Composition for scar treatment

Abstract

Disclosed herein are topical compositions that treat and reduce the visual appearance of scars through a combination of a hydrophilic occlusion-forming agent (e.g., one with a water solubility of greater than about 75%; e.g., glycerin) with an antioxidant system that includes one or more proteolytic enzymes and a polyphenol antioxidant (e.g., green tea polyphenols). Also disclosed herein are methods of administering the topical compositions described herein, by themselves or as part of a scar treatment regimen in combination with various dermatological procedures, to treat and / or reduce the visual appearance of scars. Methods of preparing the topical compositions disclosed herein are also described in certain embodiments.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 118,061, filed November 25, 2020, the entire contents of which are incorporated herein by reference.

[0002] The present invention relates to compositions for skin care applications, particularly for treating scars. [Background technology]

[0003] Each year, over 100 million patients suffer from scars, primarily as a result of surgery and trauma (Bayat, 2003). Even scars from normal skin conditions such as acne affect 40-50 million people in the United States alone (The Burden of Skin Diseases, 2004). Scars affect countless individuals from all regions and demographics, and many suffer from psychological trauma, depression, ecchymosis, and an overall reduced quality of life due to these disfiguring scars.

[0004] Most scars consist of fibrous tissue formed as a result of the human body's wound healing process following injury to the skin. Nearly all wounds result in scarring to some degree. The severity of scarring can be influenced by factors such as the type of wound, genetic predisposition, tissue tension, or prolonged inflammation during wound healing. The human body's typical response to wounds, independent of the cause of the wound—whether accidental or intentional, or injury caused by trauma, laser treatment, disease, or surgery—predisposes to healing following the same sequence of biological repair.

[0005] Although most people do their best to avoid injuries and surgeries that can result in scarring, sometimes trauma is unavoidable. Strategies to minimize the scarring they cause include maintaining a moist wound environment, removing tension from healing wounds, and refraining from using materials that can exacerbate injury, such as latex or acrylic additives, which can be overly aggressive and damage delicate tissues and cause reactions in sensitized patients.

[0006] Although prevention is preferred, there are situations where scars have already formed and treatment is clearly indicated. Scar treatment options are varied and include, but are not limited to, medical devices, silicone gel sheeting, steroid injections, orthotic coverings, elastic silicone dressings (Embrace®), topical scar preparations, pressure therapy, laser therapy, cryosurgery, dermabrasion, fractional radiofrequency skin rejuvenation, and scar revision surgery.

[0007] Although scar treatment options exist, there remains a need for topical scar treatment compositions that effectively improve the overall appearance and feel of scars while having an aesthetically pleasing texture that would encourage patient compliance throughout the recommended treatment regimen. Summary of the Invention

[0008] It is an object of certain embodiments of the present disclosure to provide topical compositions, as well as methods of preparing and using said topical compositions, for treating, preventing or minimizing the appearance of scars, reducing the red or purple appearance of scars, reducing the volume of scars, preventing the development of scars, improving the flexibility of scars, or a combination of two or more thereof.

[0009] It is an object of certain embodiments of the present disclosure to provide topical compositions, methods of preparation, and methods of using said topical compositions as part of pre- or post-dermatological procedures in a scar treatment regimen (e.g., dermatological procedures used for scar repair, scar revision, microneedling, skin planing, dermabrasion, microdermabrasion, and lasers).

[0010] It is an object of certain embodiments of the present disclosure to provide topical compositions for treating and / or improving the appearance of skin in scarred areas, for treating and / or improving skin elasticity in scarred areas, for body tightening, or for treating and / or reducing the visual signs of photoaged skin in scarred areas, for helping to treat and / or prevent sunburn in scarred areas, for preventing and / or treating and / or minimizing the formation of visible scars, and for treating associated skin disorders that are common in scarred areas.

[0011] One or more of the above objects and other objects may be met in some embodiments in the present disclosure, which is directed to a topical composition comprising a hydrophilic occlusion-forming agent (e.g., one having a water solubility of about 75% or greater, such as, but not limited to, glycerin and a binder), one or more proteolytic enzymes, and an antioxidant system comprising a polyphenol antioxidant (e.g., green tea polyphenols).

[0012] In one embodiment, the topical composition may be any of the topical compositions described herein, further having less than 10 wt.% added water, based on the total weight of the topical composition.

[0013] In one embodiment, the topical composition may be any of the topical compositions described herein, further having less than 8 wt.% urea, based on the total weight of the topical composition.

[0014] In one embodiment, the topical composition can be any of the topical compositions described herein, further having less than 1 wt.% of a silicone-based component.

[0015] In one embodiment, the topical composition may be any of the topical compositions described herein and is further a homogeneous gel.

[0016] In one embodiment, the topical composition may be any of the topical compositions described herein, further having a viscosity in the range of about 550,000 cPs to about 850,000 cPs at 25°C.

[0017] The term "topical composition," as used herein, also refers, in certain embodiments, to a medical device that provides its therapeutic effect by physical means instead of (or in addition to) pharmacological, immunological, or chemical means.

[0018] In certain embodiments, the present disclosure is directed to methods of treating, preventing, or minimizing the appearance of scars (e.g., improving the visual appearance, color, volume, or elasticity of a scar, reducing the effects of radical-induced damage in a scar, or as part of a scar treatment regimen involving certain dermatological procedures). These methods comprise administering any of the topical compositions described herein to a subject's skin in the area of ​​the scar.

[0019] As used herein, the term "administering a topical composition" refers to topically applying the topical composition to the skin of a subject, such as to the scarred area, for example, on the face, neck, hand, foot, elbow, knee, etc. As used herein, the terms "application," "applying," and "applying," in reference to the disclosed topical formulations or methods of using the disclosed topical formulations, refer to any method of administering a topical formulation to the skin, for example, human skin, for example, the skin of a patient, in medical or cosmetic practice, that delivers the formulation to the skin surface of a subject. Smearing, rubbing, spreading, or spraying the disclosed topical formulations onto the skin of a subject, with or without the aid of a suitable device, are all included within the scope of the term "application" as used herein. The terms "topical" or "topically," in reference to administering or applying the disclosed skin care formulations, refer to transdermal administration or application onto the skin. Application can be done manually (e.g., directly by hand) or can be manipulated with an applicator, cloth, device, roll-on, wipe, unit dose sponge applicator, liquid applied with a swab or cotton ball, impregnated gauze or other substrate, coated silicone sheeting or other sheeting, coated bandage or external fixation device, paper towel, individually packaged pledgets or pads, transdermal delivery system, etc. Application can be self-administered or administered by a healthcare professional or caregiver.

[0020] In certain embodiments, the present disclosure is directed to a method for preparing any of the topical compositions described herein by forming a first mixture containing a first portion of a hydrophilic occlusion-forming agent (e.g., glycerin), an antioxidant system including a polyphenol antioxidant (e.g., green tea polyphenols), and an optional preservative. The method can further include adding a binder to the first mixture. The method can further include forming a second mixture containing a second portion of a hydrophilic occlusion-forming agent (e.g., glycerin), one or more proteolytic enzymes, and optionally a carrier. The method can further include combining the first and second mixtures to form the topical composition.

[0021] The following drawings are presented herein in the present application: [Brief explanation of the drawings]

[0022] [Figure 1] Figure 1A is a photograph of a hand immediately after MOHS surgery, and Figure 1B is a photograph of the hand in Figure 1A 14 days after treatment with a hydrophilic scar treatment composition according to one embodiment of the present application. [Figure 2] Figure 2A is a photograph of the knee immediately after the scar was formed, and Figure 2B is a photograph of the knee in Figure 2A 14 days after treatment with a hydrophilic scar treatment composition according to one embodiment of the present application. [Figure 3] Figure 3A is a photograph of the scalp before CO2 laser treatment, Figure 3B is a photograph of the scalp of Figure 3A immediately after CO2 laser treatment, and Figure 3C is a photograph of the scalp of Figure 3A 14 days after treatment with a hydrophilic scar treatment composition of one embodiment of the present application. [Figure 4] Figure 4A is a photograph of the temporal region after MOHS surgery, and Figure 4B is a photograph of the temporal region in Figure 4A 14 days after treatment with a hydrophilic scar treatment composition according to one embodiment of the present application. [Figure 5] Figure 5A is a photograph of the forehead immediately after MOHS surgery, and Figure 5B is a photograph of the forehead in Figure 5A 14 days after treatment with a hydrophilic scar treatment composition according to one embodiment of the present application. DETAILED DESCRIPTION OF THE INVENTION

[0023] Unless otherwise stated, the following definitions are used:

[0024] As used herein, the term "alkyl" refers to straight-chain and branched hydrocarbon groups. References to individual groups such as propyl include only the straight-chain group; branched-chain isomers such as isopropyl are specifically referenced.

[0025] The term "halo" or "halogen" as used herein refers to fluoro, chloro, bromo and iodo.

[0026] The term "carbocycle" or "carbocyclyl" refers to a single saturated (i.e., cycloalkyl) ring or a single partially unsaturated (e.g., cycloalkenyl, cycloalkadienyl, etc.) ring having 3 to 7 carbon atoms (i.e., (C3-C7) carbocycle). The term "carbocycle" or "carbocyclyl" also includes multiple fused ring systems (e.g., ring systems containing 2, 3, or 4 carbocyclyl rings). Thus, carbocycle includes polycyclic carbocycles having 7 to 12 carbon atoms in a bicycle and up to about 20 carbon atoms in a polycycle. Polycyclic carbocycles can be linked together through one carbon atom to form a spiro bond (e.g., spiropentane, spiro[4,5]decane, spiro[4,5]decane, etc.), can be fused through two adjacent carbon atoms to form a bicyclo[4,5], [5,5], [5,6], or [6,6] system, or nine or ten ring atoms can be arranged as a bicyclo[5,6] or [6,6] system (e.g., decahydronaphthalene, norsabinane, norcarane), or form a bridged bond through two non-adjacent carbon atoms (e.g., nobornane, bicyclo[2.2.2]octane, etc.). A "carbocycle" or "carbocyclyl" can also be optionally substituted with one or more (e.g., one, two, or three) oxo groups. Non-limiting examples of monocyclic carbocycles include cyclopropyl, cyclobutyl, cyclopentyl, 1-cyclopent-1-enyl, 1-cyclopent-2-enyl, 1-cyclopent-3-enyl, cyclohexyl, 1-cyclohex-1-enyl, 1-cyclohex-2-enyl, 1-cyclohex-3-enyl, and cycloheptyl.

[0027] As used herein, the term "aryl" refers to a single aromatic ring or a multiple fused ring system. For example, an aryl group can have 6 to 20 carbon atoms, 6 to 14 carbon atoms, or 6 to 12 carbon atoms. Aryl includes phenyl groups. Aryl can also include multiple fused ring systems (e.g., ring systems containing 2, 3, or 4 rings) having about 9 to 20 carbon atoms, in which at least one ring is aromatic. Such multiple fused ring systems may be optionally substituted with one or more (e.g., 1, 2, or 3) oxo groups on any carbocyclic portion of the multiple fused ring system. It is understood that the point of attachment of the multiple fused ring system defined above can be at any position on the ring system, including the aryl or carbocyclic portion of the ring. Typical aryl groups include, but are not limited to, phenyl, indenyl, naphthyl, 1,2,3,4-tetrahydronaphthyl, anthracenyl, and the like.

[0028] It will be recognized by those skilled in the art that compounds of the present invention having chiral centers can exist in and be isolated in optically active and racemic forms. Some compounds may exhibit polymorphism. It is understood that the present invention encompasses any racemic, optically active polymorphic or stereoisomeric form of the compounds of the present invention, or mixtures thereof, which possess the useful properties described herein, and how to prepare optically active forms (e.g., by resolution of racemic forms by recrystallization techniques, by synthesis from optically active starting materials, by chiral synthesis, or by chromatographic separation using chiral stationary phases) is well known in the art.

[0029] As used herein, "free or substantially free" refers to the subject composition (e.g., topical composition) containing less than about 1 wt.%, less than about 0.5 wt.%, less than about 0.25 wt.%, less than about 0.1 wt.%, less than about 0.05 wt.%, less than about 0.01 wt., or 0 wt.% of the ingredient.

[0030] As used herein, "hydrophilic" refers to an ingredient having a water solubility of greater than about 50%, greater than about 60%, greater than about 70%, greater than about 75%, greater than about 80%, greater than about 85%, greater than about 90%, greater than about 95%, greater than about 96%, greater than about 97%, greater than about 98%, greater than about 99%, or greater than about 99.5%. For example, greater than 50% water solubility means that more than 50 g of the ingredient can be dissolved in 100 ml of water.

[0031] Topical Compositions According to various embodiments, the present disclosure relates to a topical composition for the treatment of scars, the topical composition comprising an occlusion-forming agent, such as a hydrophilic occlusion-forming agent including glycerin and a binder, one or more proteolytic enzymes, and an antioxidant system including a polyphenol antioxidant (e.g., green tea polyphenols).

[0032] The occlusion-forming agent in the topical compositions described herein mechanically softens the scar, reducing its volume and helping to form a seal on the scar. The occlusion formed on the scar (due to the presence of the occlusion-forming agent) helps the skin to sweat beneath the occlusion, which opens inlet channels in the skin and allows for more rapid transdermal uptake (i.e., increasing the transdermal flux rate of proteases beneath the occlusion). The hydrophilic nature of the occlusion-forming agent in the topical compositions described herein also allows water to hydrogen bond thereto, which can keep the scarred area moist and provide an optimal scar healing environment. In this way, one or more proteases present in the topical compositions described herein are forced into the skin to digest the skin in the scarred area and / or cause the skin in the scarred area to dissolve or be replaced more quickly. The incorporation of proteases into the skin can promote further remodeling of the scar, removing excess tissue and orienting the tissue to become more organized and dense, which is thought to improve the appearance of the scar (e.g., in terms of volume, shape, and color).

[0033] Proteolytic enzymes can be quite aggressive, which, on the one hand, is beneficial in breaking down very dense scar tissue, but, on the other hand, can cause irritation and reduce patient compliance with continuous administration of the composition.The antioxidant system with antioxidant polyphenols (e.g., green tea polyphenols) present in the topical compositions described herein soothes the skin under the occlusion by preventing and / or alleviating the irritation, stinging, burning, and / or itching sensations that can accompany proteolytic enzymes.The soothing effect of the antioxidant system incorporated into the topical compositions described herein improves patient compliance and allows for continuous administration of the topical composition for the period necessary to achieve an improvement in the visual appearance of scars.

[0034] The various components of the topical compositions described herein will be discussed in detail below.It should be noted that in some embodiments, various components can be replaced by other similar or equivalent components, as recognized by those skilled in the art.Similarly, the components can be present in various concentrations and in various ratios relative to each other, in order to achieve any of the purposes described herein.

[0035] In certain embodiments, suitable occlusion-forming agents that can be utilized in the topical compositions described herein include hydrophilic compounds. For example, in some embodiments, the occlusion-forming agent has a water solubility of greater than about 50%, greater than about 60%, greater than about 70%, greater than about 75%, greater than about 80%, greater than about 85%, greater than about 90%, greater than about 95%, greater than about 96%, greater than about 97%, greater than about 98%, greater than about 99%, or greater than about 99.5%. In certain embodiments, the occlusion-forming agent has a water solubility of greater than about 75%, greater than about 80%, greater than about 85%, greater than about 90%, greater than about 95%, greater than about 96%, greater than about 97%, greater than about 98%, greater than about 99%, or greater than about 99.5%. In one embodiment, the occlusion-forming agent has a water solubility of greater than about 75%. In one embodiment, the occlusion-forming agent has a water solubility of greater than about 85%. In one embodiment, the occlusion-forming agent has a water solubility of greater than about 95%. In one embodiment, the occlusion-forming agent is greater than about 99% water soluble.

[0036] In various embodiments, a wide variety of hydrophilic occlusion-forming agents can be used, including, but not limited to, glycerin, polyethylene glycols of various molecular weights, glycols such as butylene glycol or hexylene glycol, or other Guerbet alcohols (e.g., 2-methyl-1-pentanol, 2-ethyl-1-hexanol, 2-propyl-1-heptanol, 2-butyl-1-octanol, 2-pentyl-1-nonanol, 2-hexyl-1-decanol, 2-heptyl-1-undecanol, 2-octyl-1-dodecanol, 2-nonyl-1-tridecanol, 2-decyl-1-tetradecanol, 2-undecyl-1-pentadecanol, 2-pentyl-1-pentadecanol, 2-pentyl-1-pentan ... 2-octadecyl-1-tetracosanol, 2-hexadecyl-1-ol, 2-dodecyl-1-hexadecanol, 2-tridecyl-1-heptadecanol, 2-tetradecyl-1-octadecanol, 2-pentadecyl-1-nonadecanol, 2-hexadecyl-1-eicosanol, 2-heptadecyl-1-heneicosanol, 2-octadecyl-1-docosanol, 2-nonadecyl-1-tricosanol, 2-eicosyl-1-tetracosanol, or combinations thereof), ethoxylates (e.g., propylene glycol derivatives that are esters of polyethylene glycol with fats or fatty acids; where the polyethylene glycol number is high enough to render the ethoxylate hydrophilic), or combinations thereof.

[0037] In one embodiment, the hydrophilic occlusion-forming agent is glycerin. In certain embodiments, the hydrophilic occlusion-forming agent is glycerin in combination with a binder. In certain embodiments, the binder comprises at least one of an emulsion stabilizing or viscosity-adjusting component, a thickener, and a surfactant.

[0038] An exemplary emulsion stabilizing or viscosity adjusting component is HEA-sodium acroyldimethyltaurate-steareth-20 methacrylate copolymer, which is a (1:1) polymer of 2-propenoic acid, 2-hydroxyethyl ester, -(2-methyl-1-oxo-2-propen-1-yl)-q-(octadecyloxy)poly(oxy-1,2-ethanediyl) and sodium 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate.

[0039] An exemplary thickener is C13-14 isoparaffin, which is derived from petroleum and contains a mixture of branched chain aliphatic hydrocarbons with 13 or 14 carbons in the chain. C13-14 isoparaffin acts as a thickener due to its waxy texture.

[0040] An exemplary surfactant is the non-ionic surfactant and emulsifier polysorbate 80. Another exemplary mild non-ionic plant-derived surfactant is decyl glucoside.

[0041] In certain embodiments, the binder comprises at least one of HEA-sodium acryloyldimethyltaurate-steareth-20 methacrylate copolymer, C13-14 isoparaffin, polysorbate 80, decyl glucoside, and glycerin.

[0042] The hydrophilic occlusion-forming agent (e.g., glycerin), optionally in combination with a binder, contributes to the formation of a topical composition that is at least one of hypoallergenic, non-comedogenic, has an aesthetically pleasing texture (non-sticky or non-greasy), clear (does not stain clothing), and water-soluble, each of which, individually or cumulatively, encourages patient compliance with continued application of the topical composition.

[0043] The hydrophilic occlusion-forming agent in any of the topical compositions described herein may be present in a concentration (cumulative if one or more occlusion-forming agents are included) of from about 50 wt.%, about 60 wt.%, about 70 wt.%, about 75 wt.%, 80 wt.%, about 85 wt.%, about 90 wt.%, 92 wt.%, about 95 wt.%, or about 96 wt.%, to about 97 wt.%, about 97.5 wt.%, about 98 wt.%, about 98.5 wt.%, 99 wt.%, or about 99.5 wt.%, based on the total weight of the topical composition.

[0044] In certain embodiments, the hydrophilic occlusion-forming agent comprises glycerin, which may be present in any of the topical compositions described herein at a concentration of from about 50 wt.%, about 60 wt.%, about 70 wt.%, about 75 wt.%, about 80 wt.%, about 85 wt.%, about 90%, about 92 wt.%, about 95 wt.%, or about 96 wt.%, to about 97 wt.%, about 97.5 wt.%, about 98 wt.%, about 98.5 wt.%, about 99 wt.%, or about 99.5 wt.%, based on the total weight of the topical composition. In certain embodiments, the glycerin in the topical compositions described herein is in an amount ranging from about 70 wt.% to about 99 wt.%, from about 80 wt.% to about 98.5 wt.%, from about 90 wt.% to about 98 wt.%, or from about 95 wt.% to about 97 wt.%, based on the total weight of the topical composition.

[0045] In certain embodiments, the weight to weight ratio of hydrophilic occlusion-forming agent (e.g., glycerin) to binder may range from about 100:1, about 90:1, about 80:1, about 70:1, about 60:1, about 50:1, or about 40:1 to about 30:1, about 25:1, about 20:1, about 15:1, or about 10:1. The weight to weight ratio of hydrophilic occlusion-forming agent (e.g., glycerin) to binder is such that the topical composition can be applied and remain stationary on the scar while also maintaining an aesthetically pleasing texture of the topical composition.

[0046] In certain embodiments, suitable protease enzymes that may be utilized in the topical compositions described herein include, but are not limited to, bromelain, papain, or a combination thereof. In one embodiment, the protease in the topical composition is bromelain. In one embodiment, the protease in the topical composition is papain. In one embodiment, the protease in the topical composition is a combination of bromelain and papain.

[0047] In certain embodiments, the one or more proteolytic enzymes in the topical composition may be present in an amount effective for the removal, over production, of scar-forming proteins and tissue.

[0048] In certain embodiments, the one or more proteases are present in any of the topical compositions described herein in an amount (individually or cumulatively) ranging from greater than 0 wt.% to about 1 wt.%, from about 0.001 wt.% to about 0.5 wt.%, or from about 0.005 wt.% to about 0.3 wt.%, based on the total weight of the topical composition.

[0049] When a combination of papain and bromelain is present in the topical compositions described herein, the weight to weight ratio of papain to bromelain can range from any of about 10:1, about 8:1, about 5:1, about 3:1, about 2:1, or about 1:1, to any of about 1:2, about 1:3, about 1:5, about 1:8, or about 1:10.

[0050] As mentioned above, the uptake of proteolytic enzymes by skin can create irritation, stinging, burning and / or itching sensations, which can be quite unpleasant and cause the subject to lose the motivation to continue applying the composition.It has been discovered that incorporating an antioxidant system, including polyphenol antioxidants such as green tea polyphenols, soothes the skin (e.g., reduces redness, swelling and / or irritation), improves patient compliance with medication, and improves the overall effectiveness of the topical compositions described herein in scar treatment.In certain embodiments, polyphenols from sources other than green tea can also be suitably utilized in the topical compositions described herein (e.g., in addition to or as a substitute for green tea polyphenols).

[0051] Certain plants, such as Camellia sinensis (green tea), which is comprised of a high content of polyphenols, bioflavonoids, with antioxidant properties, can be included in any of the topical compositions described herein. The antioxidant system in the topical compositions described herein can range from greater than 0%, about 0.01 wt.%, about 0.05 wt.%, about 0.1 wt.%, about 0.15 wt.%, about 0.2 wt.%, about 0.25 wt.%, about 0.3 wt.%, about 0.35 wt.%, or about 0.4 wt.%, to about 0.45 wt.%, about 0.5 wt.%, about 0.55 wt.%, about 0.65 wt.%, about 0.75 wt.%, about 0.85 wt.%, about 0.95 wt.%, about 0.10 wt.%, about 0.15 wt.%, about 0.25 wt.%, about 0.35 wt.%, or about 0.4 wt.%, based on the total weight of the topical composition. It may be present at a concentration of up to any of about 0.6 wt.%, about 0.65 wt.%, about 0.7 wt.%, about 0.75 wt.%, about 0.8 wt.%, about 0.85 wt.%, about 0.9 wt.%, about 0.95 wt.%, about 1 wt.%, about 1.5 wt.%, about 2 wt.%, about 3 wt.%, about 4 wt.%, about 5 wt.%, about 6 wt.%, about 7 wt.%, about 8 wt.%, about 9 wt.%, or about 10 wt.%.

[0052] In certain embodiments, the topical composition comprises an effective amount of a polyphenol antioxidant to help soothe the skin in the scarred area. In certain embodiments, the topical composition comprises an effective amount of a green tea polyphenol isolate derived from green tea, which has strong antioxidant properties, to help soothe the skin in the scarred area. Suitable green tea polyphenols include, but are not limited to, catechins, such as epigallocatechin gallate (EGCG), epigallocatechin (EGC), epicatechin gallate (ECG), and epicatechin (EC), their cis and trans isomers, their salts, their equivalent derivatives, and combinations thereof.

[0053] In certain embodiments, the topical composition comprises an antioxidant system comprising any of the green tea polyphenols described herein in combination with at least one additional antioxidant.

[0054] In one embodiment, the additional antioxidants in the antioxidant system can be selected from cinnamic acid, ferulic acid, caffeic acid, p-coumaric acid, sinapic acid, their cis and trans isomers, their salts, their equivalent derivatives, or combinations thereof. In another embodiment, the additional antioxidants in the antioxidant system (and in the topical composition generally) can be free or substantially free of cinnamic acid, ferulic acid, caffeic acid, p-coumaric acid, sinapic acid, their cis and trans isomers, their salts, their equivalent derivatives, or combinations thereof.

[0055] In certain embodiments, the additional antioxidant in the antioxidant system can be selected from resveratrol, gallic acid, delphinidin, luteolin, quercetin, cyanidin, taxifolin, kaempferol, malvidin, hesperidin, pelagonidin, apigenin, naringenin, chrysin, ergothioneine, glutathione, emblica, vitamin E (tocopherol), allantoin, cis and trans isomers thereof, salts thereof, equivalent derivatives thereof, or combinations thereof.

[0056] In certain embodiments, the additional antioxidant in the antioxidant system can be selected from vitamin E (tocopherol), allantoin, or a combination thereof. The antioxidant system may include a combination of antioxidants that will be taken up by adipose tissue and antioxidants that will be taken up by the hydrophilic interstitial fluid of the skin.

[0057] Any of the above antioxidants can also be used, in certain embodiments, as a substitute for green tea polyphenols in any of the topical compositions described herein.

[0058] Each of the antioxidants in the antioxidant system may individually or cumulatively comprise, based on the total weight of the topical composition, any of greater than 0 wt.%, about 0.01 wt.%, about 0.05 wt.%, about 0.1 wt.%, about 0.15 wt.%, about 0.2 wt.%, about 0.25 wt.%, about 0.3 wt.%, about 0.35 wt.%, or about 0.4 wt.%, up to about 0.45 wt.%, about 0.5 wt.%, about 0.55 wt.%, about It may be present in a concentration of up to any of 0.6 wt.%, about 0.65 wt.%, about 0.7 wt.%, about 0.75 wt.%, about 0.8 wt.%, about 0.85 wt.%, about 0.9 wt.%, about 0.95 wt.%, about 1 wt.%, about 1.5 wt.%, about 2 wt.%, about 3 wt.%, about 4 wt.%, about 5 wt.%, about 6 wt.%, about 7 wt.%, about 8 wt.%, about 9 wt.%, or about 10 wt.%.

[0059] In certain embodiments, the cosmetically acceptable excipients include additional antioxidants, such as a form of vitamin E. Suitable forms of vitamin E that may be included in the topical composition can be selected from alpha-, beta-, delta-, and gamma-tocopherol, and alpha-, beta-, delta-, and gamma-tocotrienol, and combinations thereof. In certain embodiments, the antioxidant system comprises vitamin E present in the topical composition in an amount ranging from greater than 0 wt.% to about 0.5 wt.%, greater than 0 wt.% to about 0.1 wt.%, or greater than 0 wt.% to about 0.02 wt.%, based on the total weight of the topical composition.

[0060] In certain embodiments, the antioxidant system comprises allantoin present in the topical composition in an amount ranging from greater than 0 wt.% to about 0.5 wt.%, greater than 0 wt.% to about 0.1 wt.%, or greater than 0 wt.% to about 0.02 wt.%, based on the total weight of the topical composition.

[0061] In certain embodiments, the antioxidant system comprises green tea polyphenols in an amount ranging from greater than 0 wt.% to about 0.5 wt.%, greater than 0 wt.% to about 0.1 wt.%, or greater than 0 wt.% to about 0.05 wt.%, based on the total weight of the topical composition.

[0062] In certain embodiments, the antioxidant system comprises a combination of any of the green tea polyphenols described herein and at least one of vitamin E (tocopherol) and allantoin in an amount of from greater than 0 wt.%, about 0.01 wt.%, about 0.05 wt.%, about 0.1 wt.%, about 0.15 wt.%, about 0.2 wt.%, about 0.25 wt.%, about 0.3 wt.%, about 0.35 wt.%, or about 0.4 wt.%, based on the total weight of the topical composition, to about 0.45 wt.%, about 0. Comprises, consists of, or consists essentially of at a concentration (individually or cumulatively) of up to any of 5 wt.%, about 0.55 wt.%, about 0.6 wt.%, about 0.65 wt.%, about 0.7 wt.%, about 0.75 wt.%, about 0.8 wt.%, about 0.85 wt.%, about 0.9 wt.%, about 0.95 wt.%, about 1 wt.%, about 1.5 wt.%, about 2 wt.%, about 3 wt.%, about 4 wt.%, about 5 wt.%, about 6 wt.%, about 7 wt.%, about 8 wt.%, about 9 wt.%, or about 10 wt.%.

[0063] In certain embodiments, the weight to weight ratio of green tea polyphenols to one or more additional antioxidants (individually or cumulatively) ranges from about 10:1 to about 1:10, from about 8:1 to about 1:8, from about 5:1 to about 1:5, from about 3:1 to about 1:3, from about 2:1 to about 1:2, or is about 1:1.

[0064] In certain embodiments, any of the topical compositions described herein are anhydrous, meaning that water is not intentionally added to the topical composition, for example, when preparing the topical composition. However, because the topical compositions described herein contain a hydrophilic occlusion-forming agent (e.g., glycerin), it can hydrogen bond some water. In certain embodiments, the topical compositions described herein contain less than about 10 wt.% water, less than about 8 wt.% water, less than about 5 wt.% water, less than about 3 wt.% water, less than about 2 wt.% water, less than about 1 wt.% water, or no water, based on the total weight of the topical composition. In certain embodiments, the upper water limit reflects the maximum holding capacity of the topical composition, above which the topical composition may exhibit properties different from those described herein. In certain embodiments, the upper water limit reflects the water content in the topical composition due to moisture that may be present in the raw materials used to form the topical composition.

[0065] In certain embodiments, any of the topical compositions described herein contains less than about 8 wt.% urea or urea derivatives, less than about 5 wt.% urea or urea derivatives, less than about 3 wt.% urea or urea derivatives, less than about 1 wt.% urea or urea derivatives, or no urea or urea derivatives, based on the total weight of the topical composition. Urea derivatives contemplated by the present disclosure include derivatives of urea that function similarly to or act similarly to urea when used in skin care treatments, such as, but not limited to, dimethylurea, dimethylolurea, hydroxyethylurea, and hydroxyethoxyethylurea, among others.

[0066] In certain embodiments, any of the topical compositions described herein contains, based on the total weight of the topical composition, less than about 10 wt.% of a silicone-based component, less than about 8 wt.% of a silicone-based component, less than about 5 wt.% of a silicone-based component, less than about 3 wt.% of a silicone-based component, less than about 1 wt.% of a silicone-based component, less than about 0.5 wt.% of a silicone-based component, less than about 0.3 wt.% of a silicone-based component, less than about 0.1 wt.% of a silicone-based component, or no silicone-based component. Exemplary silicone-based components include, but are not limited to, dimethicone, dimethylpolysiloxane, methylphenylpolysiloxane, cyclic silicones, and also amino-, fatty acid-, alcohol-, polyether-, epoxy-, fluorine-, glycoside-, and / or alkyl-modified silicone components, which may be in either liquid or resinous form at room temperature. Linear polysiloxane, dimethiconol, cyclic silicone fluid, cyclopentasiloxane volatile, phenyl trimethicone, simethicone (a mixture of dimethicone having an average chain length of 200 to 300 dimethylsiloxane units with hydrogenated silicate), or combinations thereof.

[0067] In certain embodiments, the topical compositions contemplated by the present disclosure are hypoallergenic. As such, they can be utilized on sensitive skin while remaining substantially unlikely to cause an allergic reaction.

[0068] In certain embodiments, the topical compositions contemplated by the present disclosure are non-comedogenic. Thus, these topical compositions do not cause pore blockage when applied to the skin of a subject. In certain embodiments, the topical compositions described herein are substantially free of ingredients that may clog pores, such as, but not limited to, petrolatum, jojoba oil, olive oil, avocado oil, isopropyl myristate, isopropyl palmitate, ethylhexyl palmitate, propylene glycol-2 (PPG-2) myristyl propionate, acetylated lanolin, tar, artificial colors, etc.

[0069] In certain embodiments, the topical compositions described herein have an initial viscosity of about 500,000 cPs to about 1,000,000 cPs, about 550,000 cPs to about 850,000 cPs, or about 620,000 cPs to about 780,000 cPs at 25° C., measured with a viscometer model LVT equipped with a TF Heliopath spindle at 0.6 RPM and taking a 1-minute reading.

[0070] In certain embodiments, the topical compositions described herein have a pH at 25° C. of about 3.00 to about 9.00, about 4.00 to about 9.00, about 5.00 to about 9.00, about 6.00 to about 9.00, about 6.50 to about 8.50, or about 7.00 to about 8.00.

[0071] In certain embodiments, the topical compositions described herein comprise at least one additional cosmetically acceptable excipient. Exemplary cosmetically acceptable excipients include, but are not limited to, epidermal penetration enhancers, solvents, mild surfactants (e.g., polysorbate 80, decyl glucoside, etc.), oil bodies, emulsifiers, pearlescent waxes, consistency modifiers, thickeners (e.g., HEA-sodium acryloyldimethyltaurate-steareth-20 methacrylate copolymer, C13-14 isoparaffin, etc.), rheology modifiers, suspending agents, chelating agents, preservatives, superfatting agents, stabilizers or carriers (e.g., dimethicone), polymers, additional silicone or siloxane compounds, fats, waxes, resins, etc. These additives include tin, phospholipids, UV photoprotective agents, bioactive ingredients, additional antioxidants, deodorants, antiperspirants, antidandruff agents, film-forming agents, swelling agents, insect repellents, self-tanning agents, tyrosinase inhibitors, hydrotropes, solubilizers, fragrance oils, dyes, zinc oxide, fatty alcohols, esters of fatty acids, adjuvants, natural or synthetic triglyceride-containing glyceryl esters and derivatives, hydrocarbon oils, superfatting agents, hydrotropes, bacterial inhibitors, colorants, UV screening agents, agents that absorb UV light and provide photoprotection to the skin, preservatives (e.g., phenoxyethanol), and combinations thereof. In certain embodiments, the topical composition includes a cosmetically acceptable excipient selected from the group consisting of a thickener, a preservative, a stabilizer, or a carrier, or a combination thereof.

[0072] In certain embodiments, the cosmetically acceptable excipients in the topical composition include a preservative. Suitable preservatives include, for example, a solution of phenoxyethanol, parabens, pentanediol, and sorbic acid, and a silver complex known under the commercial reference Surfacine®, as well as other classes of substances, i.e., suitable preservatives, listed in Appendix 6, Parts A and B of the Cosmetics Regulations. In certain embodiments, the topical compositions described herein include a preservative that is phenoxyethanol in an amount of up to about 2 wt.%, up to about 1.5 wt.%, or up to 0.5 wt.%, based on the total weight of the topical composition. In certain embodiments, the topical compositions described herein are substantially free of or free of preservatives.

[0073] In certain embodiments, the topical compositions described herein include one or more stabilizers or carriers, such as dimethicone. In certain embodiments, the topical compositions described herein include dimethicone in an amount of at most about 10 wt.%, at most about 8 wt.%, at most about 5 wt.%, at most about 3 wt.%, at most about 1 wt.%, at most about 0.5 wt.%, or at most about 0.1 wt.%, based on the total weight of the topical composition.

[0074] The stabilizers or carriers incorporated into the topical compositions described herein enhance the aesthetic texture of the composition, making the topical composition silky, light, dry, comfortable, non-greasy and non-sticky, and easily washable.

[0075] The topical compositions described herein may be formulated in any dermatologically acceptable vehicle, such as an ointment, serum, emulsion, cream, foam, spray, salve, gel, lotion, or as a pad or roll-on application formulation, which may contain ingredients that physically or cosmetically improve, modify, or stabilize the composition. In one embodiment, the topical composition is a homogeneous gel.

[0076] Topical compositions according to the present disclosure may also contain one or more additional cosmetically acceptable excipients as described below.

[0077] solvent In certain embodiments, cosmetically acceptable excipients that may be used in the topical compositions described herein include, but are not limited to, polysorbate 20, water, alkanediols (e.g., ethylene glycol, propylene glycol, butylene glycol), ethoxylated or propoxylated diglycols, ethanol, propanol, isopropanol, glycerin, methoxyisopropanol, PPG-2 methyl ether, PPG-3 methyl ether, propylene glycol butyl ether, PPG-2 butyl ether, phenoxyisopropanol, butoxyethanol, butoxydiglycol, methoxydiglycol, phenoxyethanol, PPG-3 butyl ether, PPG-2 propyl ether, propylene glycol propyl ether, or dipropylene glycol dimethyl ether, or mixtures and combinations thereof, or individual ethoxylates, propoxylates, and glyceryl esters.

[0078] gum In certain embodiments, cosmetically acceptable excipients include, but are not limited to, natural gums (e.g., natural vegetable gums). Suitable natural gums include guar gum, carob gum, konjac gum, xanthan gum, sclerotium gum, acacia gum, cellulose gum (modified or unmodified), or combinations thereof.

[0079] chelating agents In certain embodiments, the cosmetically acceptable excipients include chelating agents. Suitable chelating agents include, but are not limited to, disodium ethylenediaminetetraacetic acid (EDTA), diethylenetriaminepentaacetic acid (DTPA), N-(hydroxyethyl)-ethylenediaminetriacetic acid (HEDTA), and nitrilotriacetic acid (NTA).

[0080] perfume oil In certain embodiments, cosmetically acceptable excipients include perfume oils.Suitable perfume oils include mixtures of natural and synthetic fragrances.Natural fragrances include extracts from flowers (lily, lavender, rose, jasmine, neroli, ylang-ylang), stems and leaves (geranium, patchouli, petitgrain), fruits (aniseed, coriander, cumin, juniper), peels (bergamot, lemon, orange), roots (nutmeg, angelica, celery, cardamom, costus, iris, carmus), wood (pine, sandalwood, holly, cedarwood, rosewood), herbs and grasses (tarragon, lemongrass, sage, thyme), needles and branches (spruce, fir, pine, low pine), resins and balsams (galbanum, elemi, benzoin, myrrh, olibanum, opoponax). Typical synthetic fragrance compounds are products of the ester, ether, aldehyde, ketone, alcohol and hydrocarbon type. Ester type fragrance compounds are, for example, benzyl acetate, phenoxyethyl isobutyrate, p-tert-butylcyclohexyl acetate, linalyl acetate, dimethylbenzylcarbinyl acetate, phenylethyl acetate, linalyl benzoate, benzyl formate, ethyl-methylphenylglycinate, allyl cyclohexylpropionate, styrallyl propionate and benzyl salicylate. Examples of ethers include benzyl ethyl ether; examples of aldehydes include linear alkanals having 8 to 18 carbon atoms, citral, citronellal, citronellyloxyacetaldehyde, cyclamen aldehyde, hydroxycitronellal, lilial, and beaujnal; examples of ketones include ionones, α-isomethylionone, and methyl cedryl ketone; examples of alcohols include anethole, citronellol, eugenol, isoeugenol, geraniol, linalool, phenylethyl alcohol, and terpinol; and examples of hydrocarbons include mainly terpenes and balsams.

[0081] Essential oils of relatively low volatility, mostly used as aroma ingredients, are also suitable as perfume oils, such as sage oil, chamomile oil, clove oil, melissa oil, mint oil, cinnamon leaf oil, linden blossom oil, juniper oil, vetiver oil, olibanum oil, galbanum oil, labranum oil and lavandin oil. Other suitable oils include, alone or in mixtures, bergamot oil, dihydromyrcenol, lilial, lyral, citronellol, phenylethyl alcohol, α-hexyl cinnamaldehyde, geraniol, benzyl acetone, cyclamen aldehyde, linalool, Boisambrene Forte®, Ambroxan®, indole, hedione, sandelice, lemon oil, mandarin oil, orange oil, allyl amyl glycolate, cyclovertal, lavandin oil, clary sage oil, β-damascone, geranium oil bourbon, cyclohexyl salicylate, Vertofix coeur®, iso-E-super®, Fixolide NP®, Evernyl®, iraldein gamma, phenylacetic acid, geranyl acetate, benzyl acetate, rose oxide, Romilat®, Irotyl® and Floramat®.

[0082] In certain embodiments, the cosmetically acceptable excipients include perfume oils that are essential oils selected from the group of lavender oil, bergamot oil, eucalyptus oil, chamomile oil, melaleuca oil, or combinations thereof.

[0083] fatty alcohols Guerbet alcohols based on fatty alcohols having 6 to 18, preferably 8 to 10, carbon atoms. Cetyl alcohols include cetyl alcohol, stearyl alcohol, cetearyl alcohol, oleyl alcohol, octyldodecanol, benzoates of C12 to C15 alcohols, acetylated lanolin alcohol, etc.

[0084] Esters of fatty acids Straight chain C6~C 24 Straight chain C3-C fatty acids 24 Esters with alcohols, branched C6-C 13 Straight chain C6-C carboxylic acids 24 Esters with fatty alcohols, linear C6-C 24 Esters of fatty acids with branched alcohols, especially 2-ethylhexanol, and linear or branched C6-C hydroxycarboxylic acids 22 Esters of fatty alcohols, in particular dioctyl maleate, of linear and / or branched fatty acids with polyhydric alcohols (for example propylene glycol, dimerdiol or trimertriol) and / or Guerbet alcohols, such as caproic acid, caprylic acid, 2-ethylhexanoic acid, caprylic acid, lauric acid, isotridecanoic acid, myristic acid, palmitic acid, palmitoleic acid, stearic acid, isostearic acid, oleic acid, elaidic acid, petroselinic acid, linoleic acid, linolenic acid, elaeostearic acid, arachidic acid, gadoleic acid, behenic acid and erucic acid, and technical grade mixtures thereof (obtained, for example, in the pressure stripping of natural fats and oils, in the reduction of aldehydes from the oxosynthesis of lauric acid or in the dimerization of unsaturated fatty acids), alcohols, for example isopropyl alcohol. alcohol, caproic alcohol, caprylic alcohol, 2-ethylhexyl alcohol, capric alcohol, lauryl alcohol, isotridecyl alcohol, myristyl alcohol, cetyl alcohol, palmoleyl alcohol, stearyl alcohol, isostearyl alcohol, oleyl alcohol, elaidyl alcohol, petroselinyl alcohol, linoyl alcohol, linolenyl alcohol, elaeostearyl alcohol, arachidyl alcohol, gadoleyl alcohol, behenyl alcohol, erucyl alcohol and brassidyl alcohol, as well as technical grade mixtures thereof (obtained, for example, in the high-pressure hydrogenation of technical grade methyl esters based on fats and oils, or as aldehydes from the oxosynthesis of laureth, and as monomer fractions in the dimerization of unsaturated fatty alcohols).

[0085] Examples of such ester oils include isopropyl myristate, isopropyl palmitate, isopropyl stearate, isopropyl isostearate, isopropyl oleate, n-butyl stearate, n-hexyl laurate, n-decyl oleate, isooctyl stearate, isononyl stearate, isononyl isononanoate, 2-ethylhexyl palmitate, 2-hexyl laurate, 2-hexyldecyl stearate, 2-octyldodecyl palmitate, and oleic acid esters. These include oleyl, oleyl erucate, erucyl oleate, erucyl erucate, cetearyl octanoate, cetyl palmitate, cetyl stearate, cetyl oleate, cetyl behenate, cetyl acetate, myristyl myristate, myristyl behenate, myristyl oleate, myristyl stearate, myristyl palmitate, myristyl lactate, propylene glycol dicaprylate / caprate, stearyl heptanoate, diisostearyl maleate, and octyl hydroxystearate.

[0086] Other adjuvants Diethylhexyl 2,6-naphthalate, di-n-butyl adipate, di(2-ethylhexyl)-adipate, di(2-ethylhexyl)succinate and diisotridecyl acetate, and also diol esters such as ethylene glycol dioleate, ethylene glycol diisotridecanoate, propylene glycol di(2-ethylhexanoate), propylene glycol diisostearate, propylene glycol dipelargonate, butanediol diisostearate and neopentyl glycol dicaprylate. 24 Esters of fatty alcohols and / or Guerbet alcohols with aromatic carboxylic acids, saturated and / or unsaturated, in particular benzoic acid, C2-C 12 Esters of dicarboxylic acids with linear or branched alcohols having 1 to 22 carbon atoms or polyols having 2 to 10 carbon atoms and 2 to 6 hydroxy groups.

[0087] Natural or synthetic triglycerides, including glyceryl esters and derivatives C6-C modified by reaction with other alcohols (e.g., caprylic / capric triglyceride, wheat germ glyceride) 18 Di- or triglycerides based on fatty acids, such as fatty acid esters of polyglycerol (polyglyceryl-n, e.g., polyglyceryl-4 caprate, polyglyceryl-2 isostearate, etc.), or castor oil, hydrogenated vegetable oil, sweet almond oil, wheat kernel oil, sesame oil, hydrogenated cottonseed oil, coconut oil, avocado oil, corn oil, hydrogenated castor oil, shea butter, cocoa butter, soybean oil, mink oil, sunflower oil, safflower oil, macadamia nut oil, olive oil, hydrogenated tallow, apricot kernel oil, hazelnut oil, borage oil, etc.

[0088] Waxes containing esters of long-chain acids and alcohols, and compounds with wax-like properties, such as carnauba wax, beeswax (white or yellow), lanolin wax, candelilla wax, ozokerite, Japan wax, paraffin wax, microcrystalline wax, ceresin, cetearyl ester wax, synthetic beeswax, etc. Also, hydrophilic waxes such as cetearyl alcohol or partial glycerides.

[0089] pearlescent wax Alkylene glycol esters, in particular ethylene glycol distearate; fatty acid alkanolamides, in particular coco fatty acid diethanolamide; partial glycerides, in particular stearic acid monoglyceride; esters of polyhydric unsubstituted or hydroxy-substituted carboxylic acids with fatty alcohols having 6 to 22 carbon atoms, in particular long-chain esters of tartaric acid; fatty substances, such as fatty alcohols, fatty ketones, fatty aldehydes, fatty ethers and fatty carbonates having a total of at least 24 carbon atoms, in particular lauryl and distearyl ether, fatty acids, such as stearic acid, hydroxystearic acid or behenic acid, ring-opening products of olefin epoxides having 12 to 22 carbon atoms with fatty alcohols having 12 to 22 carbon atoms, and / or polyols having 2 to 15 carbon atoms and 2 to 10 hydroxy groups, and mixtures thereof.

[0090] hydrocarbon oil Mineral oil (light or heavy), petrolatum (yellow or white), microcrystalline waxes, paraffin and isoparaffin compounds, hydrogenated isoparaffin molecules such as polydecene and polybutene, hydrogenated polyisobutene, squalane, isohexadecane, isododecane, and others from the plant and animal kingdoms.

[0091] Further silicones or siloxanes (organo-substituted polysiloxanes) Dimethylpolysiloxanes, methylphenylpolysiloxanes, cyclic silicones, and also amino-, fatty acid-, alcohol-, polyether-, epoxy-, fluorine-, glycoside-, and / or alkyl-modified silicone compounds, which may be in either liquid or resinous form at room temperature, include linear polysiloxanes, dimethicones (Dow Corning 200 fluid, Rhodia Mirasil DM), dimethiconol, cyclic silicone fluids, cyclopentasiloxane volatiles (Dow Corning 345 fluid), and phenyltrimethicones (Dow Corning 556 fluid). Also suitable is simethicone, a mixture of dimethicones with hydrogenated silicates having an average chain length of 200 to 300 dimethylsiloxane units. A detailed survey of suitable volatile silicones can be found in Todd et al., Cosm. Toil. 91, 27 (1976).

[0092] emulsifier Any conventionally available emulsifier can be used in the composition. Emulsifier systems may include, for example, carboxylic acids and their salts: alkaline soaps of sodium, potassium, and ammonium, metallic soaps of calcium or magnesium, and organic soaps such as lauric acid, palmitic acid, stearic acid, and oleic acid. Alkyl phosphates or phosphate esters, acid phosphates, diethanolamine phosphate, potassium cetyl phosphate. Ethoxylated carboxylic acids or polyethylene glycol esters, PEG-n acrylates. Linear fatty alcohols with 8 to 22 carbon atoms, branched fatty alcohols with 2 to 30 moles of ethylene oxide and / or 0 to 5 moles of propylene oxide, fatty acids with 12 to 22 carbon atoms in the alkyl group, and alkylphenols with 8 to 15 carbon atoms. Fatty alcohol polyglycol ethers, such as laureth-n, ceteareth-n, steareth-n, and oleth-n. Fatty acid polyglycol ethers, such as PEG-n stearate, PEG-n oleate, and PEG-n cocoate. Monoglycerides and polyol esters. C12-C22 fatty acid mono- and di-esters of adducts of 1 to 30 moles of ethylene oxide with polyols. Fatty acid and polyglycerol esters, such as glycerol monostearate, diisostearoyl polyglyceryl-3-diisostearate, polyglyceryl-3-diisostearate, triglyceryl diisostearate, polyglyceryl-2-sesquiisostearate, or polyglyceryl dimerate. Mixtures of compounds from several of these substance classes are also suitable. Fatty acid polyglycol esters, such as diethylene glycol monostearate, fatty acid and polyethylene glycol esters, fatty acid and sucrose esters, such as sucroesters, glycerol and sucrose esters, such as sucroglycerides. Sorbitol and sorbitan, sorbitan mono- and di-esters of saturated and unsaturated fatty acids having 6 to 22 carbon atoms, and ethylene oxide addition products.Polysorbate-n series, sorbitan esters such as sesquiisostearate, sorbitan, PEG-(6)-sorbitan isostearate, PEG-(10)-sorbitan laurate, and PEG-17-sorbitan dioleate. Glucose derivatives, C8-C22 alkyl mono- and oligoglycosides, and ethoxylated analogs with glucose as the preferred sugar component. O / W emulsifiers such as methyl gluceth-20 sesquistearate, sorbitan stearate / sucrose cocoate, methyl glucose sesquistearate, cetearyl alcohol / cetearyl glucoside. W / O emulsifiers such as methyl glucose dioleate / methyl glucose isostearate. Sulfates and sulfonated derivatives, dialkyl sulfosuccinates, dioctyl succinate, alkyl lauryl sulfonates, linear sulfonated paraffins, sulfonated tetrapropylene sulfonates, sodium lauryl sulfate, ammonium lauryl sulfate and ethanolamine, lauryl ether sulfate, sodium laureth sulfate, sulfosuccinates, acetyl isothionate, alkanolamide sulfates, taurine, methyl taurine, imidazole sulfate. Polysiloxane / polyalkyl / polyether copolymers and derivatives, dimethicone, copolyols, silicone polyethylene oxide copolymers, silicone glycol copolymers. Propoxylated or POE-n ethers (meroxapols), poloxamers, or poly(oxyethylene) m-block-poly(oxypropylene) n-block(oxyethylene). Zwitterionic surfactants containing at least one quaternary ammonium group and at least one carboxylate and / or sulfonate group in the molecule.Particularly suitable zwitterionic surfactants are betaines, such as N-alkyl-N,N-dimethylammonium glycinates, cocoalkyldimethylammonium glycinates, N-acylaminopropyl-N,N-dimethylammonium glycinates, cocoacylaminopropyldimethylammonium glycinates, and 2-alkyl-3-carboxymethyl-3-hydroxyethylimidazolines (each having 8 to 18 carbon atoms in the alkyl or acyl group), and also cocoacylaminoethyl hydroxyethylcarboxymethylglycinates, N-alkylbetaines, N-alkylaminobetaines, alkylimidazolines, alkylpeptides, lipoaminoacids, self-emulsifying bases, and compounds listed in K.F. DePolo, A Short Textbook of Cosmetology, Chapter 8, Table 8-7, pp. 250-251.

[0093] Nonionic bases, such as PEG-6 beeswax (and) PEG-6 stearate (and) polyglyceryl-2-isostearate, glyceryl stearate (and) PEG-100 stearate, PEG-5 glyceryl stearate, sorbitan oleate (and) polyglyceryl-3 ricinoleate, sorbitan stearate and sucrose cocoate, glyceryl stearate and laureth-23, cetearyl alcohol and ceteth-20, cetearyl alcohol and polysorbate 60, and PEG-150 and stearate-20, cetearyl alcohol and cetearyl polyglucoside, cetearyl alcohol and ceteareth-20, cetearyl alcohol and PEG-40 castor oil ... Tearyl alcohol and PEG-40 castor oil and sodium cetearyl sulfate, stearyl alcohol and steareth-7 and steareth-10, cetearyl alcohol and steareth-7 and steareth-10, glyceryl stearate and PEG-75 stearate, propylene glycol ceteth-3 acetate, propylene glycol isoceteth-3 acetate, cetearyl alcohol and ceteth-12 and oleth-12, PEG-6 stearate and PEG-32 stearate, PEG-6 stearate and ceteth-20 and steareth-20, PEG-6 stearate and ceteth-20 and glyceryl stearate and ceteareth-20, glyceryl stearate and ceteareth-20.

[0094] Anionic alkali bases, such as PEG-2 stearate SE, glyceryl stearate SE, and propylene glycol stearate. Anionic acid bases, such as cetearyl alcohol and sodium cetearyl sulfate, cetearyl alcohol and sodium lauryl sulfate, trilaneth-4 phosphate and glycol stearate and PEG-2 stearate, glyceryl stearate and sodium lauryl sulfate. Cationic acid bases, such as cetearyl alcohol and cetrimonium bromide.

[0095] Suitable emulsifiers also include, but are not limited to, PEG-30 dipolyhydroxystearate, PEG-4 dilaurate, PEG-8 dioleate, PEG-40 sorbitan peroleate, PEG-7 glyceryl cocoate, PEG-20 almond glycerides, PEG-25 hydrogenated castor oil, stearic acid glycerides (and) PEG-100 stearate, PEG-7 olivate, PEG-8 oleate, PEG-8 laurate, PEG-60 almond glycerides, PEG-20 methyl glucose sesquistearate, PEG-40 stearate, PEG-100 stearate The emulsion may also include PEG-80 sorbitan laurate, steareth-2, steareth-12, oleth-2, ceteth-2, laureth-4, oleth-10, oleth-10 / polyoxyl 10 oleyl ether, ceteth-10, isosteareth-20, ceteareth-20, oleth-20, steareth-20, steareth-21, ceteth-20, isoceteth-20, laureth-23, steareth-100, glyceryl stearate citrate, glyceryl stearate SE (self-emulsifying), stearic acid, salts of stearic acid, polyglyceryl-3-methylglycose distearate, or combinations thereof.

[0096] Further suitable emulsifiers are phosphate esters and their salts, such as cetyl phosphate (Amphisol® A), diethanolamine cetyl phosphate (Amphisol® DEA), potassium cetyl phosphate (Amphisol® K), sodium cetearyl sulfate, sodium glyceryl oleate phosphate, hydrogenated vegetable glyceride phosphate, and mixtures thereof. Further suitable emulsifiers are sorbitan oleate, sorbitan sesquioleate, sorbitan isostearate, sorbitan trioleate, cetearyl glucoside, lauryl glucoside, decyl glucoside, sodium stearoyl glutamate, sucrose polystearate, and hydrated polyisobutene. Furthermore, one or more synthetic polymers may be used as emulsifiers. For example, PVP eicosene copolymer, acrylate / C 10~30Alkyl acrylate crosspolymer, acrylates / steareth-20 methacrylate copolymer, PEG-22 / dodecyl glycol copolymer, PEG-45 / dodecyl glycol copolymer, and mixtures thereof.

[0097] Adjuvants and additives Cosmetic sunscreen compositions, such as creams, gels, lotions, alcoholic and aqueous / alcoholic solutions, emulsions, wax / fat compositions, stick preparations, powders or ointments, can further contain as further adjuvants and additives, for example mild surfactants, superfatting agents, consistency regulators, thickeners, polymers, stabilizers, bioactive ingredients, swelling agents, further UV photoprotective factors, antioxidants, hydrotropic agents, preservatives, self-tanning agents, solubilizers, perfume oils, colorants, bacteria inhibitors, etc.

[0098] Superfatting agent Substances suitable for use as superfatting agents are, for example, lanolin and lecithin, and also polyethoxylated or acetylated lanolin and lecithin derivatives, polyol fatty acid esters, monoglycerides and fatty acid alkanolamides, the latter simultaneously acting as foam stabilizers.

[0099] surfactants Examples of suitable mild surfactants, i.e. surfactants that are particularly well tolerated by the skin, include fatty alcohol polyglycol ether sulfates, sulfate monoglycerides, mono- and / or di-alkyl sulfosuccinates, fatty acid isethionates, fatty acid sarcosinates, fatty acid taurides, fatty acid glutamates, alpha-olefin sulfonates, ether carboxylic acids, alkyl oligoglucosides, fatty acid glucamides, alkylamidobetaines and / or protein fatty acid condensation products, the latter preferably based on wheat protein.

[0100] Further consistency control agents / thickeners and rheology modifiers Silicon dioxide, magnesium silicate, aluminum silicate, polysaccharides or derivatives thereof, such as hyaluronic acid, xanthan gum, guar-guar, agar-agar, alginate, carrageenan, gellan, pectin or modified celluloses, such as hydroxycellulose, hydroxypropylmethylcellulose. In addition to polyacrylates, or homopolymers of reticulated acrylic acid and polyacrylamide, there are also carbomers (CARBOPOL types 980, 981, 1382, ETD2001, ETD2020, ULTREZ10) or the SALCARE range, such as SALCARE C80 (steareth-10 allyl ether / acrylate copolymer), Salcare SC81 (acrylate copolymer), Salcare SC91 and Salcare AST (sodium acrylate copolymer / PPG-1 trideceth-6), SEPIGEL 305 (polyacrylamide / laureth-7), SIMULGEL NS and SIMULGEL EG (hydroxyethyl acrylate / sodium acryloyldimethyltaurate copolymer), STABILEN 30 (acrylates / vinyl isodecanoate crosspolymer), PEMULEN TR-1 (acrylates / C10-30 alkyl acrylate crosspolymer), LUVIGEL EM (sodium acrylate copolymer), ACULYN 28 (acrylates / beheneth-25 methacrylate copolymer), etc.

[0101] polymer Examples of anionic, zwitterionic, amphoteric, and nonionic polymers that may be considered include vinyl acetate / crotonic acid copolymers, vinylpyrrolidone / vinyl acrylate copolymers, vinyl acetate / butyl maleate / isobornyl acrylate copolymers, methyl vinyl ether / maleic anhydride copolymers and their esters, uncrosslinked polyacrylic acid and polyacrylic acid crosslinked with polyols, acrylamidopropyl-trimethylammonium chloride / acrylate copolymers, octylacrylamide / methyl methacrylate-tert-butylaminoethyl methacrylate / 2-hydroxypropyl methacrylate copolymers, polyvinylpyrrolidone, vinylpyrrolidone / vinyl acetate copolymers, vinylpyrrolidone / dimethylaminoethyl methacrylate / vinyl caprolactam terpolymers, and also optionally derivatized cellulose ethers and silicones. Furthermore, the polymers described in European Patent Application No. 1093796 (pages 3-8, paragraphs 17-68) can be used.

[0102] Bioactive ingredients Bioactive ingredients are understood to mean, for example, tocopherol palmitate, deoxyribonucleic acid, retinol, bisabolol, phytantriol, panthenol, AHA acids, amino acids, ceramides, pseudoceramides, essential oils, plant extracts and vitamin complexes.

[0103] Additional Antioxidants In addition to the primary photoprotective substance, it is also possible to use secondary photoprotective substances of the antioxidant class, which interrupt the photochemical reaction chain that is triggered when UV radiation penetrates the skin or hair. Typical examples of such antioxidants are amino acids (e.g., glycine, histidine, tyrosine, tryptophan) and their derivatives, imidazoles (e.g., urocanic acid) and their derivatives, peptides, e.g., D,L-carnosine, D-carnosine, L-carnosine and their derivatives (e.g., anserine), carotenoids, carotenes, lycopene and their derivatives, chlorogenic acid and its derivatives, lipoic acid and its derivatives (e.g., dihydrolipoic acid), aurothioglycol, propylthiouracil, and other thiols (e.g., thioredoxin, glutathione, cysteine, cystine, cystamine, and glycosyl, N-acetyl, methyl, ethyl, propyl, amyl, butyl, lauryl, palmitoyl, oleyl, linoleyl) dilauryl, cholesteryl and their glyceryl esters) and also their salts, dilauryl thiodipropionate, distearyl thiodipropionate, thiodipropionic acid and their derivatives (esters, ethers, peptides, lipids, nucleotides, nucleosides and salts), and also sulfoximine compounds (e.g. buthionine sulfoximine, homocysteine ​​sulfoximine, buthionine sulfone, penta-, hexa-, hepta-thionine sulfoximine), and also (metal) chelating agents (e.g. hydroxy fatty acids). acid, palmitic acid, phytic acid, lactoferrin), hydroxy acids (e.g. citric acid, lactic acid, malic acid), humic acid, bile acid, bile extract, bilirubin, biliverdin, EDTA, EDDS, EGTA and their derivatives, unsaturated fatty acids and their derivatives (e.g. linolenic acid, linoleic acid, oleic acid), folic acid and its derivatives, ubiquinone and ubiquinol and their derivatives, vitamin C and derivatives (e.g. ascorbyl palmitate, magnesium ascorbyl phosphate, ascorbyl acetate), Copherol and derivatives (e.g., vitamin E acetate), vitamin A and derivatives (e.g., vitamin A palmitate), and also coniferyl benzoate of benzoin resin, rutic acid and its derivatives, glycosylrutin, ferulic acid, furfurylidene glucitol, carnosine, butylhydroxytoluene, butylhydroxyanisole, nordihydroguaiaretic acid, trihydroxybutyrophenone, uric acid and its derivatives, mannose and its derivatives, superoxide dismutase, N-[3-(3,[5-di-tert-butyl-4-hydroxyphenyl)propionyl]sulfanilic acid (and its salts, e.g., disodium salt), selenium and its derivatives (e.g., selenium methionine), stilbene and its derivatives (e.g., stilbene oxide, trans-stilbene oxide), and derivatives (salts, esters, ethers, sugars, nucleotides, nucleosides, peptides, and lipids) of these mentioned active ingredients are also suitable according to the invention. HALS (= "hindered amine light stabilizer") compounds may also be mentioned.

[0104] Hydrotropic Agent To improve the flow behavior, it is also possible to utilize hydrotropic agents, such as ethoxylated or non-ethoxylated monoalcohols, diols or polyols having a small number of carbon atoms or their ethers (e.g., ethanol, isopropanol, 1,2-dipropanediol, propylene glycol, glycerin, ethylene glycol, ethylene glycol monoethyl ether, ethylene glycol monobutyl ether, propylene glycol monomethyl ether, propylene glycol monoethyl ether, propylene glycol monobutyl ether, diethylene glycol monomethyl ether; diethylene glycol monoethyl ether, diethylene glycol monobutyl ether, and similar products). Polyols that come into consideration for this purpose preferably have 2 to 15 carbon atoms and at least two hydroxy groups. The polyols may also contain additional functional groups, especially amino groups, and / or be modified with nitrogen. Typical examples are: glycerol, alkylene glycols such as ethylene glycol, diethylene glycol, propylene glycol, butylene glycol, hexylene glycol, and also polyethylene glycols with an average molecular weight of 100 to 1000 daltons; technical oligoglycerol mixtures with an intrinsic degree of condensation of 1.5 to 10, for example technical diglycerol mixtures with a diglycerol content of 40 to 50% by weight; methylol compounds such as, in particular, trimethylolethane, trimethylolpropane, trimethylolbutane, pentaerythritol and dipentaerythritol; lower alkyl glucosides, in particular those with 1 to 8 carbon atoms in the alkyl group, for example methyl and butyl glucoside; sugar alcohols with 5 to 12 carbon atoms, for example sorbitol or mannitol; sugars with 5 to 12 carbon atoms, for example glucose or saccharose; amino sugars, for example glucamine; dialcoholamines, for example diethanolamine or 2-amino-1,3-propanediol.

[0105] Additional preservatives and bacterial inhibitors Suitable preservatives include, for example, methyl-, ethyl-, propyl-, butyl-paraben, benzalkonium chloride, 2-bromo-2-nitro-propane-1,3-diol, dehydroacetic acid, diazolidinyl urea, 2-dichloro-benzyl alcohol, DMDM ​​hydantoin, formaldehyde solution, methyldibromoglutanitrile, phenoxyethanol, sodium hydroxymethylglycinate, imidazolidinyl urea, triclosan, and further classes of substances listed in the following reference: KF DePolo - A short textbook of cosmetology, Chapter 7, Tables 7-2, 7-3, 7-4 and 7-5, p 210-219.

[0106] Bacterial inhibitors Typical examples of antibacterial agents are preservatives with specific activity against gram-positive bacteria, such as 2,4,4'-trichloro-2'-hydroxydiphenyl ether, chlorhexidine (l,6-di(4-chlorophenyl-biguanide)hexane), or TCC (3,4,4'-trichlorocarbanilide). Many fragrance substances and ethereal oils also possess antimicrobial properties. Typical examples are the active ingredients eugenol, menthol, and thymol in clove oil, mint oil, and thyme oil. A natural deodorizing agent of interest is the terpene alcohol farnesol (3,7,11-trimethyl-2,6,10-dodecatrien-l-ol), present in lime blossom oil. Glycerol monolaurate has also been shown to be a bacteriostatic agent.

[0107] coloring agent Substances which may be used as colorants are suitable and accepted for cosmetic purposes, as compiled, for example, in the publication "Kosmetische Farbemittel" of the Farbstoffkommission der Deutschen Forschungsgemeinschaft, Verlag Chemie, Weinheim, 1984, pages 81 to 106.

[0108] UV sunscreen Suitable sunscreens are believed to include a range of organic UV sunscreens selected from the group consisting of: l(+ / -)-l,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo-[2.2.1]heptan-2-one; p-methylbenzylidene camphor, 1,7,7-trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one; benzylidene camphor, (2-hydroxy-4-methoxyphenyl)(4-methylphenyl)methanone, 2,4-dihydroxybenzoylbenzoylbenzoylbenzoylbenzoylbenzoylbenzoylbenzoylbenzoylbenzoylbenzoylbenzoylbenzoyl hydroxybenzophenone, 2,2',4,4'-tetrahydroxybenzophenone, 2-hydroxy-4-methoxybenzophenone, 2-hydroxy-4-methoxybenzophenone-5-sulfonic acid, 2,2'-dihydroxy-4,4'-dimethoxybenzophenone, 2,2'-dihydroxy-4-methoxybenzophenone, alpha-(2-oxoborn-3-ylidene)toluene-4-sulfonic acid and its salts, l-[4-(1,1-dimethylethyl)phenyl]-3-(4-methoxyphenyl)propane-1, 3-dione, methyl N,N,N-trimethyl-4-[(4,7,7-trimethyl-3-oxobicyclo[2,2,l]-hept-2-ylidene)methyl]anilinium sulfate, 3,3,5-trimethylcyclohexyl-2-hydroxybenzoate, isopentyl p-methoxycinnamate, methyl-o-aminobenzoate, 2-ethylhexyl 2-cyano, 3,3-diphenylacrylate, 2-ethylhexyl 4-(dimethylamino)benzoate, 2-ethylhexyl 4-methoxycinnamate, 2 -Ethylhexyl salicylate, benzoic acid, 4,4',4''-(l,3,5-triazine-2,4,6-triyltriimino)tris-, tris(2-ethylhexyl) ester, 4-aminobenzoic acid, benzoic acid, 4-amino-, ethyl ester, polymer with oxaline, 2-phenyl-lH-benzimidazole-5-sulfonic acid, 2-propenamide, N-[[4-[(4,7,7-trimethyl-3-oxobicyclo[2.2.l]hept-2-ylidene)methyl]phenyl]methyl]-, homopolymer. Salicylic acid triethanolamine, 3,3'-(1,4-phenylenedimethylene)bis[7,7-Dimethyl-2-oxo-bicyclo[2.2.1]heptane-l-methanesulfonic acid], titanium dioxide, 2,2'-methylene-bis-[6-(2H-benzotriazol-2-yl)-4-(l,l,3,3-tetramethylbutyl)-phenol], bis-ethylhexyloxyphenol methoxyphenyl triazine, lH-benzimidazole-4,6-disulfonic acid, 2,2'-(l,4-phenylene)bis-, disodium salt, benzoic acid, 4,4'-[[6-[[4-[[(l,l-dimethylethyl)amino]carbonyl]-phenyl ]amino]l,3,5-triazine-2,4-diyl]diimino]bis-, phenol, 2-(2H-benzotriazol-2-yl)-4-methyl-6-[2-methyl-3-[l,3,3,3-tetramethyl-l-[(trimethylsilyl)oxy]disiloxanyl]propyl]-, dimethicodiethyl benzalmalonate, benzenesulfonic acid, 3-(2H-benzotriazol-2-yl)-4-hydroxy-5-(1-methylpropyl)-, monosodium salt, benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexyl Silester, 1-dodecanaminium, N-[3-[[4-(dimethylamino)benzoyl]amino]-propyl]N,N-dimethyl-, salt with 4-methylbenzenesulfonic acid (1:1), 1-propanaminium, N,N,N-trimethyl-3-[(l-oxo-3-phenyl-2-propenyl)amino]-, chloride, lH-benzimidazole-4,6-disulfonic acid, 2,2'-(l,4-phenylene)bis-1,3,5-triazine, 2,4,6-tris(4-methoxyphenyl-l,3,5-triazine), 2,4,6-tris(4-methoxyphenyl)-l,3,5-triazine, [4-[(2-ethylhexyl)oxy]phenyl]-, 1-propanaminium, 3-[[3-[3-(2H-benzotriazol-2-yl)-5-(l,l-dimethylethyl)-4-hydroxyphenyl]-1-oxopropyl]amino]-N,N-diethyl-N-methyl-, methyl sulfate (salt), 2-propenoic acid, 3-(lH-imidazol-4-yl)-, benzoic acid, 2-hydroxy-, [4-(l-methylethyl)phenyl]methyl ester, 1,2,3-propanetriol, l-(4-aminobenzoate), benzeneacetic acid, 3,4-Dimethoxy-α-oxo-, 2-propenoic acid, 2-cyano-3,3-diphenyl-, ethyl ester, anthranilic acid, p-mentha-3-yl ester, 2,2'-bis(l,4-phenylene)-lH-benzimidazole-4,6-disulfonic acid monosodium salt or phenyldibenzimidazole tetrasulfonic acid disodium salt, l,3,5-triazine-2,4,6-triamine and N,N'-bis[4-[5-(l,l-dimethylpropyl)-2-benzoxazolyl]phenyl]-N''-(2-ethylhexyl).

[0109] Agents that absorb UV light and provide photoprotection to the skin Suitable agents that absorb UV light, provide photoprotection to the skin, and optionally provide sunless tanning, are represented by Formula I:

[0110] [ka] [In the formula, Each R 1 are independently H, (C1-C6) alkyl, (C3-C7) carbocycle or R a C(=0)- and two R 4 the groups together form a -(C3-C8)alkyl group, a -(C2-C6)alkyl-Y-(C2-C6)alkyl group or a -(C1-C6)alkyl-Y'-(C1-C6)alkyl group, or Each R 4 are independently H, (C1-C6) alkyl, (C3-C7) carbocycle or R a C(=0)- and two R 1 the groups together form a -(C3-C8)alkyl group, a -(C2-C6)alkyl-Y-(C2-C6)alkyl group or a -(C1-C6)alkyl-Y'-(C1-C6)alkyl-; or The Two R's 4 groups together form a -(C3-C8)alkyl group, a -(C2-C6)alkyl-Y-(C2-C6)alkyl group or a -(C1-C6)alkyl-Y'-(C1-C6)alkyl group, and two R 1the groups together form a -(C3-C8)alkyl group, a -(C2-C6)alkyl-Y-(C2-C6)alkyl group or a -(C1-C6)alkyl-Y'-(C1-C6)alkyl group, the dotted bond labeled "a" is absent and the dotted bond labeled "b" is a double bond, or all dotted bonds are single bonds; R 2 is H, (C1-C6) alkyl or aryl, where aryl is selected from one or more Z 1 optionally substituted with a group, R 3 is H, (C1-C6) alkyl or aryl, where aryl is selected from one or more Z 1 optionally substituted with a group, Y is O, S, NH, NR c , P, P(=0) or POH; Y' is Si(R b )2 or -Si(R b )2-O-Si(R b )2- and Each R a are independently (C1-C6) alkyl, (C3-C7) carbocycle, or aryl, where aryl is selected from one or more Z 1 optionally substituted with a group, Each R b are independently (C1-C6) alkyl, (C3-C7) carbocycle, or aryl, where aryl is selected from one or more Z 1 optionally substituted with a group, Each R c are independently g or C1~C 18 A saturated or unsaturated carbon chain, which may be oxo (=0), hydroxy, mercapto, (C1-C6) alkoxy, (C1-C6) alkoxycarbonyl, (C1-C6) alkanoyloxy, NR d R e , carboxy, and aryl, wherein R cAny aryl in f is optionally replaced by Each R d and R e are independently selected from H, (C1-C6) alkyl, (C1-C6) alkanoyl, phenyl, benzyl, and R g is selected from Each R f are independently selected from (C1-C6)alkyl, (C1-C6)alkoxy, (C1-C6)alkoxycarbonyl, (C1-C6)alkanoyloxy, -C(=0)-phenyl, and -C(=0)CH2C(=0)-phenyl, wherein any phenyl is optionally substituted with one or more groups independently selected from (C1-C6)alkyl, -SO3H, and (C1-C6)alkoxy; Each R g teeth,

[0111] [ka] {In the formula, each Z 1 are independently (C1-C6) alkyl, halogen, -CN, -OR n1 , -NR q1 R r1 , -NR n1 COR p1 , -NR n1 CO2R p1 , NO2, -C(O)R n1 , -C(O)OR n1 and -C(O)NR q1 R r1 where Z is selected from 1 any (C1-C6) alkyl is optionally substituted with one or more (e.g., 1, 2, 3, 4, 5, or 6) halogens; Each R n1 is independently selected from H, and (C1-C6) alkyl, where R n1 any (C1-C6) alkyl is optionally substituted with one or more (e.g., 1, 2, 3, 4, 5, or 6) halogens; Each Rp1 are independently (C1-C6) alkyl; R q1 and R r1 are each independently selected from H and (C1-C6) alkyl, or R q1 and R r1 together with the nitrogen to which they are attached to form piperidine, pyrrolidine, morpholine, azetidine, thiomorpholine, piperazine, or 4-methylpiperazine} is] or a salt thereof.

[0112] Particular groups of compounds of Formula I and particular compounds that can be incorporated into the topical compositions described herein, as well as methods for preparing such compounds, are described in U.S. Pat. Nos. 9,403,778 and 9,987,211, which are incorporated herein by reference in their entireties.

[0113] Suitable agents that absorb UV light, provide photoprotection to the skin, and optionally provide sunless tanning, are represented by Formula II:

[0114] [ka] [In the formula, R 1 is H, (C1-C6) alkyl, (C3-C7) carbocycle or R a C(=O)-, R 2 is H, (C1-C6) alkyl, or aryl, where aryl is selected from one or more (e.g., 1, 2, 3, 4, or 5) Z 1 optionally substituted with a group, R 4 is H, (C1~C 10 ) alkyl, (C3-C7) carbocycle or R a C(=O)-, R aor (C1-C6) alkyl, (C3-C7) carbocycle, or aryl, where aryl is selected from one or more (e.g., 1, 2, 3, 4, or 5) Z 1 optionally substituted with a group, each Z 1 are independently (C1-C6) alkyl, halogen, -CN, -OR n1 , -NR q1 R r1 , -NR n1 COR p1 , -NR n1 CO2R pi , NO2, -C(O)R n1 , -C(O)OR n1 and -C(O)NR q1 R r1 where Z is selected from 1 any (C1-C6) alkyl is optionally substituted with one or more (e.g., 1, 2, 3, 4, 5, or 6) halogens; Each R n1 are independently selected from H, (C1-C6) alkyl, where R n1 any (C1-C6) alkyl is optionally substituted with one or more (e.g., 1, 2, 3, 4, 5, or 6) halogens; Each R pi are independently (C1-C6) alkyl; R q1 and R r1 are each independently selected from H and (C1-C6) alkyl, or R q1 and R r1 together with the nitrogen to which they are attached to form piperidine, pyrrolidine, morpholine, azetidine, thiomorpholine, piperazine or 4-methylpiperazine] or a salt thereof.

[0115] Particular groups of compounds of formula II and particular compounds that can be incorporated into the topical compositions described herein, as well as methods for preparing such compounds, are described in U.S. Pat. No. 9,987,211, which is incorporated herein by reference in its entirety.

[0116] Suitable agents that absorb UV light and provide photoprotection to the skin are represented by formula III:

[0117] [ka] [In the formula, Each R 1 are independently H, (C1-C6) alkyl, (C3-C7) carbocycle or R a C(=O)- or two R 1 the groups together form a -(C3-C8)alkyl group, a (C2-C6)alkyl-Y-(C2-C6)alkyl group or a -(C1-C6)alkyl-Y'-(C1-C6)alkyl group; or the dotted bond labeled "a" is absent, the dotted bond labeled "b" is a double bond, or all dotted bonds are single bonds; R 2 is H, (C1-C6) alkyl or aryl, where aryl is selected from one or more (e.g., 1, 2, 3, 4 or 5) Z 1 optionally substituted with a group, R 3 is H, (C1-C6) alkyl or aryl, where aryl is selected from one or more (e.g., 1, 2, 3, 4 or 5) Z 1 optionally substituted with a group, R 4 is hydroxy, carboxy, (C1-C6) alkoxycarbonyl, -OPO3H2, -OR c , or -NR d R e and R 5 is H or taken together with R 4 and R 5 is oxo, Y is O, S, NH, P, P(=O) or POH; Y' is Si(R b )2 or -Si(R b )2-O-Si(R b )2- and Each R a are independently (C1-C6) alkyl, (C3-C7) carbocycle, or aryl, where aryl is selected from one or more (e.g., 1, 2, 3, 4, or 5) Z 1 optionally substituted with a group, Each R b are independently (C1-C6) alkyl, (C3-C7) carbocycle, or aryl, where aryl is selected from one or more (e.g., 1, 2, 3, 4, or 5) Z 1 optionally substituted with a group, R c is R f or C1~C 20 Saturated or C2~C 20 It is an unsaturated carbon chain, which is oxo (=O), hydroxy, mercapto, (C1-C6) alkoxy, (C1-C6) alkoxycarbonyl, (C1-C6) alkanoyloxy, NR d R e , carboxy, and aryl, wherein the aryl is optionally substituted with one or more (e.g., 1, 2, 3, 4, or 5) Z 1 optionally substituted with a group, R d is H, (C1-C6) alkyl or (C1-C6) alkanoyl, R e is H or C1~C 20 Saturated or C2~C 20 It is an unsaturated carbon chain, which is oxo (=O), hydroxy, mercapto, (C1-C6) alkoxy, (C1-C6) alkoxycarbonyl, (C1-C6) alkanoyloxy, NR d R e, carboxy, and aryl, wherein the aryl is optionally substituted with one or more (e.g., 1, 2, 3, 4, or 5) Z 1 optionally substituted with a group, Each R f teeth,

[0118] [ka] {In the formula, each Z 1 are independently (C1-C6) alkyl, halogen, -CN, OR n1 , -NR q1 R r1 , -NR n1 COR p1 , -NR n1 CO2R p1 , NO2, -C(O)R n1 , -C(O)OR n1 and -C(O)NR q1 R r1 where Z is selected from 1 any (C1-C6) alkyl is optionally substituted with one or more (e.g., 1, 2, 3, 4, 5, or 6) halogens; Each R n1 is independently selected from H, and (C1-C6) alkyl, where R n1 any (C1-C6) alkyl is optionally substituted with one or more (e.g., 1, 2, 3, 4, 5, or 6) halogens; Each R p1 are independently (C1-C6) alkyl; R q1 and R r1 are each independently selected from H and (C1-C6) alkyl, or R q1 and R r1 together with the nitrogen to which they are attached to form piperidine, pyrrolidine, morpholine, azetidine, thiomorpholine, piperazine, or 4-methylpiperazine} is] or a salt thereof.

[0119] Particular groups of compounds of formula III and particular compounds that can be incorporated into the topical compositions described herein, as well as methods for preparing such compounds, are described in U.S. Pat. Nos. 9,364,406 and 9,987,211, which are incorporated herein by reference in their entireties.

[0120] sunscreen The topical compositions disclosed herein can contain sunscreens such as avobenzone, ecamsule, methyl anthranilate, oxybenzone, dioxybenzone, sulisobenzone, octinoxate, homosalate, octocrylene, and octisalate. These compositions may also contain organic UV filters, so-called hydrophilic or lipophilic sunscreen filters, that are effective in the UVA and / or UVB regions and / or the IR and / or VIS regions (absorbers). These substances can be selected, in particular, from cinnamic acid derivatives, salicylic acid derivatives, camphor derivatives, triazine derivatives, β,β-diphenylacrylate derivatives, p-aminobenzoic acid derivatives, and polymeric and silicone filters, as described in WO 93 / 04665. Further examples of organic filters are given in EP-A-0487404. Particularly suitable for combination are: para-aminobenzoic acid and its derivatives: PABA, ethyl PABA, ethyldihydroxypropyl PABA, ethylhexyldimethyl PABA, such as that sold under the name "Escalol 507" by ISP, Glyceryl PABA, PEG-25 PABA, such as that sold under the name "Uvinul P25" by BASF.

[0121] Other UV filter ingredients that can be incorporated into the topical compositions of the present disclosure include:

[0122] Salicylates: homosalate, sold under the name "Eusolex HMS" by Merck; ethylhexyl salicylate, sold under the name "Neo Heliopan OS" by Symrise, dipropylen glycol salicylate, sold under the name "Dipsal" by Scher, TEA salicylate, sold under the name "Neo Heliopan TS" by Symrise.

[0123] β,β-Diphenylacrylate derivatives: octocrylene marketed, for example, under the name "Eusolex® OCR" by Merck, "Uvinul N539" from BASF, octocrylene marketed, for example, under the name "Uvinul N35" by BASF.

[0124] Benzophenone derivatives: benzophenone-1, commercially available for example under the name "Uvinul 400", benzophenone-2, commercially available for example under the name "Uvinul D50", benzophenone-3, commercially available for example under the name "Uvinul M40", or oxybenzone, such as benzophenone-4, commercially available for example under the name "Uvinul MS40", benzophenone-9, commercially available for example under the name "Uvinul DS-49" by BASF, benzophenone-5, benzophenone-6, commercially available for example under the name "Helisorb 11" by Norquay, benzophenone-8, commercially available for example under the name "Spectra-Sorb UV-24" by American Cyanamid, benzophenone-12n-hexyl 2-(4-diethylamino-2-hydroxybenzoyl)benzoate or 2-hydroxy-4-methoxybenzophenone, commercially available under the name Eusolex® 4360 by Merck, Darmstadt.

[0125] Benzylidene camphor derivatives: 3-benzylidene camphor sold, for example, under the name "Mexoryl SD" by Chimex, 4-methylbenzylidene camphor sold, for example, under the name "Eusolex 6300" by Merck, benzylidene camphorsulfonic acid sold, for example, under the name "Mexoryl SL" by Chimex, camphorbenzalkonium methosulfate sold, for example, under the name "Mexoryl SO" by Chimex, terephthalylidene dicamphorsulfonic acid sold, for example, under the name "Mexoryl SX" by Chimex, polyacrylamidomethylbenzylidene camphor sold, for example, under the name "Mexoryl SW" by Chimex.

[0126] Phenylbenzimidazole derivatives: phenylbenzimidazole sulfonic acid, marketed for example under the name "Eusolex 232" by Merck, disodium phenyldibenzimidazole tetrasulfonate, marketed for example under the name "Neo Heliopan AP" by Symrise.

[0127] Phenylbenzotriazole derivatives: for example drometrizole trisiloxane sold under the name "Silatrizole" by Rhodia Chimie.

[0128] Methylenebis(benzotriazolyl)tetramethylbutylphenol in solid form, such as that sold under the name "MIXXIM BB / 100" by Fairmount Chemical, or in micronized form as an aqueous dispersion, such as that sold under the name "Tinosorb M" by BASF.

[0129] Triazine derivatives: ethylhexyl triazone, for example sold under the name "Uvinul T150" by BASF, diethylhexylbutamido triazone, for example sold under the name "Uvasorb HEB" by Sigma 3V, 2,4,6-tris(diisobutyl 4'-aminobenzalmalonate)-s-triazine or 2,4,6-tris(biphenyl)-1,3,5-triazine, sold under the name Tinosorb A2B by BASF, 2,2'-[6-(4-methoxyphenyl)-1,3,5-triazine-2,4-diyl]bis[5-(2-ethylhexyl)oxy]phenol, sold under the name Tinosorb S by BASF, Uvasorb K by Sigma 3V. N2,N4-bis[4-[5-(l,l-dimethylpropyl)-2-benzoxazolyl]phenyl]-N-6-(2-ethylhexyl)-l,3,5-triazine-2,4,6-triamine, commercially available as 2A.

[0130] Anthraniline derivatives: for example menthyl anthranilate sold under the name "Neo Heliopan MA" by Symrise.

[0131] Imidazole derivative: Ethylhexyl dimethoxybenzylidene dioxoimidazoline propionate.

[0132] Benzalmalonate derivatives: Polyorganosiloxanes containing functional benzalmalonate groups, such as Polysilicone-15 sold under the name "Parsol SLX" by Hoffmann LaRoche.

[0133] 4,4-Diarylbutadiene derivatives: l,l-dicarboxy(2,2'-dimethylpropyl)-4,4-diphenylbutadiene.

[0134] Benzoxazole derivatives: for example 2,4-bis[5-(1-dimethylpropyl)benzoxazol-2-yl(4-phenyl)imino]-6-(2-ethylhexyl)imino-1,3,5-triazine, sold under the name Uvasorb K2A by Sigma 3V, and mixtures containing this.

[0135] Suitable organic UV protection substances may preferably be selected from: ethylhexyl salicylate, phenylbenzimidazole sulfonic acid, benzophenone-3, benzophenone-4, benzophenone-5, n-hexyl 2-(4-diethylamino-2-hydroxybenzoyl)benzoate, 4-methylbenzylidene camphor, terephthalylidene dicamphorsulfonic acid, disodium phenyldibenzimidazole tetrasulfonate, methylenebis(benzotriazolyl)tetramethylbutylphenol, ethylhexyl triazone, diethylhexylbutamidotriazone, drometrizole trisiloxane, polysilicone-15, l,l-dicarboxy(2,2'-dimethylpropyl)-4,4-diphenylbutadiene, 2,4-bis[5-l(dimethylpropyl)benzoxazol-2-yl(4-phenyl)imino]-6-(2-ethylhexyl)imino-l,3,5-triazine, and mixtures thereof.

[0136] The composition of the present invention may also contain additional inorganic UV filters, so-called particulate UV filters. These combinations with particulate UV filters can be in the form of powders, as well as dispersions or pastes. In one embodiment, the inorganic UV filter is titanium dioxide, for example, coated titanium dioxide (e.g., Eusolex® T-2000, Eusolex® T-AQUA, Eusolex® T-AVO, Eusolex® T-OLEO), zinc oxide (e.g., Sachtotec), iron oxide, or cerium oxide and / or zirconium oxide. Furthermore, a combination with pigmented titanium dioxide or zinc oxide is also possible, where the particle size of these pigments is 200 nm or more, such as Hombitan® FG or Hombitan® FFPharma.

[0137] The composition of the present invention can also comprise inorganic UV filters that are processed by conventional methods, as described for example in Cosmetics & Toiletries, 1990, 105, 53-64.One or more of the following post-processing components can be: amino acid, beeswax, fatty acid, fatty acid alcohol, anionic surfactant, lecithin, phospholipid, sodium, potassium, zinc, iron or aluminum salt of fatty acid, polyethylene, silicone, protein (particularly collagen or elastin), alkanolamine, silicon dioxide, aluminum oxide, other metal oxide, phosphate, for example sodium hexametaphosphate, or glycerin.

[0138] In one embodiment, the particulate UV filters used in the compositions of the invention are: Untreated titanium dioxide, such as the product Microtitanium Dioxide MT 500 B from Tayca or titanium dioxide P25 from Degussa; processed micronized titanium dioxide, post-treated with aluminum oxide and silicone dioxide, such as the product "Microtitanium Dioxide MT 100 SA" from Tayca or the product "Tioveil Fin" from Uniqema; treated micronized titanium dioxide, post-treated with aluminium oxide and / or aluminium stearate / aluminium laurate, e.g. Microtitanium Dioxide MT 100 T from Tayca, Eusolex T-2000 from Merck; Micronized titanium dioxide after treatment with iron oxide and / or iron stearate, such as the product "Microtitanium Dioxide MT 100 F" from Tayca; Micronized titanium dioxide after treatment with silicone dioxide, aluminum oxide and silicone, such as the product "Microtitanium Dioxide MT 100 SAS" from Tayca, • Micronized titanium dioxide after treatment with sodium hexametaphosphate, for example the product "Microtitanium Dioxide MT 150 W" from Tayca.

[0139] The treated micronized titanium dioxide utilized for the combination can also be: after treatment with octyltrimethoxysilane; for example the product Tego Sun T 805 from Evonik Goldschmidt GmbH, Silicon dioxide; for example the product Parsol TX manufactured by DSM; after treatment with aluminum oxide and stearic acid; for example the product UV-Titan M160 from Sachtleben; after treatment with aluminum and glycerin; for example the product UV-Titan from Sachtleben, Aluminum and silicone oils, for example the product UV-Titan M262 from Sachtleben, Sodium hexametaphosphate and polyvinylpyrrolidone, Polydimethylsiloxane, such as the Cardre product "70250 Cardre UF TiO2SI3"; Polydimethylhydrogenosiloxanes, such as Color Techniques' Microtitanium Dioxide USP Grade Hydrophobic.

[0140] In certain embodiments, the compositions of the present invention may comprise untreated zinc oxide, such as the products Z-Cote from BASF (Sunsmart) and Nanox from Elementis. In other particular embodiments, the compositions of the present invention may comprise treated zinc oxide, such as the following products: ●"Zinc Oxide CS-5" manufactured by Toshiba Corporation (ZnO after treatment with polymethylhydrogenosiloxane), ●Nanogard Zinc Oxide FN manufactured by Nanophase Technologies, "SPD-Z1" manufactured by Shin-Etsu Chemical Co., Ltd. (ZnO dispersed in cyclodimethylsiloxane and treated with silicone-grafted acrylic polymer) "Escalol Z100" from ISP (ZnO after aluminum oxide treatment dispersed in an ethylhexyl methoxycinnamate / PVP-hexadecene / methicone copolymer mixture), and - "Fuji ZNO-SMS-10" manufactured by Fuji Pigment Co., Ltd. (ZnO after treatment with silicone dioxide and polymethylsilane). In one embodiment, the composition of the present invention comprises ZinClear IM 50AB in an amount of about 5 wt.% to about 50 wt.%, about 15 wt.% to about 40 wt.%, or about 25 wt.% to about 35 wt.%, based on the total weight of the topical composition, or any subrange or single concentration value therein.

[0141] In another particular embodiment, the composition of the invention may comprise untreated cerium oxide micropigments, such as those manufactured by Rhone Poulenc under the name "Colloidal Cerium Oxide." In another particular embodiment, the composition of the invention may comprise untreated and / or treated iron oxide manufactured by Amaud under the name Nanogar.

[0142] For example, mixtures of various metal oxides, such as mixtures of titanium dioxide and cerium dioxide, with or without post-treatment, can also be used, such as the product Sunveil A from Ikeda Bussan Co., Ltd. In addition, mixtures of aluminum oxide, silicone dioxide and silicone-treated titanium dioxide, as well as zinc oxide mixtures, such as the product UV-Titan M261 from Sachtleben, can also be used in conjunction with the UV protection agents according to the invention.

[0143] In certain embodiments, the topical compositions described herein may comprise an active agent selected from sunscreens, antibiotics, steroids, hydroquinone, or a combination thereof.Any suitable sunscreen may be used, such as any of the sunscreens and UV sunscreens described herein.In one embodiment, the sunscreen may be an inorganic mineral sunscreen, such as zinc oxide.

[0144] In one embodiment, the topical composition may comprise a steroid, which may be a fluorinated steroid. Suitable steroids include, but are not limited to, corticosteroids, alclometasone, dexamethasone, flumethasone, hydrocortisone, hydrocortisone-21-monoester, hydrocortisone-21-acetate, hydrocortisone-21-butyrate, hydrocortisone-21-propionate, hydrocortisone-21-valerate, hydrocortisone-17,21-diester, hydrocortisone-17,21-diacetate, hydrocortisone-17,21-acetate-i-butyrate, hydrocortisone-17,21-diol ... Cortisone-17,21-dibutyrate, prednisolone, methylprednisolone, betamethasone benzoate, betamethasone dipropionate, clobetasol propionate, diflorasone diacetate, fluocinonide, fluticasone propionate, mometasone furoate, triamcinolone acetonide, topical corticosteroids, hydroxyltriamcinolone, alpha-methyldexamethasone, dexamethasone phosphate, clobetasol valerate, desonide, desoximetasone, desoxycorticosterone acetate, dexamethasone Tazone, dichlorisone, diflurazon diacetate, diflucortolone valerate, fluadrenolone, fluchlorolone acetonide, fludrocortisone, flumethasone pivalate, fluocinolone acetonide, fluocinonide, flucortine butyl ester, fluocortolone, fluprednidene acetate (fluprednylidene), flurandrenolone, halcinonide, hydrocortisone acetate, hydrocortisone butyrate, methylprednisolone, triamcinolone acetonide, cortisone, cortodoxone, flucetonide, medrysone, Included may be amcinafide, amcinafide, betamethasone, chloroprednisone, chlorprednisone acetate, clocortelone, clescinolone, dichlorisone, diflurprednate, flucloronide, flunisolide, fluoromethalone, fluperolone, fluprednisolone, hydrocortisone valerate, hydrocortisone cyclopentylpropionate, hydrocortamate, meprednisone, paramethasone, prednisone, beclomethasone dipropionate, triamcinolone, or any combination thereof.

[0145] In one embodiment, the topical composition comprises, consists of, or consists essentially of a hydrophilic occlusion-forming agent having a water solubility of about 75% or more, such as glycerin, and optionally a binder, one or more proteolytic enzymes, and an antioxidant system including a polyphenol antioxidant (green tea polyphenols), wherein the topical composition has less than 10 wt.% water, based on the total weight of the topical composition. The topical composition may further comprise, consist of, or consist essentially of at least one cosmetically acceptable excipient. The topical composition may further comprise, consist of, or consist essentially of at least one active agent.

[0146] In one embodiment, the topical composition comprises, consists of, or consists essentially of a hydrophilic occlusion-forming agent having a water solubility of about 75% or more, such as glycerin, and optionally a binder; one or more proteolytic enzymes; and an antioxidant system including a polyphenol antioxidant (e.g., green tea polyphenols), wherein the topical composition has less than 8 wt.% urea, based on the total weight of the topical composition. The topical composition may further comprise, consist of, or consist essentially of at least one cosmetically acceptable excipient. The topical composition may further comprise, consist of, or consist essentially of at least one active agent.

[0147] In one embodiment, the topical composition comprises, consists of, or essentially consists of a hydrophilic occlusion-forming agent having a water solubility of about 75% or more, such as glycerin, and optionally a binder, one or more proteolytic enzymes, and an antioxidant system including a polyphenol antioxidant (e.g., green tea polyphenols), wherein the topical composition has less than 1 wt.% of a silicone-based component based on the total weight of the topical composition. The topical composition may further comprise, consist of, or consist essentially of at least one cosmetically acceptable excipient. The topical composition may further comprise, consist of, or consist essentially of at least one active agent.

[0148] In one embodiment, the topical composition comprises, consists of, or consists essentially of a hydrophilic occlusion-forming agent having a water solubility of about 75% or greater, such as glycerin, and optionally a binder, one or more proteolytic enzymes, and an antioxidant system including a polyphenol antioxidant (e.g., green tea polyphenols). The topical composition may further comprise, consist of, or consist essentially of at least one cosmetically acceptable excipient. The topical composition may further comprise, consist of, or consist essentially of at least one active agent.

[0149] The topical compositions described herein improve patient compliance due to their aesthetically pleasing texture, as evidenced by the compositions being washable, dry, non-sticky, non-greasy, non-pore blocking, and hypoallergenic.

[0150] How to use The topical compositions described herein can be used to treat a variety of scars, including immature and mature scars, hypertrophic scars (linear or extensive), and keloids (e.g., minor and major keloids).

[0151] The term "immature scar" refers to scars in various early stages of scar tissue formation. The early stages of scar tissue formation (proliferation) occur as angiogenic and specialized cell types called fibroblasts produce new fibrous tissue. Collagen is deposited in the area, establishing granulation tissue, upon which dermal tissue forms a covering over the area. Delays in this process (epithelialization) can result in more pronounced scars, whereas successful progression through the wound healing cascade helps minimize the incidence of scar formation. The new tissue resulting from this stage is rapidly deposited and lacks orientation; if the tissue remains in this disorganized, less dense, packed state, a raised or "hypertrophic" scar can result. Immature scars are red, itchy, and / or painful.

[0152] The term "mature scar" refers to a later point in the scar formation and progression process, such as after the scar has undergone a remodeling phase. During the remodeling phase, sometimes called maturation, excess tissue is removed by cellular physiological processes, including the action of fibroclasts. Unlike fibroblasts, which produce tissue, fibroclasts help break down and remove unnecessary tissue. Working together, fibroclasts and fibroblasts allow tissue to remodel. Raised scars become lower because the collagen and connective tissue fibers orient themselves in the proper shape and become more organized and dense. This phase can be affected by stress and movement, and is a component of wound contraction. Some mature scars may flatten over time, while others may remain problematic.

[0153] Hypertrophic scars, characterized by an erythematous (red, inflamed), raised appearance confined to the borders of the injury, can be classified as linear (e.g., along a surgical incision) or widespread (e.g., sunburn or other injury affecting an area of ​​skin). Some scars are classified as keloids, which are characterized by a localized, raised scar that may extend beyond the immediate area of ​​the injury and often cause pain and itching in the patient. They may occur immediately after the injury or later and typically do not resolve on their own. Physicians may further classify keloids as minor or severe based on their protruding size and other characteristics. Minor keloids are only slightly raised and generally show limited extension beyond one year. Severe keloids generally protrude more than 5 millimeters and may continue to expand for several years.

[0154] In certain embodiments, the present disclosure is directed to methods for lightening and / or reducing discoloration (e.g., red or purple discoloration) of skin in a scarred area of ​​a subject by administering to the subject's skin an effective amount of any of the topical compositions described herein, wherein the scar is lightened or has reduced discoloration after administration of the topical composition.

[0155] In certain embodiments, the present disclosure is directed to a retrospective method of scar treatment regimen (after a scar has already formed) comprising administering to the skin of a subject who has been subjected to a dermatological procedure an effective amount of any of the topical compositions described herein.

[0156] In certain embodiments, the present disclosure is directed to a prophylactic method of scar treatment regimen (to prevent the formation of scars) comprising administering to the skin of a subject that is to be subjected to a dermatological procedure an effective amount of any of the topical compositions described herein.

[0157] Dermatological procedures that may benefit from prior (i.e., pre-procedure) or subsequent (i.e., post-procedure) administration of the topical compositions described herein include, but are not limited to, dermatological procedures used for scar repair, microneedling, skin planing, dermabrasion, microdermabrasion, and laser treatments (e.g., steroid injections).

[0158] In certain embodiments, the methods described herein further include performing a dermatological procedure after administration of the topical composition and / or before administration of the topical composition, depending on the treatment regimen. In certain embodiments, the topical compositions described herein are useful in improving the results of the dermatological procedure, for example, by speeding healing, quenching discomfort, quenching reactive oxygen species (ROS), inducing collagen formation, or any combination thereof.

[0159] As used herein, the term "treatment" or "treating" in relation to a skin condition generally means "having a positive effect on a skin condition" and includes alleviating, improving, and / or alleviating at least one symptom of a skin condition (e.g., scar); alleviating, improving, and / or alleviating the severity of a skin condition (e.g., scar); or delaying, preventing, or suppressing the progression of a skin condition (e.g., scar); or perceiving it. Thus, treatment as used herein does not require a comprehensive cure of the condition (e.g., scar). The formulations of the present disclosure that are useful for treating a skin condition (e.g., scar) or a method of treating a skin condition (e.g., scar) only need to reduce the severity of the skin condition (e.g., scar); reduce the severity of the symptoms associated therewith; improve the patient's quality of life; or delay, prevent, or suppress the onset of one or more symptoms of the skin condition (e.g., scar). As used herein, these terms also encompass aesthetic improvements to scars upon application of the disclosed formulations having a combination of occlusion-forming agents, including, for example, glycerin, proteolytic enzymes, and green tea polyphenols.

[0160] As used herein, the phrase "effective amount" refers to an amount of a topical composition of the present disclosure, or components thereof, effective to treat the above-listed skin conditions (e.g., scars), including effects ranging from detectable localized improvement in the area of ​​topical application to substantial relief of symptoms to improvement in one or more aesthetic criteria, including, but not limited to, perceived improvement in scar appearance, scar roughness, scar elasticity, scar firmness, scar volume, scar size, scar color, scar regeneration and renewal process, redness, dryness, etc.

[0161] The effective amount will vary depending on the particular scar being treated, the severity of the scar, the duration of treatment, the particular components of the composition used, and other factors. In certain embodiments, the topical compositions described herein are suitable for frequent, regular application, e.g., one, two, three, or four or more applications per day, for a period of at least 1 day, at least 3 days, at least 5 days, at least 7 days, at least 10 days, at least 14 days, at least 21 days, at least 30 days, from about 1 day to about 90 days, from about 3 days to about 60 days, or from about 5 days to about 30 days, or any subrange therein. Thus, in certain embodiments, the methods described herein further comprise periodically repeating the administration of the topical composition.

[0162] In certain embodiments, after continuous administration of the topical compositions described herein, the flexibility of the skin in and around the scarred area is improved for a period of about 1 day to about 90 days, about 3 days to about 60 days, or about 5 days to about 30 days, or any subrange therein.

[0163] In certain embodiments, the topical compositions described herein are suitable for pre- or post-procedure administration, for example, before or after a dermatological procedure (e.g., laser, microneedling, microdermabrasion, dermabrasion, dermabrasion, dermabrasion, or chemical peel), before or after a cosmetic procedure, before or after a surgical procedure, or in combination with a scar revision procedure.

[0164] In certain embodiments, the methods described herein can be used to treat, prevent, or minimize the appearance of new and old scars of varying severity, including hypertrophic scars and keloids. Similarly, in certain embodiments, the methods described herein can be used to treat, prevent, or minimize the appearance of scars resulting from surgical or cosmetic procedures, trauma, wounds, or sunburn.

[0165] Method of preparation The present disclosure also relates to a method for preparing any of the topical compositions described herein. The method includes combining any of the topical compositions described herein with a hydrophilic occlusion-forming agent (e.g., glycerin), a protease, and a polyphenol antioxidant (e.g., green tea polyphenols), for example, having a water solubility of about 75% or more, optionally with at least one cosmetically acceptable excipient. The topical composition can be formulated into an ointment serum, gel, lotion, cream, pad-applied formulation, etc.

[0166] In certain embodiments, the method includes forming a first mixture including a first portion of a hydrophilic occlusion-forming agent (e.g., glycerin), e.g., having a water solubility of about 75% or greater, an antioxidant system including a polyphenol antioxidant (e.g., green tea polyphenols), and optionally a preservative. The first mixture may be formed at a temperature of about 20°C to about 65°C, about 25°C to about 60°C, or about 30°C to about 55°C. The method may further include adding a binder to the first mixture. In certain embodiments, the binder is not aerated. The first mixture may be mixed and homogenized for a period of time sufficient to achieve a uniform mixture.

[0167] The method may further include forming a second mixture comprising a second portion of a hydrophilic occlusion-forming agent (e.g., glycerin), e.g., having a water solubility of about 75% or greater, as described hereinabove, one or more proteolytic enzymes, and, optionally, a carrier. The second mixture may be formed at a temperature of about 75°C to about 125°C, about 80°C to about 115°C, or about 90°C to about 110°C. The second mixture may then be cooled to the temperature of the first mixture such that the two mixtures can be combined (e.g., by adding the second mixture to the first mixture) to form the topical composition.

[0168] The final topical composition can be evaluated to ensure that a uniform, dispersed, homogeneous gel without lumps has been formed. [Example]

[0169] The following examples are presented to aid in the understanding of the invention and, of course, should not be construed as specifically limiting the invention as described and claimed. Such variations of the invention, including the substitution of all equivalents now known or later developed, are considered to be within the purview of one skilled in the art, and minor variations in formulation or experimental design should be considered to fall within the scope of the invention incorporated herein.

[0170] [Example 1] Topical scar treatment compositions and methods of preparation Topical compositions according to embodiments described herein were formulated into hydrophilic scar treatment compositions as set forth in Table 1 below, which were ointments in the form of viscous gels.

[0171] [Table 1]

[0172] The scar treatment ointment composition from Table 1 was prepared by forming a first mixture of a major portion of glycerin, Camellia Sinensis (green tea) polyphenols, tocopherol acetate (vitamin E), and allantoin. The binder was added to the first mixture without aeration (stirring was stopped during the addition of the binder).

[0173] Separately, a second mixture was formed by combining the remaining glycerin, one or more protease enzymes, and a silicone component. The second mixture was mixed at about 90°C to about 110°C until uniform. The second mixture was then cooled to the temperature of the first mixture, and then added to the first mixture to form the topical composition.

[0174] [Example 2] Research to improve wound healing and minimize scarring A study was conducted using the hydrophilic scar treatment compositions set out in Table 1. The study was designed to improve wound healing, resulting in a minimization of the potential for scarring and reducing the appearance of atrophic scars.

[0175] The hydrophilic scar treatment composition was applied immediately after incision, abrasion or incision, and then three times daily for 14 days. The hydrophilic scar treatment composition was applied directly to the wound or incision, underneath Steri-strip™ tape or over microporous tape in three subjects.

[0176] In the first subject, after MOHS surgery of the hand, the hydrophilic scar treatment composition was applied three times daily for 14 days. As can be seen in Figures 1A and 1B, the wound was at least about 80% healed over 14 days, and no scars formed in the healed area.

[0177] In a second subject, the hydrophilic scar treatment composition was applied to a newly acquired wound three times daily for 14 days. As can be seen in Figures 2A and 2B, the wound was at least about 70% healed upon application of the composition for 14 days.

[0178] In a third subject, the hydrophilic scar treatment composition was applied to the scalp three times daily for 14 days following CO2 laser treatment. As can be seen in Figures 3A-3C, the scalp was at least about 90% healed by the 14-day period.

[0179] In a fourth subject, the hydrophilic scar treatment composition was applied to the temples three times daily for 14 days after MOHS surgery. As can be seen in Figures 4A and 4B, the temples were at least 70% healed over the 14 days.

[0180] In a fifth subject, the hydrophilic scar treatment composition was applied to the forehead three times daily for 14 days after MOHS surgery. As can be seen in Figures 5A and 5B, the forehead was at least 70% healed over the 14 days.

[0181] For simplicity of explanation, the method embodiments of the present disclosure have been depicted and described as a series of operations. However, operations according to the present disclosure may occur in various orders and / or simultaneously, and other operations may not be presented or described herein. Moreover, not all illustrative operations are required to perform the method in accordance with the disclosed subject matter. In addition, those skilled in the art will understand and appreciate that the method may alternatively be represented as a series of interrelated states via a state diagram or events.

[0182] In the foregoing description, numerical specific details are set forth, such as particular materials, dimensions, process parameters, etc., to provide a thorough understanding of the present invention. Particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments. The words "example" or "exemplary" are used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein as "example" or "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. Rather, use of the words "example" or "exemplary" is intended to present a concept in a concrete manner. As used in this application, the term "or" is intended to mean an inclusive "or" rather than an exclusive "or." That is, unless otherwise specified or clear from context, "X includes A or B" is intended to mean any of the natural inclusive permutations. That is, if X includes A, if X includes B, or if X includes both A and B, then "X includes A or B" is satisfied under any of the foregoing examples. Additionally, the articles "a" and "an," as used in this application and the appended claims, should generally be construed to mean "one or more," unless otherwise specified or unless it is clear from the context that a singular form is intended. References throughout this specification to "embodiments," "certain embodiments," or "one embodiment" mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the appearances of the phrases "embodiments," "certain embodiments," or "one embodiment" in various places throughout this specification do not necessarily all refer to the same embodiment.

[0183] References to numerical ranges throughout this specification should not be construed as limiting and should be understood to include limits outside the range as well as narrower ranges within each number and / or enumeration within the range.

[0184] The term "about," when referring to a physical quantity, is understood to include a measurement error within and including 10%. For example, "about 100°C" should be understood to mean "100±10°C."

[0185] The present invention has been described with reference to specific exemplary embodiments thereof. Accordingly, the specification and drawings are to be regarded in an illustrative rather than a restrictive sense. Various modifications of the invention in addition to those shown and described herein will become apparent to those skilled in the art and are intended to fall within the scope of the appended claims. The present invention also includes the following aspects. <1> an occlusion-forming agent comprising glycerin and a binder; one or more proteolytic enzymes; Antioxidant system containing green tea polyphenols A topical composition comprising: having less than 10 wt.% added water, based on the total weight of the topical composition; Topical compositions. <2> an occlusion-forming agent comprising glycerin and a binder; one or more proteolytic enzymes; Antioxidant system containing green tea polyphenols A topical composition comprising: having less than 8 wt.% urea based on the total weight of the topical composition; Topical compositions. <3> an occlusion-forming agent comprising glycerin and a binder; one or more proteolytic enzymes; Antioxidant system containing green tea polyphenols A topical composition comprising: having less than 1 wt.% silicone-based components based on the total weight of the topical composition; Topical compositions. <4> an occlusion-forming agent comprising glycerin and a binder; one or more proteolytic enzymes; Antioxidant system containing green tea polyphenols 1. A topical composition comprising: <5> an occlusion-forming agent comprising glycerin; one or more proteolytic enzymes; Antioxidant system containing green tea polyphenols 1. A topical composition comprising: <6> 6. The topical composition according to any one of claims 1 to 5, wherein the one or more proteolytic enzymes are selected from papain, bromelain, and combinations thereof. <7> 7. A topical composition according to any one of claims 1 to 6, wherein the one or more proteolytic enzymes are present in the topical composition in an amount effective for removal over production of scar-forming proteins and tissue. <8> 8. The topical composition according to any one of claims 1 to 7, wherein the one or more proteases are present in the topical composition in an amount greater than 0 wt.%, up to about 1 wt.%, based on the total weight of the topical composition, from about 0.001 wt.% to about 0.5 wt.%, or from about 0.005 wt.% to about 0.3 wt.%. <9> 9. The topical composition of any one of 1 to 8 above, wherein the green tea polyphenols include one or more of epigallocatechin gallate, epigallocatechin, epicatechin gallate, catechin, epicatechin, cis and trans isomers thereof, salts thereof, equivalent derivatives thereof, and combinations thereof. <10> 10. The topical composition of claim 9, wherein the green tea polyphenols are present in the topical composition in an amount effective to soothe the skin in the scarred area. <11> 11. The topical composition of any one of claims 1 to 10, wherein the antioxidant system is present in the topical composition in an amount greater than 0 wt.% and up to about 1 wt.%, based on the total weight of the topical composition. <12> 12. The topical composition of claim 11, wherein the antioxidant system further comprises an additional antioxidant selected from the group consisting of cinnamic acid, ferulic acid, caffeic acid, p-coumaric acid, sinapic acid, gallic acid, delphinidin, luteolin, quercetin, cyanidin, taxifolin, kaempferol, malvidin, hesperidin, pelargonidin, apigenin, naringenin, chrysin, ergothioneine, glutathione, emblica, tocopherol, allantoin, cis and trans isomers thereof, salts thereof, equivalent derivatives thereof, and combinations thereof. <13> 13. The topical composition of claim 12, wherein the antioxidant system further comprises tocopherol, allantoin, or a combination thereof. <14> 14. The topical composition of claim 13, wherein the weight-to-weight ratio of the green tea polyphenols to the additional antioxidants, individually or cumulatively, ranges from about 10:1 to about 1:10, from about 8:1 to about 1:8, from about 5:1 to about 1:5, from about 3:1 to about 1:3, or from about 2:1 to about 1:2. <15> 15. The topical composition of any one of claims 1 to 14, wherein the binder comprises at least one of HEA-sodium acryloyldimethyltaurate-steareth-20 methacrylate copolymer, C13-14 isoparaffin, polysorbate 80, decyl glucoside, and glycerin. <16> 16. The topical composition of any one of claims 1 to 15, wherein the glycerin is present in an amount ranging from about 70 wt.% to about 99 wt.%, about 80 wt.% to about 98.5 wt.%, about 90 wt.% to about 98 wt.%, or about 95 wt.% to about 97 wt.%, based on the total weight of the topical composition. <17> 17. The topical composition of any one of claims 1 to 16, wherein the binder is present in an amount ranging from about 0.1 wt.% to about 10 wt.%, about 0.5 wt.% to about 7 wt.%, about 1 wt.% to about 5 wt.%, or about 2 wt.% to 3 wt.%, based on the total weight of the topical composition. <18> 18. The topical composition of any one of claims 1 to 17, further comprising a preservative. <19> 19. The topical composition of claim 18, wherein the preservative comprises phenoxyethanol in an amount of up to about 2 wt.%, up to about 1.5 wt.%, up to about 1 wt.%, or up to about 0.5 wt.%, based on the total weight of the topical composition. <20> 20. A topical composition according to any one of claims 1 to 19, further comprising a carrier. <21> 21. The topical composition of claim 20, wherein the carrier comprises dimethicone. <22> 22. A topical composition according to claim 20 or 21, wherein the carrier is present in an amount of at most about 10 wt.%, at most about 8 wt.%, at most 5 wt.%, at most about 3 wt.%, at most about 1 wt.%, at most about 0.5 wt.%, or at most about 0.1 wt.%. <23> 23. A topical composition according to any one of claims 1 to 22, which is clear. <24> 24. The topical composition according to any one of 1 to 23 above, having a pH of about 3.0 to about 9.0, about 6.0 to about 9.0, about 6.5 to about 8.5, or about 7.0 to about 8.0. <25> 25. The topical composition of any one of claims 1 to 24, further comprising an active agent selected from a sunscreen, an antibiotic, a steroid, hydroquinone, or a combination thereof. <26> 26. A topical composition according to any one of 1 to 25 above, which is hypoallergenic. <27> 27. The topical composition of any one of 1 to 26 above, which is non-comedogenic. <28> 28. A topical composition according to any one of claims 1 to 27, having less than about 8 wt.% water, less than about 5 wt.% water, less than about 3 wt.% water, less than about 1 wt.% water, or no water, based on the total weight of the topical composition. <29> 29. A topical composition according to any one of claims 1 to 28, having less than about 8 wt.% urea, less than about 5 wt.% urea, less than about 3 wt.% urea, less than about 1 wt.% urea, or no urea, based on the total weight of the topical composition. <30> 30. A topical composition according to any one of claims 1 to 29, which is a homogeneous gel. <31> 31. The topical composition of any one of claims 1 to 30, having a viscosity at 25°C in the range of about 550,000 cPs to about 850,000 cPs, about 600,000 cPs to about 800,000 cPs, or about 620,000 cPs to about 780,000 cPs. <32> an occlusion-forming agent comprising glycerin; one or more proteolytic enzymes; Antioxidant system containing green tea polyphenols A topical composition comprising: having a viscosity in the range of about 550,000 cPs to about 850,000 cPs at 25°C; Topical compositions. <33> A method for treating, preventing or minimizing the appearance of scars, comprising administering to a patient in need thereof a topical composition described in any of 1 to 32 above. <34> 34. The method of claim 33, wherein the visual appearance of the scar is reduced after administration for a period of about 1 day to about 90 days, about 3 days to about 60 days, or about 5 days to about 30 days. <35> 35. A method according to claim 33 or 34, wherein the scar is new or old and is the result of a surgical or cosmetic procedure, trauma, injury or sunburn. <36> 36. The method according to claim 35, wherein the scar is a hypertrophic scar or a keloid. <37> 37. A method according to any one of claims 33 to 36, wherein the flexibility of the skin in the scarred area is improved after administration for a period of about 1 day to about 90 days, about 3 days to about 60 days, or about 5 days to about 30 days. <38> 38. The method of any one of claims 33 to 37, wherein the administration is performed after a cosmetic procedure, after a surgical procedure, in conjunction with a scar correction procedure, or in conjunction with a dermatological procedure. <39> 39. The method of claim 38, wherein the dermatological procedure is selected from laser, microneedling, microdermabrasion, dermabrasion, dermabrasion, dermabrasion, or chemical peel. <40> forming a first mixture comprising a first portion of glycerin, an antioxidant system comprising green tea polyphenols, and an optional preservative; adding a binder to the first mixture; forming a second mixture comprising a second portion of glycerin, one or more proteolytic enzymes, and optionally a carrier; combining the first mixture and the second mixture to form a topical composition; 33. A method for preparing a topical composition according to any one of claims 1 to 32, comprising: <41> 41. The method of claim 40, wherein the first mixture with the binder is not aerated. <42> 42. The method according to claim 40 or 41, wherein the first mixture is formed at a temperature of about 20°C to about 65°C, about 25°C to about 60°C, or about 30°C to about 55°C. <43> 43. The method according to any one of claims 40 to 42, wherein the second mixture is formed at a temperature of about 75°C to about 125°C, about 80°C to about 115°C, or about 90°C to about 110°C. <44> 44. The method of claim 43, wherein the second mixture is cooled to the temperature of the first mixture before combining the first and second mixtures. <45> a hydrophilic occlusion-forming agent having a water solubility of greater than about 75%; one or more proteolytic enzymes; Antioxidant system containing green tea polyphenols 1. A topical composition comprising: <46> an occlusion-forming agent comprising glycerin; one or more proteolytic enzymes; Antioxidant systems including polyphenol antioxidants 1. A topical composition comprising: <47> a hydrophilic occlusion-forming agent having a water solubility of greater than about 75%; one or more proteolytic enzymes; Antioxidant systems including polyphenol antioxidants 1. A topical composition comprising:

Claims

1. an occlusion-forming agent comprising glycerin and a binder comprising at least one of HEA-sodium acryloyldimethyltaurate-steareth-20 methacrylate copolymer, C13-14 isoparaffin, polysorbate 80, and decyl glucoside; one or more proteolytic enzymes; Antioxidant system containing green tea polyphenols A topical composition comprising: having less than 10 wt. % added water, or no water, based on the total weight of the topical composition; Topical compositions.

2. an occlusion-forming agent comprising glycerin and a binder comprising at least one of HEA-sodium acryloyldimethyltaurate-steareth-20 methacrylate copolymer, C13-14 isoparaffin, polysorbate 80, and decyl glucoside; one or more proteolytic enzymes; Antioxidant system containing green tea polyphenols A topical composition comprising: the glycerin is present in an amount ranging from 70 wt. % to 99 wt. %, 80 wt. % to 98.5 wt. %, 90 wt. % to 98 wt. %, or 95 wt. % to 97 wt. %, based on the total weight of the topical composition; having less than 8 wt. % urea, or no urea, based on the total weight of the topical composition; Topical compositions.

3. an occlusion-forming agent comprising glycerin and a binder comprising at least one of HEA-sodium acryloyldimethyltaurate-steareth-20 methacrylate copolymer, C13-14 isoparaffin, polysorbate 80, and decyl glucoside; one or more proteolytic enzymes; Antioxidant system containing green tea polyphenols A topical composition comprising: the glycerin is present in an amount ranging from 70 wt. % to 99 wt. %, 80 wt. % to 98.5 wt. %, 90 wt. % to 98 wt. %, or 95 wt. % to 97 wt. %, based on the total weight of the topical composition; having less than 1 wt. % or no silicone-based components, based on the total weight of the topical composition; Topical compositions.

4. an occlusion-forming agent comprising glycerin and a binder comprising at least one of HEA-sodium acryloyldimethyltaurate-steareth-20 methacrylate copolymer, C13-14 isoparaffin, polysorbate 80, and decyl glucoside; one or more proteolytic enzymes; Antioxidant system containing green tea polyphenols A topical composition comprising: The glycerin is present in an amount ranging from 70 wt. % to 99 wt. %, 80 wt. % to 98.5 wt. %, 90 wt. % to 98 wt. %, or 95 wt. % to 97 wt. %, based on the total weight of the topical composition; Topical compositions.

5. an occlusion-forming agent comprising glycerin; one or more proteolytic enzymes; Antioxidant system containing green tea polyphenols A topical composition comprising: The glycerin is present in an amount ranging from 70 wt. % to 99 wt. %, 80 wt. % to 98.5 wt. %, 90 wt. % to 98 wt. %, or 95 wt. % to 97 wt. %, based on the total weight of the topical composition; Topical compositions.

6. 6. The topical composition of claim 1, wherein the one or more proteolytic enzymes are selected from papain, bromelain, and combinations thereof.

7. 7. The topical composition of claim 1, wherein the one or more proteases are present in the topical composition in an amount greater than 0 wt. % and up to 1 wt. %, based on the total weight of the topical composition.

8. 8. The topical composition of claim 1, wherein the green tea polyphenols comprise one or more of epigallocatechin gallate, epigallocatechin, epicatechin gallate, catechin, epicatechin, cis and trans isomers thereof, salts thereof, and combinations thereof.

9. 9. The topical composition of claim 1, wherein the antioxidant system is present in the topical composition in an amount greater than 0 wt. % and up to 1 wt. %, based on the total weight of the topical composition.

10. 10. The topical composition of claim 9, wherein the antioxidant system further comprises an additional antioxidant selected from the group of cinnamic acid, ferulic acid, caffeic acid, p-coumaric acid, sinapic acid, gallic acid, delphinidin, luteolin, quercetin, cyanidin, taxifolin, kaempferol, malvidin, hesperidin, pelargonidin, apigenin, naringenin, chrysin, ergothioneine, glutathione, emblica, tocopherol, allantoin, cis and trans isomers thereof, salts thereof, and combinations thereof.

11. 11. The topical composition of claim 10, wherein the antioxidant system further comprises tocopherol, allantoin, or a combination thereof.

12. 12. The topical composition of claim 11, wherein the weight to weight ratio of the green tea polyphenols to the additional antioxidants, individually or cumulatively, ranges from 10:1 to 1:10, 8:1 to 1:8, 5:1 to 1:5, 3:1 to 1:3, or 2:1 to 1:

2.

13. 13. The topical composition of any one of claims 1 to 12, wherein the binder is present in an amount ranging from 0.1 wt. % to 10 wt. %, 0.5 wt. % to 7 wt. %, 1 wt. % to 5 wt. %, or 2 wt. % to 3 wt. %, based on the total weight of the topical composition.

14. 14. The topical composition of claim 1, further comprising a preservative.

15. 15. The topical composition of claim 14, wherein the preservative comprises phenoxyethanol in an amount of up to 2 wt.%, up to 1.5 wt.%, up to 1 wt.%, or up to 0.5 wt.%, based on the total weight of the topical composition.

16. 16. The topical composition of claim 1, further comprising a carrier.

17. 17. The topical composition of claim 16, wherein the carrier comprises dimethicone.

18. 18. The topical composition of claim 16 or 17, wherein the carrier is present in an amount of at most 10 wt.%, at most 8 wt.%, at most 5 wt.%, at most 3 wt.%, at most 1 wt.%, at most 0.5 wt.%, or at most 0.1 wt.%.

19. 19. The topical composition of any one of claims 1 to 18, which is clear.

20. 20. The topical composition of any one of claims 1 to 19, having a pH of 3.0 to 9.0, 6.0 to 9.0, 6.5 to 8.5, or 7.0 to 8.

0.

21. 21. The topical composition of any one of claims 1 to 20, further comprising an active agent selected from a sunscreen, an antibiotic, a steroid, hydroquinone, or a combination thereof.

22. 22. The topical composition of any one of claims 1 to 21, which is hypoallergenic.

23. 23. The topical composition of any one of claims 1 to 22, which is non-comedogenic.

24. 24. The topical composition of any one of claims 1 to 23, which is a homogeneous gel.

25. 25. The topical composition of any one of claims 1 to 24, having a viscosity in the range of 550,000 cPs to 850,000 cPs, 600,000 cPs to 800,000 cPs, or 620,000 cPs to 780,000 cPs at 25°C.

26. an occlusion-forming agent comprising glycerin; one or more proteolytic enzymes; Antioxidant system containing green tea polyphenols A topical composition comprising: having a viscosity in the range of 550,000 cPs to 850,000 cPs at 25°C; Topical compositions.

27. 27. A topical composition according to any one of claims 1 to 26 for treating, preventing or minimising the appearance of scars.

28. forming a first mixture comprising a first portion of glycerin and an antioxidant system comprising green tea polyphenols; adding a binder to the first mixture; forming a second mixture comprising a second portion of glycerin and one or more proteolytic enzymes; combining the first mixture with the second mixture to form a topical composition; 28. A method for preparing the topical composition of any one of claims 1 to 27, comprising:

29. an occlusion-forming agent comprising glycerin; one or more proteolytic enzymes; Antioxidant systems including polyphenol antioxidants A topical composition comprising: The glycerin is present in an amount ranging from 70 wt. % to 99 wt. %, 80 wt. % to 98.5 wt. %, 90 wt. % to 98 wt. %, or 95 wt. % to 97 wt. %, based on the total weight of the topical composition; Topical compositions.

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