WO2013103944A1 - Compositions and methods for treating skin conditions - Google Patents

Compositions and methods for treating skin conditions Download PDF

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Publication number
WO2013103944A1
WO2013103944A1 PCT/US2013/020488 US2013020488W WO2013103944A1 WO 2013103944 A1 WO2013103944 A1 WO 2013103944A1 US 2013020488 W US2013020488 W US 2013020488W WO 2013103944 A1 WO2013103944 A1 WO 2013103944A1
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Prior art keywords
skin
group
composition
gel
aloe vera
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Application number
PCT/US2013/020488
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French (fr)
Inventor
Melissa J. MERCER-TACHICK
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Aloe Baby, Llc
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Publication date
Application filed by Aloe Baby, Llc filed Critical Aloe Baby, Llc
Publication of WO2013103944A1 publication Critical patent/WO2013103944A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/886Aloeaceae (Aloe family), e.g. aloe vera
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders

Definitions

  • barrier creams/ointments/aerosols directly on the cleansed skin without powder can trap moisture and encourage microbial colonization. Moreover, powders interfere with the adherence of the cream/ointment on the skin. Furthermore, talc has susceptibility of having contaminants, and corn starch is a food source for microbes.
  • Barrier creams have been used for many skin conditions for animals and humans and include such brand names as DesitinTM, A&D OintmentTM, CavilonTM, LansinohTM, CalmoseptineTM, VaselineTM, and Tuf-SkinTM. Such uses include but are not limited to: pressure sores,
  • barrier creams/ointments/aerosols are also used for fly strike, fur lice, and other open wounds.
  • the present invention provides a composition
  • a composition comprising: a.) at least about 50% concentrated Aloe vera juice by weight, as a percentage of total weight; b.) at least about 1% carrier oil by weight, as a percentage of total weight; and c.) at least about 0.05% essential oil by weight, as a percentage of total weight.
  • compositions wherein the Aloe vera is concentrated from about
  • compositions wherein the percentage of concentrated Aloe vera is selected from the group consisting of: from about 50% w/w to about 99% w/w; from about 60% w/w to about 95% w/w; from about 70% w/w to about 95% w/w; from about 80% w/w to about 95% w/w; from about 88% w/w to about 93% w/w; from about 90% w/w to about 95% w/w; from about 90% w/w to about 92% w/w; approximately 91% w/w.
  • compositions wherein the percentage of carrier oil is selected from the group consisting of: from about 1% w/w to about 15% w/w; from about 2% w/w to about 12% w/w; from about 5% w/w to about 10% w/w; from about 5% w/w to 7% w/w; approximately 6% w/w.
  • compositions wherein the percentage of essential oil is selected from the group consisting of: from about 0.05% w/w to about 10% w/w; from about 0.1% w/w to about 8% w/w; from about 0.5% to about 3% w/w; from about 0.8% w/w to about 2% w/w; from about 1% w/w to 1.5% w/w; from about 1% w/w to about 1.3% w/w; approximately 1.2% w/w.
  • compositions which further comprise an ingredient selected from the group consisting of: at least one humectant; at least one nutrient; at least one preservative; at least one gelling agent.
  • compositions which are formulated for use on human or animal skin.
  • compositions wherein the carrier oil is selected from the group consisting of: almond, apricot kernel, argan, avocado, baobab, black cumin, borage, camelina, canola (rapeseed), castor, coconut, cranberry, emu, evening primrose, grapeseed, hazelnut, hemp, jojoba, kukui nut, macadamia nut, meadowfoam, neem, olive, palm, peanut, pecan, plum, pomegranate seed, pumpkin, rosehip seed, safflower, sea buckthorn, sesame, shea, soybean, sunflower, sweet almond, tamanu, walnut, watermelon seed, or wheat germ oils.
  • the carrier oil is selected from the group consisting of: almond, apricot kernel, argan, avocado, baobab, black cumin, borage, camelina, canola (rapeseed), castor, coconut, cranberry, emu, evening primrose, grapes
  • compositions wherein the essential oil is selected from the group consisting of: allspice, ambrette, ammi visnaga, amyris, angelica root, anise seed, balsam, basil, bay laurel, benzoin, bergamot, birch, black pepper, calendula, chamomile, cardamom, carrot seed, cedar, cedarwood, celery seed, chamomile, champaca, chaste berry, cinnamon, cistus, citronella, clary sage, clove bud, coffee bean, coriander, cypress, davana, elemi, eucalyptus, fennel, fir, frangipani, frankincense, galbanum, gardenia, geranium, ginger, grapefruit, helichrysum, hyssop, inula, jasmine, juniper berry, khella, lavender, ledum, lemon
  • compositions which further comprise an additional ingredient selected from the group consisting of: at least one preservative; at least one gelling agent; vitamin A; vitamin C; vitamin D; vitamin E; camphor; at least one botanical extract; at least one sea extract;
  • glycerine at least one plant-based butter; lanolin; at least one mineral; sea salt; at least one pH balancer.
  • compositions which are formulated for delivery from a device selected from the group consisting of: tube; tub; aerosol container; bandage; diaper; polymer strip; spritz container; stick; wipe; and syringe.
  • compositions wherein the formulation has at least one property selected from the group consisting of: antibacterial; antifungal; antiprotozoal; antiviral; antiseptic; antiinflammatory; immunostimulative; analgesic; and antipruritic properties.
  • the present invention provides methods to ameliorate the symptoms of a skin disorder in a subject, comprising administering a composition of claim 1 to the skin of a subject with a skin disorder.
  • composition is administered via several applications during a 24 hour period.
  • the skin disorder is selected from the group consisting of: acne, rosacea, psoriasis, skin blisters, sunburn, dermatitis, eczema, common rashes, allergic reactions (including poison ivy, oak, or sumac), cellulitis, fungal infections, bacterial infections, viral infections, pruritus, physical or chemical burns, hives, bed/pressure sores, skin grafts, chapped lips, biopsy sites, suture sites, tattoos, laser treatments, depilation, transplant sites, catheter sites, injection sites, diabetic ulcers, radiation dermatitis, cuts, abrasions, cryosurgical post-blistering care, and scleroderma.
  • the present invention provides methods to ameliorate the symptoms of diaper rash in a human in need of diaper rash symptom amelioration, comprising: A method to ameliorate the symptoms of diaper rash in a human in need of diaper rash symptom amelioration, comprising: a. cleansing the diaper rash- affected skin of a human with diaper rash, b. applying a nutritive gel to the diaper rash-affected skin wherein the nutritive gel comprises from about 94% w/w to about 96% w/w concentrated Aloe vera, from about 3% w/w to about 4% w/w carrier oils, from about 0.2% w/w to about 0.7% essential oils, and from about 0.2% w/w to about 0.7% w/w other ingredients; c. allowing the nutritive gel to dry or actively dry the gel; and d. applying a barrier cream or ointment to the diaper rash-affected skin.
  • the Aloe vera concentrate is at least about 1.2x compared to natural Aloe vera juice
  • the carrier oils are apricot kernel oil and rosehip seed oil
  • the essential oils are selected from the group consisting of: niaouli; lavender; chamomile; and ginger.
  • the present invention provides methods to ameliorate the symptoms of nipple trauma in a human in need of nipple trauma symptom amelioration, comprising: a. cleansing the nipple trauma- affected skin of a human with nipple trauma; b. applying a nutritive gel to the nipple trauma-affected skin, wherein the nutritive gel comprises from about 90% w/w to about 92% w/w concentrated Aloe vera, from about 5% w/w to about 7% w/w carrier oils, from about 0.5% w/w to about 2% w/w essential oils, and from about 0.2% w/w to about 2.5% w/w other ingredients; c. allowing the nutritive gel to dry or actively dry the gel; and d. applying a barrier cream or ointment to the nipple trauma-affected skin.
  • the Aloe vera concentrate is at least about 1.2x compared to natural Aloe vera juice
  • the carrier oils are apricot kernel oil and rosehip seed oil
  • the essential oils are selected from the group consisting of: rosemary; lavender; chamomile; niaouli; and lemon eucalyptus
  • the other ingredients comprise 0.7% grapefruit seed extract and 0.8% gentian violet.
  • Figure 1 depicts the steps for a method of administering a composition herein.
  • the present invention provides bio-active, nutritive gels.
  • the gels may be massaged into the skin and allowed to dry prior to any application of a barrier cream/ointment/aerosol.
  • the inventors disclose gels containing skin regenerative ingredients such as concentrated Aloe vera (51-99% of the formulation by weight), carrier oils that are appropriate to the skin condition (1-15% of the formulation by weight), essential oils (0.05-10% of the formulation by weight) and miscellaneous emollients, humectants, vitamins, preservatives, and polymers (0.1-35% of the formulation by weight) is applied to the affected area.
  • a.) Aloe vera The current formulation comprises a majority (at least 50% by weight) of the mixture consisting of concentrated (l.Olx to lOx strength) Aloe vera juice.
  • concentrated Aloe vera composition is Aloecorp, 3005 First Avenue, Seattle, WA 98121.
  • Carrier Oil The current formulation comprises at least one, but optionally a combination of, carrier oil.
  • carrier oils include, but are not limited to: almond, apricot kernel, avocado, black cumin, coconut, grapeseed, hemp, jojoba, neem, olive, rosehip seed, sesame, sunflower, or tamanu oils.
  • Essential Oil The current formulation comprises at least one, but optionally a combination of, essential oil.
  • essential oils include, but are not limited to: allspice, ammi visnaga, amyris, angelica root, balsam, basil, bay laurel, bergamot, birch, calendula, chamomile, cardamom, carrot seed, cedar, cinnamon, cistus, citronella, clary sage, clove bud, coriander, cypress, davana, elemi, eucalyptus, fennel, fir, frangipani, frankincense, galbanum, geranium, ginger, grapefruit, helichrysum, hyssop, inula, jasmine, juniper berry, lavender, lemon, lemon verbena, lemongrass, lime, lotus, mandarin, marjoram, melissa, myrrh, myrtle,
  • Optional ingredients of the bio-active, nutritive elements are many, but they make up a minority of the formulation by volume. Preservatives and gelling polymers are expected but may not be necessary.
  • Other bio-active, nutritive ingredients include but are not limited to: Vitamins A, C, D, and E; camphor; botanical (land and sea) extracts; glycerin; plant-based butters; lanolin; natural mineral sources (such as coral reef sea salt).
  • pH balancers and other chemical additives may be necessary for the stabilization and safety of the product.
  • this formulation may be formulated so as to be capable of being aerosolized in order to reduce skin-to-skin contact or otherwise aid application.
  • the present formulations may be made according to the following series of events, although any manufacturing process which results in producing a formulation herein is acceptable.
  • the concentrated aloe base is prepared.
  • Concentrated Aloe vera powder for example,
  • 200x Aloe vera powder is measured and added to measured deionized water to achieve the desired concentration of hydrated aloe.
  • any Aloe vera juice that is within the concentrations useful in the present invention may be used; the formulation does not require the use of re -hydrated powdered Aloe vera.
  • Thickening/gelling agents such as xanthum gum or carbopol are added to the base. The base is vigorously mixed in order to activate the thickening agent.
  • oils and aloe gel are combined and final ingredients, such as buffers, preservatives, and any other ingredients, are added.
  • the present invention provides skin care treatments, optionally in conjunction with barrier creams/ointments/aerosols.
  • the formulations herein may be applied directly to the affected area, optionally after cleansing the skin but before application of barrier creams, ointments, or aerosols. This additional step adds a layer of botanically active gel that is completely absorbed by the skin and air dried prior to use of traditional creams or ointments.
  • the gel may be massaged into the skin to aid in absorption.
  • the massage step may be skipped in instances where touching the skin is exceedingly painful or exposes the patient to new contaminants or others to contracting a contaminant, such as in the case of the treatment of necrotizing fasciitis or new or unknown pathogens.
  • the bio-active, nutritive gel may then be optionally allowed to dry, or active steps to dry the gel to the skin may be taken.
  • the drying step can result in complete or partial drying, and can be accomplished by waiting for a specified drying time or by using an air movement and/or heating device with optional low heat (preferably no more than body temperature for sensitive skins or up to 110 degrees Fahrenheit for less sensitive uses).
  • the skin is completely dried.
  • Barrier creams/ointments/aerosols may then optionally be applied.
  • Figure 1 shows a flowchart: (100)
  • cleanse the affected area (200) Apply a nutritive, bioactive gel comprising concentrated Aloe vera, an appropriate carrier oil, and essential oils to the affected area. In some cases, it may be beneficial to aerosolize the gel and apply without touching the skin; (300) Optionally gently massage the gel into the skin. ; (400) Optionally, allow time for gel to air dry, OR, using a mildly warm (70-100 or 110 degrees Fahrenheit) source of moving air, exsiccate the affected area until it is completely dry. (500) Optionally, apply a barrier cream/ointment/aerosol.
  • the formulations and methods herein provide antibacterial, antifungal, antiprotozoal, antiviral, antiseptic, anti-inflammatory, immunostimulative, analgesic, and antipruritic properties.
  • the present invention stimulates healing in the skin, retards growth of harmful microbes, and, when completely dried as directed, allows barrier creams to adhere to the skin, sealing in biologically active, nutritive elements while sealing out moisture and irritants.
  • This process could be useful to any sort of wound care for humans and animals, particularly those in which barrier creams are an indicated treatment. Applying an intermediate nutritive gel and drying it completely (optionally using some sort of fan, hair dryer, or other air delivery device) prior to use of barrier creams/ointments/aerosols could be useful in the treatment of many issues, including but not limited to: acne, rosacea, psoriasis, skin blisters, sunburn, dermatitis, eczema, common rashes, allergic reactions (including poison ivy, oak, or sumac), cellulitis, fungal infections, bacterial infections, viral infections, pruritus, physical or chemical burns, hives, bed/pressure sores, skin grafts, chapped lips, biopsy sites, suture sites, tattoos, laser treatments, depilation, transplant sites, catheter sites, injection sites, diabetic ulcers, radiation dermatitis, cuts, abrasions, cryosurgical post-blistering care,
  • the steps of the present methods for diaper rash treatment include the following: [0028] 1. Cleanse the affected area;
  • a formula for this purpose may be (by weight): 95% Aloe vera , 4% carrier oils (apricot kernel oil, rosehip seed oil), 0.5% essential oils (such as: niaouli, lavender, chamomile, ginger), and 0.5% preservatives, buffers, and gelling polymers.
  • creams/ointments/aerosols such as lanolin may be used).
  • the present methods include the use of a bio-active, nutritive gel as follows:
  • a gel containing Aloe vera, appropriate food-grade carrier oil(s), and essential oils is applied to the affected area.
  • a formula for this purpose is (by weight): 91.35% Aloe vera , 5.5% carrier oils (Rosehip seed, borage, apricot kernel, olive, and coconut oils), 0.35 % essential oils (such as: labender, geranium, myrrh, niaouli, and fennel), and 2.8% preservatives, buffers and gelling polymers.
  • the gel is gently massaged in and then air dried, optionally completely. For instance, a hair dryer on a "cold” or "warm” setting, with care taken not to burn the sensitive skin, may be used. When the skin is completely dry to the touch, then barrier creams/ointments/aerosols may be applied.
  • any human skin pathology or cosmetic procedure wherein barrier creams are indicated are within the scope of the present invention, including:incontinence, any ostomy site including gastronomy tubes, radiotherapy; difficult to treat human issues— pressure sores, diabetic ulcers, necrotizing fasciitis; eczema, psoriasis, external hemorrhoids; dermabrasion, epilation/waxing.
  • the present invention is not limited to human skin care; the present formulations and methods are useful for the treatment of skin pathologies or cosmetic applications in horses, cats, dogs, and any other animals.
  • Aloe gel base About 93.5% of 1.35 times concentrated Aloe vera barbadensis, from 200 times strength Aloe vera powder mixed with deionized water. The required volume relative to other ingredients will vary slightly based on buffering and neutralizing requirements.
  • 0.5% essential oil blend made up of:
  • Water base Mix the aloe base from 200x aloe powder and deionized water at 40
  • Oil mix Mix the carrier oils and essential oils at 40 degrees C.
  • a gel of the formula of Example 1 was manufactured and applied to moderate diaper rash as such:
  • Aloe gel base About 91.5% of 1.6 times concentrated Aloe vera barbadensis, from 200 times strength Aloe vera gel powder mixed with deionized water. The required volume relative to other ingredients will vary slightly based on buffering and neutralizing requirements.
  • Water base Mix the aloe base from 200x aloe powder and deionized water at 40 degrees C.
  • Oil mix Mix the carrier oils and essential oils at 40 degrees C.
  • EXAMPLE 5 Formulation for eczema
  • Aloe gel base About 92% of 1.65 times concentrated Aloe vera barbadensis, from 200 times strength Aloe vera gel powder mixed with deionized water. The required volume relative to other ingredients will vary slightly based on buffering and neutralizing requirements.
  • Water base Mix the aloe base from 200x aloe powder and deionized water at 40 degrees C.
  • Oil mix Mix the carrier oils and essential oils at 40 degrees C.

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Abstract

The present invention provides bio-active, nutritive gels. The gel composition can comprise a) at least about 50% concentrated Aloe vera gel by weight, as a percentage of total weight; b) at least about 1 % carrier oil by weight, as a percentage of total weight; and c) at least about 0.05% essential oil by weight, as a percentage of total weight. The gels may be massaged into the skin and allowed to dry prior to any application of a barrier cream/ointment/aerosol. Related compositions and methods are also provided herein.

Description

TITLE
COMPOSITIONS AND METHODS FOR TREATING SKIN CONDITIONS
INVENTOR: MELISSA MERCER-TACHICK
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of United States Provisional Application No. 61/584,234 filed January 7, 2012, the disclosure of which is incorporated herein by reference.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH
[0002] This invention was not made with U.S. Government financial support.
BACKGROUND OF THE INVENTION
[0001] The usual approach to treat skin trauma, inflammation, or infection involves:
[0002] (1) cleanse the affected area;
[0003] (2) optionally apply powder or dry the skin; and
[0004] (3) apply a barrier cream/ointment/aerosol.
[0005] The use of barrier creams/ointments/aerosols directly on the cleansed skin without powder can trap moisture and encourage microbial colonization. Moreover, powders interfere with the adherence of the cream/ointment on the skin. Furthermore, talc has susceptibility of having contaminants, and corn starch is a food source for microbes.
[0006] Barrier creams have been used for many skin conditions for animals and humans and include such brand names as Desitin™, A&D Ointment™, Cavilon™, Lansinoh™, Calmoseptine™, Vaseline™, and Tuf-Skin™. Such uses include but are not limited to: pressure sores,
diaper/incontinence and other rashes, hemorrhoids, post-operative sites, burns, chapped skin, chafing, diabetic and other skin ulcers, workplace chemical/biological hazards, contact dermatitis, eczema, itching, allergic reactions, insect bites, leaks around feeding tubes, areas around colostomies, fistulas. In animals, barrier creams/ointments/aerosols are also used for fly strike, fur lice, and other open wounds.
SUMMARY OF THE INVENTION
[0007] The present invention provides a composition comprising: a.) at least about 50% concentrated Aloe vera juice by weight, as a percentage of total weight; b.) at least about 1% carrier oil by weight, as a percentage of total weight; and c.) at least about 0.05% essential oil by weight, as a percentage of total weight.
[0008] Further provided are such compositions wherein the Aloe vera is concentrated from about
1.01 to about 10 times of naturally-occurring juice. [0009] Further provided are such compositions wherein the percentage of concentrated Aloe vera is selected from the group consisting of: from about 50% w/w to about 99% w/w; from about 60% w/w to about 95% w/w; from about 70% w/w to about 95% w/w; from about 80% w/w to about 95% w/w; from about 88% w/w to about 93% w/w; from about 90% w/w to about 95% w/w; from about 90% w/w to about 92% w/w; approximately 91% w/w.
[0010] Further provided are such compositions wherein the percentage of carrier oil is selected from the group consisting of: from about 1% w/w to about 15% w/w; from about 2% w/w to about 12% w/w; from about 5% w/w to about 10% w/w; from about 5% w/w to 7% w/w; approximately 6% w/w.
[0011] Further provided are such compositions wherein the percentage of essential oil is selected from the group consisting of: from about 0.05% w/w to about 10% w/w; from about 0.1% w/w to about 8% w/w; from about 0.5% to about 3% w/w; from about 0.8% w/w to about 2% w/w; from about 1% w/w to 1.5% w/w; from about 1% w/w to about 1.3% w/w; approximately 1.2% w/w.
[0012] Further provided are such compositions which further comprise an ingredient selected from the group consisting of: at least one humectant; at least one nutrient; at least one preservative; at least one gelling agent.
[0013] Further provided are such compositions which are formulated for use on human or animal skin.
[0014] Further provided are such compositions wherein the carrier oil is selected from the group consisting of: almond, apricot kernel, argan, avocado, baobab, black cumin, borage, camelina, canola (rapeseed), castor, coconut, cranberry, emu, evening primrose, grapeseed, hazelnut, hemp, jojoba, kukui nut, macadamia nut, meadowfoam, neem, olive, palm, peanut, pecan, plum, pomegranate seed, pumpkin, rosehip seed, safflower, sea buckthorn, sesame, shea, soybean, sunflower, sweet almond, tamanu, walnut, watermelon seed, or wheat germ oils.
[0015] Further provided are such compositions wherein the essential oil is selected from the group consisting of: allspice, ambrette, ammi visnaga, amyris, angelica root, anise seed, balsam, basil, bay laurel, benzoin, bergamot, birch, black pepper, calendula, chamomile, cardamom, carrot seed, cedar, cedarwood, celery seed, chamomile, champaca, chaste berry, cinnamon, cistus, citronella, clary sage, clove bud, coffee bean, coriander, cypress, davana, elemi, eucalyptus, fennel, fir, frangipani, frankincense, galbanum, gardenia, geranium, ginger, grapefruit, helichrysum, hyssop, inula, jasmine, juniper berry, khella, lavender, ledum, lemon, lemon verbena, lemongrass, lime, lotus, mandarin, marjoram, may chang, melissa, myrrh, myrtle, neroli, niaouli, nutmeg, oakmoss, orange, oregano, owyhee, palmarosa, palo santo, patchouli, peppermint, petitgrain, pine, rose otto, ravensara aromatic, rosemary, rosewood, sage, sandalwood, spearmint, spikenard, spruce, St. Johns Wort, tangerine, tansy, tarragon, tea tree, thyme, tobacco, tuberose, vanilla, verbena, vetivert, violet, vitex, wintergreen, yarrow, and ylang ylang. [0016] Further provided are such compositions which further comprise an additional ingredient selected from the group consisting of: at least one preservative; at least one gelling agent; vitamin A; vitamin C; vitamin D; vitamin E; camphor; at least one botanical extract; at least one sea extract;
glycerine; at least one plant-based butter; lanolin; at least one mineral; sea salt; at least one pH balancer.
[0017] Further provided are such compositions which are formulated for delivery from a device selected from the group consisting of: tube; tub; aerosol container; bandage; diaper; polymer strip; spritz container; stick; wipe; and syringe.
[0018] Further provided are such compositions wherein the formulation has at least one property selected from the group consisting of: antibacterial; antifungal; antiprotozoal; antiviral; antiseptic; antiinflammatory; immunostimulative; analgesic; and antipruritic properties.
[0019] The present invention provides methods to ameliorate the symptoms of a skin disorder in a subject, comprising administering a composition of claim 1 to the skin of a subject with a skin disorder.
[0020] Further provided are such methods wherein the subject is selected from the group consisting of: dog; cat; horse; and human.
[0021] Further provided are such methods which further comprise a step of drying the skin after administration of the composition.
[0022] Further provided are such methods which further comprise a step of administering a barrier layer after drying the skin.
[0023] Further provided are such methods wherein the composition is administered via several applications during a 24 hour period.
[0024] Further provided are such methods wherein the skin disorder is selected from the group consisting of: acne, rosacea, psoriasis, skin blisters, sunburn, dermatitis, eczema, common rashes, allergic reactions (including poison ivy, oak, or sumac), cellulitis, fungal infections, bacterial infections, viral infections, pruritus, physical or chemical burns, hives, bed/pressure sores, skin grafts, chapped lips, biopsy sites, suture sites, tattoos, laser treatments, depilation, transplant sites, catheter sites, injection sites, diabetic ulcers, radiation dermatitis, cuts, abrasions, cryosurgical post-blistering care, and scleroderma.
[0025] Further provided are such methods wherein the method results in a reduction in a microorganism population selected from the group consisting of: bacteria; fungus; and protozoa.
[0026] Further provided are such methods wherein the method results in an activity selected from the group consisting of: antibacterial; antifungal; antiprotozoal; antiviral; antiseptic; anti-inflammatory; immunostimulative; analgesic; and antipruritic properties.
The present invention provides methods to ameliorate the symptoms of diaper rash in a human in need of diaper rash symptom amelioration, comprising: A method to ameliorate the symptoms of diaper rash in a human in need of diaper rash symptom amelioration, comprising: a. cleansing the diaper rash- affected skin of a human with diaper rash, b. applying a nutritive gel to the diaper rash-affected skin wherein the nutritive gel comprises from about 94% w/w to about 96% w/w concentrated Aloe vera, from about 3% w/w to about 4% w/w carrier oils, from about 0.2% w/w to about 0.7% essential oils, and from about 0.2% w/w to about 0.7% w/w other ingredients; c. allowing the nutritive gel to dry or actively dry the gel; and d. applying a barrier cream or ointment to the diaper rash-affected skin.
[0027] Further provided are such methods wherein the Aloe vera concentrate is at least about 1.2x compared to natural Aloe vera juice, the carrier oils are apricot kernel oil and rosehip seed oil, the essential oils are selected from the group consisting of: niaouli; lavender; chamomile; and ginger.
[0028] The present invention provides methods to ameliorate the symptoms of nipple trauma in a human in need of nipple trauma symptom amelioration, comprising: a. cleansing the nipple trauma- affected skin of a human with nipple trauma; b. applying a nutritive gel to the nipple trauma-affected skin, wherein the nutritive gel comprises from about 90% w/w to about 92% w/w concentrated Aloe vera, from about 5% w/w to about 7% w/w carrier oils, from about 0.5% w/w to about 2% w/w essential oils, and from about 0.2% w/w to about 2.5% w/w other ingredients; c. allowing the nutritive gel to dry or actively dry the gel; and d. applying a barrier cream or ointment to the nipple trauma-affected skin.
[0029] Further provided are such methods wherein the Aloe vera concentrate is at least about 1.2x compared to natural Aloe vera juice, the carrier oils are apricot kernel oil and rosehip seed oil, the essential oils are selected from the group consisting of: rosemary; lavender; chamomile; niaouli; and lemon eucalyptus, and the other ingredients comprise 0.7% grapefruit seed extract and 0.8% gentian violet.
[0001] Various objects and advantages of this invention will become apparent to those skilled in the art from the following detailed description, when read in light of the accompanying figures.
BRIEF DESCRIPTION OF THE FIGURES
[0002] Figure 1 depicts the steps for a method of administering a composition herein.
DETAILED DESCRIPTION
[0003] The present invention provides bio-active, nutritive gels. The gels may be massaged into the skin and allowed to dry prior to any application of a barrier cream/ointment/aerosol.
[0004] Formulations
[0005] Herein, the inventors disclose gels containing skin regenerative ingredients such as concentrated Aloe vera (51-99% of the formulation by weight), carrier oils that are appropriate to the skin condition (1-15% of the formulation by weight), essential oils (0.05-10% of the formulation by weight) and miscellaneous emollients, humectants, vitamins, preservatives, and polymers (0.1-35% of the formulation by weight) is applied to the affected area. [0006] a.) Aloe vera. The current formulation comprises a majority (at least 50% by weight) of the mixture consisting of concentrated (l.Olx to lOx strength) Aloe vera juice. One source of an acceptable Aloe vera composition is Aloecorp, 3005 First Avenue, Seattle, WA 98121.
[0007] b.) Carrier Oil. The current formulation comprises at least one, but optionally a combination of, carrier oil. Such carrier oils include, but are not limited to: almond, apricot kernel, avocado, black cumin, coconut, grapeseed, hemp, jojoba, neem, olive, rosehip seed, sesame, sunflower, or tamanu oils.
[0008] c.) Essential Oil. The current formulation comprises at least one, but optionally a combination of, essential oil. Such essential oils include, but are not limited to: allspice, ammi visnaga, amyris, angelica root, balsam, basil, bay laurel, bergamot, birch, calendula, chamomile, cardamom, carrot seed, cedar, cinnamon, cistus, citronella, clary sage, clove bud, coriander, cypress, davana, elemi, eucalyptus, fennel, fir, frangipani, frankincense, galbanum, geranium, ginger, grapefruit, helichrysum, hyssop, inula, jasmine, juniper berry, lavender, lemon, lemon verbena, lemongrass, lime, lotus, mandarin, marjoram, melissa, myrrh, myrtle, neroli, niaouli, nutmeg, oakmoss absolute, orange, oregano, patchouli, peppermint, pine, rose otto, rosemary, rosewood, sage, sandalwood, spearmint, spruce, tangerine, tea tree, thyme, vanilla, verbena, vetivert, violet, vitex, wintergreen, yarrow, and ylang ylang.
[0009] Optional ingredients of the bio-active, nutritive elements are many, but they make up a minority of the formulation by volume. Preservatives and gelling polymers are expected but may not be necessary. Other bio-active, nutritive ingredients include but are not limited to: Vitamins A, C, D, and E; camphor; botanical (land and sea) extracts; glycerin; plant-based butters; lanolin; natural mineral sources (such as coral reef sea salt). Finally, pH balancers and other chemical additives may be necessary for the stabilization and safety of the product. In certain cases, this formulation may be formulated so as to be capable of being aerosolized in order to reduce skin-to-skin contact or otherwise aid application.
[0010] Additional exemplified ranges acceptable for the present compositions are provided in the tables.
Table 1. Ranges of Aloe vera Concentration
Figure imgf000006_0001
described as multiplier of natural Aloe vera juice concentration Table 2. Ranges of Ingredient Percentages
Figure imgf000007_0001
* described as percent, using the weight of the ingredient compared to the weight of the total formulation ( w/w).
[0011] Methods to Make the concentrated Aloe vera Formulations
[0012] In general, the present formulations may be made according to the following series of events, although any manufacturing process which results in producing a formulation herein is acceptable. First, the various oils are mixed together. Essential oils are combined, and carrier oils combined separately. The essential oil mixture is then added to carrier oil mixture.
[0013] Next, the concentrated aloe base is prepared. Concentrated Aloe vera powder, for example,
200x Aloe vera powder, is measured and added to measured deionized water to achieve the desired concentration of hydrated aloe. Alternatively, any Aloe vera juice that is within the concentrations useful in the present invention may be used; the formulation does not require the use of re -hydrated powdered Aloe vera. Thickening/gelling agents such as xanthum gum or carbopol are added to the base. The base is vigorously mixed in order to activate the thickening agent.
[0014] Finally, oils and aloe gel are combined and final ingredients, such as buffers, preservatives, and any other ingredients, are added.
[0015] Methods to Use the concentrated Aloe vera Formulations
[0016] The present invention provides skin care treatments, optionally in conjunction with barrier creams/ointments/aerosols. The formulations herein may be applied directly to the affected area, optionally after cleansing the skin but before application of barrier creams, ointments, or aerosols. This additional step adds a layer of botanically active gel that is completely absorbed by the skin and air dried prior to use of traditional creams or ointments.
[0017] After application of the gel to the affected area, the gel may be massaged into the skin to aid in absorption. However, the massage step may be skipped in instances where touching the skin is exceedingly painful or exposes the patient to new contaminants or others to contracting a contaminant, such as in the case of the treatment of necrotizing fasciitis or new or unknown pathogens.
[0018] The bio-active, nutritive gel may then be optionally allowed to dry, or active steps to dry the gel to the skin may be taken. The drying step can result in complete or partial drying, and can be accomplished by waiting for a specified drying time or by using an air movement and/or heating device with optional low heat (preferably no more than body temperature for sensitive skins or up to 110 degrees Fahrenheit for less sensitive uses). Preferably, the skin is completely dried. Barrier creams/ointments/aerosols may then optionally be applied.
[0019] An exemplified method is shown in Figure 1. Figure 1 shows a flowchart: (100)
Optionally, cleanse the affected area; (200) Apply a nutritive, bioactive gel comprising concentrated Aloe vera, an appropriate carrier oil, and essential oils to the affected area. In some cases, it may be beneficial to aerosolize the gel and apply without touching the skin; (300) Optionally gently massage the gel into the skin. ; (400) Optionally, allow time for gel to air dry, OR, using a mildly warm (70-100 or 110 degrees Fahrenheit) source of moving air, exsiccate the affected area until it is completely dry. (500) Optionally, apply a barrier cream/ointment/aerosol.
[0020] The formulations and methods herein provide antibacterial, antifungal, antiprotozoal, antiviral, antiseptic, anti-inflammatory, immunostimulative, analgesic, and antipruritic properties. The present invention stimulates healing in the skin, retards growth of harmful microbes, and, when completely dried as directed, allows barrier creams to adhere to the skin, sealing in biologically active, nutritive elements while sealing out moisture and irritants.
[0021] This process could be useful to any sort of wound care for humans and animals, particularly those in which barrier creams are an indicated treatment. Applying an intermediate nutritive gel and drying it completely (optionally using some sort of fan, hair dryer, or other air delivery device) prior to use of barrier creams/ointments/aerosols could be useful in the treatment of many issues, including but not limited to: acne, rosacea, psoriasis, skin blisters, sunburn, dermatitis, eczema, common rashes, allergic reactions (including poison ivy, oak, or sumac), cellulitis, fungal infections, bacterial infections, viral infections, pruritus, physical or chemical burns, hives, bed/pressure sores, skin grafts, chapped lips, biopsy sites, suture sites, tattoos, laser treatments, depilation, transplant sites, catheter sites, injection sites, diabetic ulcers, radiation dermatitis, cuts, abrasions, cryosurgical post-blistering care, and scleroderma.
[0022] Methods to Treat Diaper Rash
[0023] The usual approach to diaper rash treatment when the rash is advanced is:
[0024] 1. Cleanse the affected area, which leaves the skin damp. This step can cause barrier creams to not stick or it can lock moisture beneath the barrier creams, thereby feeding microbes.
[0025] 2. Optionally apply powder to the skin, which may dry the skin but can cause other problems. Talc may be contaminated with other minerals whereas plant-based powders are foods that can feed microbes and worsen the rash condition. Both mineral and plant-based powders can also invade lung tissue when airborne.
[0026] 3. Apply a barrier cream/ointment/aerosol.
[0027] The steps of the present methods for diaper rash treatment include the following: [0028] 1. Cleanse the affected area;
[0029] 2. Apply a nutritive gel of the present invention;
[0030] 3. Allow the the gel to dry or actively dry the gel; and
[0031] 4. Apply the barrier cream/ointment/aerosol.
[0032] A formula for this purpose may be (by weight): 95% Aloe vera , 4% carrier oils (apricot kernel oil, rosehip seed oil), 0.5% essential oils (such as: niaouli, lavender, chamomile, ginger), and 0.5% preservatives, buffers, and gelling polymers.
[0033] Methods to Treat Nipple Trauma
[0034] The usual approach to lactation-induced nipple trauma treatment is:
[0035] 1. Cleanse the affected area either with water or with freshly expressed breast milk.
[0036] 2. Allow skin to air dry. This traditional method is not completely effective because milk let-down may continue even after air-drying and/or the deep cracks may lack access to proper air circulation to completely dry.
[0037] 3. Apply a cream or ointment. For advanced cracked nipples, barrier
creams/ointments/aerosols such as lanolin may be used).
[0038] The present methods include the use of a bio-active, nutritive gel as follows:
[0039] 1. Cleanse the affected area;
[0040] 2. Apply a nutritive gel of the present invention;
[0041] 3. Allow the gel to dry or actively dry the gel; and
[0042] 4. Apply the barrier cream/ointment/aerosol.
[0043] A gel containing Aloe vera, appropriate food-grade carrier oil(s), and essential oils is applied to the affected area. One example of a formula for this purpose is (by weight): 91.35% Aloe vera , 5.5% carrier oils (Rosehip seed, borage, apricot kernel, olive, and coconut oils), 0.35 % essential oils (such as: labender, geranium, myrrh, niaouli, and fennel), and 2.8% preservatives, buffers and gelling polymers. The gel is gently massaged in and then air dried, optionally completely. For instance, a hair dryer on a "cold" or "warm" setting, with care taken not to burn the sensitive skin, may be used. When the skin is completely dry to the touch, then barrier creams/ointments/aerosols may be applied.
[0044] Benefits of applying and completely drying the bio-active, nutritive gel: (1) Barrier creams adhere better to the perfectly dry skin than to moist skin. (2) The Aloe vera layer promotes basal keratinocyte regeneration (skin cell healing). (3) The aloe, carrier oils, and essential oils in the gel layer can provide antimicrobial, antiseptic, anti-inflammatory, immunostimulative, and other important functions for the healing and regeneration of healthy skin cells.
[0045] Methods to Treat Skin Pathologies and Methods of Use for Cosmetic Purposes
[0046] Various skin pathologies may be treated using the present formulations and according to the present methods. For instance, any human skin pathology or cosmetic procedure wherein barrier creams are indicated are within the scope of the present invention, including:incontinence, any ostomy site including gastronomy tubes, radiotherapy; difficult to treat human issues— pressure sores, diabetic ulcers, necrotizing fasciitis; eczema, psoriasis, external hemorrhoids; dermabrasion, epilation/waxing. Moreover, the present invention is not limited to human skin care; the present formulations and methods are useful for the treatment of skin pathologies or cosmetic applications in horses, cats, dogs, and any other animals.
[0047] Certain embodiments of the present invention are defined in the Examples herein. It should be understood that these Examples, while indicating preferred embodiments of the invention, are given by way of illustration only. From the above discussion and these Examples, one skilled in the art can ascertain the essential characteristics of this invention, and without departing from the spirit and scope thereof, can make various changes and modifications of the invention to adapt it to various usages and conditions. All publications, including patents and non-patent literature, referred to in this specification are expressly incorporated by reference herein. Citation of the any of the documents recited herein is not intended as an admission that any of the foregoing is pertinent prior art. All statements as to the date or representation as to the contents of these documents is based on the information available to the applicant and does not constitute any admission as to the correctness of the dates or contents of these documents
[0048] EXAMPLES
[0049] EXAMPLE 1: Diaper Rash Formulation
[0050] The following formulation was made according to these steps. All percentages are by weight,
Water base
Aloe gel base: About 93.5% of 1.35 times concentrated Aloe vera barbadensis, from 200 times strength Aloe vera powder mixed with deionized water. The required volume relative to other ingredients will vary slightly based on buffering and neutralizing requirements.
Oil additives
0.85% Rosehip seed oil, from wildcrafted or organic, cold pressed source
2.55% Apricot kernel oil, from wildcrafted or organic, cold pressed source
0.5% essential oil blend made up of:
0.120% from nialouli,
0.040% from ginger,
0.210% from high altitude lavender, and
0.130% from Roman chamomile, all from wildcrafted or organic, cold processed sources, and Gelling, buffering, and preserving
0.75% Carbopol gelling polymer, from powdered Carbopol Ultrez 20 polymer q.s. (About 0.5-1%) Sodium Hydroxide, to neutralize gelling polymer 0.5% Potassium Sorbate
0.5. Sodium Benzoate
q.s. Citric Acid
Mixing instructions:
1. Water base: Mix the aloe base from 200x aloe powder and deionized water at 40
degrees C.
2. Oil mix: Mix the carrier oils and essential oils at 40 degrees C.
3. Gel: Using rapid but smooth agitation at 40 degrees C, add Carbopol to water base. Mix for 15 minutes. Neutralize to pH of 5.9 with sodium hydroxide to achieve desired viscosity. Mix until uniform. Add oil mix and preservatives to gel. Mix until uniform.
4. Add citric acid to preserved gel (from Step 3) to attain a target pH of 5.4 at 40 degrees C.
5. Cool or heat to appropriate temperature for filling packages. [0051] EXAMPLE 2. Diaper Rash Treatment Method
[0052] A gel of the formula of Example 1 was manufactured and applied to moderate diaper rash as such:
Diaper area cleansed completely with non-irritating wet wipe(s).
1. About 3 ml of treatment gel was applied to diaper area, approximately 150-200 cm2 in surface area.
2. Gel was massaged into skin.
3. Cool (20-25 degrees C) low-velocity airflow was applied to speed drying of gel.
4. These steps were repeated at each diaper change.
[0053] Results: The rash was reduced by 50% in 12-18 hours, 75% in 24 hours, and 100% in 36-48 hours, compared to an average of 3 days for conventional treatment.
[0054] EXAMPLE 3: Formulation for Nipple Trauma
[0055] The following formulation was made according to these steps. All percentages are by weight.
Water base
Aloe gel base: About 91.5% of 1.6 times concentrated Aloe vera barbadensis, from 200 times strength Aloe vera gel powder mixed with deionized water. The required volume relative to other ingredients will vary slightly based on buffering and neutralizing requirements.
Oil additives
1.32% Rosehip seed oil, from wildcrafted or organic, cold pressed source
0.88% Borage kernel oil, from wildcrafted or organic, cold pressed source
0.77% Apricot kernel oil, from wildcrafted or organic, cold pressed source
0.55% Coconut oil, from organic, cold pressed source
1.98% Olive oil, from organic, cold pressed source
0.35% essential oil blend made up of:
0.224% from High altitude lavender,
0.032% from Geranium,
0.028% from Myrrh,
0.028% from Niaouli, and
0.025% from Fennel, all from wildcrafted or organic, cold processed sources Gelling, buffering, and preserving
1.05% Carbopol gelling polymer, from powdered Carbopol Ultrez 20 polymer q.s. (About 0.5-1%) Sodium Hydroxide, to neutralize gelling polymer
0.5% Potassium Sorbate
0.5% Sodium Benzoate
q.s. Citric Acid
Mixing instructions:
1. Water base: Mix the aloe base from 200x aloe powder and deionized water at 40 degrees C.
2. Oil mix: Mix the carrier oils and essential oils at 40 degrees C.
3. Gel: Using rapid but smooth agitation at 40 degrees C, add Carbopol to water base. Mix for 15 minutes. Neutralize to pH of 5.9 with sodium hydroxide to achieve desired viscosity. Mix until uniform. Add oil mix and preservatives to gel. Mix until uniform.
4. Add citric acid to preserved gel (from Step 3) to attain a target pH of 5.4 at 40 degrees C.
5. Cool or heat to appropriate temperature for filling packages.
[0056] EXAMPLE 5: Formulation for eczema
[0057] The following formulation was made according to these steps. All percentages are by weight.
Water base
Aloe gel base: About 92% of 1.65 times concentrated Aloe vera barbadensis, from 200 times strength Aloe vera gel powder mixed with deionized water. The required volume relative to other ingredients will vary slightly based on buffering and neutralizing requirements.
Oil additives
1.56% Rosehip seed oil, from wildcrafted or organic, cold pressed source
1.24% Apricot kernel oil, from wildcrafted or organic, cold pressed source
0.60% Baobab seed oil, from wildcrafted or organic, cold pressed source
0.60% Argan oil, from wildcrafted or organic, cold pressed source
1.0% essential oil blend made up of:
0.540% from Roman chamomile,
0.150% from blue yarrow,
0.100% from thyme,
0.100% from niaouli,
0.060% from high altitude lavender, and
0.050% from cedarwood, all from wildcrafted or organic, cold pressed sources , and
Gelling, buffering, and preserving
0.95% Carbopol gelling polymer, from powdered Carbopol Ultrez 20 polymer q.s. (About 0.5-1%) Sodium Hydroxide, to neutralize gelling polymer
0.5% Potassium Sorbate
0.5% Sodium Benzoate
q.s. Citric Acid
Mixing instructions:
1. Water base: Mix the aloe base from 200x aloe powder and deionized water at 40 degrees C.
2. Oil mix: Mix the carrier oils and essential oils at 40 degrees C.
3. Gel: Using rapid but smooth agitation at 40 degrees C, add Carbopol to water base. Mix for 15 minutes. Neutralize to pH of 5.9 with sodium hydroxide to achieve desired viscosity. Mix until uniform. Add oil mix and preservatives to gel. Mix until uniform.
4. Add citric acid to preserved gel (from Step 3) to attain a target pH of 5.4 at 40 degrees C.
5. Cool or heat to appropriate temperature for filling packages.

Claims

CLAIMS What is claimed is:
1. A composition comprising:
a. ) at least about 50% concentrated Aloe vera gel by weight, as a percentage of total weight; b. ) at least about 1% carrier oil by weight, as a percentage of total weight; and
c. ) at least about 0.05% essential oil by weight, as a percentage of total weight.
2. A composition of claim 1, wherein the Aloe vera is concentrated from about 1.01 to about 10 times of naturally-occurring Aloe vera juice.
3. A composition of claim 1, wherein the percentage of concentrated Aloe vera is selected from the group consisting of: from about 50% w/w to about 99% w/w; from about 60% w/w to about 95% w/w; from about 70% w/w to about 95% w/w; from about 80% w/w to about 95% w/w; from about 88% w/w to about 93% w/w; from about 90% w/w to about 95% w/w; from about 90% w/w to about 92% w/w; approximately 91% w/w.
4. A composition of claim 1 , wherein the percentage of carrier oil is selected from the group consisting of: from about 1% w/w to about 15% w/w; from about 2% w/w to about 12% w/w; from about 5% w/w to about 10% w/w; from about 5% w/w to 7% w/w; approximately 6% w/w.
5. A composition of claim 1, wherein the percentage of essential oil is selected from the group consisting of: from about 0.05% w/w to about 10% w/w; from about 0.1% w/w to about 8% w/w; from about 0.5% to about 3% w/w; from about 0.8% w/w to about 2% w/w; from about 1% w/w to 1.5% w/w; from about 1% w/w to about 1.3% w/w; approximately 1.2% w/w.
6. A composition of claim 1, which further comprises an ingredient selected from the group consisting of: at least one humectant; at least one nutrient; at least one preservative; at least one gelling agent.
7. A composition of claim 1, which is formulated for use on human skin.
8. A composition of claim 1, wherein the carrier oil is selected from the group consisting of: almond, apricot kernel, argan, avocado, baobab, black cumin, borage, camelina, canola (rapeseed), castor, coconut, cranberry, emu, evening primrose, grapeseed, hazelnut, hemp, jojoba, kukui nut, macadamia nut, meadowfoam, neem, olive, palm, peanut, pecan, plum, pomegranate seed, pumpkin, rosehip seed, safflower, sea buckthorn, sesame, shea, soybean, sunflower, sweet almond, tamanu, walnut, watermelon seed, or wheat germ oils.
9. A composition of claim 1, wherein the essential oil is selected from the group consisting of: allspice, ambrette, ammi visnaga, amyris, angelica root, anise seed, balsam, basil, bay laurel, benzoin, bergamot, birch, black pepper, calendula, chamomile, cardamom, carrot seed, cedar, cedarwood, celery seed, chamomile, champaca, chaste berry, cinnamon, cistus, citronella, clary sage, clove bud, coffee bean, coriander, cypress, davana, elemi, eucalyptus, fennel, fir, frangipani, frankincense, galbanum, gardenia, geranium, ginger, grapefruit, helichrysum, hyssop, inula, jasmine, juniper berry, khella, lavender, ledum, lemon, lemon verbena, lemongrass, lime, lotus, mandarin, marjoram, may chang, melissa, myrrh, myrtle, neroli, niaouli, nutmeg, oakmoss, orange, oregano, owyhee, palmarosa, palo santo, patchouli, peppermint, petitgrain, pine, rose otto, ravensara aromatic, rosemary, rosewood, sage, sandalwood, spearmint, spikenard, spruce, St. Johns Wort, tangerine, tansy, tarragon, tea tree, thyme, tobacco, tuberose, vanilla, verbena, vetivert, violet, vitex, wintergreen, yarrow, and ylang ylang.
10. A composition of claim 1, which further comprises an additional ingredient selected from the group consisting of: at least one preservative; at least one gelling agent; vitamin A; vitamin C; vitamin D; vitamin E; camphor; at least one botanical extract; at least one sea extract; glycerine; at least one plant-based butter; lanolin; at least one mineral; sea salt; at least one pH balancer.
11. A composition of claim 1 , which is formulated for delivery from a device selected from the group consisting of: tube; tub; aerosol container; bandage; diaper; polymer strip; spritz container; stick; wipe; and syringe.
12. A composition of claim 1, wherein the formulation has at least one property selected from the group consisting of: antibacterial; antifungal; antiprotozoal; antiviral; antiseptic; anti-inflammatory; immunostimulative; analgesic; and antipruritic properties.
13. A method to ameliorate the symptoms of a skin disorder in a subject, comprising administering a composition of claim 1 to the skin of a subject with a skin disorder.
14. A method of claim 13, wherein the subject is selected from the group consisting of: dog; cat; horse; cow; sheep; rabbit; goat; and human.
15. A method of claim 14, which further comprises a step of drying the skin after administration of the composition.
16. A method of claim 15, which further comprises a step of administering a barrier layer after drying the skin.
17. A method of claim 13, wherein the composition is administered via several applications during a 24 hour period.
18. A method of claim 13, wherein the skin disorder is selected from the group consisting of: acne, rosacea, psoriasis, skin blisters, sunburn, dermatitis, eczema, common rashes, allergic reactions (including poison ivy, oak, or sumac), cellulitis, fungal infections, bacterial infections, viral infections, pruritus, physical or chemical burns, hives, bed/pressure sores, skin grafts, chapped lips, biopsy sites, suture sites, tattoos, laser treatments, depilation, transplant sites, catheter sites, injection sites, diabetic ulcers, radiation dermatitis, cuts, abrasions, cryosurgical post-blistering care, and scleroderma.
19. A method of claim 13, wherein the method results in a reduction in a microorganism population selected from the group consisting of: bacteria; fungus; and protozoa.
20. A method of claim 13, wherein the method results in an activity selected from the group consisting of: antibacterial; antifungal; antiprotozoal; antiviral; antiseptic; anti-inflammatory;
immunostimulative; analgesic; and antipruritic properties.
21. A method to ameliorate the symptoms of diaper rash in a human in need of diaper rash symptom amelioration, comprising:
a. cleansing the diaper rash-affected skin of a human with diaper rash,
b. applying a nutritive gel to the diaper rash-affected skin wherein the nutritive gel comprises from about 94% w/w to about 96% w/w concentrated Aloe vera, from about 3% w/w to about 4% w/w carrier oils, from about 0.2% w/w to about 0.7% essential oils, and from about 0.2% w/w to about 0.7% w/w other ingredients;
c. allowing the nutritive gel to dry or actively dry the gel; and
d. applying a barrier cream or ointment to the diaper rash-affected skin.
22. The method of claim 21, wherein the Aloe vera concentrate is at least about 1.2x compared to natural Aloe vera juice, the carrier oils are apricot kernel oil and rosehip seed oil, the essential oils are selected from the group consisting of: niaouli; lavender; chamomile; and ginger.
23. A method to ameliorate the symptoms of nipple trauma in a human in need of nipple trauma symptom amelioration, comprising:
a. cleansing the nipple trauma-affected skin of a human with nipple trauma;
b. applying a nutritive gel to the nipple trauma-affected skin, wherein the nutritive gel comprises from about 90% w/w to about 92% w/w concentrated Aloe vera, from about 5% w/w to about 7% w/w carrier oils, from about 1% w/w to about 2% w/w essential oils, and from about 0.2% w/w to about 2.5% w/w other ingredients;
c. allowing the nutritive gel to dry or actively dry the gel; and
d. applying a barrier cream or ointment to the nipple trauma-affected skin.
24. The method of claim 21, wherein the Aloe vera concentrate is at least about 1.2x compared to natural Aloe vera juice, the carrier oils are apricot kernel oil and rosehip seed oil, the essential oils are selected from the group consisting of: rosemary; lavender; chamomile; niaouli; and lemon eucalyptus, and the other ingredients comprise 0.7% grapefruit seed extract and 0.8% gentian violet.
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WO2016049088A1 (en) * 2014-09-22 2016-03-31 Vama, Inc. Tick and flea control compositions comprising plant essential oils and different forms for the ease of application
WO2016144196A1 (en) * 2015-03-07 2016-09-15 Furmaniak Andrzej Karol A pharmaceutical and/or cosmetic composition for treating skin diseases and damages, the process for preparing of the pharmaceutical and/or cosmetic composition and its use
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RU2638798C1 (en) * 2017-03-06 2017-12-15 Александр Владимирович Локарев Gel with antifungal action (versions)
WO2019194775A3 (en) * 2017-12-27 2019-12-26 Montero Gida Sanayi Ve Ticaret Anonim Sirketi A composition for the treatment of diseases of nipple and areola
CN108553357A (en) * 2018-05-19 2018-09-21 邵俊轩 A kind of natural antalgesic-antipruritic aloe water
US11717437B2 (en) 2019-03-22 2023-08-08 Natasha Polster Compress for relief from radiation treatments
CN110623920A (en) * 2019-11-05 2019-12-31 张伟 Exosome restoration gel capable of being stored for long time and preparation method thereof
US11707427B2 (en) 2020-04-29 2023-07-25 Mary Kay Inc. Cosmetic compositions and methods
US20230133004A1 (en) * 2021-11-01 2023-05-04 Solaana MD LLC Vitamin d base layer
CN114344219A (en) * 2022-01-27 2022-04-15 山西万龄国际贸易有限公司 Aromatic plant composition for treating red swelling, itching and pain of skin and preparation method thereof
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