A TOPICAL COMPOSITION OF SODIUM LAURYL SULFATE AND ACACIA CONCINNA FOR TREATING ATOPIC DERMATITIS

Abstract

Atopic dermatitis (AD) is a prevalent inflammatory skin condition characterized by intense itching, redness, and skin barrier dysfunction, impacting a significant portion of the population. This study evaluates the comparative effects of sodium lauryl sulfate (SLS) and Acacia concinna extract in a murine model of AD induced by Dermatophagoides farinae (DNFB) extract. Mice were treated with SLS, Acacia concinna, or a corticosteroid (betamethasone dipropionate) following the application of DNFB ointment. The severity of dermatitis was assessed using a scoring system, and transepidermal water loss (TEWL) was measured to evaluate skin barrier function. Additionally, inflammatory markers, including interleukin-4 (IL-4), interferon-gamma (IFN-γ), and immunoglobulin E (IgE) levels, were quantified to elucidate the underlying immunological response. Our findings demonstrated that Acacia concinna significantly reduced the severity of dermatitis, epidermal thickness, and TEWL compared to SLS. Furthermore, Acacia concinna treatment resulted in lower levels of inflammatory cytokines and improved skin hydration. These results suggest that Acacia concinna offers a promising natural alternative to SLS for managing atopic dermatitis, potentially minimizing the side effects associated with traditional chemical treatments.

Specification

Description:[0031]. The following description provides specific details of certain aspects of the disclosure illustrated in the drawings to provide a thorough understanding of those aspects. It should be recognized, however, that the present disclosure can be reflected in additional aspects and the disclosure may be practiced without some of the details in the following description.
[0032]. The various aspects including the example aspects are now described more fully with reference to the accompanying drawings, in which the various aspects of the disclosure are shown. The disclosure may, however, be embodied in different forms and should not be construed as limited to the aspects set forth herein. Rather, these aspects are provided so that this disclosure is thorough and complete, and fully conveys the scope of the disclosure to those skilled in the art. In the drawings, the sizes of components may be exaggerated for clarity.
[0033]. It is understood that when an element or layer is referred to as being "on," "connected to," or "coupled to" another element or layer, it can be directly on, connected to, or coupled to the other element or layer or intervening elements or layers that may be present. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
[0034]. The subject matter of example aspects, as disclosed herein, is described with specificity to meet statutory requirements. However, the description itself is not intended to limit the scope of this patent. Rather, the inventor/inventors have contemplated that the claimed subject matter might also be embodied in other ways, to include different features or combinations of features similar to the ones described in this document, in conjunction with other technologies.
[0035]. Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease characterized by severe itching. It is a significant global public health issue, affecting 10-20% of children and 1-3% of adults. Despite the increasing prevalence of AD, its pathophysiology remains only partially understood. While corticosteroids and calcineurin inhibitors are commonly used to treat AD, there is a growing need for topical anti-inflammatory treatments with fewer side effects. Various mouse models have been developed to study AD, including a spontaneously developed dermatitis model in specific mouse strains and hapteninduced dermatitis models. These models, while useful, do not fully replicate the pathogenesis of human AD. For instance, spontaneous dermatitis in NC mice was believed to be triggered by rodent-specific parasites, which do not affect humans. Similarly, the triggers in other mouse models are not directly relevant to human AD. Patients with AD are often highly sensitized to house dust mite (HDM) allergens, as evidenced by positive results in radioallergosorbent, scratch, and patch tests.
[0036]. In Japan, Dermatophagoides farinae (DNFB) is a major species of HDM, and its body and faeces are recognized as significant environmental allergens. Given this relevance, DNFB extract was explored for its potential to induce dermatitis in mice, with previous studies indicating its ability to create AD-like skin lesions when applied as a suspension. However, the onset of dermatitis in these models was slow, likely due to the rapid disappearance of allergens from the skin. To address this, DNFB extract was formulated into an ointment, hypothesizing that it would prolong allergen presence and thus accelerate the onset of skin lesions. Repeated application of DNFB extract ointment, along with barrier disruption, successfully induced AD-like skin lesions in mice, with significant dermatitis observed just two weeks after the first application.
[0037]. The clinical, immunological, and histological features of this model closely resembled those of human AD, and the model's responsiveness to corticosteroid treatment (Betamethasone dipropionate ointment) further validated its utility for studying AD pathogenesis and evaluating therapeutic agents. Sodium Lauryl Sulfate (SLS) is a widely used anionic surfactant found in various products, including shampoos, toothpaste, mouthwash, soap, and cosmetics.
[0038]. While SLS is effective in these applications, scientific research has highlighted its potential harmful effects, particularly due to its surfactant properties, disruption of cell membranes, and alteration of protein conformation. Consequently, SLS is typically recommended for use only once or twice a week in personal care products to minimize its adverse effects. In contrast, Acacia concinna Linn., a medicinal plant used in Ayurveda, offers a natural alternative. The fruits of this plant, commonly known as Shikakai, are traditionally used for washing hair, promoting hair growth, and serving as an expectorant, emetic, and purgative. Given the rising concerns over chemical formulations like SLS, there is increasing interest in exploring the potential of Acacia concinna as a safer alternative for managing conditions like AD. On this interest we explored the comparative analysis of sodium lauryl sulfate and Acacia concinna shampoos on atopic dermatitis.
[0039]. The present invention pertains to advancements in the field of dermatological treatments, specifically focusing on innovative therapies for atopic dermatitis (AD), a prevalent chronic inflammatory skin disorder that significantly affects individuals across various age groups. Characterized by symptoms such as severe pruritus, erythema, and dryness, AD poses a considerable burden on quality of life and can lead to secondary infections, sleep disturbances, and psychological stress. The increasing incidence of AD highlights the urgent need for effective, safe, and well-tolerated treatment options, especially considering the limitations and side effects associated with traditional therapies.
[0040]. At present, common treatments for AD include topical corticosteroids and calcineurin inhibitors, which serve to reduce inflammation and alleviate symptoms. However, prolonged use of these medications often results in adverse effects, such as skin thinning, hormonal imbalances, and heightened vulnerability to infections. These concerns have fostered a growing interest in exploring alternative therapeutic avenues, particularly those leveraging natural ingredients with anti-inflammatory and barrier-repairing properties.
[0041]. One such ingredient is sodium lauryl sulfate (SLS), a widely utilized anionic surfactant known for its effectiveness in creating foam and cleansing properties in a variety of personal care products, including shampoos and soaps. Despite its popularity, SLS has garnered significant attention for its potential detrimental effects on the skin, particularly in individuals with compromised skin barriers. Research has shown that SLS can lead to skin irritation, increased dryness, and disruption of the stratum corneum, which is crucial for maintaining skin hydration and protection against environmental irritants and allergens. Given these adverse effects, it is critical to evaluate safer alternatives for patients, particularly those with atopic dermatitis.
[0042]. In contrast, Acacia concinna, a plant with a rich history in traditional Ayurvedic medicine, presents a compelling natural alternative for managing atopic dermatitis. Commonly referred to as shikakai, this plant is renowned for its mild cleansing properties, derived from its rich content of saponins. Saponins are natural surfactants that create a gentle lather, allowing for effective cleansing without the harsh stripping effects often associated with synthetic surfactants like SLS. Furthermore, Acacia concinna has demonstrated anti-inflammatory and antimicrobial properties, which can play a vital role in soothing irritated skin and promoting healing.
[0043]. To investigate the comparative efficacy of SLS and Acacia concinna extract in managing atopic dermatitis, this study employed a well-established murine model. Mice were sensitized using dermatophagoides farinae (DNFB) ointment to induce AD-like lesions, mimicking the pathophysiological features of the disease observed in human patients. Following sensitization, the mice were treated with either SLS, Acacia concinna extract, or a corticosteroid, specifically betamethasone dipropionate, which serves as a positive control due to its established efficacy in managing AD.
[0044]. The severity of dermatitis in each treatment group was meticulously assessed using a standardized scoring system that evaluates multiple clinical features, including erythema, edema, excoriation, and dryness. Additionally, transepidermal water loss (TEWL) measurements were conducted to quantify the integrity of the skin barrier. TEWL is a critical parameter that reflects the skin's ability to retain moisture; elevated levels indicate compromised barrier function, a hallmark of atopic dermatitis.
[0045]. To further elucidate the immunological mechanisms involved in the treatment responses, various inflammatory markers were quantified. Levels of interleukin-4 (IL-4) and interferon-gamma (IFN-γ) were assessed to determine the Th1 and Th2 immune responses associated with AD, while serum immunoglobulin E (IgE) levels were measured to evaluate the allergic component of the disease. These cytokines play pivotal roles in the pathogenesis of atopic dermatitis, with IL-4 being a key driver of Th2 responses that promote allergic inflammation.
[0046]. The results of this comparative study indicated that treatment with Acacia concinna significantly reduced the severity of dermatitis and improved skin barrier function, as evidenced by lower TEWL values when compared to the SLS-treated group. Furthermore, Acacia concinna treatment resulted in a marked decrease in the levels of pro-inflammatory cytokines, indicating its potential to modulate the underlying immune responses in atopic dermatitis. The positive impact on both clinical and immunological parameters supports the hypothesis that Acacia concinna may serve as an effective and safer alternative to traditional chemical treatments for managing atopic dermatitis.
[0047]. The findings of this study highlight the comparative efficacy of Acacia concinna extract as a promising natural alternative to sodium lauryl sulfate (SLS) in the management of atopic dermatitis (AD) induced by Dermatophagoides farinae in a murine model. While SLS is widely used in personal care products for its cleansing and foaming properties, its potential to irritate and compromise the skin barrier underscores the need for safer alternatives, especially for individuals with sensitive skin conditions like AD.
[0048]. In contrast, Acacia concinna, with its rich composition of saponins and demonstrated anti-inflammatory properties, offers a dual advantage: effective cleansing without the harsh effects typically associated with synthetic surfactants. The results of our study showed that treatment with Acacia concinna significantly reduced the severity of dermatitis, improved skin hydration as indicated by lower transepidermal water loss (TEWL), and modulated the inflammatory responses associated with AD.
[0049]. Moreover, the ability of Acacia concinna to lower levels of key inflammatory markers, such as interleukin-4 (IL-4) and immunoglobulin E (IgE), supports its potential role in addressing the underlying immunological mechanisms of atopic dermatitis. These findings not only validate the traditional uses of Acacia concinna in Ayurvedic medicine but also pave the way for its application in modern dermatological treatments.
[0050]. In conclusion, incorporating Acacia concinna into therapeutic formulations presents a viable strategy for managing atopic dermatitis, enhancing the quality of life for affected individuals while minimizing the risks associated with conventional treatments. Further research and clinical trials are warranted to fully establish its safety and efficacy in diverse populations, but the current study provides a strong foundation for exploring natural, effective alternatives in the fight against atopic dermatitis.
[0051]. In conclusion, this invention underscores the importance of leveraging natural botanical extracts such as Acacia concinna in the development of therapeutic interventions for atopic dermatitis. By providing a formulation that combines the gentle cleansing properties of Acacia concinna with its anti-inflammatory effects, this study paves the way for the creation of innovative skincare solutions that not only alleviate symptoms but also enhance the overall health of the skin. Such advancements are crucial for improving the quality of life for individuals affected by atopic dermatitis, offering them a viable option that minimizes the risks associated with conventional treatments while maximizing therapeutic benefits.
[0052]. In conclusion, our study successfully established a novel animal model of atopic dermatitis (AD) using DNFB extract ointment, which effectively replicated the clinical, histological, and immunological characteristics of the disease seen in humans. The model demonstrated significant skin lesions, including erythema, edema, and excoriation, accompanied by a marked increase in inflammatory cells, aligning closely with the pathophysiology of AD. Our findings highlighted the efficacy of traditional and natural treatments, such as Acacia concinna, which showed superior effects in alleviating dermatitis symptoms compared to SLS. Notably, while corticosteroids like betamethasone are first-line treatments for AD, their long-term use poses risks of side effects, underscoring the need for alternative therapies. The positive response of the established model to both Acacia concinna and SLS suggests their potential as effective treatments in managing AD. Moreover, our observations on the scratching behavior of the mice indicated the chronic nature of the condition, reinforcing the importance of exploring both symptomatic relief and therapeutic interventions. This research not only advances our understanding of AD but also opens avenues for developing eco-friendly and safe alternatives for treating skin disorders, aligning with modern needs for sustainable healthcare solutions. Future studies should aim to further elucidate the mechanisms behind the beneficial effects of Acacia concinna and explore its potential integration into AD management protocols. Overall, this model serves as a valuable tool for evaluating the efficacy of various treatments in the quest for effective AD management.
[0053]. Future trends in atopic dermatitis (AD) research are likely to focus on several key areas. First, there will be an increasing emphasis on exploring natural and traditional treatments, such as Acacia concinna, as alternatives to corticosteroids. This aligns with a growing consumer demand for safe and eco-friendly skincare solutions. Second, the integration of advanced technologies, such as genomics and metabolomics, will enhance our understanding of AD pathophysiology and treatment responses. These approaches can identify biomarkers that predict individual responses to therapies, allowing for more personalized treatment strategies.
[0054]. Third, research will likely delve deeper into the role of the microbiome in skin health. Investigating how restoring microbial balance can influence AD symptoms will pave the way for innovative prebiotic and probiotic therapies. Additionally, novel drug delivery systems, including microneedles and nanoparticles, will be explored to improve the efficacy of topical treatments while minimizing systemic absorption. This can enhance patient adherence and outcomes. Finally, clinical studies will increasingly focus on long-term safety and efficacy profiles of alternative treatments, ensuring that new therapies are not only effective but also safe for chronic use. Overall, these trends indicate a shift towards holistic and patient-centered approaches in AD management.
, Claims:1. A topical composition for treating atopic dermatitis, comprising:
a) An effective amount of Acacia concinna extract, and
b) A pharmaceutically acceptable carrier, wherein said composition is capable of reducing the severity of dermatitis, improving epidermal thickness, and lowering trans epidermal water loss in atopic dermatitis patients.
2. The composition as claimed in claim 1, wherein the Acacia concinna extract is obtained from the dried and pulverized fruit of the plant Acacia concinna. The extract is prepared using ethanol or distilled water.
3. The composition as claimed in claim 1, wherein the topical composition further comprises a corticosteroid selected from the group consisting of betamethasone dipropionate. The Acacia concinna extract inhibits the infiltration of CD4+ and CD8+ T cells in skin lesions associated with atopic dermatitis.
4. The composition as claimed in claim 1, wherein the Acacia concinna extract reduces scratching behavior in patients with atopic dermatitis. The concentration of Acacia concinna extract is between 50 mg/kg and 100 mg/kg.
5. The composition as claimed in claim 1, wherein the extract reduces the production of interleukin-4 (IL-4) and interferon-gamma (IFN-γ) in patients with atopic dermatitis. The extract also reduces the level of immunoglobulin E (IgE) in patients with atopic dermatitis.
6. A method of treating atopic dermatitis, comprising:
a) Administering an effective amount of Acacia concinna extract in a topical composition to a subject in need thereof, wherein the administration reduces the severity of dermatitis and improves skin hydration.
7. The method as claimed in claim 6, wherein the administration reduces epidermal thickness and trans epidermal water loss in the subject.
8. The method as claimed in claim 6, wherein the subject exhibits reduced scratching behavior after administration of the composition.

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