.iii) Adverse Events :

[0091] There was no adverse event recorded during the study.DISCUSSION:

[0092] The objective of this study was to evaluate efficacy of presentProduct on Diabetes Patients with itchy dry skin and in use tolerance of present Product. The observations from the study are as follows.A. Instrumental evaluation:Table 12: % improvement in skin hydration and TEWLTable 13: Self-assessment for efficacy:B) Self-assessment for reduction in itching, based on participant perception:Table 14: % improvement from baselineTable 15: Self-assessment in overall improvement in the Quality Of Life :C) Clinical evaluation for skin tolerance :

[0093] None of the participants had any skin intolerances when examined clinically, after using the product at 1 hr, Day 28 and Day 45.D) Self-assessment questionnaire for skin tolerance :

[0094] None of the participants reported any skin intolerances (pricking, tingling, or burning sensations) after using the product at 1 hr, Day 28 and Day 45.CONCLUSION:

[0095] At the end of 45 days of application of present invention it can be concluded that present composition was efficacious in :• Significantly increasing skin hydration,• Significantly reducing Transepidermal water loss.• Significantly reducing itching.• 100% participants agreed that skin had become hydrated, and soft and smooth, itching had reduced and that they liked the product.• 100% participants agreed significant improvement in Quality of Life. The Product was well tolerated.

[0096] The embodiments of the invention shown and discussed herein are merely illustrative of modes of application of the present invention. Reference to details in this discussion is not intended to limit the scope of the claims to these details, or to the figures used to illustrate the invention.

Claims

CLAIMS:1) A non-steroidal, non-comedogenic and fragrance-free topical composition for treatment or management of diabetic skin conditions, comprising:3-10 wt.% of one or more emollients;1-10 wt.% of one or more emulsifying agents;5-25 wt.% of one or more moisturizing agents;0.1-3 wt.% of one or more antioxidants;0.01-0.5 wt.% of one or more chelating agents;0.01-1 wt.% of one or more soothing agents;0.5-5 wt.% of one or more skin conditioners;0.5-10 wt.% of one or more humectants;1-4 wt.% of one or more skin protectants;0.1-1 wt.% of one or more anti-inflammatory agents;1-8 wt.% of one or more viscosity builders;0.01-0.5 wt.% of one or more collagen-production-stimulating agents;0.1-5 wt.% of one or more anti-itching agents;0.1-5 wt.% of an amino acid complex comprising at least ten amino acids;0.5-5 wt.% of filagrinol;0.5-5 wt.% of one or more antihistaminic agents;0.5-5 wt.% of one or more preservatives;0.5-5 wt.% of one or more occlusive agents; andan aqueous solvent,wherein one or more ingredients perform multiple functional roles, and wherein the composition is configured to reduce itching, reduce skin dryness, reduce transepidermal water loss, repair a damaged skin barrier, improve filaggrin levels, and improve quality of life in diabetic subjects.2) The topical composition according to claim 1 , wherein the composition is formulated as a cream, ointment, gel, lotion, foam, powder, paste, aerosol, patch, balm, spray, mousse, emollient, emulsion, or serum.3) The topical composition according to claim 1, wherein the composition has a pH in the range of 5.0 to 6.0.4) The topical composition according to claim 1, wherein the composition provides a skin hydration improvement of 40-70%.5) The topical composition according to claim 1, wherein the composition has a viscosity in the range of 5,000 to 50,000 centipoise (cP).6) The topical composition according to claim 1, wherein the emollients are selected from cetostearyl alcohol, shea butter, caprylic / capric triglycerides, and combinations thereof.7) The topical composition according to claim 1, wherein the moisturizing agents are selected from glycerin, hyaluronic acid, sodium hyaluronate, hydroxyethyl urea, urea, lactic acid, panthenol, allantoin, propylene glycol, butylene glycol, sodium PCA, sorbitol, aloe vera, colloidal oatmeal (Avena sativa kernel flour), mango butter, shea butter, cocoa butter, lanolin, jojoba oil, almond oil, coconut oil, olive oil, squalane, beeswax, ceramide-based complexes, hydrogenated lecithin, glyceryl stearate, dipropylene glycol, and combinations thereof.8) The topical composition according to claim 1, wherein the antioxidants are selected from vitamin C, vitamin E, coenzyme Q10, butylated hydroxytoluene (BHT), resveratrol, green tea extract, niacinamide, alpha-lipoic acid, ferulic acid, astaxanthin, grape seed extract, lycopene, curcumin, beta-carotene, Glycyrrhiza inflata root extract, glutathione, selenium, Polypodium leucotomos extract, and combinations thereof.9) A process for preparing the topical composition according to claim 1, comprising the steps of: preparing an oil phase by heating emollients, emulsifying agents, antioxidants and moisturizing agents to 75-80 °C under stirring;preparing an aqueous phase by mixing demineralized water with chelating agents and soothing agents at 75-80 °C;combining the oil phase and aqueous phase under stirring followed by homogenization to form an emulsion;adding skin conditioners and viscosity builders with continued homogenization; separately preparing a hydrated moisturizing gel and incorporating the same at 45-50 °C; separately heating humectants and anti-inflammatory agents and adding them at 40-45 °C; incorporating additional moisturizing agents, collagen-stimulating agents, amino acid complex, filagrinol, antihistaminic agents, and preservatives at about 45 °C; adjusting the pH to 5.0-6.0; andmaking up the final volume with demineralized water to obtain a homogeneous topical formulation.

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