WO2016161074A1 - Compositions synergiques et procédés pour atténuer l'irritation de la peau et améliorer la fonction de barrière de la peau - Google Patents

Compositions synergiques et procédés pour atténuer l'irritation de la peau et améliorer la fonction de barrière de la peau Download PDF

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WO2016161074A1
WO2016161074A1 PCT/US2016/025193 US2016025193W WO2016161074A1 WO 2016161074 A1 WO2016161074 A1 WO 2016161074A1 US 2016025193 W US2016025193 W US 2016025193W WO 2016161074 A1 WO2016161074 A1 WO 2016161074A1
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Prior art keywords
composition
acetyl hexapeptide
skin
viscosity
acetyl
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PCT/US2016/025193
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English (en)
Inventor
Jessica R. Tittl
Christopher A. Wolf
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Gojo Industries, Inc.
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Priority to CA2980759A priority Critical patent/CA2980759A1/fr
Priority to EP16716380.7A priority patent/EP3277255A1/fr
Publication of WO2016161074A1 publication Critical patent/WO2016161074A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08—Peptides having 5 to 11 amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/92—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof
    • A61K8/922—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof of vegetable origin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/64—Proteins; Peptides; Derivatives or degradation products thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like

Definitions

  • compositions of the present invention provide methods and compositions for improving skin barrier function and skin hydration. More particularly, it relates to compositions containing synergistic combinations of acetyl hexapeptides in a cosmetically or pharmaceutically acceptable carrier. Compositions of the invention reduce inflammation and protect and heal damaged skin.
  • SLS sodium lauryl sulfate
  • Retinoid and its derivatives can cause severe local irritation manifested as mild erythema and stratum corneum peeling of the skin.
  • Topical or systemic use of some skin cleansers and disinfectants is linked to skin irritation.
  • ingredients such as benzyol peroxide, alpha-hydroxyl acids and derivatives thereof, salicylic acid, natural plant extracts, sunscreen actives, urea, and preservatives are also known to cause external skin irritations.
  • skin irritations may be caused by inherent disease conditions such as acne, rosacea, atopic dermatitis, and other disease states.
  • Typical approaches to reduce irritation include reducing the concentration of the inflammatory ingredient, use of alternatives or formulation/delivery approaches, such as encapsulation, controlled release, compartmentalization, inclusion of non-irritating excipients. None of the above has successfully reduced irritation while retaining efficacy. As a result, there is a need for anti-irritant substances to mitigate external skin irritations, or irritations caused by inherent skin conditions.
  • Acetyl hexapeptides such as acetyl hexapeptide-3 have been employed for properties including anti-wrinkle, collagen boosting, anti-aging, and relaxing of facial tension. Acetyl hexapeptide-3 is said to be non-irritating. Some peptides have been described as capable of stimulating collagen synthesis, and increasing the hydration of the skin.
  • Pressure sores sometimes referred to as bed sores or decubitus ulcers, may develop if a person spends a significant amount of time in a wheelchair, regular chair, or bed.
  • the likelihood of developing pressure sores is exacerbated if the person is incontinent, is elderly, has received radiation therapy, and/or has not been eating well.
  • Conventional incontinence pads and bandages can make skin problems worse. Although they may keep bedding and clothing cleaner, these products can trap urine, feces, or other possible irritants, keeping them in constant contact with the skin. Over time, the skin may break down, and ulcers are likely to develop.
  • FIG. 1 is a graphical representation of the effect of compositions containing oligopeptides on the irritation response of cells treated with known irritants, as quantified by measuring IL-8 secretion.
  • FIG. 2 is a graphical representation of the reduction of IL-8 secretion for test samples, compared to Control B, which contained no oligopeptide.
  • FIG. 3 is a graphical representation of the effect of oligopeptides on cell binding, as measured by Real-Time Quantitative Reverse Transcription Polymerase Chain Reaction (qRT- PCR) for desmoglein (DSG1).
  • qRT- PCR Real-Time Quantitative Reverse Transcription Polymerase Chain Reaction
  • FIG. 4 is a graphical representation of the effect of oligopeptides on cell binding, as measured by qRT-PCR for democollin (DSC3).
  • FIG. 5 is a graphical representation of the effect of various compositions on the irritation response of cells treated with known irritants, as quantified by measuring IL-8 secretion, and on cell viability.
  • FIG. 6 is a graphical representation of Involucrin Expression.
  • FIG. 7 is a graphical representation of PPAR5 expression.
  • FIG. 8 is a graphical representation of ABCA12 expression.
  • FIG. 9 is a graphical representation of DSC 1 expression.
  • FIG. 10 is a graphical representation of APQ3 expression.
  • FIG. 11 is a graphical representation of yield stress point for compositions according to the present invention and comparative samples.
  • FIG. 12 is a graphical representation of thixotropic behavior for compositions according to the present invention and comparative samples.
  • compositions of the present invention include a combination of at least two oligopeptides in a cosmetically or pharmaceutically acceptable carrier.
  • oligopeptides are short chains of amino acid moieties linked by amide bonds. Any combination of amino acids may be included.
  • the oligopeptides include 12 amino acid moieties or less, in other embodiments, 10 amino acid moieties or less, and in other embodiments, 8 amino acid moieties or less.
  • the peptides include at least 5 amino acid moieties. In one or more embodiments, the peptide includes at least 6 amino acid moieties. In one or more embodiments, the peptides include from 5 to 6 amino acid moieties. Longer peptides are believed to have at least the potential for causing undesirable responses on application to the human body. In one or more embodiments, the stereochemistry of at least one of the amino acids of the peptide is L-.
  • the oligopeptide may be identified by an INCI (International Nomenclature of Cosmetic Ingredients) name, such as acetyl hexapeptide followed by a numerical designation.
  • INCI names for suitable oligopeptides include Polmitoyl Oligopeptide, Glycerin (and) Aqua (and) Myristoyl Pentapeptide-17, Aqua (and) Butylene Glycol (and) Oryza Sativa (Rice) Bran Extract (and) Boswellia Serrata Extract (and) Honey Extract (and) Oligopeptide- 10 (and) Phenoxyethanol (and) Sodium Benzoate, Oligopeptide- 1, rh-Oligopeptide- 1, rh-Oligopeptide-1 (and) Mannitol (and) Glycerin (and) EDTA (and) Methylparaben (and) Ethylparaben, Butylene Glycol (and) Hydrogenated Lecithin (and)
  • compositions of the present invention include at least two acetyl hexapeptides.
  • a synergistic effect is seen when two or more oligopeptides are combined.
  • the reduction in irritancy when two or more oligopeptides are combined is greater than just an additive effect.
  • the positive effect on cell regeneration is more than the sum of the improvement that is seen with equivalent amounts of the individual components.
  • compositions of the present invention comprise two or more oligopeptides. In one or more embodiments, compositions of the present invention comprise two or more acetyl hexapeptides. In one or more embodiments, compositions of the present invention comprise two or more acetyl hexapeptides, and at least one of the acetyl hexapeptides is selected from acetyl hexapeptide-38 and acetyl hexapeptide-46. In one or more embodiments, compositions of the present invention comprise acetyl hexapeptide-38 and acetyl hexapeptide-46.
  • hexapeptides contain six amino acid moieties.
  • Some non-limiting examples of acetyl hexapeptides are acetyl hexapeptide-1, acetyl hexapeptide-7, acetyl hexapeptide-8, acetyl hexapeptide-19, acetyl hexapeptide-20, acetyl hexapeptide-22, acetyl hexapeptide-24, acetyl hexapeptide-30, acetyl hexapeptide-31 , acetyl hexapeptide-37, acetyl hexapeptide-38, acetyl hexapeptide-39, acetyl hexapeptide-46, and acetyl hexapeptide-49.
  • Acetyl Hexapeptide-1 is reaction product of alanine, arginine, histidine, leucine, phenylalanine and tryptophane hexapeptide with acetic acid.
  • Acetyl hexapeptide-1 is commercially available, for example from Lucas Meyer Cosmetics as a blend with glycerin and water and dextran under the tradename Melitane®.
  • Acetyl hexapeptide-8 is commercially available, for example from Theraderm Clinical Skin Care under the tradename Argireline®.
  • Acetyl hexapeptide-30 is commercially available, for example from Lipotec LLC under the tradename Inyline®.
  • Acetyl hexapeptide-38 is commercially available, for example from Lipotec LLC as a blend with butylene glycol and water, under the tradename AdifylineTM.
  • Acetyl hexapeptide-39 is commercially available, for example from Lipotec LLC under the tradename Silusyne®.
  • Acetyl hexapeptide-46 is commercially available, for example from Lipotec LLC as a blend with butylene glycol, water and citric acid, under the tradename Delisens®.
  • the composition includes acetyl hexapeptide-38 and acetyl hexapeptide-46.
  • compositions of the present invention include at least one pentapeptide.
  • pentapeptides contain five amino acid moieties.
  • Some non-limiting examples of pentapeptides include acetyl pentapeptide- 1, pamitoyl pentapeptide-3, pamitoyl pentapeptide-4, and myristoyl pentapeptide- 17.
  • compositions of the present invention comprise pamitoyl pentapeptide-3.
  • compositions of the present invention comprise pamitoyl pentapeptide-4.
  • compositions of the present invention comprise myristoyl pentapeptide-17.
  • Acetyl pentapeptide- 1 is commercially available, for example from Spec Chem Ind. Under the tradename SpecPed SC-AP1.
  • Pamitoyl pentapeptide-3 is commercially available, for example from Spec Chem Ind. Under the tradename SpecPed SC-PP3.
  • Myristoyl pentapeptide-17 is commercially available, for example from Spec Chem Ind. Under the tradename SpecPed SC- MP17.
  • the cosmetically or pharmaceutically effective amount of the peptides of the invention which should be administered, as well as their dosage, will depend on numerous factors, including age, state of the patient, the nature or severity of the condition, disorder or disease to be treated and/or cared for, the route and frequency of administration and of the particular nature of the peptides to be used.
  • compositions of the present invention comprise at least an effective amount of the oliopeptide, wherein an effective amount is the amount that mitigates skin irritation, enhances skin conditioning, enhances the skin barrier function, provides hydration, or enhances healing of damaged skin, when compared to the same composition but not containing any oligopeptide.
  • an effective amount of each oligopeptide is at least about 0.06 parts per million by weight (ppm), based upon the total weight of the composition.
  • an effective amount is at least about 0.10 ppm, in other embodiments at least about 0.12 ppm, based upon the total weight of the composition.
  • the total amount of oligopeptides in the composition is at least about 0.12 ppm, in other embodiments, at least about 0.15 ppm, in other embodiments, at least about 0.17 ppm, in other embodiments, at least about 0.2 ppm, in other embodiments, at least about 0.25 ppm, based upon the total weight of the composition.
  • the composition comprises about 100 ppm or less of each oligopeptide, in other embodiments, about 50 ppm or less, in other embodiments, about 25 ppm or less, in other embodiments, about 10 ppm or less, in other embodiments, about 7.5 ppm or less, in other embodiments, about 5 ppm or less, in other embodiments, about 2.5 ppm or less, in other embodiments, about 2 ppm or less, in other embodiments, about 1.5 ppm or less, in other embodiments, about 1 ppm or less, based upon the total weight of the composition.
  • the total amount of oliopeptides in the composition is not particularly limited.
  • the total amount of oligopeptide may be reduced.
  • the composition comprises a total of about 1000 ppm or less of oligopeptides, in other embodiments, about 800 ppm or less, in other embodiments, about 600 ppm or less, in other embodiments, about 500 ppm or less, in other embodiments, about 250 ppm or less, in other embodiments, about 200 ppm or less, in other embodiments, about 150 ppm or less, in other embodiments, about 100 ppm or less, in other embodiments, about 75 ppm or less, in other embodiments, about 50 ppm or less, in other embodiments, about 25 ppm or less, in other embodiments, about 20 ppm or less, in other embodiments, about 10 ppm or less, based upon the total weight of the composition.
  • the composition comprises from about 0.06 to about 100 ppm of each oligopeptide, based upon the total weight of the composition. In one or more embodiments, the composition comprises from about 0.08 to about 50 ppm of each oligopeptide, based upon the total weight of the composition. In one or more embodiments, the composition comprises from about 0.1 to about 30 ppm of each oligopeptide, based upon the total weight of the composition. In one or more embodiments, the composition comprises from about 0.5 to about 25 ppm of oligopeptide, based upon the total weight of the composition. [0048]
  • the oligopeptides of this invention may have variable solubility in water.
  • Water- soluble oligopeptides may be incorporated directly into aqueous compositions.
  • Water-insoluble oligopeptides and those with limited water solubility may be solubilized in cosmetically or pharmaceutically acceptable solvents such as and not restricted to, ethanol, propanol, isopropanol, propylene glycol, glycerin, butylene glycol or polyethylene glycol or any combination thereof.
  • the oligopeptide may be added to the composition as a solution or emulsion.
  • the oligopeptide may be premixed with a diluent, and optionally one or more other ingredients, to form an oligopeptide solution or emulsion, with the proviso that the diluent does not deleteriously affect the beneficial properties of the composition.
  • diluents include water, alcohol, or blends of water and other diluents such as glycols, ketones, linear and/or cyclic hydrocarbons, triglycerides, carbonates, silicones, alkenes, esters such as acetates, benzoates, fatty esters, glyceryl esters, ethers, amides, polyethylene glycols, PEG PPG copolymers, inorganic salt solutions such as saline, and mixtures thereof.
  • diluents include water, alcohol, or blends of water and other diluents such as glycols, ketones, linear and/or cyclic hydrocarbons, triglycerides, carbonates, silicones, alkenes, esters such as acetates, benzoates, fatty esters, glyceryl esters, ethers, amides, polyethylene glycols, PEG PPG copolymers, inorganic salt solutions such as saline, and
  • the amount of solution or emulsion that is added to the composition is selected so that the amount of oligopeptide falls within the ranges set forth hereinabove.
  • the cosmetically or pharmaceutically acceptable carrier may be prepared according to convention known to persons skilled in the art.
  • the formulation of cosmetic and pharmaceutical lotion compositions is described in "Harry's Cosmeticology,” Eighth edition, (2000), Harry, Ralph Gordon, Reiger, Martin M., ed. Chemical Publishing Company, which is hereby incorporated by reference.
  • compositions of the present invention may be formulated as liquids, lotions, creams, gels, foams, salves, suspensions, emulsions, and the like. Suitable formulations are described, for example, in U.S. Patent Nos. 5,980,970, 8, 105,616, U.S. Patent Application Publication Nos. 2006/0159649 Al, 2009/0041697 Al, 2014/0011894 Al, and 2014/0328769 Al, all of which are incorporated by reference herein.
  • compositions according to the present invention may be formulated as lotions.
  • lotions include oil-in-water emulsions as well as water-in-oil emulsions, oil-water-oil, and water-oil-water.
  • ingredients may be present in either the oil or water phase of the emulsion. That is, the lotion formulation is not particularly limited.
  • Examples of lotion formulations include those containing water and/or alcohols and emollients such as hydrocarbon oils and waxes, silicone oils, hyaluronic acid, vegetable, animal or marine fats or oils, glyceride derivatives, fatty acids or fatty acid esters or alcohols or alcohol ethers, lanolin and derivatives, polyhydric alcohols or esters, wax esters, sterols, phospholipids and the like, and generally also emulsifiers (nonionic, cationic or anionic), although some of the emollients inherently possess emulsifying properties.
  • emollients such as hydrocarbon oils and waxes, silicone oils, hyaluronic acid, vegetable, animal or marine fats or oils, glyceride derivatives, fatty acids or fatty acid esters or alcohols or alcohol ethers, lanolin and derivatives, polyhydric alcohols or esters, wax esters, sterols, phospholipids and the like, and generally
  • creams and ointments are typically spreadable in the range from room temperature to skin temperature, and lotions and milks are more flowable within this temperature.
  • the carrier is water-based. In one or more embodiments, the carrier contains one or more emulsifiers, one or more vegetal waxes, and one or more olive derivatives or extracts.
  • a surprising enhancement of the skin barrier function is observed when the composition includes a vegetal wax.
  • the vegetal wax promotes a liquid crystal network structure to the emulsion.
  • a liquid crystal network structure in the compositions of the present invention improves the physiological penetration of active ingredients, increases the barrier integrity, and aids in functional hydration.
  • carriers including vegetal wax according to the present invention provide a complex combination of fatty acids that are chemically similar to the skin surface lipid composition, and that have the distinctive property to self-emulsify in hydrophilic or lipophilic millieus.
  • the distinctive complex combination of fatty acids represent a unique biomimetic restructuring agent endowed with the double feature of first restoring and maintaining the integrity of the skin barrier and then providing itself the emulsifying base.
  • compositions of the present invention containing a liquid crystalline carrier provide liquid crystals with a skin-like fatty acid composition.
  • the highly stable and dermo-compatible liquid crystals are similar to the lipids of the cutaneous barrier.
  • the liquid crystals act as biomimetic restructuring agents and restore the optimal integrity of the skin barrier function and increase the integrity of the stratum corneum barrier function leading to an increased and sustained skin hydration.
  • the vegetal wax is a vegetable-based liquid crystal promoter that is believed to stabilize oil-in-water emulsions and to improve the texture of emulsions.
  • the vegetal wax re-organizes the emulsion's microscopic structure, acting as an emulsion stabilizing agent.
  • the lamellar liquid crystals produce several bi-layers that enrobe the oil droplets, producing an energy layer preventing coalescence.
  • the vegetal wax provides the lotion with sebum-control benefits. In one or more embodiments, it provides skin-hydration and a unique texture due to the high water content of the liquid crystalline structure (water incorporated between several bilayers). In one or more embodiments, the vegetal wax influences positively the delivery of active ingredients to the skin.
  • vegetal waxes include a blend of cetyl palmitate, sorbitan palmitate and sorbitan olivate such as the blend that is available from B&T S.r.l. under the tradename Oliwax LC.
  • the composition includes at least one vegetal wax in an amount of at least about 0.5 wt. %, in other embodiments, at least about 0.75 wt. %, in other embodiments, at least about 1 wt. %, in other embodiments, at least about 1.5 wt. %, in other embodiments, at least about 2 wt. %, in other embodiments, at least about 2.5 wt. %, based upon the total weight of the composition.
  • the composition includes at least one vegetal wax in an amount of up to about 10 weight percent (wt. %), in other embodiments, up to about 8 wt. %, in other embodiments, up to about 5 wt. %, in other embodiments, up to about 3 wt. %, in other embodiments, up to about 2.5 wt. %, in other embodiments, up to about 2 wt. %, in other embodiments, up to about 1.5 wt. %, in other embodiments, up to about 1 wt. %, based upon the total weight of the composition.
  • wt. % weight percent
  • the composition includes at least one vegetal wax in an amount of up to about 10 weight percent (wt. %), in other embodiments, up to about 8 wt. %, in other embodiments, up to about 5 wt. %, in other embodiments, up to about 3 wt. %, in other embodiments, up to about 2.5 wt. %, in other embodiments
  • the composition includes at least one vegetal wax in an amount of from about 0.5 to about 10 wt. %, in other embodiments, from about 0.75 to about 8 wt. %, and in other embodiments, based upon the total weight of the composition.
  • the composition further comprises at least one derivative or extract of olives.
  • the olive derivative includes olive oil.
  • the olive derivative includes a cetearylic ester derivative and/or a sorbitan ester derivative.
  • the olive derivative includes a blend of a cetearylic ester derivative and a sorbitan ester derivative.
  • the olive derivative includes a blend having an INCI designation of Cetearyl Olivate (and) Sorbitan Olivate. Cetearyl olivate (and) sorbitan olivate is available from B&T S.r.l. under the tradename OliveM®1000. OliveM is sometimes described as an O/W emulsifier derived from olive oil. It is substantially free of polyethylene oxides (PEG).
  • the cetearylic ester derivative stabilizes the liquid crystals.
  • the sorbitan ester derivative enhances the emolliency properties of the composition and/or provides easier dispersion for powders.
  • UV filters and pigments may be easily dispersed at high percentages.
  • the blend of a cetearylic ester derivative and a sorbitan ester derivative of olive combines a liquid crystal structure with an oleic component derived from olive oil.
  • skin penetration is enhanced, and a soft, silky smooth after-feel is obtained.
  • the substantivity of its composition being very similar to the human sebum, provides retention of the skin moisture and increases the active ingredient's resistance to water and/or sweat.
  • the blend of a cetearylic ester derivative and a sorbitan ester derivative of olive operates by forming liquid crystals in emulsions, by placing itself at the interface of a two phase system in a preferential direction, placing the polar head into the aqueous phase and the nonpolar tail into the lipidic phase.
  • the postmicellar organization of the blend of a cetearylic ester derivative and a sorbitan ester derivative of olive in water is the typical structure of a liquid crystal reticule, where the bilayer micelles create a multilayer lamellar formation.
  • emulsions that are formulated with the blend of a cetearylic ester derivative and a sorbitan ester derivative of olive appear very shiny and light and have an original, fresh and silky touch, even if they contain high percentages of lipids.
  • the blend of a cetearylic ester derivative and a sorbitan ester derivative of olive, promoting the formation of this reticular structure inside the emulsion, allows the formulation to contain quite large amounts of natural and polar lipids without affecting the final stability of the emulsion.
  • up to about 25 wt. % of the emulsion may be natural and/or polar lipids.
  • the composition includes at least one olive derivative or extract in an amount of at least about 0.1 wt. %, in other embodiments, at least about 0.25 wt. %, in other embodiments, at least about 0.5 wt. %, in other embodiments, at least about 0.75 wt. %, in other embodiments, at least about 1 wt. %, in other embodiments, at least about 1.5 wt. %, in other embodiments, at least about 2 wt. %, in other embodiments, at least about 2.5 wt. %, based upon the total weight of the composition.
  • the composition includes at least one olive derivative or extract in an amount of up to about 20 wt. %, in other embodiments, up to about 18 wt. %, in other embodiments, up to about 15 wt. %, in other embodiments, up to about 10 wt. %, in other embodiments, up to about 8 wt. %, in other embodiments, up to about 5 wt. %, in other embodiments, up to about 3 wt. %, in other embodiments, up to about 2 wt. %, in other embodiments, up to about 1 wt. %, in other embodiments, up to about 0.5 wt. %, based upon the total weight of the composition.
  • the composition includes at least one olive derivative or extract in an amount of from about 0.1 to about 20 wt. %, in other embodiments, from about 0.5 to about 15 wt. %, based upon the total weight of the composition.
  • the lotion compositions include olive oil.
  • the composition includes at least one olive oil in an amount of at least about 0.1 wt. %, in other embodiments, at least about 0.25 wt. %, in other embodiments, at least about 0.5 wt. %, in other embodiments, at least about 0.75 wt. %, in other embodiments, at least about 1 wt. %, in other embodiments, at least about 1.5 wt. %, in other embodiments, at least about 2 wt. %, in other embodiments, at least about 2.5 wt. %, based upon the total weight of the composition. [0077] In one or more embodiments, the composition includes at least one olive oil in an amount of up to about 20 wt.
  • % in other embodiments, up to about 18 wt. %, in other embodiments, up to about 15 wt. %, in other embodiments, up to about 10 wt. %, in other embodiments, up to about 8 wt. %, in other embodiments, up to about 5 wt. %, in other embodiments, up to about 3 wt. %, in other embodiments, up to about 2 wt. %, in other embodiments, up to about 1 wt. %, in other embodiments, up to about 0.5 wt. %, based upon the total weight of the composition.
  • the composition includes at least one olive oil in an amount of from about 0.1 to about 20 wt. %, in other embodiments, from about 0.5 to about 15 wt. %, based upon the total weight of the composition.
  • the carrier includes one or more emulsifiers.
  • emulsifiers include glycerol esters, in particular glycerol esters of a-hydroxycarboxylic acids and saturated fatty acids. Specific examples include glyceryl stearate.
  • the total amount of the glycerol esters in the composition is advantageously chosen from the range from about 0.1 to about 10.0 wt. %, in one or more embodiments, from about 0.5 to about 6.0 wt. %, based on the total weight of the composition.
  • the carrier comprises a cold process formulation aid.
  • the carrier comprises at least one wax selected from the group consisting of natural waxes and synthetic waxes and at least one cationic polymer.
  • the carrier comprises one or more C12 -C18 fatty acid-C2 -C5 polyol esters such as glyceryl monostearate, ethylene glycol monostearate and polyethylene glycol distearate. Examples of polyethylene glycol distearates include PEG- 150 distearate. Examples of cationic polymers include polyquaternium polymers, such as polyquaternium-37.
  • the carrier may further comprise one or more fatty alcohols.
  • fatty alcohols include cetearyl alcohol.
  • Cold process formulation aids are further described in U.S. Patent Application Publication Nos. 2011/0250148, 2011/0250151, 2014/0094558, and 2014/0336308, all of which are incorporated by reference herein.
  • compositions or the present invention may further comprise one or more of a wide range of optional ingredients, with the proviso that they do not deleteriously affect the beneficial properties of the composition.
  • optional ingredients classified by function, include: abrasives, anti-acne agents, anticaking agents, antioxidants, binders, biological additives, bulking agents, chelating agents, chemical additives; colorants, cosmetic astringents, cosmetic biocides, denaturants, drug astringents, emulsifiers, external analgesics, film formers, fragrance components, humectants, opacifying agents, plasticizers, preservatives (sometimes referred to as antimicrobials), propellants, reducing agents, skin bleaching agents, skin-conditioning agents (emollient, miscellaneous, and occlusive), skin protectants, solvents, surfactants, foam boosters, hydrotropes, solubilizing agents, suspending agents (nonsurfactant), sunscreen agents, ultraviolet light absorbers, detackifiers, and viscosity increasing agents (aqueous and nonaqueous).
  • abrasives anti-acne agents, anticaking agents, antioxidants
  • Examples of other functional classes of materials useful herein include solubilizing agents, sequestrants, and keratolytics, topical active ingredients, deposition enhancers, humectants, moisturizing esters, emulsifying agents, silicone glycols, miscellaneous skin conditioners, thickeners, and/or antimicrobial agents.
  • compositions of the present invention may include one or more pharmacological and/or antibiotic agents, with the proviso that the pharmacological and/or antibiotic ingredient does not deleteriously affect the skin barrier function or skin conditioning properties of the composition.
  • pharmacological and/or antibiotic agents include, but are not limited to, antifungal agents, antiviral agents, antimicrobial agents, and antiparasitic agents.
  • one or more antimicrobial agents are included.
  • antimicrobial agents include, but are not limited to, triclosan, also known as 5-chloro-2(2,4-dichlorophenoxy) phenol (PCMX) and available from Ciba-Geigy Corporation under the tradename IRGASAN®; chloroxylenol, also known as 4-chloro-3,5-xylenol, available from Nipa Laboratories, Inc. under the tradenames NIPACIDE® MX or PX; hexetidine, also known as 5-amino-l,3-bis(2-ethylhexyl)-5-methyl-hexahydropyrimidine; chlorhexidine salts including chlorhexidine gluconate and the salts of
  • the composition comprises from about 0.05 to about 3 wt. %, in other embodiments, from about 0.07 to about 2.5 wt. %, in other embodiments, from about 0.09 to about 1 wt. %, in other embodiments, from about 0.1 to about 0.75 wt. %, in other embodiments, from about 0.15 to about 0.5 wt. %, of at least one antimicrobial agents, based upon the total weight of the composition.
  • the composition may include at least one antibiotic.
  • antibiotics include asaminoglycoside antibiotics, cephalosporins, carbapenems, quinolone, macrolide antibiotics, penicillins, sulfonamides, tetracyclines, oxazolidinones, lipopeptides, gemifloxacin, ketolides, clindamycin, metronidazole, vancomycin, rifabutin, rifampin, nitrofurantoin, chloramphenicol, erythromycin, gentamicin, vancomycin, ciproflaxin, doxycycline, minocycline, isoniazid, ethambutol, clofazimine, fluoroquinolones, pyrazinamide, streptomycin, ofloxacin, ganciclovir, azithromycin, clarithromycin, dapsone, ampicillin, amphotericin B, keto
  • compositions of the present invention may further include one or more probiotics and/or prebiotics.
  • the one or more probiotics include one or more skin commensal microorganisms which positively affect the skin microbiota.
  • the one or more probiotics can include microorganisms that positively affect the skin surface environment, e.g., by altering the pH or inhibiting growth of pathogenic microorganisms.
  • the one or more probiotics can include one or more microorganisms naturally found on the skin surface of the individual.
  • the one or more probiotics can include one or more microorganism that are not naturally found on the skin surface of the individual, but positively affect the skin surface environment.
  • the one or more probiotics can include one or more engineered microorganisms.
  • the one or more probiotics can include a microorganism genetically engineered to have a property that positively affects the skin surface environment, e.g., by synthesizing and excreting an inhibitor of pathogenic microorganisms. See, e.g., Martin et al. (2013) Microbial Cell Factories, 12:71, which is incorporated herein by reference.
  • the probiotic comprises live probiotic microorganisms.
  • the probiotics may be included in a live form, dead form, semi- active or in deactivated form and fragments or fractions originating from the microorganism either live or dead (e.g., as a lyophilized powder).
  • the probiotic includes culture supernatants of the microorganisms.
  • the one or more probiotics include one or more bacterial probiotics. See, e.g., U.S. Pat. No. 8,557,560, U.S. Patent Application Publication Nos. 2011/0274676 Al, 2014/0037688 Al, Schrezenmeir & De Vrese (2001) Am. J. Clin. Nutr. 73(suppl):361 S-364S, and Gueniche et al. (2009) Exp. Dermatol. 19:el-e8, all of which are incorporated herein by reference.
  • the one or more bacterial probiotics include one or more of Firmicutes, Actinobacteria, Bacteriodetes, Proteobacteria, or Cyanobacteria. In one or more embodiments, the one or more bacterial probiotics include one or more of Corynebacteria, Propionibacteria, Micrococci, or Staphylococci. In one or more embodiments, the one or more bacterial probiotics include non-lactic acid and/or lactic acid producing bacteria (LAB) and can include Bacteroides, Bifidobacterium, and Lactobacillus. In one or more embodiments, the one or more bacterial probiotics include certain strains of Aerococcus, E.
  • the one or more probiotics include one or more non-pathogenic strains of pathogenic bacteria.
  • the one or more probiotic may include a bacterial strain that inhibits a second bacterial strain, e.g., by out competing for resources or by inhibiting the growth of the second bacterial stain.
  • the one or more probiotics include skin commensal microorganism Staphylococcus epidermidis.
  • Staphylococcus epidermidis may be used as a probiotic to modulate growth of pathogenic bacteria on the skin surface by producing microbial peptides that inhibit Staphylococcus aureus biofilm formation and/or by producing lanthionine-containing antibacterial peptides, e.g., bacteriocins, which are known to exhibit antibacterial properties toward certain species of harmful bacteria, e.g., Streptococcus aureus and Streptococcus pyogenes.
  • Staphylococcus epidermidis may be used as a probiotic to stimulate the immune system by influencing the innate immune response of keratinocytes through Toll-like receptor ("TLR”) signaling.
  • TLR Toll-like receptor
  • Staphylococcus epidermidis may be used as a probiotic to inhibit the action of more virulent microorganisms such as Staphylococcus aureus by occupying receptors on a host cell that also bind the virulent microorganism. See, e.g., Orrice & Segre (2011) Nat. Rev. Microbiol. 9:244-53, which is incorporated herein by reference.
  • the one or more probiotics can include skin commensal microorganism Propionibacterium acnes.
  • Propionibacterium acnes can be used as a probiotic to consume skin oil and to produce byproducts such as short-chain fatty acids and propionic acid known to help maintain a healthy skin barrier.
  • the one or more treatment agents include one or more prebiotics.
  • the one or more prebiotics are agents that promote the survival and/or growth of microorganisms of interest on the skin surface of the individual.
  • the one or more prebiotics include at least one of galacto-oligosaccharides, fructo-oligosaccharides, inulin, or lactulose.
  • the one or more prebiotics include one or more of iron, biotin, nicotinic acid, D-pantothenic acid, pyridoxal, pyridoxamine dihydrochloride, thiamin hydrochloride, valine, arginine, galactose, mannose, fructose, sucrose, lactose, or maltose.
  • the one or more prebiotics include one or more of plant derived prebiotics, e.g., derived from acacia gum, konjac, chicory root, Jerusalem artichoke, asparagus, and dandelion greens. See, e.g., U.S. Patent Application Publication NO. 2013/0115317 Al; and Bateni et al. (2013) Am. J. Dermatology Venereology 2: 10-14, both of which are incorporated herein by reference.
  • the composition may further comprise one or more zinc compounds.
  • zinc compounds include aluminum zinc oxide, ammonium silver zinc aluminum silicate, ethylene/zinc acrylate copolymer, lactobacillus/milk/calcium/phosphorus/magnesium/zinc ferment, lactobacillus/milk/manganese/zinc ferment lysate, luminescent zinc sulfide, magnesium/aluminum/zinc/hydroxide/carbonate, porphyridium/zinc ferment, saccharomyces/zinc ferment, saccharomyces/zinc/iron /germanium/copper /magnesium /silicon ferment, saccharomyces/zinc/magnesium/calcium/germanium/selenium ferment, silicon /titanium/cerium/zinc oxides, sodium zinc cetyl phosphate, sodium zinc histidine dithiooctanamide, zinc acetate, zinc acetylmethionate, zinc adenosine triphosphat
  • the total amount of zinc compounds may be limited.
  • the total amount of zinc compounds in the composition may be less than about 2 wt. %, in other embodiments, less than about 1 wt. %, in other embodiments, less than about 0.5 wt. %, in other embodiments, less than about 0.1 wt. %, in other embodiments, less than about 0.05 wt. %, based upon the total weight of the composition.
  • the composition is devoid of zinc compounds.
  • the amount of zinc oxide may be less than about 2 wt. %, in other embodiments, less than about 1 wt. %, in other embodiments, less than about 0.5 wt. %, in other embodiments, less than about 0.1 wt. %, in other embodiments, less than about 0.05 wt. %, based upon the total weight of the composition. In other words, the amount of zinc oxide may be from about zero to about 2 wt. %, based upon the total weight of the composition. In one or more embodiments, the composition is devoid of zinc oxide.
  • the composition comprises one or more humectants.
  • humectants include propylene glycol, hexylene glycol, 1,4-dihydroxyhexane, 1,2,6- hexanetriol, sorbitol, butylene glycol, propanediols, such as methyl propane diol, dipropylene glycol, triethylene glycol, glycerin (glycerol), polyethylene glycols, ethoxydiglycol, polyethylene sorbitol, glycolic acid, glycolate salts, lactate salts, urea, hydroxyethyl urea, alpha-hydroxy acids, such as lactic acid, sodium pyrrolidone carboxylic acid, hyaluronic acid, chitin, and combinations thereof.
  • polyethylene glycol humectants examples include PEG-4, PEG-6, PEG-7, PEG-8, PEG-9, PEG-10, PEG-12, PEG-14, PEG-16, PEG-18, PEG-20, PEG-32, PEG-33, PEG-40, PEG- 45, PEG-55, PEG-60, PEG-75, PEG-80, PEG-90, PEG-100, PEG-135, PEG-150, PEG-180, PEG- 200, PEG-220, PEG-240, and PEG-800.
  • the composition includes at least one humectant in an amount of at least about 0.001 wt. %, in other embodiments, at least about 0.002 wt. %, in other embodiments, at least about 0.005 wt. %, in other embodiments, at least about 0.01 wt. %, in other embodiments, at least about 0.02 wt. %, in other embodiments, at least about 0.05 wt. %, in other embodiments, at least about 0.1 wt. %, in other embodiments, at least about 0.2 wt. %, in other embodiments, at least about 0.5 wt. %, in other embodiments, at least about 0.7 wt. %, in other embodiments, at least about 1 wt. %, in other embodiments, at least about 1.5 wt. %, in other embodiments, at least about 2 wt. %, based upon the total weight of the composition.
  • the composition includes at least one humectant in an amount of up to about 20 wt. %, in other embodiments, up to about 15 wt. %, in other embodiments, up to about 10 wt. %, in other embodiments, up to about 8 wt. %, in other embodiments, up to about 5 wt. %, in other embodiments, up to about 3 wt. %, based upon the total weight of the composition.
  • the total amount ofhumectants in the composition may be less than about 2 wt. %, in other embodiments, less than about 1 wt. %, in other embodiments, less than about 0.5 wt. %, in other embodiments, less than about 0.1 wt. %, in other embodiments, less than about 0.05 wt. %, based upon the total weight of the composition.
  • the composition is devoid of any of the above humectants.
  • the amount of glycerin may be less than about 2 wt. %, in other embodiments, less than about 1 wt. %, in other embodiments, less than about 0.5 wt. %, in other embodiments, less than about 0.1 wt. %, in other embodiments, less than about 0.05 wt. %, based upon the total weight of the composition.
  • the composition is devoid of glycerin. It is believed that one of the reasons that compositions of the present invention have better aesthetics is due to the lower amount of total raw materials that are required to produce a product with effective skin-conditioning benefits.
  • the composition comprises one or more conditioning or moisturizing esters that are not olive derivatives.
  • conditioning or moisturizing esters include cetyl myristate, cetyl myristoleate, and other cetyl esters, diisopropyl sebacate, and isopropyl myristate.
  • the composition includes at least one conditioning or moisturizing ester in an amount of up to about 10 % by weight, in other embodiments, up to about 5 wt. %, in other embodiments, up to about 2 wt. %, in other embodiments, up to about 1 wt. %, based upon the total weight of the composition.
  • the composition includes at least one conditioning or moisturizing ester in an amount of at least about 0.001 wt. %, in other embodiments, at least about 0.002 wt. %, in other embodiments, at least about 0.005 wt. %, in other embodiments, at least about 0.01 wt. %, in other embodiments, at least about 0.02 wt. %, in other embodiments, at least about 0.05 wt. %, in other embodiments, at least about 0.1 wt. %, in other embodiments, at least about 0.2 wt. %, in other embodiments, at least about 0.5 wt. %, in other embodiments, at least about 0.7 wt. %, in other embodiments, at least about 1 wt. %, based upon the total weight of the composition.
  • each ester that is included is present in an amount of from about 0.5 to about 5 % by weight, in another embodiment from about 1 to about 2 % by weight, based upon the total weight of the composition.
  • the total amount of moisturizing esters that are not olive-derived in the composition may be less than about 1 wt. %, in other embodiments, less than about 0.5 wt. %, in other embodiments, less than about 0.1 wt. %, in other embodiments, less than about 0.05wt. %, based upon the total weight of the composition.
  • the composition is devoid of moisturizing esters that are not olive-derived.
  • the composition may be a gel, cream, lotion, ointment, and the like, and may also contain one or more thickening agents.
  • thickeners include stearyl alcohol, cationic hydroxy ethyl cellulose (Ucare; JR30), hydroxy propyl methyl cellulose, hydroxy propyl cellulose (Klucel), chitosan pyrrolidone carboxylate (Kytamer), behenyl alcohol, zinc stearate, and emulsifying waxes, including but not limited to Incroquat and Polawax.
  • thickening and/or gelling agents suitable for incorporation into the anti-irritant gels, creams, lotions or ointments described herein include, for example, an addition polymer of acrylic acid, a resin such as Carbopol® ETD 2020, guar gum, acacia, acrylates/steareth-20 methacrylate copolymer, agar, algin, alginic acid, ammonium acrylate co- polymers, ammonium alginate, ammonium chloride, ammonium sulfate, amylopectin, attapulgite, bentonite, C9-15 alcohols, calcium acetate, calcium alginate, calcium carrageenan, calcium chloride, caprylic alcohol, carbomer 910, carbomer 934, carbomer 934P, carbomer 940, carbomer 941, carboxymethyl hydroxy ethyl cellulose, carboxymethyl hydroxypropyl guar, carrageenan, cellulose, cellulose gum,
  • thickeners/rheology modifiers include associative polymers.
  • Associative polymers include non-ionic polymeric thickeners.
  • the associative polymer includes a hydrophilic backbone and hydrophobic end groups.
  • the non-ionic polymer includes urethane-based and polyether polyol-based associative thickeners.
  • Typical amounts of the above thickeners are from about 0.6 to about 2 wt.%, based upon the total weight of the composition.
  • the composition may be thickened with polyacrylate thickeners such as those conventionally available and/or known in the art.
  • polyacrylate thickeners include carbomers, acrylates/C 10-30 alkyl acrylate crosspolymers, copolymers of acrylic acid and alkyl (C5 -CIO) acrylate, copolymers of acrylic acid and maleic anhydride, and mixtures thereof.
  • Polyacrylate thickeners are further described in U.S. Patent Application Publication No. 2010/0317743 Al, which is hereby incorporated by reference.
  • strong acids and other ingredients that may attack the peptide bonds in the oligopeptide may be limited.
  • the amount of protein denaturants is limited.
  • elevated temperatures are avoided.
  • the compositions according to the present invention include from zero up to about 2 wt. % dimethicone.
  • the total amount of dimethicones in the composition is less than about 2 wt. %, in other embodiments, less than about 1.5 wt. %, in other embodiments, less than about 1 wt. %, in other embodiments, less than about 0.5 wt. %, in other embodiments, less than about 0.1 wt. %, in other embodiments, less than about 0.05 wt. %, based upon the total weight of the composition.
  • the composition is devoid of dimethicones.
  • the amount of petrolatum may be limited. More specifically, in one or more embodiments, the total amount of petrolatum in the composition may be less than about 2 wt. %, in other embodiments, less than about 1 wt. %, in other embodiments, less than about 0.5 wt. %, in other embodiments, less than about 0.1 wt. %, in other embodiments, less than about 0.05 wt. %, based upon the total weight of the composition. In one or more embodiments, the composition is devoid of petrolatum.
  • the amount of mineral oil may be limited. More specifically, in one or more embodiments, the total amount of mineral oil in the composition may be less than about 2 wt. %, in other embodiments, less than about 1 wt. %, in other embodiments, less than about 0.5 wt. %, in other embodiments, less than about 0.1 wt. %, in other embodiments, less than about 0.05 wt. %, based upon the total weight of the composition. In one or more embodiments, the composition is devoid of mineral oil.
  • ingredients identified throughout this specification may be individually or combinatorially encapsulated for delivery to a target area such as skin.
  • encapsulation techniques include the use of liposomes, vesicles, and/or nanoparticles (e.g., biodegradable and non-biodegradable colloidal particles comprising polymeric materials in which the ingredient is trapped, encapsulated, and/or absorbed—examples include nanospheres and nanocapsules) that can be used as delivery vehicles to deliver the ingredient to skin.
  • Encapsulation is further described in U.S. Pat. Nos. 6,387,398, 6,203,802, and 5,411,744, all of which are incorporated by reference herein. Encapsulation of the oligopeptides may allow the use of ingredients that would otherwise be limited, such as strong acids and ethanol.
  • composition may be prepared by simply mixing the components together.
  • the order of addition is not particularly limited, but may advantageously be selected based upon the solubility of the various ingredients.
  • the composition may be prepared by combining at elevated temperature water, at least one emulsifier, a vegetal wax, and one or more olive derivatives or extracts, and mixing until a homogeneous mixture is obtained.
  • the elevated temperature is about 82 °C.
  • an additional olive derivative or extract may be added, along with other optional ingredients, if desired.
  • the oligomeric peptides may be added, along with other optional ingredients such as preservatives, if desired.
  • compositions of the present invention are smooth and uniform, and easy to spread, leaving a uniform residue on skin.
  • the compositions are stable and pass standard laboratory stability test methods. In one or more embodiments, compositions were stable at 4, 25, 40 and 50 °C for at least three months. In one or more embodiments, compositions were also stable under freeze - thaw test conditions.
  • Sensory aesthetics deals with evaluating cosmetic preparations on the basis of sensory impressions.
  • a sensory assessment of a cosmetic is made by reference to visual, olfactory and haptic impressions.
  • Haptic impressions include sensations of the sense of touch, which relate primarily to structure and consistency of the product, i.e., texture.
  • Texture is an aesthetic property of cosmetic products that is very important for the consumer, but which can only be quantitatively measured with difficulty. Texture is generally understood to mean those properties of a cosmetic which relate to the structure of the preparation, and are perceived by the sense of touch.
  • a method of sensory analysis that is often used in research and development is the difference test.
  • a sample is compared to a control sample, and differences are perceived.
  • the use of groups of trained test persons, screening the testers from one another, and statistical evaluation of the data all help to counter the inherent subjectivity of the sensory analysis.
  • this product has a light and easy to spread sensory experience that is desired by end users. Also leaves a light film on skin that is perceived as continued protection.
  • compositions of the present invention may also be characterized by reference to viscosity and/or rheological properties.
  • the viscosity may be expressed as a standard, single-point type viscosity, as measured on a Brookfield Digital viscometer at a temperature of about 20 °C, using spindle T-D, heliopath, at a speed of 10 rpm.
  • the compositions may have a viscosity of from about 2000 to about 120,000 cPs.
  • compositions of the present invention may be characterized as lotions, having a viscosity of less than about 120,000 centipoise (cPs), in other embodiments, less than about 100,000, and in other embodiments, less than about 75,000 cPs.
  • the lotion compositions may have a viscosity of from about 3000 to about 50,000 cPs, in other embodiments, from about 4000 to about 30,000 cPs.
  • compositions of the present invention may be characterized as serum, having a viscosity of from about 2000 to about 3000 cPs.
  • compositions of the present invention may be characterized as creams, having a viscosity of from about 30,000 to about 100,000 cPs, in other embodiments from about 50,000 to about 80,000 cPs.
  • compositions according to the present invention are pourable at room temperature, i.e. a temperature in the range of from about 20 to about 25 °C.
  • the lotion formulations are viscous enough to hold a shape or not flow for a desired period of time.
  • compositions of the present invention are creams or ointments, and are not pourable and do not flow at room temperature and will not conform to a container when placed into the container at room temperature.
  • yield stress point is understood as meaning the smallest shear stress above which a plastic material behaves in rheological terms like a liquid.
  • the yield stress point may be used to indicate the amount of shear stress that is needed to initiate flow, relating to the ability to both pump and spread the product.
  • the yield stress point may be determined by plotting a flow curve.
  • Flow curves of the compositions according to the invention may be prepared using an SR-2000 from Rheometric Scientific (now TA-Instruments), StressTec High Resolution Research Rheometer, or the like.
  • This instrument is a shear-stress-controlled rheometer with an air-bearing transducer.
  • the measurement system consists of a parallel plate measurement system (so-called plate/plate arrangement) where the lower plate can be temperature controlled. The measurement is carried out at a measuring temperature of 25° C.
  • the measurement method includes a linear shear stress-time slope with a strain rate of 40 Pa/min starting at 0 Pa.
  • compositions of the present invention become less viscous when relatively low amount of stress is applied.
  • the compositions are easily spreadable.
  • compositions of the present invention may be characterized in that the flow curve indicates a significant drop in viscosity at a stress of about 10 pascals (Pa), in other embodiments, at a stress of about 50 Pa, in other embodiments, at a stress of about 75 Pa, and in other embodiments, at a stress of about 100 Pa.
  • significant drop is meant a rather sudden drop, as opposed to a gradual decline.
  • the yield stress point is less than about 1000 Pa, at 1 s - 1 at about 20 °C, in other embodiments, the yield stress point is less than about 500 Pa, in other embodiments, less than about 100 Pa, in other embodiments, less than about 50 Pa, at 1 s " 1 at about 20 °C.
  • the compositions of the present invention are thixotropic. Another way to express this feature is to say that the compositions exhibit a thixotropic rheology.
  • Thixotropy is a time-dependent shear thinning property.
  • the viscosity of thixotropic compositions decreases when shear forces are applied. Certain gels or fluids that are viscous under static conditions will flow, i.e. become less viscous, overtime when stress is applied. The compositions then take a fixed amount of time to return to a more viscous state.
  • compositions of the present invention recover quickly when the stress is removed.
  • the shear-thinning effect is substantially reversible.
  • compositions of the present invention exhibit a first viscosity under static conditions, a second, reduced viscosity when shear force is applied, and then, when the shear force is removed, the viscosity of the composition returns to the first viscosity, or to a viscosity that is substantially the same as the first viscosity.
  • the second viscosity is at least 25 % of the first viscosity, in other embodiments, the second viscosity is at least 50 % of the first viscosity, in other embodiments, at least 75 % of the first viscosity, when a stress of up to about 10 to about 100 Pa is applied as described above.
  • the second viscosity is at least 85 % of the first viscosity, in other embodiments, the second viscosity is at least 90 % of the first viscosity, in other embodiments, at least 95 % of the first viscosity, in other embodiments, at least 98 % of the first viscosity, when a stress of up to about 10 to about 100 Pa is applied as described above. Stated another way, the reduction in viscosity in relation to stress applied at a stress of about 100 Pa is less than about 75 %, in other embodiments, less than about 50 %, in other embodiments, less than about 25 %, based upon the original viscosity of the composition.
  • the reduction in viscosity in relation to stress applied at a stress of about 10 to about 100 Pa is less than about 20 %, in other embodiments, less than about 10 %, in other embodiments, less than about 5 %, based upon the original viscosity of the composition.
  • the composition is topically applied to skin. In one or more embodiments, the composition may be topically applied to an affected skin area in a predetermined or as-needed regimen. In one or more embodiments, the composition is included as part of a skin cleansing or sanitizing regimen.
  • lotions according to the present invention provide protection against irritants.
  • Irritants may include chemical irritants, biological irritants, such as result from incontinence.
  • lotions according to the present invention enhance the healing of damaged skin. Damaged skin may be the result of environmental factors, aging, or disease.
  • lotions according to the present invention prevent pressure ulcers.
  • the present invention further provides a method for reducing the irritancy potential of a skin cleanser or sanitizer.
  • the method includes the step of combining a skin cleanser or sanitizer composition with one or more oligopeptides prior to form a less irritating skin cleanser or sanitizer composition.
  • the method includes the further step of contacting the skin with the less irritating composition for a period sufficient to cleanse and/or sanitize the skin.
  • when the amount of skin irritation is measured, as for example by testing the IL-8 secretion, the amount of skin irritation is reduced, compared to when the method is repeated but using the same skin cleanser or sanitizer composition without any oligopeptide.
  • compositions containing two or more oligopeptides provide a synergistic reduction of the skin irritation potential of the compositions.
  • skin cleansers and sanitizers containing one or more oligopeptide according to the present invention enhance the skin barrier function, when compared to the same skin cleanser or sanitizer but not containing one or more oligopeptide according to the present invention.
  • the present invention further provides a method for the treatment of the skin comprising the step of contacting the skin with a cosmetically or pharmaceutically acceptable amount of the compositions described above.
  • the skin condition is improved after contact with the composition.
  • the amount of skin barrier function is improved, compared to when the method is repeated but using the same composition without the two or more oligopeptides.
  • compositions containing two or more oligopeptides, a vegetal wax and a derivative or extract of olives provide a synergistic enhancement of the skin barrier function.
  • compositions and methods of the present invention may be useful to treat a variety of skin conditions that result in inflammation or erythema.
  • inflammation or erythema can result from external causes such as sun or wind burn or irritating soaps or cleansers. It is also known that inflammation and erythema can be caused from inherent conditions such as rosacea, atopic dermatitis, or allergic skin reactions.
  • compositions of the present invention may be formulated as a spray cleansing lotion.
  • General characteristics of spray products are further described in U.S. Patent Application Publication No. 2010/0239624 Al, which is incorporated by reference herein.
  • compositions of the present invention are well suited for spray applications, because they are relatively thin compared to compositions containing zinc compounds. For the same reason, compositions of the present invention are also useful in glide gel and roll on products.
  • the invention further provides wipes or other fibrous structures comprising the compositions as described herein. Suitable wipes and fibrous structures are described, for example, in U.S. Patent Application Publication Nos. 2010/0239624 Al and 2013/0004602 Al, both of which are incorporated by reference herein.
  • compositions of the present invention are imbedded in diapers, wipes, tissues, and/or bandages.
  • compositions of the present invention may be employed to cover and protect skin wounds or ulcers, such as pressure ulcers.
  • skin cover is easily applied, does not need to be removed, protects the skin from irritants and contaminants, and similarly, irritants cannot get trapped under the cover.
  • the present invention provides a method of cleaning and treating decubitus ulcers.
  • a patient in need of treatment of one or more decubitus ulcers is identified.
  • the compositions of the present invention are applied to the skin area containing the decubitus ulcer.
  • the composition provides cleaning to the one or more decubitus ulcers, provides wound healing, and provides a moisture barrier.
  • compositions according to the present invention prevent infection and accelerate healing.
  • compositions may be assessed for sensory aesthetic characteristics by an expert sensory panel, for example as described in U.S. Patent Application Publication No. 2006/0159649 Al, which is hereby incorporated by reference.
  • the '649 publication also describes methods for assessing rheological characteristics, TEWL, in vitro skin retention test, controlled application dryness test with wash protocols, and skin hydration (corneometer).
  • compositions of the present invention have many advantages, including the following. Because the compositions do not have a base odor like petrolatum-based products, compositions may be fragrance-free, or may more easily be formulated with a pleasing fragrance. Rheological properties allow for ease of application with minimum contact and minimum skin tearing. The synergistic improvement in skin hydration and barrier repair make the compositions useful for dry skin and dry lip repair, soothing, healing skin cracking, acne, UV damage, aging, cuts and burns. The compositions provide a barrier against pollutants, irritants, infection, blisters, pressure ulcers, chaffing, diaper rash, tough soils.
  • Interleukin 8 is a chemokine and proinflammatory cytokine produced by macrophages and other cell types such as epithelial cells. It is secreted from keratinocytes in skin in response to inflammatory stimuli. IL-8 is secreted and is an important mediator of the immune reaction in the innate immune system response. IL-8 overexpressed is a biomarker of skin irritation.
  • Control A human dermal keratinocytes are left untreated. No irritation is expected, and therefore Control A provides a baseline.
  • Control B IL-8 is induced in human dermal keratinocytes by applying a surfactant mixture that is a combination of sodium laureth sulfate and polyquaternium-10.
  • the human dermal keratinocytes are co- treated with the surfactant mixture and a composition containing the ingredient of interest. Decreased 11-8 expression reflects the ingredient's anti-irritation activity.
  • an assay kit was employed that was obtained from R&D Systems: Human CXCL8/IL-8 Quantikine ELISA Kit.
  • the MTT assay is a colorimetric assay for assessing cell viability, cell proliferation, and/or cytotoxicity.
  • NAD(P)H-dependent cellular oxidoreductase enzymes may, under defined conditions, reflect the number of viable cells present. These enzymes are capable of reducing the tetrazolium dye MTT 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide to insoluble formazan, which has a purple color.
  • MTT assay can also be used to measure cytotoxicity (loss of viable cells) or cytostatic activity (shift from proliferative to resting status) of potential medicinal agents and toxic materials.
  • Controls A and B described above for the IL-8 Assay were also employed in this test.
  • the mitigating effect of the test samples on the effect of Control B on the keratinocytes was measured. More specifically, while Control B has a negative effect on cell viability, cell proliferation, and/or cytotoxicity, this mitigation of this negative effect was determined by measuring the reduction of MTT.
  • Tight Junctions are the closely associated areas of two cells whose membranes join together forming a virtually impermeable barrier to fluid.
  • a desmosome is a cell structure specialized for cell-to-cell adhesion. A type of junction complex, they are localized spot-like adhesions randomly arranged on the lateral sides of plasma membranes.
  • Desmosomes are molecular complexes of cell adhesion proteins and linking proteins that attach the cell surface adhesion proteins to intracellular keratin cytoskeletal filaments.
  • the cell adhesion proteins of the desmosome, desmoglein (DSG) and desmocollin (DSC), are members of the cadherin family of cell adhesion molecules. They are biomarker of skin tight junctions.
  • DSG1 is a biomarker for cell binding, the higher the expression, the better skin cell-cell junction and the better skin barrier function will be.
  • DSC3 is a protein in humans that is encoded by the DSC3 gene, the higher the expression, the better skin cell-cell junction and the better skin barrier function will be.
  • keratinocytes were treated with the sample compositions in a 6-well plate overnight. After washing with cold phosphate-buffered saline (PBS), total RNAs were prepared from each well.
  • PBS cold phosphate-buffered saline
  • qRT-PCR Real-Time Quantitative Reverse Transcription PCR
  • Aqueous solutions of acetyl hexapeptide-46 and acetyl hexapeptide-38 were prepared by dilution to achieve the concentrations shown in Table 1.
  • Acetyl hexapeptide-46 was obtained from Lipotec under the tradename Delisens.TM DelisensTM is a proprietary blend of butylene glycol, water, citric acid and acetyl hexapeptide-46, containing 0.025 wt. % acetyl hexapeptide- 46.
  • Acetyl hexapeptide-38 was obtained from Lipotec under the tradename AdifylineTM.
  • AdifylineTM is a proprietary blend of butylene glycol, water and acetyl hexapeptide-38, containing 0.05 wt. % acetyl hexapeptide-38.
  • the concentration of acetyl hexapeptide shown in the following table represents the concentration of the active ingredient.
  • Adifyline® was mixed with 98 g deionized water to prepare a solution that was 2 wt % Adifyline and 10 parts per million by weight (ppm) acetyl hexapeptide-38, based upon the total weight of the solution.
  • compositions containing the tested pentapeptides produce an enhanced reduction in IL-8 secretion, and that they produce an enhanced cell-cell junction when compared to Vitamin D3 and KGM.
  • FIG. 5 is a graphical representation of the effect of various compositions on the irritation response of cells treated with known irritants, as quantified by measuring IL-8 secretion, and on cell viability.
  • FIG. 6 is a graphical representation of Involucrin Expression - Keratinocytes (KC) differentiation.
  • FIG. 7 is a graphical representation of PPAR5 expression - ceramides related biomarker.
  • FIG. 8 is a graphical representation of ABCA12 expression - fatty acid related biomarker.
  • FIG. 9 is a graphical representation of DSC1 expression - cell-cell junction biomarker.
  • FIG. 10 is a graphical representation of APQ3 expression - skin water channel.
  • Interleukin 8 is a chemokine and proinflammatory cytokine produced by macrophages and other cell types such as epithelial cells. It is secreted from keratinocytes in skin in response to inflammatory stimuli. IL-8 is secreted and is an important mediator of the immune reaction in the innate immune system response. IL-8 overexpressed is a biomarker of skin irritation.
  • Control A human dermal keratinocytes are left untreated. No irritation is expected, and therefore Control A provides a baseline.
  • IL-8 is induced in human dermal keratinocytes by applying a surfactant mixture that is a combination of sodium laureth sulfate and polyquaternium-10.
  • a surfactant mixture that is a combination of sodium laureth sulfate and polyquaternium-10.
  • the human dermal keratinocytes are co- treated with the surfactant mixture and a composition containing the ingredient of interest. Decreased 11-8 expression reflects the ingredient's anti-irritation activity.
  • an assay kit was employed that was obtained from R&D Systems: Human CXCL8/IL-8 Duoset ELISA Development Kit.
  • the MTT assay is a colorimetric assay for assessing cell viability, cell proliferation, and/or cytotoxicity.
  • NAD(P)H-dependent cellular oxidoreductase enzymes may, under defined conditions, reflect the number of viable cells present. These enzymes are capable of reducing the tetrazolium dye MTT 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide to insoluble formazan, which has a purple color.
  • MTT assay can also be used to measure cytotoxicity (loss of viable cells) or cytostatic activity (shift from proliferative to resting status) of potential medicinal agents and toxic materials.
  • Controls A and B described above for the IL-8 Assay were also employed in this test.
  • the mitigating effect of the test samples on the effect of Control B on the keratinocytes was measured. More specifically, while Control B has a negative effect on cell viability, cell proliferation, and/or cytotoxicity, this mitigation of this negative effect was determined by measuring the reduction of MTT.
  • Tight Junctions are the closely associated areas of two cells whose membranes join together forming a virtually impermeable barrier to fluid.
  • a desmosome is a cell structure specialized for cell-to-cell adhesion. A type of junction complex, they are localized spot-like adhesions randomly arranged on the lateral sides of plasma membranes.
  • Desmosomes are molecular complexes of cell adhesion proteins and linking proteins that attach the cell surface adhesion proteins to intracellular keratin cytoskeletal filaments.
  • the cell adhesion proteins of the desmosome, desmoglein (DSG) and desmocollin (DSC), are members of the cadherin family of cell adhesion molecules. They are biomarker of skin tight junctions.
  • DSG1 is a biomarker for cell binding, the higher the expression, the better skin cell-cell junction and the better skin barrier function will be.
  • DSC3 is a protein in humans that is encoded by the DSC3 gene, the higher the expression, the better skin cell-cell junction and the better skin barrier function will be.
  • keratinocytes were treated with the sample compositions in a 6- well plate overnight. After washing with cold phosphate-buffered saline (PBS), total RNAs were prepared from each well.
  • PBS cold phosphate-buffered saline
  • qRT-PCR Real-Time Quantitative Reverse Transcription PCR
  • a base lotion composition was prepared according to the method described above, except omitting the Adifyline and Delisens.
  • the base lotion is denoted as Example 7.
  • Example 8 was prepared according to the method described above, except omitting the Delisens.
  • Example 8 contained contained 1 wt. % Adifyline.
  • Example 9 was prepared according to the method descrived above, except omitting the Adifyline.
  • Example 9 contained 1 wt. % Delisens.
  • Example 10 was prepared according to the method described above, and contained 1 wt. % each of Adifyline and Delisens.
  • Acetyl hexapeptide-46 was obtained from Lipotec under the tradename Delisens.TM DelisensTM is a proprietary blend of butylene glycol, water, citric acid and acetyl hexapeptide-46, containing 0.025 wt. % acetyl hexapeptide-46. Acetyl hexapeptide-38 was obtained from Lipotec under the tradename AdifylineTM. AdifylineTM is a proprietary blend of butylene glycol, water and acetyl hexapeptide-38, containing 0.05 wt. % acetyl hexapeptide-38.
  • Example 8 Base Lotion + 1 wt. % 1/100 84 % 84 % Adifyline (5 ppm acetyl
  • Example 9 Base Lotion + 1 wt. % 1/100 116 % 83 %
  • Example 10 Base Lotion + 1 wt. % 1/100 48 % 86 %
  • KGM monolayer human dermal keratinocytes culture
  • IL-lb inflammatory cytokines interleukin
  • Skin Barrier Biomarkers ABCA12, Involucrin, PPAR5. Different concentrations of ingredients were used to treat the keratinocyte for 24 hours. Cells were collected and total RNA prepared from the treated cells. Real-time RT-PCT was used to detect different barrier function related biomarker's gene expression level. Comparative Benchmark: Vitamin D3 (cholecalciferol) in three different concentrations.
  • PPARs Peroxisome proliferator-activated receptors
  • ABCA12 belongs to a group of genes called the ATP -binding cassette family, which makes proteins that transport molecules across cell membranes.
  • Involucrin is a protein component of human skin and in humans is encoded by the IVL gene. In binding the protein loricrin, involucrin contributes to the formation of a cell envelope that protects corneocytes in the skin. Involucrin is a highly reactive, soluble, transglutaminase substrate protein present in keratinocytes of epidermis and other stratified squamous epithelia. It first appears in the cell cytosol, but ultimately becomes cross-linked to membrane proteins by transglutaminase thus helping in the formation of an insoluble envelope beneath the plasma membrane functioning as a glutamyl donor during assembly of the cornified envelope.
  • Involucrin is synthesised in the stratum spinosum and cross linked in the stratum granulosum by the transglutaminase enzyme that makes it highly stable. Thus it provides structural support to the cell, thereby allowing the cell to resist invasion by micro-organisms.
  • composition containing a combination of acetyl hexapeptides has the best efficacy in anti-irritation, skin barrier (KC differentiation, lipids production and cell-cell junction) and skin hydration (water channel).
  • Yield Stress Point was used to determine the amount of shear stress needed to initiate flow, relating to the ability to both pump and spread a product.
  • Example 11 was a composition according to the present invention. More specifically, the Example 11 contained glyceryl stearate, cetearyl olivate, sorbitan olivate, cetyl palmitate, sorbitan palmitate, olive oil, heptyl undecylenate, butylene glycol, acetyl hexapeptide-38, citric acid, acetyl hexapeptide-49, phenoxyethanol, and ethylhexyl glycerin.
  • Example 12 was a commercially available lotion containing aloe barbadensis leaf juice, ascorbic acid, ascorbyl palmitate, cl2-cl3 pareth-3, cl2-cl3 pareth-23, carthamus tinctorius seed oil, cetyl dimethicone, cholecalciferol, citric acid, citrus aurantium dulcis peel oil, citrus grandis peel oil, citrus tangerina peel oil, cyclopentasiloxane, diazolidinyl urea, dimethiconol, divinyldimethicone/dimethicone copolymer, glycine, hydroxytyrosol, 1-proline, 1- taurine, methylparaben, methyl sulfonylmethane, n-acetyl-l-cysteine, niacinamide, olea europaea fruit oil, peg-8, peg/ppg-18/18 dimethicone, propy
  • Example 13 was a commercially available ointment containing 0.44 wt. % menthol, 20.6 wt. % zinc oxide, and also containing calamine, chlorothymol, glycerin, lanolin, phenol, sodium bicarbonate, and thymo, sold under the tradename CalmoseptineTM by Calmoseptine, Inc.
  • Example 14 was a commercially available lotion containing 3.5 wt. % calamine, 0.2 wt. % menthol, 69 wt. % white petrolatum, 20 wt. % zinc oxide, and also containing Aloe Barbadensis Leaf Juice, Ascorbic Acid, Ascorbyl Palmitate, Carthamus Tinctorius (Safflower) Seed Oil, Cholecalciferol, Citric Acid, Citrus Aurantium Dulcis Peel Oil, Citrus Grandis Peel Oil, Glycine, Helianthus Annuus (Sunflower) Seed Oil, Hydroxytyrosol, L-proline, L-taurine,
  • Methylparaben Modified Corn Starch, Methyl sulfonymethane, N-acetyl-L-cysteine, Niacinamide, Olea Europaea (Olive) Fruit Oil, PEG-8, Pyridoxine Hydrochloride, Retinyl Palmitate, Tapioca Starch Polymethylsilsesquioxane, Tocopherol, Vanillin, and Zea Mays (Corn) Oil, and sold under the tradename CalazimeTM by Medline Industries, Inc.
  • Example 11 requires about 100 pascals (Pa) to initiate flow. Once flow has started, the product is very shear-sensitive and needs very little additional stress to keep the lotion flowing. The lotion is easy to spread, compared to Examples 12-14.
  • Example 12 (Nutrashield) requires slightly more than 10 Pa of stress to start the product to flow, but is not as shear-sensitive as Example 11. In order to spread the lotion of Example 12, consistently increased stress is required.
  • Example 13 Calmoseptine
  • Example 14 Calazime
  • Yield Stress data for Examples 13 (Calmoseptine) and 14 (Calazime) indicate that these products are very viscous and require almost 10 times the amount of stress in order to initiate spreading. Additionally, Example 13 (Calmoseptine) requires consistently increased stress to continue applying this product.
  • the Yield Stress assessment of Example 14 (Calazime) indicates that this product has a stress transition phase. Once the product has reached about 5000 Pa, the viscosity increases, showing that it also has shear thickening properties. As stress is increased, in order to spread this product, it becomes tacky and is less spreadable.
  • Example 11 becomes less viscous when very little stress is applied, and when stress is removed, the product recovers quickly to its original, viscous state.
  • Example 12 Thixotropic assessment of Example 12 (Nutrashield) indicates that once stress is applied, the sample is extremely shear sensitive. When stress is applied, the product has no elasticity, and does not return to original state, but is irreversibly altered.

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Abstract

L'invention concerne des procédés et des compositions pour atténuer l'irritation des cellules de la peau d'un mammifère, protéger la viabilité cellulaire et/ou augmenter la jonction cellule à cellule, ce qui permet d'améliorer la fonction barrière de la peau. Les compositions contiennent des combinaisons d'acétyle hexapeptides et d'un support cosmétiquement et/ou pharmaceutiquement acceptable. Les supports qui donnent un aspect cristallin liquide aux compositions sont bénéfiques.
PCT/US2016/025193 2015-03-31 2016-03-31 Compositions synergiques et procédés pour atténuer l'irritation de la peau et améliorer la fonction de barrière de la peau WO2016161074A1 (fr)

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EP16716380.7A EP3277255A1 (fr) 2015-03-31 2016-03-31 Compositions synergiques et procédés pour atténuer l'irritation de la peau et améliorer la fonction de barrière de la peau

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WO2018098156A1 (fr) * 2016-11-23 2018-05-31 Gojo Industries, Inc. Composition nettoyante stimulant les peptides antimicrobiens
WO2018098143A1 (fr) * 2016-11-23 2018-05-31 Gojo Industries, Inc. Composition désinfectante stimulant les peptides antimicrobiens
US10806769B2 (en) 2016-03-31 2020-10-20 Gojo Industries, Inc. Antimicrobial peptide stimulating cleansing composition
US10874700B2 (en) 2016-03-31 2020-12-29 Gojo Industries, Inc. Sanitizer composition with probiotic/prebiotic active ingredient

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10806769B2 (en) 2016-03-31 2020-10-20 Gojo Industries, Inc. Antimicrobial peptide stimulating cleansing composition
US10874700B2 (en) 2016-03-31 2020-12-29 Gojo Industries, Inc. Sanitizer composition with probiotic/prebiotic active ingredient
US11633451B2 (en) 2016-03-31 2023-04-25 Gojo Industries, Inc. Antimicrobial peptide stimulating cleansing composition
WO2018098156A1 (fr) * 2016-11-23 2018-05-31 Gojo Industries, Inc. Composition nettoyante stimulant les peptides antimicrobiens
WO2018098143A1 (fr) * 2016-11-23 2018-05-31 Gojo Industries, Inc. Composition désinfectante stimulant les peptides antimicrobiens

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