Alcohol-free dermatological formulation for acne, herpes and superficial wounds

Abstract

The present invention relates to an antimicrobial and healing formulation for skin, designed to effectively target and treat skin conditions such as acne caused by Cutibacterium acnes, cold sore lesions due to the herpes simplex virus, and superficial wounds. This unique formulation combines antimicrobial agents, plant extracts and essential oils in specific proportions in order to exert a synergistic action, enhancing their individual efficacy in the treatment of skin conditions and promoting skin healing. The innovative formulation composed of niaouli (Melaleuca viridiflora) essential oil and tea tree (Melaleuca alternifolia) essential oil, chlorhexidine digluconate, Hamamelis virginiana extract, panthenol, glycerol, and propylene glycol. Each ingredient has been selected for its proven pharmacological properties and its synergistic potential. The formulation works in concert to reduce microbial load, alleviate inflammation, and accelerate skin healing, while providing a gentle and effective application.

Description

[0001] Alcohol-free dermatological formulation for acne, herpes, and superficial wounds

[0002] DESCRIPTION

[0003] TECHNOLOGICAL FIELD:

[0004] This invention relates to an innovative dermatological formulation for the treatment of skin conditions such as acne caused by Cutibacterium acnes, cold sores caused by the Herpes simplex virus, and the healing of superficial wounds. The formulation is characterized by a specific synergy of active components that promote skin health and tissue repair.

[0005] STATE OF THE ART:

[0006] Skin conditions such as acne, cold sores, and superficial wounds are a constant concern in clinical dermatology. Existing treatments can be limited by issues of efficacy, side effects, microbial resistance, or poor wound healing.

[0007] Acne vulgaris, commonly known as acne, is one of the most prevalent skin conditions, affecting millions of people worldwide. It is a chronic inflammatory condition of the pilosebaceous unit, which comprises the hair follicle and the sebaceous gland. The primary cause of acne is the bacterium Cutibacterium acnes (formerly Propionibacterium acnes), which thrives in the lipid environment of the sebaceous glands.

[0008] The pathogenesis of acne is multifactorial. It involves increased sebum production, hyperkeratinization leading to comedone formation, follicle colonization by C. acnes, and the resulting inflammatory response. Hormonal fluctuations, particularly androgens, can exacerbate sebum production and are a key factor in the prevalence of acne during adolescence. Clinical manifestations of acne range from non-inflammatory comedones to inflammatory papules, pustules, and nodules. Severe cases can lead to scarring and significant psychological distress. Treatment includes topical agents such as retinoids and benzoyl peroxide, systemic therapies including antibiotics and isotretinoin, and hormonal treatments for some individuals.A holistic approach, taking into account lifestyle factors such as diet and stress management, can also be beneficial.

[0009] Oral herpes, commonly known as cold sores or fever blisters, is primarily caused by the Herpes simplex virus type 1 (HSV-1). HSV-2 can also cause oral lesions but is more commonly associated with genital herpes. HSV-1 is a highly contagious virus that can be transmitted through direct contact with infected bodily fluids or lesions.

[0010] The virus has the unique ability to enter a latent phase after the initial infection, residing in the trigeminal ganglion. It can reactivate periodically, leading to recurrent herpetic lesions, often triggered by factors such as stress, illness, or sun exposure. The classic presentation of oral herpes includes painful blisters on the lips, surrounding skin, and sometimes on the mucous membranes of the mouth.

[0011] Treatment for cold sores primarily involves antiviral medications such as acyclovir, valacyclovir, and famciclovir, which can reduce the duration and severity of outbreaks. These treatments are recommended when started at the first signs of an outbreak, such as tingling or itching before the lesions appear. Using sunscreen and employing stress management techniques can help reduce the frequency of reactivation.

[0012] Patent W02008 / 135085 describes a formulation containing antimicrobial agents for cosmetic, pharmaceutical, or household applications. This formulation comprises: a) 1,2-decanediol, which has antimicrobial activity; b) other antimicrobial compounds, which may include ethyl alcohol (ethanol), propanol isomers, and various agents such as chlorhexidine digluconate and benzalkonium chloride, among others; and c) additional agents with antimicrobial activity, such as benzyl-C12-18-alkyldimethylammonium chloride and glutaraldehyde. The total concentration of 1,2-decanediol is maintained between 0.1% and 2% by weight of the total preparation.

[0013] Patent CN1 1 1265452 relates to a composition for the treatment of acne and consists of a selection of active ingredients in specific proportions. The formula contains glycerin, which acts as a humectant to moisturize the skin, at a concentration of 8 to 12%. It also includes extract of wild purple peony, known for its soothing and beneficial properties for the skin, at a concentration of 1.0 to 1.5%. Triethanolamine, at a concentration of 0.3 to 0.5%, is used to adjust the pH of the cream. And oils selected for their nourishing and restorative properties, including Plukenetia volubilis oil (also known as Sacha Inchi oil) at a concentration of 6 to 10%, and melaleuca alternifolia essential oil (or tea tree oil), at 0.5 to 1.0%, recognized for its antimicrobial actions.White oil (probably liquid paraffin) is added for its occlusive properties at 6 to 10%, while glyceryl monostearate, an emulsifier, is present at 8 to 10%.

[0014] In the ever-evolving field of dermatological care, the transition from the state of the art to the unveiling of a new invention requires a delicate articulation of innovation. Our formula stands out for its significant contribution to the advancement of topical treatments for skin conditions such as acne, herpes, and superficial wounds.

[0015] SUMMARY OF THE INVENTION

[0016] The present invention reveals a cutting-edge pharmaceutical composition designed for the topical treatment of various skin conditions, such as acne, cold sores, and superficial wounds. This innovative formulation relies on a synergy of components whose pharmacological properties and mechanisms of action have been meticulously selected for their efficacy and safety.

[0017] The invention relates to a composition designed to promote wound healing while providing astringent properties. This composition is used to treat various conditions related to disruptions in the anatomical continuity of the outer layers of the skin. These conditions include superficial skin inflammations caused by conditions such as herpes and acne, which represent significant health problems. Inadequate or insufficient treatment of these conditions can lead to a risk of infection. The healing process of these wounds is often painful and can result in limitations in mobility and quality of life.

[0018] The use of this invention also aims to promote the healing of superficial wounds by restoring their integrity and triggering a molecular and cellular response that activates the hemostasis process. Hemostasis is a complex, multifactorial process without which healing cannot begin. The essential component of hemostasis is blood coagulation, which leads to the formation of a clot. This clot is primarily composed of a fibrinous structure with embedded platelets. Clot formation is crucial because it prevents further loss of fluids and electrolytes from the wound, while also reducing the risk of external contamination.

[0019] To accelerate the skin healing process using previous techniques, various chemical substances, primarily of synthetic origin, have been employed, but these are often associated with undesirable side effects, notably the deterioration of skin protein elasticity. To achieve the objectives mentioned above, the composition of the present invention comprises:

[0020] Glycerin (C3H8O3), present at a concentration of 15-30%, acts as an emollient solvent by attracting and retaining water in the stratum corneum, thus improving skin hydration and suppleness. Propylene glycol (C3H8O2), also at a concentration of 15-30%, reinforces this action by facilitating the absorption of active ingredients thanks to its solvent and skin penetration properties.

[0021] - Chlorhexidine digluconate concentrated at 20% (C22H3oCl2Nio-2C6Hi2O7) is included at a level of 5-10% for its broad and robust antimicrobial spectrum, acting by disruption of the cytoplasmic membrane of pathogens.

[0022] -Panthenol (C9H19NO4), at 2-5%, promotes healing by stimulating cell regeneration and hyaluronic acid synthesis. -Hamamelis virginiana extract, at a concentration of 2-5%, provides anti-inflammatory and astringent properties due to its high tannin content, helping to reduce inflammation and sebum production.

[0023] - The oils of Melaleuca alternifolia and Melaleuca viridiflora, between 0.2-1%, complement the antimicrobial action of the composition with their terpinen-4-ol content, effective against a variety of microorganisms.

[0024] This composition is stabilized with xanthan gum (2-5%), which ensures a suitable consistency for easy application. The pH is adjusted with citric acid to optimize antimicrobial activity and maintain the integrity of the active ingredients. Purified water (Aqua) q.s. 100 is used as a solvent to dissolve and homogeneously distribute the active ingredients throughout the formulation. The composition was developed after rigorous evaluation of scientific and clinical studies, making it an advanced therapeutic solution for modern dermatology.

[0025] Propylene glycol, also used at concentrations of 15% to 30%, acts as a secondary solvent. Due to its ability to penetrate the skin, it is used to facilitate the absorption of active ingredients, such as chlorhexidine digluconate 20%. Propylene glycol optimizes the release of chlorhexidine, maximizing its antimicrobial activity.

[0026] Panthenol, at a concentration between 2% and 5%, acts as a repairing agent, strengthening the skin barrier and promoting skin cell regeneration. As a precursor to vitamin B5, it is essential for the synthesis of coenzyme A and plays a role in maintaining skin integrity.

[0027] The gel also contains Ethylhexylglycerin (and) Propanediol (2% to 5%) as a preservative, extending the shelf life of the formulation while enhancing the moisturizing properties of glycerin, and Silica (1% to 3%) which acts as a thickening supplement.

[0028] BRIEF DESCRIPTION OF THE FIGURES:

[0029] Figure 1: The effect tested at different concentrations on the replication of Herpes Simplex Virus type 1 (HSV-1) in Vero cell monolayers. These data are represented in terms of viral titer, which is indicated as a percentage of the control (% of the control), where the control is the amount of virus without the application of the tested substance. Viral titers are expressed in plaque-forming units (PFU) per milliliter.

[0030] Figure 2: which illustrates the average number of non-inflammatory lesions.

[0031] Figure 3: which illustrates the concentrations of Hamamelis virginiana extract and their corresponding effect on TNF-α-induced VEGF release in HaCaT cells after 24 hours.

[0032] Figure 4: Experiment to measure the mortality time of C. acnes; The relative number of viable bacteria of this isolate was measured for 6 hours and calculated in CFU / ml (percentage relative to the control) in the presence of tea tree oil (Before the experiment, all bacteria were in the logarithmic growth phase. Aliquots were taken at times 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours, and the number of viable colonies on blood agar was calculated in CFU / ml.

[0033] Figure 5: Post-treatment skin regeneration photos comparing before and after application of the new composition

[0034] DETAILED DESCRIPTION OF THE INVENTION

[0035] Skin diseases such as acne and herpes are significant therapeutic, psychological, and social problems. Although often underestimated due to their chronic nature and low mortality rate, they can affect a large portion of the population. Acne, in particular, is a chronic inflammatory disease that primarily affects adolescents, with complex and multifactorial causes, including excessive sebum production, increased keratinocyte proliferation, and colonization by Cutibacterium acnes. Altered sebum composition also plays a role in the pathogenesis of acne. Acne treatments aim to manage these various pathogenic mechanisms and may include retinoids, antibiotics such as tetracycline and clindamycin, benzoyl peroxide, cationic antimicrobial peptides, and azelaic acid.Clinical improvement may take 8 to 12 weeks after starting treatment.

[0036] Superficial wounds, such as minor scrapes or lacerations, are common injuries that disrupt the integrity of the skin. These wounds are susceptible to infection by various opportunistic bacteria, such as Staphylococcus aureus or Streptococcus pyogenes. The risk of infection depends on several factors, including the depth, size, and location of the wound, as well as the individual's overall health and immune status.

[0037] The present invention relates to an advanced dermatological formulation that combines antimicrobial agents, humectants, plant extracts, and essential oils. This combination is specifically designed to target complex skin conditions such as inflammatory acne, herpes infections, and the healing of superficial wounds. The efficacy of this formulation relies on the synergy of its components, which work together to exert an antiseptic, restorative, and protective effect on the skin, while minimizing the potential for irritation or antimicrobial resistance.

[0038] The term "Repairing Active" in this description refers to an ingredient or compound used in formulations intended to restore the structure and function of damaged skin or other tissues. These actives work by stimulating biological healing processes, promoting cell proliferation, aiding in the synthesis of essential structural components such as collagen, or providing protection against external aggressors that may delay the healing process. They may be of natural or synthetic origin and are often used in dermatological products, repairing creams, balms, and post-procedure treatments.

[0039] The term "antiseptic active ingredient" as used in the present invention refers to an ingredient or substance used in products intended to inhibit the growth of microorganisms on living tissue to prevent infection, capable of neutralizing, eliminating, or significantly restricting the development and proliferation of various microbial agents. In one implementation of this invention, such active ingredients are essential in treatments aimed at cleaning wounds, abrasions, or cuts, and can also be used in skincare products to treat or prevent acne or other bacterial skin conditions.The term "Astringent active" as used in the present invention refers to a substance which has the ability to tighten and tone the skin, thereby reducing oil and diminishing the appearance of pores, clarifying the skin by removing excess sebum and drying out inflammatory lesions.

[0040] As used here, a "thickener" is a compound designating a class of substances or compounds capable of increasing the viscosity and consistency of a composition without significantly altering its other physical or chemical properties. Thickeners can be of natural, synthetic, or semi-synthetic origin and are selected based on their compatibility with the other components of the formulation, as well as their ability to achieve the desired viscosity. These substances are used to improve the stability, texture, and workability of products and can be employed in a wide variety of applications, ranging from food and cosmetic products to pharmaceutical and industrial products. This invention can therefore incorporate one or more thickeners adapted to the specific requirements of the composition developed.

[0041] Throughout this description, concentrations, quantities, and other numerical data may be expressed or presented in a range format. It should be understood that such a range format is used simply for convenience and brevity and should therefore be interpreted flexibly to include not only the numerical values ​​explicitly stated as the range limits, but also to include all individual numerical values ​​or subranges encompassed within that range, as if each numerical value and subrange had been explicitly stated. For example, a numerical range of approximately 1 to approximately 30% should be interpreted as including not only the explicitly stated values ​​from approximately 1 to approximately 30%, but also individual values ​​and subranges within the stated range. Thus, this numerical range includes individual values.

[0042] The composition of the present invention takes the form of a hydrophilic gel, specially formulated for the topical treatment of herpes and acne. This dosage form was chosen for its specific physical properties, which promote precise local application and controlled release of the active ingredients. The gel base allows for optimal adhesion to the skin, thus ensuring prolonged availability of the therapeutic agents at the site of action. The composition is designed to maximize the stability of the active ingredients and guarantee their integrity until application. The polymer network formed by thickeners such as xanthan gum maintains a constant viscosity, which is crucial for ensuring a uniform dose with each application. This property is particularly important for the treatment of herpes and acne, where consistent and homogeneous application can influence the efficacy of the treatment.

[0043] Treating herpes and acne requires careful selection of solvents and emollients that meet strict criteria for biocompatibility, chemical stability, and the ability to facilitate the delivery of active ingredients. Glycerin and propylene glycol, present in this formulation, are chosen for their specific pharmaceutical properties, and their use is supported by established clinical and toxicological data.

[0044] In a preferred embodiment of the invention, glycerin, also known as glycerol, is a humectant chosen for its ability to stabilize formulations and protect preparations from drying out. In the medical field, glycerin is recognized for its high safety profile and lack of skin irritation, making it suitable for use on damaged or inflamed skin, such as that affected by herpes or acne. Its mechanism of action is primarily based on its hygroscopic properties, which attract water from the environment to the stratum corneum, the outermost layer of the skin, thus ensuring sufficient hydration and a barrier effect.

[0045] Thus, in one embodiment of the invention, propylene glycol, a low molecular weight alcohol, is used as a solvent and penetration agent in many topical preparations. It increases the solubility of the active ingredients and promotes their transdermal absorption, which is crucial for ingredients requiring optimal bioavailability on the surface or in the superficial layers of the skin.

[0046] The present invention aims to solve these problems by using a formulation that combines the efficacy of antiseptic and healing agents with an application strategy optimized to improve skin health. The table below provides a meticulous inventory of active compounds from various natural and synthetic sources, each characterized by its distinctive chemical formula. Extracts of Melaleuca viridiflora and Melaleuca alternifolia, for example, are valued for constituents such as 1,8-cineole and terpinen-4-ol for their antiseptic and anti-inflammatory actions. Chlorhexidine digluconate is a widely used antiseptic agent that offers potent antibacterial activity. Similarly, Hamamelis virginiana is renowned for its tannins, flavonoids, and other components.

[0047] These substances, when incorporated into a coherent formulation, synergistically offer comprehensive skin treatment. The present invention capitalizes on this synergy by combining the proven efficacy of antiseptic agents with healing and astringent actives to create a holistic solution. This innovative formulation aims to optimize the application of active components to improve skin health. By emphasizing an optimized application strategy, the invention offers a holistic approach to treating skin conditions, accelerating the healing process, reducing the risk of infection, and promoting healthier, more resilient skin.

[0048]

[0049] The mechanisms of action are based on complex chemical interactions between the components of Melaleuca alternifolia oil and skin cells, bacteria, and components of the immune system.

[0050] Terpinen-4-ol disrupts the bacterial cell membrane. It interacts with membrane lipids, leading to increased permeability and, eventually, bacterial cell lysis (rupture). By disrupting the cell membrane, terpinen-4-ol inhibits the growth and survival of C. acnes, thus reducing its ability to cause inflammation and acne lesions. Terpinen-4-ol can modulate the immune response by influencing the production of cytokines, which are signaling molecules in the immune system. By reducing the release of pro-inflammatory cytokines, terpinen-4-ol helps decrease the local inflammation associated with acne.

[0051] Melaleuca alternifolia oil, including terpinen-4-ol, reduces the activity of immune cells that contribute to inflammation, such as lymphocytes and macrophages. Terpinen-4-ol influences the sebaceous glands. This manifests as a modulation of sebum production, although the exact mechanism remains to be clarified.

[0052] Exploring the antiseptic properties of niaouli (Melaleuca viridiflora) and tea tree (Melaleuca alternifolia) essential oils reveals remarkable efficacy against two key pathogens: Actinobacterium acnes, implicated in the pathogenesis of acne, and the Herpes Simplex Virus (HSV), responsible for skin and mucous membrane infections. Their antiseptic action is based on the presence of compounds such as terpinene-4-ol, alpha-terpineol, and 1,8-cineole, which play a crucial role in inhibiting microbial growth and neutralizing pathogens. Regarding Actinobacterium acnes, niaouli oil demonstrates significant antibacterial activity, primarily due to 1,8-cineole, which penetrates and alters the bacterial cell membrane, leading to cell death.This action is complemented by tea tree essential oil, rich in terpinene-4-ol, which exhibits a powerful ability to disrupt the cell membranes of Actinobacterium acnes, thus inducing effective cell lysis. Studies published in journals such as the "Journal of Applied Microbiology" and "Antimicrobial Agents and Chemotherapy" confirm these effects, highlighting the efficacy of these essential oils in reducing inflammation and preventing acne breakouts.

[0053] In parallel, the antiviral action of the synergistic oils against HSV highlights a mechanism of interference with viral attachment and entry into host cells. Furthermore, an inhibition of viral replication has been demonstrated for its ability to reduce the replication of HSV-1 and HSV-2, thus offering a promising avenue for the treatment of herpes infections. The action of 1,8-cineole complements this effect by preventing viral attachment to cells, suggesting a synergistic effect between these oils in combating viral infections.

[0054] The present invention has considerable therapeutic potential as natural alternatives or complements to conventional treatments for acne and HSV infections. The active compounds in these oils offer a solution that is potentially less likely to induce microbial resistance, while also exhibiting a favorable safety profile for topical applications.

[0055] Acne is often aggravated by hormonal fluctuations, particularly androgens. Its mechanisms of action are based on complex chemical interactions between skin components and cells, bacteria, and components of the immune system.

[0056] Indeed, cytokines produced by macrophages, such as IL-1β, IL-6, and IL-10, orchestrate the skin's immune and inflammatory response in the inflammatory process associated with acne. IL-1β and IL-6 are pro-inflammatory cytokines. IL-1β initiates the inflammatory reaction in response to infection by bacteria such as Propionibacterium acnes, a major cause of acne. This cytokine stimulates sebum production and promotes inflammation of the sebaceous glands, leading to the formation of skin lesions. IL-6, for its part, amplifies inflammation and can influence sebum production, thus exacerbating acne symptoms.

[0057] Conversely, IL-10, an anti-inflammatory cytokine, plays a regulatory role by controlling the activity of pro-inflammatory cytokines and limiting excessive inflammation. An imbalance in IL-10 production can therefore contribute to the chronic inflammation characteristic of certain forms of acne.

[0058] Table 2: Inhibition zones (cm 2 ) produced by Melaleuca Oils (Alternifolia and Viridiflora): with certain constituent antiseptic terpenes.

[0059] The data indicate that the composition has a significant antimicrobial effect against Propionibacterium acnes, the pathogen associated with acne. The areas of inhibition show increasing activity with increasing oil concentrations, consistent with a dose-dependent response.

[0060] The minimum inhibitory concentration (MIC) values ​​obtained for P. acnes, ranging from 0.31 to 0.63% v / v, further strengthen the reliability of these results. This confirms not only the efficacy of Melaleuca oil in treating acne but also the consistency of the antimicrobial effects observed in various commercial samples of this oil.

[0061] In the experiment, ct-terpineol and α-pinene also showed antimicrobial activity. Despite a low concentration of α-terpineol (2-12%), its lower MIC value suggests that it contributes substantially to the antimicrobial effect.

[0062] In another preferred embodiment of the invention, the composition comprises 2%–5% witch hazel (Hamamelis virginiana L.) extract as an astringent active ingredient, of which hamamelitannin (HT) and proanthocyanidins are the most abundant compounds (0.29% and 0.30% w / w of extract, respectively). Hamamelis virginiana inhibited C. acnes-induced IL-6 release (IC50: 136.90 pg / mL) by partially altering NF-κB activation; however, no antibacterial or anti-biofilm activity was found. Furthermore, Hamamelis virginiana showed greater anti-inflammatory activity when TNF-α was used as a pro-inflammatory stimulus (IC50: 38.93 pg / mL for IL-8 release), acting in part through antioxidant mechanisms.

[0063] The effects of witch hazel (Hamamelis virginiana) extract are primarily based on its proanthocyanidin content, as hamamelitannin was found to be inactive across all tested parameters. The potential of witch hazel extract in modulating the inflammatory response associated with acne is highlighted. By inhibiting the release of IL-6 induced by C. acnes, witch hazel extract demonstrates an ability to reduce skin inflammation without exerting direct antibacterial or anti-biofilm activity. This action is significant because it targets one of the key mechanisms of inflammation in acne, underscoring the potential role of witch hazel extract as a complementary treatment to reduce inflammation without disrupting the skin's microbial balance.

[0064] The mechanism of action of witch hazel (Hamamelis virginiana) extract is complex, involving partial modulation of NF-κB activation, a key signaling pathway in inflammatory processes. Furthermore, the increased anti-inflammatory activity observed in response to TNF-α suggests that witch hazel (Hamamelis virginiana) extract acts through multiple pathways, including antioxidant mechanisms. This versatility in its mechanisms of action reinforces the interest in witch hazel (Hamamelis virginiana) extract for treating inflammatory skin conditions beyond acne.

[0065] Figure 3 shows the concentration of VEGF (Vascular Endothelial Growth Factor), the protein that plays a crucial role in angiogenesis, the process of forming new blood vessels from pre-existing ones. VEGF is important in normal development and in pathological processes, including wound healing: In the presence of TNF-α or C. acnes, the amount of VEGF was 407.48 ± 3.98 pg / mL.

[0066] At the heart of this formulation, chlorhexidine digluconate, present at a concentration of 5 to 10%, serves as the primary antimicrobial agent. Chlorhexidine is renowned for its ability to rapidly inactivate a wide range of microorganisms by disrupting the cell membrane, leading to leakage of intracellular components and resulting in cell death. This action is crucial for reducing the bacterial load of Cutibacterium acnes on the skin, the cause of acne, and for providing an antiseptic barrier that is beneficial in the treatment and prevention of herpes infections.

[0067] Chlorhexidine digluconate is an antiseptic widely used in medicine, dentistry, and other healthcare fields for its antimicrobial properties. This substance works by disrupting the cell membranes of microorganisms, including bacteria and viruses. With regard to HSV and Propionibacterium acnes, chlorhexidine digluconate interacts with the membrane lipids of the viral envelope. The interaction of chlorhexidine digluconate with the viral envelope lipids disrupts the stability of the HSV lipid membrane. This has several important effects on the virus:

[0068] - Alteration of membrane stability: Chlorhexidine digluconate causes structural changes in the lipid membrane of HSV, weakening its stability.

[0069] - Leakage of viral components: The modifications induced by chlorhexidine digluconate lead to the leakage of essential viral components, including viral proteins and enzymes, from the viral envelope. This disrupts the normal functioning of the virus.

[0070] - Vulnerability of the viral capsid: Following the alteration of the lipid envelope, the HSV viral capsid is exposed and becomes vulnerable. The capsid is the structure that protects the viral genome, and its exposure renders the virus non-infectious.

[0071] By reducing the population of P. acnes bacteria on the skin, chlorhexidine helps reduce inflammation and the formation of new acne lesions. By killing the bacteria responsible for this infection, chlorhexidine can reduce the skin inflammation associated with acne. Chlorhexidine is also an effective cleansing agent. It helps remove excess sebum, dead skin cells, and other impurities that contribute to clogged pores. By keeping pores cleaner, it can prevent the formation of new acne lesions. In addition to its immediate effect on acne-causing bacteria, chlorhexidine can also help prevent acne recurrence by maintaining better skin hygiene and reducing bacterial growth in the long term.

[0072] Glycerin and propylene glycol, each included in a 15–30% concentration, act as solvents. They attract and retain moisture, which is essential for maintaining the integrity of the skin barrier and promoting an optimal healing environment. Glycerin is a simple triol, an alcohol with three hydroxyl groups (-OH), giving it a strong affinity for water. When applied to the skin, glycerin draws water from the deeper layers of the epidermis as well as from the environment, helping to maintain skin surface hydration. This osmotic property makes glycerin an ideal component in topical formulations, as it helps prevent transepidermal water loss (TEWL), a key factor in skin dryness and the exacerbation of various dermatological conditions.

[0073] Propylene glycol is a diol, possessing two hydroxyl groups, and acts similarly to glycerin, although it is smaller and more versatile in terms of chemical solubility. It is effective at absorbing water, making it useful not only as a humectant but also as a solvent in many pharmaceutical preparations. Propylene glycol can penetrate the stratum corneum (the outermost layer of skin) and carry moisture into the underlying layers, thus helping to maintain skin hydration.

[0074] Furthermore, these solvent agents have an emollient effect, softening the skin by filling the intercellular spaces of the stratum corneum with moisture, making the skin more supple and less prone to flaking and cracking. This mechanism is particularly beneficial in dermatological conditions characterized by dry skin or impaired skin barrier function, such as eczema and dermatitis. In a preferred embodiment of the invention, panthenol, included in the composition at a concentration of 2 to 5%, is essential for skin regeneration. Acting as a precursor to pantothenic acid, it is involved in the epidermal repair process. When applied to the skin, panthenol is converted into pantothenic acid, a component of coenzyme A, which plays a vital role in the epidermal repair and regeneration cycle.

[0075] By concentrating the use of panthenol between 2 and 5% in our gel formulation, we optimize its ability to penetrate the skin layers where it can exert its beneficial effects. At the cellular level, panthenol actively participates in the synthesis of lipids and proteins that constitute the fundamental components of the skin barrier. This barrier is essential for maintaining skin hydration and protecting the body against pathogens and environmental factors.

[0076] The anti-inflammatory role of panthenol is also crucial in managing skin lesions. By modulating the inflammatory response, panthenol helps reduce the swelling and redness often associated with herpes and acne. This action can contribute to a significant reduction in the pain and discomfort experienced by those affected by these conditions. Furthermore, panthenol stimulates the proliferation and activity of fibroblasts, cells specialized in the production of collagen, an essential structural protein that gives skin its strength and elasticity. By promoting the formation of new collagen, panthenol can accelerate the wound healing process, thus promoting faster healing and reducing the risk of scarring.

[0077] In a preferred embodiment of the invention, the composition comprises ethylhexylglycerin combined with propanediol at a concentration of 2% to 5%. This combination of preservatives is effective and increasingly popular in the cosmetics industry, particularly for preserving skincare products such as creams, lotions, and gels. Its choice is justified by its moisturizing and emollient properties, thus contributing to the feeling of softness and hydration of the skin after application. In addition to its role as a skin conditioning agent, ethylhexylglycerin also acts as a mild preservative that helps enhance the effectiveness of other preservatives such as propanediol. Propanediol, for its part, is a humectant and solvent of plant origin that offers the advantage of excellent absorption and low skin irritation.As a preservative, propanediol enhances the microbiological stability of cosmetic formulations by inhibiting the growth of microorganisms. The combination of ethylhexylglycerin and propanediol creates a synergistic preservation system that not only effectively protects the product from contamination but also improves the feel and performance of the final product. This synergy also allows for a reduction in the required concentration of harsher preservatives, contributing to the product's gentleness and skin tolerance, making this combination particularly suitable for products intended for sensitive skin. Furthermore, this combination is valued for its safety profile and compatibility with a wide variety of formulations, making it a preferred choice for formulas aiming for a more natural and gentle approach to preservation.

[0078] According to a preferred embodiment of the invention, the composition, in the form of an alcohol-free anti-acne gel, represents a significant advance in acne treatment. The alcohol-free formulation of this gel offers several advantages over traditional anti-acne treatments, which often contain alcohol and can dry out the skin.

[0079] Indeed, alcohol is frequently used in skincare products for its antimicrobial properties and its ability to enhance the penetration of other active ingredients into the skin. However, alcohol can have a dehydrating effect on the skin, especially with repeated use. This dehydration can lead to dryness, irritation, and may even worsen acne by stimulating excessive sebum production in response to dry skin.

[0080] In contrast, our alcohol-free gel harnesses the natural antiseptic properties of essential oils, offering a gentle yet effective alternative. These essential oils work synergistically to combat acne-causing bacteria, such as Actinobacterium acnes, without compromising the skin's hydration. Their direct antimicrobial action targets and reduces pathogenic bacteria while preserving the skin's natural balance and promoting a healthy environment for regeneration.

Claims

DEMANDS 1. Alcohol-free dermatological pharmaceutical composition comprising at least one antiseptic active ingredient, one astringent active ingredient, one repairing active ingredient, pharmaceutically acceptable excipients, one or more thickener(s) characterized in that it comprises a compositional weight ratio of: 5 to 10% of chlorhexidine digluconate concentrated to 20%; 2 to 5% of panthenol; 2 to 5% of Hamamelis virginiana extract; 2 to 5% of ethylhexylglycerin and propanediol; 1 to 3% of silica; 0.2 to 1% of Melaleuca viridiflora oil; 0.2 to 1% of Melaleuca alternifolia oil; 2. Dermatological pharmaceutical composition according to claim 1 characterized in that it comprises a composition weight ratio of: 15% - 30% glycerin as emollient solvent and 15% - 30% propylene glycol as solvent.

3. Dermatological pharmaceutical composition according to claim 2, wherein said antiseptic actives are: melaleuca viridiflora oil, melaleuca alternifolia oil and chlorhexidin digluconate concentrated at 20%.

4. Dermatological pharmaceutical composition according to claim 3, characterized in that it comprises a composition weight ratio of: 2% to 5% xanthan gum as thickener and citric acid as pH regulator; 5. Dermatological pharmaceutical composition according to claim 3, for its use in the treatment of forms of acne as well as against Propionibacterium acnes.

6. Dermatological pharmaceutical composition according to claim 4, for its use in the treatment of herpes labialis lesions due to the Herpes simplex virus (HSV).

7. Dermatological pharmaceutical composition according to claim 6, for its use in the treatment of superficial wounds.

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