Methods and compositions for therapeutic skin treatment in dermatological procedures affecting the skin barrier

Abstract

In certain embodiments, skin care formulations and treatment methods are disclosed that comprise hyaluronic acid or its related salts and one or more of ascorbic acid, glycolic acid, or lactic acid.In certain embodiments, the formulations and treatments are applied to the skin during and / or before and / or after dermatological procedures that affect the skin barrier, in order to reduce patient discomfort and enable rapid healing of irritated and damaged skin.

Description

Technical Field

[0001] Cross-reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 089,903 filed on October 9, 2020, the entire contents of which are incorporated herein by reference in their entirety.

[0002] The present invention relates to the field of therapeutic treatments and compositions for skincare, including skincare treatments and formulations for application to the skin. For example, some skincare treatments may include dermatological procedures that affect the skin barrier to reduce scarring and post-inflammatory hyperpigmentation, as well as patient discomfort, and enable rapid healing of the skin. Methods of application to the skin, formulations, and the preparation and use thereof are also provided.

Background Art

[0003] Various dermatological procedures, such as microneedling, laser treatment, chemical peels, intense pulsed light therapy, microdermabrasion, or skin exfoliation, are used to treat and improve conditions such as acne scars, fine lines and wrinkles, skin laxity, skin texture, pore size, brown spots, striae, and pigmented ulcers. Such procedures tend to disrupt the skin barrier or cause redness, irritation, and inflammation among other skin conditions, which need to be addressed and corrected.

[0004] In microneedling procedures, the skin is prepared to facilitate microneedling. In some cases, the depth of the needle may draw in blood, which can irritate and / or inflame the skin. Other anti-aging and corrective skin treatments may involve chemical, thermal, and mechanical wounds. Patients undergoing such treatments require further post-treatment care because their skin is extremely irritated and sensitive after the procedure. Some treatments may include, for example, applying cold compresses, moist immersions, or occlusive ointments. However, some post-treatments may cause further irritation and inflammation rather than alleviate the post-treatment condition, and often post-treatment may be ineffective.

[0005] Skin treatments may be used when the skin is prepared for dermatological procedures such as microneedling, which disrupt the skin barrier. The components of skin treatments are limited because certain activators cannot be used if the skin becomes inflamed or irritated by the procedure. In particular, dermatological procedures that disrupt, i.e., damage, the skin barrier tend to make the skin sensitive to most skin treatments, resulting in the inability to perform any skin treatment. Therefore, stronger activators are not used during, immediately before, and / or immediately after, these dermatological procedures. Instead, moist pads containing water and / or other soothing solutions are applied to alleviate patient discomfort.

[0006] Therefore, there is a need in the art for improved formulations that can be used in conjunction with dermatological procedures affecting the skin barrier to reduce patient discomfort, scarring, and post-inflammatory hyperpigmentation, stimulate collagen growth, and effectively heal the skin of patients undergoing the above types of treatments. More specifically, there is a need in the art for improved skin care formulations and methods that can be used during and / or before and / or after procedures such as microneedling to provide effective healing and repair of the skin barrier. [Overview of the Initiative]

[0007] This disclosure provides skincare formulations and methods for skincare treatment. More specifically, therapeutic treatments and formulations comprising a therapeutically effective amount of hyaluronic acid, or a salt thereof such as sodium hyaluronate, and optionally one or more alpha hydroxy acids (AHAs) are disclosed in certain embodiments. In certain embodiments of this disclosure, the skincare treatments and formulations may optionally include one or more organic acids such as ascorbic acid, glycolic acid, or lactic acid.

[0008] In some embodiments of this disclosure, the formulation may comprise hyaluronic acid and / or sodium hyaluronate, water, one or more AHAs or combinations of AHAs, one or more antioxidants or combinations of antioxidants, or one or more peptides or combinations of peptides.

[0009] In some embodiments, the formulation may contain sodium hyaluronate in amounts of at least 0.00001% w / w, at least 0.0001% w / w, at least 0.001% w / w, at least 0.01% w / w, at least 0.05% w / w, or at least 0.1% w / w. In other embodiments, the formulation may contain sodium hyaluronate in amounts of at most 0.001% w / w, at most 0.01% w / w, at most 0.1% w / w, at most 1% w / w, at most 2% w / w, at most 5% w / w, or at most 10% w / w. In certain embodiments, the amount of sodium hyaluronate is within the range having either the lower or upper limit disclosed above. In other embodiments, the formulation may contain one or more of ascorbic acid, glycolic acid, or lactic acid, each in an amount of at least 0.001 ppm, at least 0.01 ppm, at least 1 ppm, at least 5 ppm, or at least 10 ppm. In other embodiments, the formulation may contain one or more of ascorbic acid, glycolic acid, or lactic acid, each in an amount of at most 1 ppm, at most 10 ppm, at most 50 ppm, at most 80 ppm, or at most 100 ppm. The disclosed embodiments can, for example, treat melanosis, i.e., hyperpigmentation including post-inflammatory hyperpigmentation, patient discomfort, and scarring, stimulate collagen growth, and provide effective healing to the skin of patients receiving the above types of treatment.

[0010] Certain surfactants, such as ascorbic acid, glycolic acid, or lactic acid, should not be used during and / or immediately before and / or immediately after dermatological procedures such as microneedling, due to their strong effect on damaged, i.e., injured, or irritated skin barriers. However, by the efficacy of certain embodiments of the present invention, such surfactants are beneficial in a variety of ways, including, but not limited to, the treatment of hyperpigmentation including melanosis, i.e., post-inflammatory hyperpigmentation, patient discomfort, scarring, stimulation of collagen growth, and effective healing of the skin of patients undergoing the above types of treatments.

[0011] The inventors have surprisingly found that when such activators are used, for example, in the amounts disclosed herein, e.g., 1 ppm, and combined with a salt of hyaluronic acid, e.g., a solution of sodium hyaluronate in a honeycomb arrangement, formulations having any other activators as disclosed below can be used in dermatological treatments. In particular, the inventors have surprisingly found that certain embodiments of the formulations disclosed herein can be effectively used during and / or before and / or after microneedling treatments that disrupt the skin barrier, producing unexpectedly remarkable results on the patient's skin.

[0012] For example, the formulations of this disclosure may be applied to the skin of a patient undergoing dermatological treatment before the procedure, for example, by rubbing them into the skin with gloved hands, and then the skin may be wiped to remove any excess solution. Subsequently, a dermatological treatment is performed a short time later, for example, immediately, within 1 minute, within 5 minutes, within 10 minutes, within 30 minutes, within 1 hour, or within 2 hours, so that the applied formulation penetrates the skin barrier. In procedures such as microneedling, lasers, and phototherapy, the procedure disrupts the skin barrier, so the penetrating effect of the procedure delivers or pushes the applied formulation into the skin barrier. For example, in microneedling, the needles "tattoo" the applied formulation into the skin. The formulation can be administered after the procedure (optionally after washing), for example, immediately, within 10 minutes, within 30 minutes, within 1 hour, within 4 hours, or within 6 hours. Subsequently, if necessary, it can be applied, for example, once, twice, three, or four times a day.

[0013] Surprisingly and unexpectedly, the formulations of the present invention contain activators that could not previously be used during these treatments due to the strong discomfort experienced by the patient, and the inventors have found that the formulations disclosed herein can be effectively used to produce beneficial results on the patient's skin. Once the dermatological treatment is complete, the formulations can be reapplied and left on the patient's skin to continue to provide therapeutic and other beneficial effects to the patient. Previously, it was impossible to use formulations containing activators such as ascorbic acid, glycolic acid, and lactic acid on the skin of patients whose skin barrier was compromised, i.e., severely irritated. Unexpectedly, the inventors have noted the remarkable results when the formulations disclosed herein are used in dermatological treatments, which include, but are not limited to, hyperpigmentation including melanosis, i.e., post-inflammatory hyperpigmentation, patient discomfort, scar treatment, stimulation of collagen growth, and providing effective healing to the skin of patients undergoing the above types of treatments.

[0014] In certain embodiments, the composition exhibits low irritancy and improved synergistic efficiency of the formulated components, the synergistic efficiency including improved relief of discomfort and healing in the subject. In particular, this disclosure provides therapeutic treatments by formulations having a combination of components that, in certain embodiments, exhibit lower irritancy, better recovery time, and improved skin penetration characteristics of all formulated active ingredients compared to other skincare products.

[0015] In some embodiments, formulations of the present disclosure may be used as pre- and / or post-treatment agents for skin care treatments such as microneedling. As will be discussed in more detail below, formulations of certain embodiments of the present disclosure strongly relieve discomfort and strongly heal skin conditions resulting from dermatological procedures that disrupt the skin barrier.

[0016] In some embodiments, the Disclosure provides formulations comprising sodium hyaluronate, such as hydrolyzed sodium hyaluronate. In some embodiments of the Disclosure, other combinations of the active ingredients disclosed herein can achieve desired improved therapeutic outcomes. Surprisingly, combinations of hyaluronic acid, or salts thereof such as sodium hyaluronate, with organic acids such as ascorbic acid, glycolic acid, and / or lactic acid have been found to produce surprising and unexpected results for healing and irritation relief in skin care treatments.

[0017] In some embodiments, the formulation may comprise one or more humectants and / or wetting agents. In one aspect of this embodiment, the humectant and / or wetting agent is sodium hyaluronate, for example, fractionated and long-chain sodium hyaluronate, having a size ranging from a single monomer to about 5 million daltons, which binds moisture to the skin and allows the moisture it carries to penetrate the skin.

[0018] In some embodiments, the formulation may contain skin sedatives, such as antioxidants, to reduce skin inflammation and irritation.

[0019] In some embodiments, the treatment may include one or more sedative antioxidants to soothe the skin and reduce inflammation. In one embodiment, the antioxidant is a polyphenol. In another embodiment, the antioxidant includes a polyphenol isolate from Camellia sinensis.

[0020] In certain embodiments of the present disclosure, a method is provided for the therapeutic treatment of skin in a dermatological procedure affecting the skin barrier. The method may include the steps of: applying a therapeutically effective amount of a formulation to skin selected for a dermatological procedure affecting the skin barrier; the formulation comprising hyaluronic acid or a salt thereof and one or more of ascorbic acid, glycolic acid, and lactic acid, wherein the hyaluronic acid or a related salt thereof is at least 1% (w / w) and each of ascorbic acid, glycolic acid, and lactic acid is at least 1 ppm; and performing the dermatological procedure on the skin.

[0021] In some embodiments, the dermatological treatment may include microneedling, laser, chemical peel, phototherapy, microdermabrasion, and / or skin peeling. In certain embodiments, the step of performing the dermatological treatment includes the step of applying a microneedling treatment to the skin, and the formulation may be applied before and / or after the microneedling treatment.

[0022] In some embodiments, after treatment of the present invention, the skin can reduce scarring by at least about 5%, 10%, 15%, 20%, 25%, 40%, 50%, 60%, 75%, or 90% compared to treatment without application of the formulations disclosed herein. In other embodiments, after treatment of the present invention, the skin can reduce scar depth by at least about 5%, 10%, 20%, 25%, or 40% compared to treatment without application of the formulations disclosed herein, to at least 30%, 50%, 60%, 80%, or 99%.

[0023] In some embodiments, the salt of hyaluronic acid may be sodium hyaluronate. In other embodiments, the sodium hyaluronate may be a solution of sodium hyaluronate in a honeycomb arrangement. In further embodiments of the present disclosure, the formulation may further contain an antioxidant, which is one or more of the following: Camellia sinensis leaf extract, Camellia sinensis polyphenols, ascorbic acid, ubiquinone, bisabolol, Thiotaine®, ergothioneine, glutathione, or superoxide dismutase. In some embodiments, the formulation may further comprise one or more of the following: purified water, hydrolyzed sodium hyaluronate, sodium hyaluronate, Camellia sinensis leaf extract, benzyl alcohol, ubiquinone, bisabolol, Thiotaine®, TEGO PEP417®, Matrixyl® (glycerin, butylene glycol, carbomer, polysorbate 20, palmitoyl pentapeptide-4), glutathione, superoxide dismutase, phenoxyethanol, sodium benzoate, or disodium EDTA. In certain embodiments of the present disclosure, the formulation may be a sterile formulation.

[0024] In some embodiments of this disclosure, formulations can provide therapeutic treatment of the skin in dermatological procedures affecting the skin barrier. The formulations may comprise hyaluronic acid or a salt thereof and one or more of ascorbic acid, glycolic acid, and lactic acid, wherein the hyaluronic acid or salt thereof is present in an amount of at least 1% (w / w), and each of ascorbic acid, glycolic acid, or lactic acid is present in an amount of at least 1 ppm.

[0025] In certain embodiments of this disclosure, the formulation is (in %w / w): purified water (50%~99.8%); hydrolyzed sodium hyaluronate (0%~25%); sodium hyaluronate (0.1%~10%); Camellia sinensis leaf extract (0%~1%); ascorbic acid (0%~5%); glycolic acid (0%~5%); lactic acid (0%~5%); benzyl alcohol (0%~5%); ubiquinone (0%~0.5%); bisabolol (0%~1%); TEGO The formulation may contain PEP417® (0%~10%); Matrixyl® (glycerin, butylene glycol, carbomer, polysorbate 20, palmitoyl pentapeptide-4) (0%~10%); glutathione (0%~1%); superoxide dismutase (0%~5%); phenoxyethanol (0%~2%); sodium benzoate (0%~0.5%); and / or disodium EDTA (0%~0.2%). In other embodiments, the lower limit of any of the above components is about 0.00001%, about 0.0001%, about 0.001%, about 0.01%, or about 0.1%.

[0026] In other embodiments of this disclosure, the formulation is (in %w / w): 0.097539% purified water; 0.001% hydrolyzed sodium hyaluronate; 1% (aqueous solution) sodium hyaluronate; 0.000001% Camellia sinensis leaf extract; 0.000001% ascorbic acid; 0.000001% glycolic acid; 0.000001% lactic acid; 0.00025% benzyl alcohol; 0.000001% ubiquinone; 0.000001% bisabolol; 0.000001% Thiotaine®; 0.000001% TEGO It may contain PEP417(registered trademark); 0.000001% Matrixyl; 0.000001% Glutathione; 0.000001% Superoxide Dismutase; 0.001% Phenoxyethanol; 0.0001% Sodium Benzoate; and / or 0.0001% Disodium EDTA.

[0027] In certain embodiments, the present invention allows for a significant reduction in the administration of potentially irritating ingredients and potentially tissue-damaging ingredients. Observations in certain embodiments have demonstrated significant benefits at doses substantially reduced compared to topically used doses. In certain embodiments, the present invention achieves the reported results using physiological doses more commonly used in tissue culture experiments such as fibroblast culture. In addition, in certain embodiments, after a subsequent treatment, for example, at the end of a microneedling procedure, the formulation of the present invention may be applied as a topical soothing and protective agent after the treatment area has been cleansed. In certain embodiments, the serum is soothing and provides a water reservoir for the treatment area where the natural protective barrier of the skin has been damaged. In certain embodiments, this prevents one or more of dryness and discomfort, accelerates healing, and improves treatment outcome. [BRIEF DESCRIPTION OF THE DRAWINGS]

[0028] [Figure 1] It is a bar graph showing the results of a questionnaire in a study on improvement of acne scars. [Figure 2] It is a bar graph showing the results of a questionnaire in a study on improvement of facial wrinkles. [Figure 3] It is a bar graph showing the results of a questionnaire in a study on improvement of facial skin texture. [MODE FOR CARRYING OUT THE INVENTION]

[0029] In certain embodiments, this disclosure provides skincare formulations and methods of use for the mitigation or improvement of skin conditions associated with dermatological treatments that irritate and / or damage human skin. Skin conditions suitable for treatment as disclosed herein include, but are not limited to, skin conditions characterized by inflammatory disorders of the skin and increased cell turnover, including psoriasis, photoaging, visible signs of extrinsic and endogenous aging, yellowing, loss of elasticity, loss of collagen-rich appearance and / or youthfulness, redness, dryness, blemishes, wrinkles, acne, rosacea, ichthyosis, and skin cancer. In certain embodiments, the therapeutic formulations are also useful for improving one or more aesthetic criteria, which include, but are not limited to, perceived improvements in apparent skin age, skin tone, sunburn, yellowing, loss of elasticity, redness, dryness, blemishes, wrinkles, skin smoothness, brightness, radiance, and reduced visibility of skin pores. The therapeutic formulation is also useful for treating melanosis, i.e., hyperpigmentation including post-inflammatory hyperpigmentation, patient discomfort, scarring, and stimulating collagen growth, providing effective healing to the skin of patients receiving the types of treatment described herein.

[0030] As used herein, the terms “treatment” or “to treat” in relation to a skin condition generally mean “having a positive effect on the skin condition,” and include reduction, improvement, and / or relief of at least one symptom of the skin condition, reduction, improvement, and / or relief of the severity of the skin condition, or delay, prevention, or inhibition of the progression of the skin condition. Therefore, as used herein, treatment does not require a complete cure of the condition. A formulation of the Disclosure useful for treating a skin condition, or a method for treating a skin condition, only requires reducing the severity of the skin condition, reducing the severity of associated symptoms, providing an improvement in the patient’s quality of life, or delaying, preventing, or inhibiting the onset of one or more symptoms of the skin condition. As used herein, these terms also include, for example, aesthetic improvement to the skin upon application of a disclosed formulation having a combination of oligopeptides, antioxidants, one or more AHAs, and hyaluronic acid or its derivatives.

[0031] As used herein, the terms “apply,” “apply,” and “to apply” refer to any form of administering the topical formulation to a patient’s skin, delivering the formulation to the surface of the patient’s skin in a medical or cosmetic practice. All smearing, rubbing, spreading, and spraying the disclosed topical formulation onto a patient’s skin, with or without the help of appropriate equipment, falls within the scope of the term “apply” as used herein. The terms “topical” or “topically” with respect to the administration or application of the disclosed skin care formulation refer to transdermal administration or application onto the skin.

[0032] As used herein, the term “effective dose” means the amount of any formulation or component of the present disclosure that is effective in treating any of the above-described skin conditions, and includes effects ranging from detectable local improvement in the area of ​​topical application to substantial relief of symptoms that improve one or more aesthetic criteria, including, but not limited to, perceived improvements in obvious dry skin, keratosis pilaris, age, radiation damage, sun or UV damage, skin tone, tan, yellowing, loss of elasticity, redness, dryness, blemishes, wrinkles, skin smoothness, brightness, radiance, and reduced visibility of skin pores. In certain embodiments, an effective dose of the disclosed therapeutic formulation is also useful for treating melanosis, i.e., hyperpigmentation including post-inflammatory hyperpigmentation, patient discomfort, scarring, stimulating collagen growth, and providing effective healing to the skin of patients receiving the types of treatment described herein. The effective dose varies depending on the specific condition or condition being treated, the severity of the condition, the duration of treatment, the specific components of the composition used, and other factors. More specifically, the disclosed compositions and formulations, in some embodiments, provide methods for therapeutic treatment of the skin by providing a combination of hyaluronic acid or its related salts with one or more of ascorbic acid, glycolic acid, and lactic acid in an effective manner to the skin. In certain embodiments, the disclosed compositions, formulations, and methods of use thereof reduce, minimize, or eliminate commonly observed melanosis, i.e., hyperpigmentation including post-inflammatory hyperpigmentation, patient discomfort, and scarring, stimulate collagen growth, and provide effective healing to the skin of patients receiving the type of treatment described herein. Further advantages of certain embodiments include, in particular, reducing, minimizing, or eliminating one or more of the dry skin conditions, including those characterized by keratosis pilaris, itchiness, severe exfoliation, disruption of the skin barrier, discomfort, extreme dryness, skin cracking, and sensitization.In certain embodiments, the disclosed compositions, formulations, and methods of use thereof also provide aesthetic improvements to the skin, including, but not limited to, skin that looks younger, has a more even skin tone, has less visible pores, and is smoother as judged by the user, and / or is improved with respect to sunburn or aged appearance, yellowing, loss of elasticity, redness, dryness, blemishes, and / or wrinkles.

[0033] As used herein, the term “skin barrier” refers to the outermost layer of the skin surface. As is commonly known, the skin barrier has cells and lipids and may also be called a permeable barrier, water barrier, or lipid barrier. Among other functions, the skin barrier prevents the evaporation of essential water and electrolytes from the skin. As disclosed herein, various methods of particular embodiments may disrupt, i.e., weaken, or affect the skin barrier, causing, among other things, pain, swelling, redness, dryness, and irritation that require healing and repair. The degree of skin barrier disruption may vary depending on the particular dermatological treatment, from slight penetration to depths that draw blood to the skin surface. For example, in microneedling treatments, the depth of penetration may be adjusted based on the skin condition being treated. Various dermatological treatments have been used to treat skin conditions by promoting collagen production.

[0034] As used herein, the term "by activity" refers to the actual percentage or composition of the active ingredient, such as a peptide, used in the formulation.

[0035] As used herein, the singular forms “a,” “an,” and “the” include plural references unless the context explicitly indicates otherwise. For example, a reference to “formulation” includes a single formulation as well as multiple formulations, etc.

[0036] As used herein, the term “about” in relation to a measured quantity or time means the normal variation in the measured quantity or time that would be expected by a person skilled in the art when performing a measurement and paying a level of care appropriate to the purpose of the measurement. In certain embodiments, the term “about” includes ±10% of the stated number, “about 10” includes 9 to 11, or “about 1 hour” includes 54 to 66 minutes.

[0037] In addition to the foregoing, this disclosure intends to describe, in certain embodiments, further methods for applying the formulation, including, but not limited to, spray aerosols, cotton pads and cotton balls, gauze, foam, tissue applicators, and human hands.

[0038] In certain embodiments, the skincare formulations and delivery systems disclosed herein not only maintain the active properties of the activator but also enhance the efficiency of the activator. In one embodiment of this disclosure, skin is human skin. In other embodiments of this disclosure, skin is the skin of a companion animal, livestock, or commercially useful animal.

[0039] The inventors have found that the treatments of the present disclosure are therapeutically effective for treating dermatological conditions. In certain embodiments of the present disclosure, a skin care formulation is provided comprising about 0.1% to about 5% or about 1% w / w of sodium hyaluronate, for example, a 1% w / w solution of honeycomb-arranged sodium hyaluronate; 0.05 ppm to 10 ppm or 3 ppm of one or more of ascorbic acid, glycolic acid, or lactic acid; 1 ppm to 10 ppm or 7 ppm of an antioxidant; and 0.00001% to about 1% or 0.001% w / w of hydrolyzed sodium hyaluronate.

[0040] In one embodiment, the skincare formulation of the present disclosure may contain one or more organic acids, in particular organic acids having a molecular weight of less than 300 g / mol, such as glycolic acid and alpha hydroxy acids (AHAs) containing fewer than 12 carbon atoms, but are not limited thereto. Examples include salicylic acid or beta hydroxy acid, ascorbic acid, dicarboxylic acid, mandelic acid, pyruvic acid, tartaric acid, citric acid, malic acid, lactic acid, and others.

[0041] In certain embodiments, the disclosed composition may comprise one or more humectants and / or wetting agents.

[0042] Wetting agents are hygroscopic substances used to keep things moist, and are often molecules that have several hydrophilic groups, or can form hydrogen bonds with water, or have other polar organic functional groups. Wetting agents can also function as solvents or co-solvents.

[0043] Some examples of wetting agents include, but are not limited to, amino acids; glycols and polyols, e.g., propylene glycol, hexylene glycol, and butylene glycol; polymers and sugar-based polyols / alcohols, e.g., glycerol, sorbitol, xylitol, maltitol, and polydextrose; mucopolysaccharides and carbohydrates, e.g., aloe vera gel, yucca extract, dextrose, and polydextrose; alpha hydroxy acids, e.g., glycolic acid, lactic acid; albumin; esters or amides of acetic acid or its analogues; soluble carbohydrates, e.g., sugars, honey; salts, e.g., potassium chloride, sodium PCA, and salts of polycarboxylic acids; and amides, e.g., urea and urea derivatives.

[0044] In some embodiments, the skincare formulation may contain lubricants or gliding agents, i.e., ingredients that provide any kind of "slip," in particular, for example, hyaluronic acid or its salts, solutions and derivatives thereof; cellulosic gums, solutions thereof and their esters and salts or derivatives, for example, carboxymethylcellulose, sodium carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose, cellulose gum, microcrystalline cellulose, C12-16 alkylPEG-2 hydroxypropylhydroxyethylethylcellulose; natural gums and biopolymers, solutions thereof and their esters and salts or derivatives, for example Examples of synthetic and other polymers include, but are not limited to, gellan gum, xanthan gum, tragacanth gum, locust bean gum, guar gum, acacia gum, sclerotium gum, astragalus gum, biosaccharides, hydrated starch solutions, gelatin, mucus, hydrophilic colloids, chitosan; carbomers, acrylic resins, polyacrylamides, sodium polyacrylate, sodium C8-16 isoalkyl succinyl lactoglobulin sulfonate, acrylate copolymers, acrylate / steareth-20 itaconic acid copolymers, PVM / MA decadiene crosspolymers, glyceryl acrylate / acrylic acid copolymers, Lubrajel®, etc.

[0045] In one embodiment, the humectant and / or wetting agent is sodium hyaluronate, e.g., fractionated and long-chain sodium hyaluronate, ranging in size from a single monomer to about 5 million daltons, which binds moisture to the skin and allows the moisture it carries to penetrate the skin. Hyaluronic acid salts are moisture-binding agents that help keep the skin hydrated and provide the disclosed formulation with "slippery" (sensory aesthetics).

[0046] This preparation may contain one or more solubilizers, rheological modifiers, and / or emulsifiers.

[0047] In some embodiments, the skin care formulations of the present disclosure may include one or more solubilizers / emulsifiers, but these are not always required. More specifically, one or more solubilizers / emulsifiers may be included if the hydrophobic components in the formulation are, individually or collectively, in concentrations exceeding the carrying capacity of a diluent, such as water or the water and wetting agents listed herein.

[0048] In one embodiment, the solubilizer / emulsifier is a nonionic solubilizer / emulsifier. In another embodiment, the solubilizer / emulsifier is polysorbate 20.

[0049] In other embodiments, the emulsifier may be one or more of PEG-100 stearate, cetearyl alcohol, cetearyl glucoside, polysorbate 60, stearyl alcohol, glyceryl stearate, sodium polyacrylate, and emulsifying wax.

[0050] In further embodiments of the formulation, xanthan gum, such as Keltrol T®, can be provided as an emulsifier for stable emulsions.

[0051] In certain embodiments of the formulation, artificial thickeners such as Rapithix A-60® manufactured by Ashland Chemical can be provided.

[0052] The treatment and formulation may contain one or more sedative antioxidants to soothe the skin and reduce inflammation.

[0053] Antioxidants can generate free radicals and inhibit oxidation, a type of chemical reaction. Antioxidants can help prevent or reduce allergic or irritant reactions in the skin, including regulating inflammation and overstimulating histamine.

[0054] In formulations and treatments, antioxidants help reduce the stinging and irritation typically associated with the application of high levels of active ingredients, as well as soothe any pre-existing conditions of the skin being treated. This provides relief to the user, which improves adherence to the treatment protocol for the subject.

[0055] Examples of antioxidants include, but are not limited to, polyphenols, ergothioneine, glutathione, tetrahexyldecyl ascorbate, ascorbic acid derivatives, tocopherol or its derivatives, herbs such as pomegranate, cranberry, quercetin, carotenoids, resveratrol, ferulic acid, caffeic acid, gallic acid, and topical compounds that prevent or reduce oxidative events in the skin, whether induced by UV light or sun exposure.

[0056] More specifically, various anti-irritant and anti-inflammatory agents intended by certain embodiments of this disclosure include hydrocortisone, betamethasone, topical corticosteroids, diphenhydramine, licorice extract, arnica, turmeric, cucumber extract, green tea leaf, zinc oxide, and Centella asiatica. Examples of ingredients include, but are not limited to, asiatica, mugwort, colloidal oatmeal, burdock, chamomile, camphor, resveratrol, hops, blue tancy, oatmeal, white willow bark, rosehip, tamanu oil, sandalwood, aloe vera, yucca extract, witch hazel, tea tree, menthol, cornflower extract, frankincense, balm mint, ginger extract, niacin, mallow, astaxanthin, sage extract, manuka honey, raspberry extract, alpha-lipoic acid, glycerin, allantoin, urea, prostaglandin E3, ceramide, eicosapentaenoic acid, niacinamide, docosahexaenoic acid, hyaluronic acid, pycnogenol, mupirosin calcium USP, acetylsalicylic acid, clotrimazole, and terbinafine hydrochloride.

[0057] In some embodiments, the antioxidant is a polyphenol. In more specific embodiments of these embodiments, the antioxidant includes a polyphenol isolate from Camellia sinensis. The antioxidant may be a chemically synthesized polyphenol or mixture thereof isolated from a plant; the antioxidant may also be a semi-synthetic compound prepared by modifying a natural polyphenol or a mixture of polyphenols.

[0058] In certain embodiments of this disclosure, the antioxidants include “green tea polyphenols” isolated and purified from the leaves of the Camellia sinensis plant. When formulated and delivered herein, these antioxidants provide antioxidant and anti-inflammatory activity, as well as skin soothing, protective, and reparative activity.

[0059] Other antioxidants include, but are not limited to, vitamin E acetate.

[0060] Therapies and formulations may contain one or more emollients. Mollients soften, smooth, and protect the skin from transepidermal water loss (TEWL). Some examples of emollients include, but are not limited to, lipids, phospholipids, occlusive agents, petrolatum, waxes, paraffin oils, vegetable and animal fats, esters such as isopropyl myristate, dicaprylyl carbonate, and isopropyl palmitate, ethoxylate or propoxylate esters and fats, silicones, butters (such as cocoa butter and shea butter), and polyethylene glycol (PEG).

[0061] Skin lipids are the "mortar" in the brick-and-mortar model of skin. These fats, oils, and waxes have a more or less hydrophilic tendency and help prevent transepidermal water loss (TEWL), allowing the skin to retain moisture and repair itself more effectively. Examples include ceramides, phospholipids, phytosphingosine, cholesterol, lanosterol, fatty acids, and sebum components, many of which can exist and function in their natural forms, or can function in the compositions and treatments of this disclosure as derivatives or synthetic analogs.

[0062] In one embodiment, the emollient is an ester or an oil. In other embodiments, the emollient is one or more of the following: shea butter, cocoa butter, mineral oil, lanolin, petrolatum, paraffin, beeswax, squalene, squalane, cetyl alcohol, olive oil, triethylhexanoin, coconut oil, jojoba oil, sesame oil, almond oil, or other vegetable oils, lipids, and two or more combinations thereof.

[0063] Other emollients intended by this disclosure include, but are not limited to, caprylic / capric triglyceride.

[0064] The formulation may also contain other skin sedatives, such as antioxidants to reduce skin inflammation and irritation, and biomimetic ceramide complexes that mimic the skin's natural lipid profile.

[0065] In certain embodiments of the formulations of this disclosure, the components thereof include an amino acid mixture having one or more amino acids. In certain embodiments, the amino acid mixture has the profile of the natural moisturizing factors (NMF) of human skin.

[0066] In other embodiments of the present disclosure, a skin therapeutic formulation may contain amino acids or amino acid mixtures having a profile of the natural moisturizing factor (NMF) of human skin, and may include one or more of the following components: water, e.g., purified water (100% from QS), disodium EDTA, glycine, L-citrulline, L-alanine, L-proline, L-ornithine monohydrochloride, L-arginine, L-glutamic acid, L-histidine, valine, L-lysine, L-aspartic acid, leucine, threonine, tyrosine, DL-phenylalanine, taurine, L-isoleucine, methionine, and serine. The individual amino acids may be present in a preferred amount (w / w), for example, about 0.001% to about 5%, about 0.01% to about 2%, or about 0.1% to about 1%. In certain embodiments, the amounts of one or more amino acids may be as follows: EDTA disodium (0.10%), glycine (1.612%), L-citrulline (1.00%), L-alanine (0.921%), L-proline (0.148%), L-ornithine monohydrochloride (0.287%), L-arginine (0.073%), L-glutamic acid (0.243%). L-histidine (0.429%), valine (0.381%), L-lysine (0.179%), L-aspartic acid (0.30%), leucine (0.262%), threonine (0.713%), tyrosine (0.295%), DL-phenylalanine (0.283%), taurine (0.032%), L-isoleucine (0.194%), methionine (0.072%), serine (2.32%).In certain embodiments of this disclosure, the formulation contains butylene glycol, caprylic / capric triglyceride, phospholipids, SK-Influx V®, glycerin, lecithin, tocopherol acetate, ubiquinone (coenzyme Q10), hydrolyzed glycosaminoglycan, hexanoyl dipeptide-3 norleucine acetate, and salix nigra. It may contain one or more solubilizers / emulsifiers, skin conditioning agents / therapeutic agents and preservatives / stabilizers, such as willow bark extract, mandelic acid, bisabolol, ceramide NP, ceramide AP, phytosphingosine, cholesterol, ceramide EOP, glycine, citrulline, alanine, proline, ornithine HCl, arginine, glutamic acid, histidine, valine, lysine, aspartic acid, leucine, threonine, tyrosine, phenylalanine, taurine, isoleucine, methionine, serine, sodium lauroyl lactylate, hydrogenated polydecene, trideceth-6, xanthan gum, carbomer, sodium benzoate, phenoxyethanol, and disodium EDTA.

[0067] In one embodiment of the present disclosure, the skin therapeutic formulation may contain two or more of the following ingredients: purified water, hydrolyzed sodium hyaluronate, sodium hyaluronate, ascorbic acid, glycolic acid, lactic acid, Camellia sinensis leaf extract, benzyl alcohol, ubiquinone, bisabolol, Thiotaine®, TEGO PEP417®, Matrixyl (glycerin, butylene glycol, carbomer, polysorbate 20, palmitoyl pentapeptide-4), glutathione, superoxide dismutase, phenoxyethanol, sodium benzoate, and disodium EDTA.

[0068] In certain embodiments of this disclosure, the formulation may be a sterile formulation.

[0069] In other embodiments of the present disclosure, the skin therapeutic formulation may contain two or more of the following components: water, e.g., purified water, hydrolyzed sodium hyaluronate, sodium hyaluronate, Camellia sinensis leaf extract, ascorbic acid, glycolic acid, lactic acid, benzyl alcohol, ubiquinone, bisabolol, collagen-enhancing tetrapeptide (TEGO PEP417®), Matrixyl® (glycerin, butylene glycol, carbomer, polysorbate 20, palmitoyl pentapeptide-4), glutathione, superoxide dismutase, phenoxyethanol, sodium benzoate, or disodium EDTA.

[0070] In other embodiments of this disclosure, a skin therapeutic formulation is formulated within the indicated ranges (all expressed as %(w / w)) of the following components: purified water (10% to 99.8%), hydrolyzed sodium hyaluronate (0.1% to 25%), sodium hyaluronate (0.1% to 10%), Camellia sinensis leaf extract (0.001% to 1%), ascorbic acid (0.1% to 5%), glycolic acid (0.1% to 5%), lactic acid (0.1% to 5%), benzyl alcohol (0.1% to 5%), ubiquinone (0.1% to 0.5%), bisabolol (0.01% to 1%), collagen-enhancing tetrapeptide, TEGO The mixture may contain two or more of the following: PEP417® (0.1%~10%), Matrixyl® (glycerin, butylene glycol, carbomer, polysorbate 20, palmitoyl pentapeptide-4) (0.1%~10%), glutathione (0.1%~1%), superoxide dismutase (0.1%~5%), phenoxyethanol (0.1%~2%), sodium benzoate (0.1%~0.5%), or disodium EDTA (0.1%~0.2%). In certain embodiments, the lower limit of any of the above components is 1%, 0.1%, 0.001%, 0.0001%, 0.00001%, 0.000001%, or 0.0000001%.

[0071] In other embodiments of this disclosure, a skin therapeutic formulation is formulated within the indicated ranges (all expressed as %(w / w)) of the following components: purified water (50% to 99.8%), hydrolyzed sodium hyaluronate (0% to 25%), sodium hyaluronate (0.1% to 10%), Camellia sinensis leaf extract (0% to 1%), ascorbic acid (0% to 5%), glycolic acid (0% to 5%), lactic acid (0% to 5%), benzyl alcohol (0% to 5%), ubiquinone (0% to 0.5%), bisabolol (0% to 1%), collagen-enhancing tetrapeptide, TEGO It may contain two or more of the following: PEP417 (registered trademark) (0%~10%), Matrixyl (registered trademark) (glycerin, butylene glycol, carbomer, polysorbate 20, palmitoyl pentapeptide-4) (0%~10%), glutathione (0%~1%), superoxide dismutase (0%~5%), phenoxyethanol (0%~2%), sodium benzoate (0%~0.5%), or disodium EDTA (0%~0.2%).

[0072] In certain embodiments of this disclosure, the formulation is formulated within the indicated range (all expressed as %(w / w)) of the following components: purified water (0.097539%), hydrolyzed sodium hyaluronate (0.001%), sodium hyaluronate (1% (aqueous solution)), Camellia sinensis leaf extract (0.000001%), ascorbic acid (0.000001%), glycolic acid (0.000001%), lactic acid (0.000001%), benzyl alcohol (0.00025%), ubiquinone (0.000001%), bisabolol (0.000001%), Thiotaine® (0.000001%), TEGO It may also contain two or more of the following: PEP417® (0.000001%), Matrixyl® (glycerin, butylene glycol, carbomer, polysorbate 20, palmitoyl pentapeptide-4) (0.000001%), glutathione (0.000001%), superoxide dismutase (0.000001%), phenoxyethanol (0.001%), sodium benzoate (0.0001%), and disodium EDTA (0.0001%).

[0073] All references to purified water in this specification can generally be replaced with water.

[0074] Topical application of the formulations may include application to specific areas of the body susceptible to the types of skin conditions requiring therapeutic treatment as disclosed herein, for example, but not limited to, the feet, elbows, and knees. Such treatment may be applied, for example, 1 to 3 times per day, before and / or after dermatological treatment of the affected area, followed by periodic topical applications as desired or necessary to maintain the improved condition of the treated area of ​​the body. In particular embodiments, the actual dose of the formulations of the disclosure applied topically to the skin will depend, among other things, on the condition being treated, the specific regimen being followed, and the personal preference of the user.

[0075] The formulations of the present disclosure can be prepared under ambient conditions. In certain embodiments, the formulations of the present disclosure are prepared under an inert atmosphere. In particular, the inert atmosphere is an inert gas, which may include, but is not limited to, nitrogen, argon, or a combination thereof. In certain embodiments, the formulations of the present disclosure are prepared under a dry inert atmosphere, which may contain, essentially consist of, one or more dry inert gases, or consist of one or more dry inert gases, which may include, but is not limited to, dry nitrogen, dry argon, or a combination thereof.

[0076] Exemplary composition range The formulations of this disclosure may have the following compositions shown in Tables 1 and 2.

[0077] [Table 1]

[0078] [Table 2]

[0079] [Table 3]

[0080] List of specific embodiments In the first embodiment, a method for the therapeutic treatment of the skin in a dermatological procedure affecting the skin barrier: The steps include applying a therapeutically effective amount of a formulation containing hyaluronic acid or a related salt and one or more of ascorbic acid, glycolic acid, and lactic acid to skin selected for a dermatological treatment affecting the skin barrier, Hyaluronic acid or its related salts are present at least 1% (w / w), and ascorbic acid, glycolic acid, and lactic acid are each present at least 1 ppm. The steps involved in performing dermatological treatments on the skin. Includes.

[0081] The method of the first embodiment includes dermatological treatments such as microneedling, laser, chemical peel, phototherapy, microdermabrasion, and skin peeling.

[0082] A method according to the first embodiment, the step of performing a dermatological treatment includes the step of applying a microneedling treatment to the skin.

[0083] A method according to the first embodiment, further comprising the step of applying the formulation before the microneedling procedure.

[0084] A method according to the first embodiment, further comprising the step of applying the formulation after a microneedling procedure.

[0085] The method according to the first embodiment, wherein the salt of hyaluronic acid is sodium hyaluronate.

[0086] The method of the first embodiment is a solution of sodium hyaluronate arranged in a honeycomb pattern.

[0087] A method according to the first embodiment, wherein the formulation further comprises an antioxidant, one or more of the following: Camellia sinensis leaf extract, Camellia sinensis polyphenols, ascorbic acid, ubiquinone, bisabolol, Thiotaine®, ergothioneine, glutathione, and superoxide dismutase.

[0088] A method according to the first embodiment, wherein the formulation further comprises one or more of the following: purified water, hydrolyzed sodium hyaluronate, sodium hyaluronate, Camellia sinensis leaf extract, benzyl alcohol, ubiquinone, bisabolol, Thiotaine®, TEGO PEP417®, Matrixyl® (glycerin, butylene glycol, carbomer, polysorbate 20, palmitoyl pentapeptide-4), glutathione, superoxide dismutase, phenoxyethanol, sodium benzoate, and disodium EDTA.

[0089] The method according to the first embodiment, wherein the formulation is a sterile formulation.

[0090] In a second embodiment, a formulation for the therapeutic treatment of the skin in dermatological procedures affecting the skin barrier, comprising hyaluronic acid or a related salt and one or more of ascorbic acid, glycolic acid, and lactic acid, wherein the hyaluronic acid or a related salt is at least 1% (w / w), and each of ascorbic acid, glycolic acid, and lactic acid is at least 1 ppm.

[0091] The formulation of the second embodiment is (in %w / w): Purified water (50%~99.8%), Hydrolyzed sodium hyaluronate (0%~25%) Sodium hyaluronate (0.1%~10%) Camellia sinensis leaf extract (0%~1%) Ascorbic acid (0%~5%) Glycolic acid (0%~5%) Lactic acid (0%~5%) Benzyl alcohol (0%~5%) Ubiquinone (0%~0.5%) Bisabolol (0%~1%) TEGO PEP417 (registered trademark) (0%~10%) Matrixyl® (Glycerin, Butylene Glycol, Carbomer, Polysorbate 20, Palmitoyl Pentapeptide-4) (0%~10%) Glutathione (0%~1%) Superoxide dismutase (0%~5%) Phenoxyethanol (0%~2%) Sodium benzoate (0%~0.5%) EDTA disodium (0%~0.2%) Includes.

[0092] The formulation of the second embodiment is (in %w / w): 0.097539% purified water, 0.001% hydrolyzed sodium hyaluronate, 1% (aqueous solution) sodium hyaluronate, 0.000001% Camellia sinensis leaf extract, 0.000001% ascorbic acid, 0.000001% glycolic acid, 0.000001% lactic acid, 0.00025% benzyl alcohol, 0.000001% ubiquinone, 0.000001% bisabolol, 0.000001% Thiotaine (registered trademark), 0.000001%TEGO PEP417(registered trademark), 0.000001% Matrixyl, 0.000001% glutathione, 0.000001% superoxide dismutase, 0.001% phenoxyethanol, 0.0001% sodium benzoate, 0.0001% EDTA disodium Includes.

[0093] The formulation according to the second embodiment is sodium hyaluronate, where the salt of hyaluronic acid is sodium hyaluronate.

[0094] The formulation of the second embodiment is a solution of sodium hyaluronate arranged in a honeycomb pattern.

[0095] A formulation according to a second embodiment, the formulation further comprising an antioxidant, the antioxidant being one or more of the following: Camellia sinensis leaf extract, Camellia sinensis polyphenol, ascorbic acid, ubiquinone, bisabolol, Thiotaine®, ergothioneine, glutathione, and superoxide dismutase.

[0096] A formulation of the second embodiment further comprising one or more of the following: purified water, hydrolyzed sodium hyaluronate, sodium hyaluronate, Camellia sinensis leaf extract, benzyl alcohol, ubiquinone, bisabolol, Thiotaine®, TEGO PEP417®, Matrixyl® (glycerin, butylene glycol, carbomer, polysorbate 20, palmitoyl pentapeptide-4), glutathione, superoxide dismutase, phenoxyethanol, sodium benzoate, and disodium EDTA.

[0097] A formulation according to any of the embodiments described above, wherein the formulation is a sterile formulation. [Examples]

[0098] The following examples are provided to aid in understanding the present invention and, naturally, should not be construed as specifically limiting the present invention as described herein and claimed. Modifications of the present invention, including substitutions of all currently known or subsequently developed equivalents that are within the scope of the knowledge of those skilled in the art, and minor changes in formulation or experimental design, should be considered within the scope of the present invention as incorporated herein.

[0099] Efficacy and safety of microneedling combined with sterile hyaluronic acid serum for acne scars, wrinkles, and skin texture. This study aimed to measure the efficacy and safety of microneedling using sterile hyaluronic acid in improving skin texture and reducing the appearance of acne scars and wrinkles. The objective of this study was to test the safety and efficacy of sterile hyaluronic acid during and after microneedling treatment. Since hyaluronic acid is inherent in our skin, utilizing its sterile form reduces the likelihood of hypersensitivity responses in subjects. Furthermore, hyaluronic acid can further enhance improvements in subjects' acne scarring and skin texture by stimulating fibroblasts that trigger collagen synthesis.

[0100] The following products were used in this study: Topix Sterile Hyaluronic Acid Serum; Topix Replenix Green Tea Fortified Cleanser #836; Topix #1030 Sterile Post-Procedure Mask; Topix #895 Replenix Restorative Nighttime Moisturizer; and Topix #858 Replenix Sheer Physical Sunscreen SPF 50.

[0101] To be considered, each candidate must meet the following criteria: • Must be between 18 and 70 years old; • Having acne-induced depressions, scars, and fine lines on the face; • Being in good general health; • Willingness to avoid sun exposure to the face, including sunbathing (as much as possible), and the use of tanning booths and self-tanning products during the study period; • Demonstrate willingness to cooperate with the principal investigator and comply with research requirements; • To demonstrate her ability to understand the purpose of the research and what is required of her to lead it to meaningful conclusions; • Demonstrate the ability to understand what risks are associated with participation; Demonstrate the ability to read and understand all items in an informed consent document; To sign the informed consent document based on their free will, without any reservations.

[0102] Participants will be excluded if any of the following is revealed during the interview and examination: • Moderate to severe active facial acne • Having a history of bleeding disorders and / or taking anticoagulants • Having a history of keloid formation • Systemic diseases or infections that contraindicate participation; • Any skin disorder in the test area, including atopic dermatitis, psoriasis, vitiligo, excessive freckles, and discoloration. • Having any form of suspected lesion or skin cancer in the treatment area; • In the test area, the participant must be receiving care from a dermatologist regardless of their condition; • Any infection, burns, cuts, tattoos, visible scars, or acne in the test area; • Pregnancy, breastfeeding, or attempts to become pregnant reported by the subject within three months prior to or during the study period; • You have used acne medication containing isotretinoin and other retinoids (excluding OTC benzoyl peroxide products) within the past three months. • Participation in a facial-related study within the month prior to the baseline survey; Having received any skin treatment (i.e., exfoliation, skin surface regeneration) in the past six months; Market research companies and cosmetics / personal care manufacturers will be excluded from participation in clinical research.

[0103] Microneedling treatment performed by a dermatologist Participants arrived for baseline investigation with clean skin free from creams, fragrance powders, and therapeutic products. Inclusion / exclusion criteria were validated. Participants who met all study requirements were enrolled.

[0104] Using two 3D cameras, the 3D LifeViz Micro Camera and the 3D LifeViz Mini Camera, images were taken following the standard operating procedures provided by QuantifiCare. Four images were taken using the 3D LifeViz Mini Camera, and three close-up images of the scar were taken using the 3D LifeViz Micro Camera.

[0105] The subjects received microneedling therapy using sterile HA serum as described below. They received a post-care kit with detailed instructions and took it home. A total of 10 subjects participated in the study.

[0106] One month after the first treatment: Photographs were taken as described below. Participants completed a questionnaire to determine their perception of the product and the therapeutic effect. Participants received a second treatment with hyaluronic acid serum and microneedling as described below. Participants received the test materials and instructions and took them home.

[0107] One month after the second treatment: Photographs were taken. Participants completed a questionnaire to determine their perception of the product and its therapeutic effect. Participants received a third treatment with hyaluronic acid serum and microneedling. Participants received test materials and instructions and took them home.

[0108] One month after the third treatment: Photographs were taken. Participants completed a questionnaire to determine their perception of the product and its therapeutic effect. Participants returned all unused products and empty containers.

[0109] HA and Microneedling Treatment: The subject underwent microneedling treatment with sterile hyaluronic acid serum. Prior to treatment, the entire face was anesthetized for 10-15 minutes with a topical cream containing 20% ​​benzocaine, 6% lidocaine, and 4% tetracaine (BLT). The cream was removed from the face using chlorohexidine, followed by alcohol. Sterile hyaluronic acid serum (HA serum) was applied to the entire face using a sterile syringe. The face was then microneedled in vertical, horizontal, and circular patterns, to a depth of 1.0 on the forehead and 2.0 on the entire face. Upon completion, excess blood was wiped from the face, a #1030 sterile post-treatment mask was applied for 10 minutes, then the subject's skin was wiped, another layer of sterile HA serum was applied and allowed to absorb for 5 minutes. The subject was then given sunscreen (#858 SPF50 sunscreen).

[0110] Care Instructions: Postoperative care was provided using the product regimen described below. Participants were instructed to avoid touching or fiddling with their faces during the study.

[0111] Instructions for post-care treatment: morning: • Clean with cleanser #836 After washing, apply moisturizer #885, followed by sunscreen #858. evening: • Clean with cleanser #836 • For the first four days, use a post-sterilization mask #1030 for 15 minutes, as instructed in the video shown to participants during the initial assessment. Next, apply moisturizer #895.

[0112] Photo: The following cameras were used to take a 3D photograph of the entire face of the subject. The 3D LifeViz® Mini (QuantifiCare, San Francisco, California) is a stereoscopic camera equipped with dual-LED pointer technology. This technology also generates high-quality 3D reconstructions, which enable 3D visualization and quantification of target areas with a depth accuracy of 25 microns. This method is useful for measuring surface, depth, height, volume, etc. During each examination, the camera took four images: a frontal view, a right lateral view, a left lateral view, and a frontal low-angle jaw view. The 3D LifeViz microcamera (QuantifiCare, San Francisco, California) is a stereoscopic camera equipped with dual-LED pointer technology that generates high-quality 3D reconstructions. These high-quality 3D reconstructions enable 3D visualization and accurate quantification of target areas with a depth accuracy of 8 microns and a field of view of 5 x 7 cm. This method is useful for measuring surface, depth, height, volume, etc. Three images were taken with this camera during each study: one of the forehead, one of the right cheek, and one of the left cheek.

[0113] Results and statistical analysis Staff at Bergen Dermatology analyzed the images. SCR consultant Neelam Muizzuddin, PhD, evaluated all data. From this analysis, it was found that the usual problems and complications reported in the literature were not observed. While not limited by theory, this is mainly attributed to the selection and administration of raw materials, as well as the much higher-than-expected synergistic effect from the effects of each component. The vehicle, hyaluronic acid, is a glycosaminoglycan polysaccharide and a physiological component of the extracellular matrix. Hyaluronic acid can further enhance the improvement of the target in acne scarring and skin texture by stimulating fibroblasts that cause collagen synthesis. This biocompatibility and administration resulted in much lower-than-expected irritation observed, providing a product with no risk of granuloma. No withdrawal or treatment due to side effects was required. Post-treatment care was well tolerated, mainly due to the lower level of irritation and inflammation resulting from the treatment.

[0114] Clinical grading for the treatment of acne scars, wrinkles (especially fine wrinkles), and improved skin texture showed statistically significant results. Regarding acne scars, subjects showed approximately a 20% reduction in scarring.

[0115] Improved treatment outcomes were achieved compared to conventional microneedling, and clinical evaluations showed a much better avoidance of pain, irritation, redness, papules, pustules or milia, swelling and dryness, and discomfort than expected. In addition to improved repair of scarring, depressions, fine lines and wrinkles, the overall skin tone and texture, firmness and plumpness were improved, resulting in a collagen-rich appearance. This improvement was presumed to be due to the additional volume added by newly deposited collagen.

[0116] Figures 1-3 show the results of questionnaires indicating that subjects found the formulations and treatments improved acne scars, facial wrinkles, and facial skin texture. The present invention also includes the following embodiments. <1> A method for treating the skin, A step of applying a therapeutically effective amount of the preparation to the skin, wherein the preparation comprises hyaluronic acid or a related salt and one or more of ascorbic acid, glycolic acid, and lactic acid, and The step of performing a dermatological treatment on the skin. Methods that include... <2> The method according to item 1, wherein the dermatological treatment includes microneedling, laser, chemical peel, phototherapy, microdermabrasion, or skin peeling. <3> The method according to claim 1, wherein the step of performing the dermatological treatment includes the step of applying a microneedling treatment to the skin. <4> The method according to the above-mentioned paragraph 3, further comprising the step of applying the formulation before the microneedling procedure. <5> The method according to the above-mentioned microneedling procedure, further comprising the step of applying the formulation after the microneedling procedure. <6> The method according to claim 1, wherein the related salt is sodium hyaluronate. <7> The method according to 6 above, wherein the sodium hyaluronate is a solution of sodium hyaluronate arranged in a honeycomb pattern. <8> The method according to claim 1, wherein the formulation further comprises an antioxidant. <9> The method according to 8 above, wherein the antioxidant is one or more of the following: Camellia sinensis leaf extract, Camellia sinensis polyphenol, ascorbic acid, ubiquinone, bisabolol, Thiotaine®, ergothioneine, glutathione, and superoxide dismutase. <10> The method according to 1 above, wherein the preparation further comprises one or more of the following: water, hydrolyzed sodium hyaluronate, sodium hyaluronate, Camellia sinensis leaf extract, benzyl alcohol, ubiquinone, bisabolol, Thiotaine®, TEGO PEP417®, Matrixyl® (glycerin, butylene glycol, carbomer, polysorbate 20, palmitoyl pentapeptide-4), glutathione, superoxide dismutase, phenoxyethanol, sodium benzoate, or disodium EDTA. <11> The method according to the above 10, wherein the preparation is a sterile preparation. <12> A formulation for treating the skin in dermatological procedures, comprising hyaluronic acid or a related salt and one or more of ascorbic acid, glycolic acid, and lactic acid, wherein the hyaluronic acid or a related salt is at least about 1% (w / w), and each of ascorbic acid, glycolic acid, and lactic acid is at least about 1 ppm. <13> 50% to 99.8% water, 0% to 25% of hydrolyzed sodium hyaluronate, 0.1% to 10% sodium hyaluronate, 0% to 1% of Camellia sinensis leaf extract, 0% to 5% ascorbic acid, 0% to 5% glycolic acid, 0% to 5% lactic acid, 0% to 5% of benzyl alcohol, Ubiquinone in amounts of 0% to 0.5%, 0% to 1% of bisabolol, 0% to 10% of TEGO PEP417 (registered trademark) (glycerin, butylene glycol, water, tetrapeptide-21), 0% to 10% of Matrixyl® (glycerin, butylene glycol, carbomer, polysorbate 20, palmitoyl pentapeptide-4), 0% to 1% of glutathione, 0% to 5% of superoxide dismutase, 0% to 2% phenoxyethanol, 0% to 0.5% sodium benzoate, or 0% to 0.2% of EDTA disodium The formulation described in item 12 above, containing (%w / w). <14> The preparation described in item 12 above, comprising three or more of the listed ingredients. <15> The preparation according to 12 above, wherein the related salt is sodium hyaluronate. <16> The formulation according to 15, wherein the sodium hyaluronate is a solution of sodium hyaluronate arranged in a honeycomb pattern. <17> The preparation according to item 12 above, further comprising an antioxidant. <18> The preparation according to 17 above, wherein the antioxidant is one or more of the following: Camellia sinensis leaf extract, Camellia sinensis polyphenol, ascorbic acid, ubiquinone, bisabolol, Thiotaine®, ergothioneine, glutathione, and superoxide dismutase. <19> The preparation according to item 12 above, further comprising one or more of the following: purified water, hydrolyzed sodium hyaluronate, sodium hyaluronate, Camellia sinensis leaf extract, benzyl alcohol, ubiquinone, bisabolol, Thiotaine®, TEGO PEP417®, Matrixyl® (glycerin, butylene glycol, carbomer, polysorbate 20, palmitoyl pentapeptide-4), glutathione, superoxide dismutase, phenoxyethanol, sodium benzoate, or disodium EDTA. <20> The preparation described in item 19 above, which is a sterile preparation.

Claims

1. A pharmaceutical composition used in a skin treatment method for alleviating or improving skin diseases, including skin conditions characterized by inflammatory disorders of the skin and increased cell turnover, wherein the method comprises performing a skin treatment including a microneedling procedure on the skin. The pharmaceutical composition comprises hyaluronic acid or a related salt, ascorbic acid, lactic acid, and at least 0.001 ppm of glycolic acid, wherein a therapeutically effective amount of the pharmaceutical composition is applied to the skin.

2. The pharmaceutical composition according to claim 1, further comprising the step of applying the pharmaceutical composition before the microneedling procedure.

3. The pharmaceutical composition according to claim 1, further comprising the step of applying the pharmaceutical composition after the microneedling treatment.

4. The pharmaceutical composition according to claim 1, wherein the related salt is sodium hyaluronate.

5. The pharmaceutical composition according to claim 4, wherein the sodium hyaluronate is a solution of sodium hyaluronate arranged in a honeycomb pattern.

6. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition further comprises an antioxidant.

7. The pharmaceutical composition according to claim 6, wherein the antioxidant is one or more of the following: Camellia sinensis leaf extract, Camellia sinensis polyphenol, ascorbic acid, ubiquinone, bisabolol, Thiotaine®, ergothioneine, glutathione, and superoxide dismutase.

8. The pharmaceutical composition according to claim 1, further comprising one or more of the following: water, hydrolyzed sodium hyaluronate, sodium hyaluronate, Camellia sinensis leaf extract, benzyl alcohol, ubiquinone, bisabolol, Thiotaine®, TEGO PEP417®, Matrixyl® (glycerin, butylene glycol, carbomer, polysorbate 20, palmitoyl pentapeptide-4), glutathione, superoxide dismutase, phenoxyethanol, sodium benzoate, or disodium EDTA.

9. The pharmaceutical composition according to claim 8, wherein the pharmaceutical composition is a sterile preparation.

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