NZ734222A - Composition and method for treating skin conditions - Google Patents
Composition and method for treating skin conditionsInfo
- Publication number
- NZ734222A NZ734222A NZ734222A NZ73422217A NZ734222A NZ 734222 A NZ734222 A NZ 734222A NZ 734222 A NZ734222 A NZ 734222A NZ 73422217 A NZ73422217 A NZ 73422217A NZ 734222 A NZ734222 A NZ 734222A
- Authority
- NZ
- New Zealand
- Prior art keywords
- agent
- topical composition
- amount
- topical
- weight
- Prior art date
Links
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Abstract
Provided are biocompatible topical compositions including a novel combination of an inflammatory management agent, a vascular repair agent, a neurogenic agent, a sebum suppression agent and an exfoliating agent. Also provided are methods for treating, preventing or ameliorating rosacea, a symptom thereof or a condition related thereto by administering the biocompatible topical compositions describe herein. ereof or a condition related thereto by administering the biocompatible topical compositions describe herein.
Description
COMPOSITION AND METHOD FOR TREATING SKIN CONDITIONS
FIELD
The present subject matter relates to biocompatible topical compositions and
methods of treating rosacea by administering the same.
BACKGROUND
Rosacea is a chronic skin condition characterized by recurrent episodes of
flushing, erythema, vasodilation, telangiectasia, edema, papules, pustules,
hyperplasia, fibroplasia, itching, burning, pain, and skin tightness. Symptoms of
rosacea are exacerbated by sun exposure, hot weather, immersion in hot water, high
humidity, sweating, exercise, emotional stress, and spicy food.
The etiology of rosacea is not well understood. Furthermore, treatments,
including, for example, antibiotic administration, topical drugs and known cosmetics
may yield only marginal improvement. In addition, such treatments have been known
to aggravate rosacea rather than alieve it. For example, in a National Rosacea
Society survey of 1,066 patients, 41 percent reported that certain skin-care products
aggravated their condition and 27 percent said certain cosmetics also caused rosacea
flare-ups.
Therefore, there is a need to identify compositions that can be used to treat,
prevent or ameliorate rosacea, symptoms thereof and conditions related thereto,
especially compositions that do not aggravate the rosacea or symptoms associated
therewith.
SUMMARY
The present subject matter relates to topical compositions and methods for
treating rosacea including administering a topical composition.
More specifically, provided is a biocompatible topical composition comprising or
consisting of a novel combination of an inflammatory management agent, a vascular
repair agent, a neurogenic agent, a sebum suppression agent and an exfoliating agent
for treating, preventing and/or stabilizing Rosacea conditions and symptoms thereof or a
condition related thereto.
The topical composition may optionally comprise or consist of one or more
additional agents. For example, the topical composition may optionally comprise or
consist of a carrier, which may be a solvent, a chelating agent, a humectant, a
thickener, an emollient, an emulsifier, a skin conditioning agent, an anti-inflammatory
agent, an antioxidant, a pH adjuster and/or a preservative. In addition, the topical
composition may also comprise or consist of one or more biocompatible carrier,
excipient, filler and/or diluent.
Also provided is a rosacea treatment, prevention or amelioration skin kit. The
skin kit may comprise or consist of the topical composition provided herein and one or
more additional composition. The one or more additional composition may be a skin
cleanser, an oral composition for treating skin, a sunscreen such as, e.g., an organic
sunscreen, a moisturizing composition, an exfoliating composition such as, e.g., an
exfoliating polish, a barrier protecting composition and/or an additional topical
composition for treating, preventing or ameliorating rosacea, a symptom thereof or a
condition related thereto such as, e.g., a topical formulation comprising salicylic acid or
benzoyl peroxide. The kit may also include a device for concomitant therapy.
Additionally the kit may include one or more topical or oral homeopathic composition.
The kit may further include instructions for use and packaging.
The presently described subject matter also relates to a method of treating,
preventing or ameliorating rosacea or a symptom thereof in a subject, comprising or
consisting of topically administering to the subject a therapeutically effective amount of
the biocompatible topical composition described herein.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 shows a side-by-side photographic comparison of a patient suffering from
rosacea prior to and following six weeks of regular administration of the topical
compositions described herein.
Fig. 2 shows a side-by-side photographic comparison of another patient
suffering from rosacea prior to and following six weeks of regular administration of the
topical compositions described herein.
DETAILED DESCRIPTION
Definitions
The term “about” as used herein refers to a quantity, level, value, dimension,
size, or amount that varies to some extent based on the context in which it is used.
For example, such variation can be by as much as 5%. At the least, each numerical
parameter can be construed in light of the number of reported significant digits and by
applying ordinary rounding techniques.
As used herein, the terms “administer,” “administering,” and “administration,”
refer to any method which, in sound medical practice, delivers the composition to a
subject in such a manner as to provide a therapeutic effect.
For the purposes of the presently described subject matter, the present topical
biocompatible compositions can be topically administered. For example, administration
can include, but is not limited to, direct topical administration. For example, a viscous
formulation, including for example a cream, gel, ointment, or salve formulation, or a
liquid formulation, for example, a solution, can be administered directly to a desired skin
surface. Administration can also be accomplished via a compress or a wet dressing.
For example, a liquid, e.g., solution, emulsion, suspension, etc., formulation of the
presently described topical composition can be applied to a skin surface via a compress
or wet dressing.
As used herein, the phrases “anti-inflammatory agent” and “inflammatory
management agent” refer to a compound or composition capable of preventing,
reducing or ameliorating inflammation. Non-limiting examples of inflammatory
management agents include, e.g., lactose and milk protein, or a combination thereof.
Anti-inflammatory agent may also refer to, for example a chemical compound, that acts
to reduce one or more indications of inflammation, such indications including, but not
limited to, swelling, redness, tenderness, and pain. Such compounds can include but
are not limited to Beta Glucan, Avena Sativa (Oat) Kernel Meal, Avena Sativa (Oat)
Kernal Protein USP, Avena sativa (Oat) Kernal Flour, whey protein concentrates, and
combinations thereof.
The term “antioxidant” refers to an atom, molecule, or a compound that inhibits
the oxidation of other molecules, has a greater oxidation potential than a second atom
or molecule, such that the antioxidant is preferentially oxidized instead of the second
atom or molecule. For example, an antioxidant can have a greater oxidation potential
than hematein, and thus help prevent oxidation of hematein to oxyhematein.
Furthermore, an antioxidant also can function as a reducing agent, for example, a
reducing agent that converts oxyhematein back to hematein. Antioxidants can be
present in the disclosed compositions at concentrations ranging from about 1 mM to
about 1M, for example, from about 5 mM to about 500 mM, such as from about 50 mM
to about 150 mM. Antioxidants serve to neutralize the deleterious effects of reactive
oxygen species and/or free radicals that can be generated by various internal and
external stimuli within human tissue.
Non-limiting examples of antioxidants include one or more of Leontopodium
Alpinum Meristem Cell Culture, Marrubium Vulgare Meristem Cell Culture (e.g.,
DISTINCTIVE® Phytostem Edelweiss), Tocopheryl Acetate, Ascorbic Acid and/or
Retinyl Palmitate, soluble soy protein, Idebenone, coenzyme Q10, Lycopene,
Epigallocatechin 3-gallate (EGCG), green tea polyphenols (GTP), Silymarin,
CoffeeBerry®, Grape seed extract, Pomegranate extracts, Genistein, pycnogenol,
niacinamide, methionine, glutathione, tocotrienol, dimethyl glycine, betaine, butylated
hydroxyanisole, butylated hydroxytoluene, turmerin, vitamin E, ascorbyl palmitate,
deteroxime mesylate, methyl paraben, ethyl paraben, butylated hydroxyanisole,
butylated hydroxytoluene, propyl gallate, sodium or potassium metabisulfite, sodium or
potassium sulfite, alpha tocopherol or derivatives thereof, sodium ascorbate, disodium
edentate, BHA (butylated hydroxyanisole), flavonoids, a pharmaceutically acceptable
salt or ester of the mentioned compounds, and mixtures thereof. Flavonoids include, for
example, quercetin, morin, naringenin and hesperetin, taxifolin, afzelin, quercitrin,
myricitrin, genistein, apigenin and biochanin A, flavone, flavopiridol, isoflavonoids such
as the soy isoflavonoid, genistein, catechins such as the tea catechin epigallocatechin
gallate, flavonol, epicatechin, hesperetin, chrysin, diosmin, hesperidin, luteolin, and
rutin.
The term “biocompatible” or “physiologically compatible,” as used herein, refers
to the ability to be in contact with a living system without producing a significant adverse
effect, for example, by not being toxic, injurious, or physiologically reactive.
As used herein, the phrases an “effective amount" or a “therapeutically effective
amount” of a composition and/or active agent or ingredient, which are synonymous
herein, refer to an amount of the active agent sufficient enough to have a therapeutic
effect upon administration. A therapeutically effective amount of the active agent may,
will, or is expected to cause a relief of symptoms. Effective amounts of the active agent
will vary with the particular condition or conditions being treated, the severity of the
condition, the duration of the treatment, the specific components of the composition
being used, and like factors. For example, the presently described compositions can be
topically applied in an amount sufficient to cover an affected area. The presently
described compositions can be topically applied in an amount sufficient to cover an
affected area plus a margin of healthy skin or tissue surrounding the affected area, for
example, a margin of about .5 inches.
“Chelating agent,” as used herein refers to an agent, e.g., a chemical, capable of
removing a metal ion from a system by forming a complex so that the metal ion cannot
readily participate in or catalyze chemical reactions. Non-limiting examples of chelating
agents include, for example, one or more of citric acid, phosphates, disodium EDTA,
tetrasodium EDTA, ethylene glycol-bis-(b-aminoethylether)-N,N,N′,N′-tetraacetic acid
(EGTA), 1,2-bis(2-aminophenoxy)ethane-N,N,N′,N′-tetraacetic acid (BAPTA); ethylene-
N,N′-diglycine (EDDA), 2,2′-(ethylendiimino)-dibutyric acid (EBDA), lauroyl EDTA,
dilauroyl EDTA, triethylene tetramine dihydrochloride (TRIEN), diethylenetriamin-
pentaacetic acid (DPTA), triethylenetetramine hexaacetic acid (TTG), deferoxamine,
Dimercaprol, zinc citrate, penicilamine succimer, Editronate, and edetate calcium
disodium.
As used herein the term "emollient" refers to any product applied to the skin
which softens and/or soothes irritation of the skin, including, for example, ointments,
liniments, lotions, creams, moisturizers, oils, skin softeners, soaps, shampoo,
sunscreens, cosmetics and the like. Non-limiting examples of emollients suitable for the
biocompatible topical compositions herein include, for example, one or more of Aleurites
Moluccan Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Isohexadecane,
Methylheptyl Isostearate, Neopentyl Glycol Diethylhexanoate, Neopentyl Glycol
Diisostearate and/or C12-15 Alkyl Benzoate, Hydrogenated Polyisobutene, CC-15
alcohols benzoate, isopropyl myristate, mineral oils, lanolin and lanolin derivatives, and
triglycerides such as coconut oil, cetostearyl alcohol, cetyl alcohol, isopropyl palmitate,
caprylic/capric triglyceride, PPG-2 myristyl ether propionate, dimethicone, methicone,
petrolatum, lanolin, and mineral oil.
As used herein “emulsifier” refers to a compound or substance at acts as a
stabilizer for emulsions preventing the liquids from separating. Non-limiting examples of
emulsifiers suitable for the present biocompatible topical compositions include, for
example one or more of PEG-100 Stearate, PEG-15/Lauryl Dimethicone Crosspolymer,
Polyglyceryl-4 Isostearate and/or Cetyl PEG / PPG 10/1 Dimethicone and/or Hexyl
Laurate, polyoxyethylene fatty ethers derived from stearyl alcohols, Isopropyl
Isostearate, Cetyl Alcohol, polyethylene glycol stearate, a glycol stearate, a glyceryl
stearate, cetearyl alcohol, ceteareth 20, methylcellulose, cetomacrogol 1000, and
lecithin.
The term “humectant” refers to a substance capable of reducing the loss of
moisture. Non-limiting examples of humectants include, for example, glycerin, sodium
hyaluronate, glycerin, glycerol, propylene glycol, glyceryl triacetate, a lanolin product,
such as PPGPEG 50, polyhydric alcohols, water soluble alkoxylated nonionic
polymers, and mixtures thereof. Polyhydric alcohols useful herein include glycerin,
sorbitol, propylene glycol, butylene glycol, hexylene glycol, ethoxylated glucose, 1, 2-
hexane diol, hexanetriol, dipropylene glycol, erythritol, trehalose, diglycerin, xylitol,
maltitol, maltose, glucose, fructose, sodium chondroitin sultate, sodium hyaluronate,
sodium adenosin phosphate, sodium lactate, pyrrolidone carbonate, glucosamine,
cyclodextrin, and mixtures thereof. Water soluble alkoxylated nonionic polymers useful
herein include polyethylene glycols and polypropylene glycols having a molecular
weight of up to about 1000 such as those with CTFA names PEG-200, PEG-400, PEG-
600, PEG-1000, and mixtures thereof. Commercially available humectants herein
include: glycerin with tradenames STAR and SUPEROL available from The Procter &
Gamble Company, CRODEROL GA7000 available from Croda Universal Ltd.,
PRECERIN series available from Unichema, and a same tradename as the chemical
name available from NOF; propylene glycol with tradename LEXOL PG-865/855
available from Inolex, 1,2-PROPYLENE GLYCOL USP available from BASF; sorbitol
with tradenames LIPONIC series available from Lipo, SORBO, ALEX, A-625, and A-641
available from ICI, and UNISWEET 70, UNISWEET CONC available from UPI;
dipropylene glycol with the same tradename available from BASF; diglycerin with
tradename DIGLYCEROL available from Solvay GmbH; xylitol with the same
tradename available from Kyowa and Eizai; maltitol with tradename MALBIT available
from Hayashibara, sodium chondroitin sulfate with the same tradename available from
Freeman and Bioiberica, and with tradename ATOMERGIC SODIUM CHONDROITIN
SULFATE available from Atomergic Chemetals; sodium hyaluronate with tradenames
ACTIMOIST available from Active Organics, AVIAN SODIUM HYALURONATE series
available from Intergen, HYALURONIC ACID Na available from Ichimaru Pharcos;
sodium adenosin phophate with the same tradename available from Asahikasei, Kyowa,
and Daiichi Seiyaku; sodium lactate with the same tradename available from Merck,
Wako, and Showa Kako, cyclodextrin with tradenames CAVITRON available from
American Maize, RHODOCAP series available from Rhone-Poulenc, and DEXPEARL
available from Tomen; and polyethylene glycols with the tradename CARBOWAX series
available from Union Carbide.
As used herein, the phrase “exfoliating agent” refers to any mechanical, chemical
or naturally derived agent that is applied to the skin to accelerate the removal of dead
cells from the skin surface to relive dry skin, assist removal of papules or pustules,
and/or reducing wrinkles. The exfoliating agent may include at least one plant derived
cysteine protease enzyme.
Suitable exfoliating agents may include one or more proteases including, e.g.,
papain, bromelain, protease, serrapeptase, chymotrypsin, trypsin, fungal protease,
amylase, plasmin, fibrinolysin, ficin, snake venom proteases, and peptidase. The
protease may be alone or in combination with other agents. For example the exfoliating
agent may be a combination of one or more of a carbomer, Papain, 1,2 Hexanediol,
Caprylyl Glycol and Algin. An example of an exfoliating agent that includes all of the
aforementioned agents is X-PRESSIN C manufactured by BASF. Other combinations
may be found, e.g., in US Patent Application Publication No. 20110177052 and US
Patent No. 8,778,336, which are incorporated herein by reference in their enteritis.
“Neurogenic agent,” as used herein, refers to any agent capable of treating
preventing, or ameliorating inflammation or other conditions arising from the local
release of inflammatory mediators from afferent neurons such as, for example,
Substance P, Calcitonin Gene-Related Peptide (CGRP), neurokinin A (NKA), and/or
endothelin-3 (ET-3). Sensory as well as autonomic (sympathetic) nerves influence a
variety of Physiological and Pathophysiological functions within the skin such as
vasocontraction/vasoldilation, inflammation and barrier function. Autonomous nerves in
skin, mainly sympathetic cholinergic innervate several cells in the skin are responsible
for maintaining skin homeostasis and regulating inflammation. A dense network of
sensory nerves in skin also release neuropeptides, thereby modulating inflammation,
cell growth, as well as immune responses in the skin. Neurodegeneration in skin causes
a loss of homeostatic control over these various biological functions in human skin. It is
further understood that:
- neurovascular issues affect both nerves and blood vessels;
- subepidermal afferent nerves are involved in the reflex activation of sweat
glands;
- prominent flushing may be attributed to abnormalities in neurovascular
homeostasis; and
- over production of inflammatory inducing Reactive Oxygen Species is also a
central feature of all Neurodegenerative disorders.
With aging, neurons (among them cutaneous neurons) degenerate, especially
in the dermis, where fibroblasts and neurons are continuously communicating. A
neurogenic agent is capable of protecting nerve endings and/or maintains healthy
communications between nerves and fibroblasts.
Suitable neurogenic agents in the present compositions include, for example,
one or more of hydrolyzed algin (alone or with water), substance P antagonists,
extracts of at least one non-photosynthetic filamentous bacterium, CGRP antagonists,
NO-synthase inhibitors, bradykinin antagonists, cytokine antagonists, histamine
antagonists, antagonists of interleukin-1 and/or of tumor necrosis factor α (TNF-α),
sodium-channel blockers and potassium-channel openers.
NEUROCAP (available from Codif/Barrnet) is a preffered neurogenic agent for
use in the compositions described herein. NEUROCAP is an oligosaccharide mainly
composed of 2 uronic acids (guluronic and mannuronic) obtained by enzymatic
depolymerization from saccharides coming from brown algae. NEUROCAP includes
water and hydrolyzed algin.
As used herein the terms “pH adjuster” and “neutralizing agent” refer to any
composition, compound, or agent, suitable for adjusting the pH of the presently
described topical compositions without negatively affecting any property thereof.
Suitable pH adjusters can include any acid or base. Suitable pH adjusters can include
but are not limited to one or more of sodium hydroxide, aminomethyl propanol,
hydrochloric acid, sulfuric acid, citric acid, acetic acid, formic acid, phosphoric acid,
tartric acid, and triethanolamine.
“Solvent” or “carrier” refers to inorganic and/or organic molecules and
compounds capable of at least partially dissolving another substance (i.e., the solute).
Solvents may be liquids at room temperature. Non-limiting examples of solvents
include, for example, one or more of water, deionized water, hydrocarbon solvents (e.g.,
n- pentane, n-hexane, n-heptane, n-octane, paraffin, cyclohexane, methylcyclohexane,
decahydronaphthalene, mineral oil, crude oils, etc.) which also includes aromatic
hydrocarbon solvents (e.g., benzene, toluene, o-xylene, m-xylene, and p-xylene),
halogenated hydrocarbon solvents (e.g., carbon tetrachloride, 1,2-dichloroethane,
dichloromethane, chloroform, etc.), ester solvents (e.g., ethyl formate, methyl acetate,
ethyl acetate, ethyl malonate, etc.), ketone solvents (e.g., acetone, methyl ethyl ketone,
cyclohexanone, cyclopentanone, etc.), ether solvents (e.g., diethyl ether, dipropyl ether,
diphenyl ether, tetrahydrofuran, 1,4-dioxane, etc.), amine solvents (e.g., propyl amine,
diemylamine, triethylamine, aniline, pyridine), alcohol solvents (e.g., methanol, ethanol,
1-propanol, 1-butanol, 1-octanol, benzyl alcohol, trifluoroethanol), glycol solvents
(glycerol, ethylene glycol, propylene glycol, m-cresol, etc.), acid solvents (e.g., acetic
acid, hexanoic acid, etc.), carbon disulfide, nitrobenzene, N,N-dimethylformamide, N,N,-
dimethylacetamide, dimethyl sulfoxide, N-methylpyrrolidone, acetonitrile, silicone
solvents (e.g., silicone oils, polysiloxanes, cyclosilicones). A preferred solvent in the
present compositions is water.
As used herein, “skin conditioning agent” or refers to any material capable of
protecting, treating compromised skin. Non-limiting examples of skin conditioning
agents include one or more of allantoin, aluminium hydroxide gel, calamine, cocoa
butter, cod liver oil, cyclopentasiloxane, dimethicone, dimethicone crosspolymer,
dimethiconol, glycerine, kaolin, petrolatum, lanolin, mineral oil, shark liver oil, white
petrolatum, talc, topical starch, zinc acetate, zinc carbonate, zinc oxide, live yeast cell
derivatives, aldioxa, aluminum acetate, microporous cellulose, cholecalciferol, colloidal
oatmeal, cysteine hydrochloride, dexpanthenol, protein hydrolysates, racemic
methionine, sodium bicarbonate, vitamin A, buffered mixture of cation and anion
exchange resins, corn starch, trolamine, bismuth subnitrate, boric acid, ferric chloride,
polyvinylpyrrolidone-vinyl acetate, copolymers, sulfur, tannic acid, derivatives thereof
and mixtures thereof.
As used herein, the term "salt" refers to salts of certain ingredient(s) which
possess the same activity as the unmodified compound(s) and which are neither
biologically nor otherwise undesirable. A salt can be formed with, for example, organic
or inorganic acids. Non-limiting examples of suitable acids include acetic acid,
acetylsalicylic acid, adipic acid, alginic acid, ascorbic acid, aspartic acid, benzoic acid,
benzenesulfonic acid, bisulfic acid, boric acid, butyric acid, camphoric acid,
camphorsulfonic acid, carbonic acid, citric acid, cyclopentanepropionic acid, digluconic
acid, dodecylsulfic acid, ethanesulfonic acid, formic acid, fumaric acid, glyceric acid,
glycerophosphoric acid, glycine, glucoheptanoic acid, gluconic acid, glutamic acid,
glutaric acid, glycolic acid, hemisulfic acid, heptanoic acid, hexanoic acid, hippuric acid,
hydrobromic acid, hydrochloric acid, hydroiodic acid, hydroxyethanesulfonic acid, lactic
acid, maleic acid, malic acid, malonic acid, mandelic acid, methanesulfonic acid, mucic
acid, naphthylanesulfonic acid, naphthylic acid, nicotinic acid, nitrous acid, oxalic acid,
pelargonic, phosphoric acid, propionic acid, saccharin, salicylic acid, sorbic acid,
succinic acid, sulfuric acid, tartaric acid, thiocyanic acid, thioglycolic acid, thiosulfuric
acid, tosylic acid, undecylenic acid, and naturally and synthetically derived amino acids.
As used herein the term “preservative” refers to any known biocompatible
preservative that functions by inhibiting bacteria and/or fungi, and/or by inhibiting
oxidation. Suitable preservatives can include but are not limited to antimicrobial agents
and/or antioxidants. Suitable antimicrobial agents as preservatives can include but are
not limited to benzoates, benzyl alcohol, sodium benzoate, n-alkyl dimethyl benzyl
ammonium chloride, Caprylyl Glycol, Chlorphenesin, methylparaben, propylparaben,
ethylhexylglycerin, phenoxyethanol, Phenoxyethanol and Caprylyl Glycol and
Chlorphenesin, chlorocresol, potassium sorbate, sorbic acid, bronopol,
methychloroisothiazolinone, methylisothiazolinone, sorbates, propionates, and nitrites.
Suitable antioxidants can include but are not limited to vitamin C, butylated
hydroxytoluene (BHT), sulphites, and vitamin E.
The phrase “sebum suppression agent,” as used herein, refers to any agent
capable of decreasing the production of sebum by the sebaceous glands. Nonlimiting
examples of sebum suppression agents include, for example, ASEBIOL (available from
Laboratories Serobiologiques), BIODERMINE (available from Sederma),
COMPLETECH MBAC-OS (available from Lipo), cucumber extracts, dehydroacetic acid
and its salts, dichlorophenyl imidazoldioxolan, niacinamide, phloretin, PHLOROGINE
(available from Secma), S-carboxylmethyl cysteine, tioxolone, tocopherol, UNITRIENOL
T27, which includes Panthenyl Triacetate, Farnesol and Farnesyl Acetate (available
from Induchem), UNITRIENOL, which includes PEG-12 Glyceryl Laurate, PEG-36
Castor Oil, Panthenyl Triacetate, Farnesol and Farnesyl Acetate (available from
Induchem) and mixtures thereof.
As used herein, “symptom” refers to an indication of disorder or disease,
especially when experienced by an individual as a change from normal function,
sensation, or appearance. See “symptom”. The American Heritage® Science
Dictionary. Houghton Mifflin Company. A symptom may also be referred to as a “sign.”
Non-limiting examples of symptoms of rosacea include, for example, erythema,
telangiectasia, abnormal skin texture, skin discoloration, excess sebum production,
swelling of the skin, skin nodularities, red patches on the skin, desquamation, skin
lesions, stinging/burning, flushing and/or dry/tight skin.
The phrase “substantially pure” as used herein refers to an individual compound
form, which is substantially devoid of all other forms, as well as degradation products of
a form, and any residual solvent, and is at least 85% pure on a % weight basis, unless
otherwise specified. The compound form can have at least 90% purity on a % weight
basis, at least 93% purity on a % weight basis, at least 95% purity on a % weight basis,
or at least 97% purity on a % weight basis. As used herein substantially pure may refer
to food grade ingredients used in topical compositions.
As used herein, "subject" or "individual" or "animal" or "patient" or "mammal,"
refers to any subject, particularly a mammalian subject, for whom diagnosis, prognosis,
or therapy is desired, for example, a human.
As used herein, “thickener” or “thickening agent” refers to any agent useful as an
aid to thicken or add structure to a topical formulations. These agents impart physical
stability and increased viscosity. Additionally, a thickener refers to one or more agents
that, in combination, result in a viscosity suitable for dermatologic applications.
Thickening agents herein may be, for example, gums and natural polysaccharides,
mineral thickeners, oils, and synthetic polymeric thickeners. Non limiting examples of
thickeners suitable for use in the present topical compositions include, for example, one
or more of Xanthan Gum, Cetyl Alcohol, PEG-100 Stearate, Glyceryl Stearate, and
Magnesium Aluminum Silicate.
As used herein, a “treatment” or “treating” of a disease, disorder, or condition
encompasses alleviation of at least one symptom thereof, a reduction in the severity
thereof, or the delay or inhibition of the progression thereof. Treatment need not mean
that the disease, disorder, or condition is totally cured. In this regard, treatment may
include treating, preventing or ameliorating a disease, a symptom thereof or a condition
related thereto. A useful composition herein needs only to reduce the severity of a
disease, disorder, or condition, reduce the severity of symptoms associated therewith,
provide improvement to a patient or subject’s quality of life, or delay or inhibit the onset
of a disease, disorder, or condition.
The phrase “vascular repair agent” refers to an agent, i.e., a compound or
composition, capable of healing and/or restructuring of the skin including, for example,
promotion of neovascularization, which leads to a restoration of blood flow. Non-limiting
examples of vascular repair agents include, for example, water-soluble vitamins such as
palmitoyl glycine, vitamin A or derivatives thereof, vitamin E or derivatives thereof, N-
acetyl-hydroxyproline, extracts of Centella asiatica and of dill, papain, the essential oils
of thyme, of niaouli, of rosemary and of sage, hyaluronic acid, allantoin, Héma'tîte®
(Gattefossé), vitamin C, TEGO® Pep 4-17 (Evonik), Toniskin® (Silab), Collageneer®
(Expanscience), TIMECODE®, which includes Palmitoyl Glycine (Seppic), GATULINE®
skin repair (Gattefossé), panthenol, PHYTOCELTEC Alp Rose (MibelleBiochemistry),
Serilesine® (Lipotec), heterosides of Talapetraka (Bayer), STOICHIOLl® (Codif),
macarose (Sensient), DERMAVEIL (Ichimaru Pharcos), Phycosaccharide AI (Codif)
and/or metformin.
Any concentration ranges, percentage range, or ratio range recited herein are to
be understood to include concentrations, percentages or ratios of any integer within that
range and fractions thereof, such as one tenth and one hundredth of an integer, unless
otherwise indicated.
Any number range recited herein relating to any physical feature, such as
polymer subunits, size or thickness, are to be understood to include any integer within
the recited range, unless otherwise indicated.
It should be understood that the terms "a" and "an" as used above and elsewhere
herein refer to "one or more" of the enumerated components. It will be clear to one of
ordinary skill in the art that the use of the singular includes the plural unless specifically
stated otherwise. Therefore, the terms “a,” “an” and “at least one” are used
interchangeably in this application. For example, "an" astringent component refers to
both one astringent component or a mixture comprising two or more astringent
components.
Unless otherwise indicated, all numbers expressing quantities, percentages or
proportions, and other numerical values used in the specification and claims, are to be
understood as being modified in all instances by the term “about.” Accordingly, unless
indicated to the contrary, the numerical parameters set forth in the following
specification and attached claims are approximations that may vary depending upon the
desired properties sought to be obtained.
Throughout the application, descriptions of various embodiments use
“comprising” language; however, it will be understood by one of skill in the art, that in
some specific instances, an embodiment can alternatively be described using the
language “consisting essentially of” or “consisting of.”
Other terms as used herein are meant to be defined by their well-known
meanings in the art.
Biocompatible Topical Compositions
The presently described biocompatible topical compositions can be provided in
any form, including, but not limited to a gel, a cream, a lotion, an ointment, a foam, an
aerosol, a powder, a solution, an emulsion, and a serum.
The biocompatible topical compositions described herein may include an
inflammatory management agent.
The topical compositions may comprise one or more anti-inflammatory or
inflammatory management agents as described and defined above. The anti-
inflammatory or inflammatory management agent may be present in the topical
compositions in an amount of from > 0.01 wt. % to about 12.5 wt. %; from > 0.01 wt. %
to about 10 wt. %; from 0.01 wt. % to about 9 wt. %; from 0.01 wt. % to about 8 wt. %;
from 0.01 wt. % to about 7 wt. %; from 0.01 wt. % to about 6 wt. %; from 0.01 wt. % to
about 5 wt. %; from 0.01 wt. % to about 4.5 wt. %; from 0.01 wt. % to about 4 wt. %;
from 0.01 wt. % to about 3.5 wt. %; from 0.01 wt. % to about 3 wt. %; from 0.01 wt. % to
about 2.5 wt. %; from 0.01 wt. % to about 2.25 wt. %; from 0.01 wt. % to about 2 wt. %;
from about 0.01% to about 4 wt. %; from about 0.01 wt. % to about 3 wt. %; from about
0.01 wt. % to about 2.5 wt. %; from about 0.01 wt. % to about 2.25 wt. %; from about
0.01 wt. % to about 2 wt. %; from about 0.01 wt. % to about 1.5 wt. %; from about 0.01
wt. % to about 1 wt. %; from about 0.01 wt. % to about 0.5 wt. %; from 0.1 wt. % to
about 10 wt. %; from 0.1 wt. % to about 9 wt. %; from 0.1 wt. % to about 8 wt. %; from
0.1 wt. % to about 7 wt. %; from 0.1 wt. % to about 6 wt. %; from 0.1 wt. % to about 5
wt. %; from 0.1 wt. % to about 4.5 wt. %; from 0.1 wt. % to about 4 wt. %; from 0.1 wt.
% to about 3.5 wt. %; from 0.1 wt. % to about 3 wt. %; from 0.1 wt. % to about 2.5 wt.
%; from 0.1 wt. % to about 2.25 wt. %; from 0.1 wt. % to about 2 wt. %; from about 0.1
wt. % to about 4 wt. %; from about 0.1 wt. % to about 3 wt. %; from about 0.1 wt. % to
about 2.5 wt. %; from about 0.1 wt. % to about 2.25 wt. %; from about 0.1 wt. % to
about 2 wt. %; from about 0.1 wt. % to about 1.5 wt. %; from about 0.1 wt. % to about 1
wt. %; from about 0.1 wt. % to about 0.5 wt. %; from 0.25 wt. % to about 12.5 wt. %;
from 0.25 wt. % to about 10 wt. %; from 0.25 wt. % to about 9 wt. %; from 0.25 wt. % to
about 8 wt. %; from 0.25 wt. % to about 7 wt. %; from 0.25 wt. % to about 6 wt. %; from
0.25 wt. % to about 5 wt. %; from 0.25 wt. % to about 4.5 wt. %; from 0.25 wt. % to
about 4 wt. %; from 0.25 wt. % to about 3.5 wt. %; from 0.25 wt. % to about 3 wt. %;
from 0.25 wt. % to about 2.5 wt. %; from 0.25 wt. % to about 2.25 wt. %; from 0.25 wt.
% to about 2 wt. %; from 0.25 wt. % to about 1.75 wt. %; from 0.7 wt. % to about 10 wt.
%; from 0.7 wt. % to about 9 wt. %; from 0.7 wt. % to about 8 wt. %; from 0.7 wt. % to
about 7 wt. %; from 0.7 wt. % to about 6 wt. %; from 0.7 wt. % to about 5 wt. %; from
0.7 wt. % to about 4.5 wt. %; from 0.7 wt. % to about 4 wt. %; from 0.7 wt. % to about
3.5 wt. %; from 0.7 wt. % to about 3 wt. %; from 0.7 wt. % to about 2.5 wt. %; from 0.7
wt. % to about 2.25 wt. %; from 0.7 wt. % to about 2 wt. %; from about 0.7 wt. % to
about 4 wt. %; from about 0.7 wt. % to about 3 wt. %; from about 0.7 wt. % to about 2.5
wt. %; from about 0.7 wt. % to about 2.25 wt. %; from about 0.7 wt. % to about 2 wt. %;
from about 0.7 wt. % to about 1.5 wt. %; from about 0.7 wt. % to about 1 wt. %; from 0.9
wt. % to about 10 wt. %; from 0.9 wt. % to about 9 wt. %; from 0.9 wt. % to about 8 wt.
%; from 0.9 wt. % to about 7 wt. %; from 0.9 wt. % to about 6 wt. %; from 0.9 wt. % to
about 5 wt. %; from 0.9 wt. % to about 4.5 wt. %; from 0.9 wt. % to about 4 wt. %; from
0.9 wt. % to about 3.5 wt. %; from 0.9 wt. % to about 3 wt. %; from 0.9 wt. % to about
2.5 wt. %; from 0.9 wt. % to about 2.25 wt. %; from 0.9 wt. % to about 2 wt. %; from
about 0.9 wt. % to about 4 wt. %; from about 0.9 wt. % to about 3 wt. %; from about 0.9
wt. % to about 2.5 wt. %; from about 0.9 wt. % to about 2.25 wt. %; from about 0.9 wt.
% to about 2 wt. %; from about 0.9 wt. % to about 1.5 wt. %; from about 0.9 wt. % to
about 1 wt. %; from 1 wt. % to about 10 wt. %; from 1 wt. % to about 9 wt. %; from 1 wt.
% to about 8 wt. %; from 1 wt. % to about 7 wt. %; from 1 wt. % to about 6 wt. %; from 1
wt. % to about 5 wt. %; from 1 wt. % to about 4.5 wt. %; from 1 wt. % to about 4 wt. %;
from 1 wt. % to about 3.5 wt. %; from 1 wt. % to about 3 wt. %; from 1 wt. % to about
2.5 wt. %; from 1 wt. % to about 2.25 wt. %; from 1 wt. % to about 2 wt. %; from about
1% to about 4 wt. %; from about 1 wt. % to about 3 wt. %; from about 1 wt. % to about
2.5 wt. %; from about 1 wt. % to about 2.25 wt. %; from about 1 wt. % to about 2 wt. %;
from about 1 wt. % to about 1.5 wt. %; from about 1.5 wt. % to about 10 wt. %; from
about 1.5 wt. % to about 9 wt. %; from about 1.5 wt. % to about 8 wt. %; from about 1.5
wt. % to about 7 wt. %; from about 1.5 wt. % to about 6 wt. %; from about 1.5 wt. % to
about 5 wt. %; from about 1.5 wt. % to about 4.5 wt. %; from about 1.5 wt. % to about 4
wt. %; from about 1.5 wt. % to about 3.5 wt. %; from about 1.5 wt. % to about 3 wt. %;
from about 1.5 wt. % to about 2.5 wt. %; from about 1.5 wt. % to about 2.25 wt. %; from
about 1.5 wt. % to about 2 wt. %; from about 3 wt. % to about 10 wt. %; or in any other
amount within any of the above ranges.
The topical compositions may also include one or more vascular repair agents as
described and defined above. The vascular repair agent may be present in the topical
compositions in an amount of from > 0.01 wt. % to about 15 wt. %; from > 0.01 wt. % to
about 10 wt. %; from 0.01 wt. % to about 9 wt. %; from 0.01 wt. % to about 8 wt. %;
from 0.01 wt. % to about 7 wt. %; from 0.01 wt. % to about 6 wt. %; from 0.01 wt. % to
about 5 wt. %; from 0.01 wt. % to about 4.5 wt. %; from 0.01 wt. % to about 4 wt. %;
from 0.01 wt. % to about 3.5 wt. %; from 0.01 wt. % to about 3 wt. %; from 0.01 wt. % to
about 2.5 wt. %; from 0.01 wt. % to about 2.25 wt. %; from 0.01 wt. % to about 2 wt. %;
from about 0.01% to about 4 wt. %; from about 0.01 wt. % to about 3 wt. %; from about
0.01 wt. % to about 2.5 wt. %; from about 0.01 wt. % to about 2.25 wt. %; from about
0.01 wt. % to about 2 wt. %; from about 0.01 wt. % to about 1.5 wt. %; from about 0.01
wt. % to about 1 wt. %; from about 0.01 wt. % to about 0.5 wt. %; from 0.1 wt. % to
about 10 wt. %; from 0.1 wt. % to about 9 wt. %; from 0.1 wt. % to about 8 wt. %; from
0.1 wt. % to about 7 wt. %; from 0.1 wt. % to about 6 wt. %; from 0.1 wt. % to about 5
wt. %; from 0.1 wt. % to about 4.5 wt. %; from 0.1 wt. % to about 4 wt. %; from 0.1 wt.
% to about 3.5 wt. %; from 0.1 wt. % to about 3 wt. %; from 0.1 wt. % to about 2.5 wt.
%; from 0.1 wt. % to about 2.25 wt. %; from 0.1 wt. % to about 2 wt. %; from about 0.1
wt. % to about 4 wt. %; from about 0.1 wt. % to about 3 wt. %; from about 0.1 wt. % to
about 2.5 wt. %; from about 0.1 wt. % to about 2.25 wt. %; from about 0.1 wt. % to
about 2 wt. %; from about 0.1 wt. % to about 1.5 wt. %; from about 0.1 wt. % to about 1
wt. %; from about 0.1 wt. % to about 0.5 wt. %; from 0.25 wt. % to about 15 wt. %; from
0.25 wt. % to about 10 wt. %; from 0.25 wt. % to about 9 wt. %; from 0.25 wt. % to
about 8 wt. %; from 0.25 wt. % to about 7 wt. %; from 0.25 wt. % to about 6 wt. %; from
0.25 wt. % to about 5 wt. %; from 0.25 wt. % to about 4.5 wt. %; from 0.25 wt. % to
about 4 wt. %; from 0.25 wt. % to about 3.5 wt. %; from 0.25 wt. % to about 3 wt. %;
from 0.25 wt. % to about 2.5 wt. %; from 0.25 wt. % to about 2.25 wt. %; from 0.25 wt.
% to about 2 wt. %; from 0.25 wt. % to about 1.75 wt. %; from 0.7 wt. % to about 10 wt.
%; from 0.7 wt. % to about 9 wt. %; from 0.7 wt. % to about 8 wt. %; from 0.7 wt. % to
about 7 wt. %; from 0.7 wt. % to about 6 wt. %; from 0.7 wt. % to about 5 wt. %; from
0.7 wt. % to about 4.5 wt. %; from 0.7 wt. % to about 4 wt. %; from 0.7 wt. % to about
3.5 wt. %; from 0.7 wt. % to about 3 wt. %; from 0.7 wt. % to about 2.5 wt. %; from 0.7
wt. % to about 2.25 wt. %; from 0.7 wt. % to about 2 wt. %; from about 0.7 wt. % to
about 4 wt. %; from about 0.7 wt. % to about 3 wt. %; from about 0.7 wt. % to about 2.5
wt. %; from about 0.7 wt. % to about 2.25 wt. %; from about 0.7 wt. % to about 2 wt. %;
from about 0.7 wt. % to about 1.5 wt. %; from about 0.7 wt. % to about 1 wt. %; from 0.9
wt. % to about 10 wt. %; from 0.9 wt. % to about 9 wt. %; from 0.9 wt. % to about 8 wt.
%; from 0.9 wt. % to about 7 wt. %; from 0.9 wt. % to about 6 wt. %; from 0.9 wt. % to
about 5 wt. %; from 0.9 wt. % to about 4.5 wt. %; from 0.9 wt. % to about 4 wt. %; from
0.9 wt. % to about 3.5 wt. %; from 0.9 wt. % to about 3 wt. %; from 0.9 wt. % to about
2.5 wt. %; from 0.9 wt. % to about 2.25 wt. %; from 0.9 wt. % to about 2 wt. %; from
about 0.9 wt. % to about 4 wt. %; from about 0.9 wt. % to about 3 wt. %; from about 0.9
wt. % to about 2.5 wt. %; from about 0.9 wt. % to about 2.25 wt. %; from about 0.9 wt.
% to about 2 wt. %; from about 0.9 wt. % to about 1.5 wt. %; from about 0.9 wt. % to
about 1 wt. %; from 1 wt. % to about 10 wt. %; from 1 wt. % to about 9 wt. %; from 1 wt.
% to about 8 wt. %; from 1 wt. % to about 7 wt. %; from 1 wt. % to about 6 wt. %; from 1
wt. % to about 5 wt. %; from 1 wt. % to about 4.5 wt. %; from 1 wt. % to about 4 wt. %;
from 1 wt. % to about 3.5 wt. %; from 1 wt. % to about 3 wt. %; from 1 wt. % to about
2.5 wt. %; from 1 wt. % to about 2.25 wt. %; from 1 wt. % to about 2 wt. %; from about
1% to about 4 wt. %; from about 1 wt. % to about 3 wt. %; from about 1 wt. % to about
2.5 wt. %; from about 1 wt. % to about 2.25 wt. %; from about 1 wt. % to about 2 wt. %;
from about 1 wt. % to about 1.5 wt. %; from about 1.5 wt. % to about 10 wt. %; from
about 1.5 wt. % to about 9 wt. %; from about 1.5 wt. % to about 8 wt. %; from about 1.5
wt. % to about 7 wt. %; from about 1.5 wt. % to about 6 wt. %; from about 1.5 wt. % to
about 5 wt. %; from about 1.5 wt. % to about 4.5 wt. %; from about 1.5 wt. % to about 4
wt. %; from about 1.5 wt. % to about 3.5 wt. %; from about 1.5 wt. % to about 3 wt. %;
from about 1.5 wt. % to about 2.5 wt. %;from about 1.5 wt. % to about 2.25 wt. %; from
about 1.5 wt. % to about 2 wt. %; from about 3 wt. % to about 10 wt. %; or in any other
amount within any of the above ranges.
The topical compositions may also include one or more neurogenic agents as
described and defined above. The neurogenic agent may be present in the topical
compositions in an amount of from > 0.01 wt. % to about 22.5 wt. %; from > 0.01 wt. %
to about 15 wt. %; from > 0.01 wt. % to about 10 wt. %; from 0.01 wt. % to about 9 wt.
%; from 0.01 wt. % to about 8 wt. %; from 0.01 wt. % to about 7 wt. %; from 0.01 wt. %
to about 6 wt. %; from 0.01 wt. % to about 5 wt. %; from 0.01 wt. % to about 4.5 wt. %;
from 0.01 wt. % to about 4 wt. %; from 0.01 wt. % to about 3.5 wt. %; from 0.01 wt. % to
about 3 wt. %; from 0.01 wt. % to about 2.5 wt. %; from 0.01 wt. % to about 2.25 wt. %;
from 0.01 wt. % to about 2 wt. %; from about 0.01% to about 4 wt. %; from about 0.01
wt. % to about 3 wt. %; from about 0.01 wt. % to about 2.5 wt. %; from about 0.01 wt. %
to about 2.25 wt. %; from about 0.01 wt. % to about 2 wt. %; from about 0.01 wt. % to
about 1.5 wt. %; from about 0.01 wt. % to about 1 wt. %; from about 0.01 wt. % to about
0.5 wt. %; from 0.1 wt. % to about 10 wt. %; from 0.1 wt. % to about 9 wt. %; from 0.1
wt. % to about 8 wt. %; from 0.1 wt. % to about 7 wt. %; from 0.1 wt. % to about 6 wt. %;
from 0.1 wt. % to about 5 wt. %; from 0.1 wt. % to about 4.5 wt. %; from 0.1 wt. % to
about 4 wt. %; from 0.1 wt. % to about 3.5 wt. %; from 0.1 wt. % to about 3 wt. %; from
0.1 wt. % to about 2.5 wt. %; from 0.1 wt. % to about 2.25 wt. %; from 0.1 wt. % to
about 2 wt. %; from about 0.1 wt. % to about 4 wt. %; from about 0.1 wt. % to about 3
wt. %; from about 0.1 wt. % to about 2.5 wt. %; from about 0.1 wt. % to about 2.25 wt.
%; from about 0.1 wt. % to about 2 wt. %; from about 0.1 wt. % to about 1.5 wt. %; from
about 0.1 wt. % to about 1 wt. %; from about 0.1 wt. % to about 0.5 wt. %; from 0.25 wt.
% to about 22.5 wt. %; from 0.25 wt. % to about 20 wt. %; from 0.25 wt. % to about 15
wt. %; from 0.25 wt. % to about 10 wt. %; from 0.25 wt. % to about 9 wt. %; from 0.25
wt. % to about 8 wt. %; from 0.25 wt. % to about 7 wt. %; from 0.25 wt. % to about 6 wt.
%; from 0.25 wt. % to about 5 wt. %; from 0.25 wt. % to about 4.5 wt. %; from 0.25 wt.
% to about 4 wt. %; from 0.25 wt. % to about 3.5 wt. %; from 0.25 wt. % to about 3 wt.
%; from 0.25 wt. % to about 2.5 wt. %; from 0.25 wt. % to about 2.25 wt. %; from 0.25
wt. % to about 2 wt. %; from 0.25 wt. % to about 1.75 wt. %; from 0.7 wt. % to about 10
wt. %; from 0.7 wt. % to about 9 wt. %; from 0.7 wt. % to about 8 wt. %; from 0.7 wt. %
to about 7 wt. %; from 0.7 wt. % to about 6 wt. %; from 0.7 wt. % to about 5 wt. %; from
0.7 wt. % to about 4.5 wt. %; from 0.7 wt. % to about 4 wt. %; from 0.7 wt. % to about
3.5 wt. %; from 0.7 wt. % to about 3 wt. %; from 0.7 wt. % to about 2.5 wt. %; from 0.7
wt. % to about 2.25 wt. %; from 0.7 wt. % to about 2 wt. %; from about 0.7 wt. % to
about 4 wt. %; from about 0.7 wt. % to about 3 wt. %; from about 0.7 wt. % to about 2.5
wt. %; from about 0.7 wt. % to about 2.25 wt. %; from about 0.7 wt. % to about 2 wt. %;
from about 0.7 wt. % to about 1.5 wt. %; from about 0.7 wt. % to about 1 wt. %; from 0.9
wt. % to about 10 wt. %; from 0.9 wt. % to about 9 wt. %; from 0.9 wt. % to about 8 wt.
%; from 0.9 wt. % to about 7 wt. %; from 0.9 wt. % to about 6 wt. %; from 0.9 wt. % to
about 5 wt. %; from 0.9 wt. % to about 4.5 wt. %; from 0.9 wt. % to about 4 wt. %; from
0.9 wt. % to about 3.5 wt. %; from 0.9 wt. % to about 3 wt. %; from 0.9 wt. % to about
2.5 wt. %; from 0.9 wt. % to about 2.25 wt. %; from 0.9 wt. % to about 2 wt. %; from
about 0.9 wt. % to about 4 wt. %; from about 0.9 wt. % to about 3 wt. %; from about 0.9
wt. % to about 2.5 wt. %; from about 0.9 wt. % to about 2.25 wt. %; from about 0.9 wt.
% to about 2 wt. %; from about 0.9 wt. % to about 1.5 wt. %; from about 0.9 wt. % to
about 1 wt. %; from 1 wt. % to about 10 wt. %; from 1 wt. % to about 9 wt. %; from 1 wt.
% to about 8 wt. %; from 1 wt. % to about 7 wt. %; from 1 wt. % to about 6 wt. %; from 1
wt. % to about 5 wt. %; from 1 wt. % to about 4.5 wt. %; from 1 wt. % to about 4 wt. %;
from 1 wt. % to about 3.5 wt. %; from 1 wt. % to about 3 wt. %; from 1 wt. % to about
2.5 wt. %; from 1 wt. % to about 2.25 wt. %; from 1 wt. % to about 2 wt. %; from about
1% to about 4 wt. %; from about 1 wt. % to about 3 wt. %; from about 1 wt. % to about
2.5 wt. %; from about 1 wt. % to about 2.25 wt. %; from about 1 wt. % to about 2 wt. %;
from about 1 wt. % to about 1.5 wt. %; from about 1.5 wt. % to about 10 wt. %; from
about 1.5 wt. % to about 9 wt. %; from about 1.5 wt. % to about 8 wt. %; from about 1.5
wt. % to about 7 wt. %; from about 1.5 wt. % to about 6 wt. %; from about 1.5 wt. % to
about 5 wt. %; from about 1.5 wt. % to about 4.5 wt. %; from about 1.5 wt. % to about 4
wt. %; from about 1.5 wt. % to about 3.5 wt. %; from about 1.5 wt. % to about 3 wt. %;
from about 1.5 wt. % to about 2.5 wt. %;from about 1.5 wt. % to about 2.25 wt. %; from
about 1.5 wt. % to about 2 wt. %; from about 3 wt. % to about 10 wt. %; or in any other
amount within any of the above ranges.
The topical compositions may also include one or more sebum suppression
agents as described and defined above. The sebum suppression agent may be present
in the topical compositions in an amount of from > 0.01 wt. % to about 25 wt. %; from >
0.01 wt. % to about 15 wt. %; from > 0.01 wt. % to about 10 wt. %; from 0.01 wt. % to
about 9 wt. %; from 0.01 wt. % to about 8 wt. %; from 0.01 wt. % to about 7 wt. %; from
0.01 wt. % to about 6 wt. %; from 0.01 wt. % to about 5 wt. %; from 0.01 wt. % to about
4.5 wt. %; from 0.01 wt. % to about 4 wt. %; from 0.01 wt. % to about 3.5 wt. %; from
0.01 wt. % to about 3 wt. %; from 0.01 wt. % to about 2.5 wt. %; from 0.01 wt. % to
about 2.25 wt. %; from 0.01 wt. % to about 2 wt. %; from about 0.01% to about 4 wt. %;
from about 0.01 wt. % to about 3 wt. %; from about 0.01 wt. % to about 2.5 wt. %; from
about 0.01 wt. % to about 2.25 wt. %; from about 0.01 wt. % to about 2 wt. %; from
about 0.01 wt. % to about 1.5 wt. %; from about 0.01 wt. % to about 1 wt. %; from about
0.01 wt. % to about 0.5 wt. %; from 0.1 wt. % to about 10 wt. %; from 0.1 wt. % to about
9 wt. %; from 0.1 wt. % to about 8 wt. %; from 0.1 wt. % to about 7 wt. %; from 0.1 wt.
% to about 6 wt. %; from 0.1 wt. % to about 5 wt. %; from 0.1 wt. % to about 4.5 wt. %;
from 0.1 wt. % to about 4 wt. %; from 0.1 wt. % to about 3.5 wt. %; from 0.1 wt. % to
about 3 wt. %; from 0.1 wt. % to about 2.5 wt. %; from 0.1 wt. % to about 2.25 wt. %;
from 0.1 wt. % to about 2 wt. %; from about 0.1 wt. % to about 4 wt. %; from about 0.1
wt. % to about 3 wt. %; from about 0.1 wt. % to about 2.5 wt. %; from about 0.1 wt. % to
about 2.25 wt. %; from about 0.1 wt. % to about 2 wt. %; from about 0.1 wt. % to about
1.5 wt. %; from about 0.1 wt. % to about 1 wt. %; from about 0.1 wt. % to about 0.5 wt.
%; from 0.25 wt. % to about 25 wt. %; from 0.25 wt. % to about 20 wt. %; from 0.25 wt.
% to about 15 wt. %; from 0.25 wt. % to about 10 wt. %; from 0.25 wt. % to about 9 wt.
%; from 0.25 wt. % to about 8 wt. %; from 0.25 wt. % to about 7 wt. %; from 0.25 wt. %
to about 6 wt. %; from 0.25 wt. % to about 5 wt. %; from 0.25 wt. % to about 4.5 wt. %;
from 0.25 wt. % to about 4 wt. %; from 0.25 wt. % to about 3.5 wt. %; from 0.25 wt. % to
about 3 wt. %; from 0.25 wt. % to about 2.5 wt. %; from 0.25 wt. % to about 2.25 wt. %;
from 0.25 wt. % to about 2 wt. %; from 0.25 wt. % to about 1.75 wt. %; from 0.7 wt. % to
about 10 wt. %; from 0.7 wt. % to about 9 wt. %; from 0.7 wt. % to about 8 wt. %; from
0.7 wt. % to about 7 wt. %; from 0.7 wt. % to about 6 wt. %; from 0.7 wt. % to about 5
wt. %; from 0.7 wt. % to about 4.5 wt. %; from 0.7 wt. % to about 4 wt. %; from 0.7 wt.
% to about 3.5 wt. %; from 0.7 wt. % to about 3 wt. %; from 0.7 wt. % to about 2.5 wt.
%; from 0.7 wt. % to about 2.25 wt. %; from 0.7 wt. % to about 2 wt. %; from about 0.7
wt. % to about 4 wt. %; from about 0.7 wt. % to about 3 wt. %; from about 0.7 wt. % to
about 2.5 wt. %; from about 0.7 wt. % to about 2.25 wt. %; from about 0.7 wt. % to
about 2 wt. %; from about 0.7 wt. % to about 1.5 wt. %; from about 0.7 wt. % to about 1
wt. %; from 0.9 wt. % to about 10 wt. %; from 0.9 wt. % to about 9 wt. %; from 0.9 wt. %
to about 8 wt. %; from 0.9 wt. % to about 7 wt. %; from 0.9 wt. % to about 6 wt. %; from
0.9 wt. % to about 5 wt. %; from 0.9 wt. % to about 4.5 wt. %; from 0.9 wt. % to about 4
wt. %; from 0.9 wt. % to about 3.5 wt. %; from 0.9 wt. % to about 3 wt. %; from 0.9 wt.
% to about 2.5 wt. %; from 0.9 wt. % to about 2.25 wt. %; from 0.9 wt. % to about 2 wt.
%; from about 0.9 wt. % to about 4 wt. %; from about 0.9 wt. % to about 3 wt. %; from
about 0.9 wt. % to about 2.5 wt. %; from about 0.9 wt. % to about 2.25 wt. %; from
about 0.9 wt. % to about 2 wt. %; from about 0.9 wt. % to about 1.5 wt. %; from about
0.9 wt. % to about 1 wt. %; from 1 wt. % to about 10 wt. %; from 1 wt. % to about 9 wt.
%; from 1 wt. % to about 8 wt. %; from 1 wt. % to about 7 wt. %; from 1 wt. % to about 6
wt. %; from 1 wt. % to about 5 wt. %; from 1 wt. % to about 4.5 wt. %; from 1 wt. % to
about 4 wt. %; from 1 wt. % to about 3.5 wt. %; from 1 wt. % to about 3 wt. %; from 1 wt.
% to about 2.5 wt. %; from 1 wt. % to about 2.25 wt. %; from 1 wt. % to about 2 wt. %;
from about 1% to about 4 wt. %; from about 1 wt. % to about 3 wt. %; from about 1 wt.
% to about 2.5 wt. %; from about 1 wt. % to about 2.25 wt. %; from about 1 wt. % to
about 2 wt. %; from about 1 wt. % to about 1.5 wt. %; from about 1.5 wt. % to about 10
wt. %; from about 1.5 wt. % to about 9 wt. %; from about 1.5 wt. % to about 8 wt. %;
from about 1.5 wt. % to about 7 wt. %; from about 1.5 wt. % to about 6 wt. %; from
about 1.5 wt. % to about 5 wt. %; from about 1.5 wt. % to about 4.5 wt. %; from about
1.5 wt. % to about 4 wt. %; from about 1.5 wt. % to about 3.5 wt. %; from about 1.5 wt.
% to about 3 wt. %; from about 1.5 wt. % to about 2.5 wt. %;from about 1.5 wt. % to
about 2.25 wt. %; from about 1.5 wt. % to about 2 wt. %; from about 3 wt. % to about 10
wt. %; or in any other amount within any of the above ranges.
The topical compositions may also include one or more exfoliating agents as
described and defined above. The exfoliating agent may be present in the topical
compositions in an amount of from > 0.01 wt. % to about 10 wt. %; from 0.01 wt. % to
about 9 wt. %; from 0.01 wt. % to about 8 wt. %; from 0.01 wt. % to about 7 wt. %; from
0.01 wt. % to about 6 wt. %; from 0.01 wt. % to about 5 wt. %; from 0.01 wt. % to about
4.5 wt. %; from 0.01 wt. % to about 4 wt. %; from 0.01 wt. % to about 3.5 wt. %; from
0.01 wt. % to about 3 wt. %; from 0.01 wt. % to about 2.5 wt. %; from 0.01 wt. % to
about 2.25 wt. %; from 0.01 wt. % to about 2 wt. %; from about 0.01% to about 4 wt. %;
from about 0.01 wt. % to about 3 wt. %; from about 0.01 wt. % to about 2.5 wt. %; from
about 0.01 wt. % to about 2.25 wt. %; from about 0.01 wt. % to about 2 wt. %; from
about 0.01 wt. % to about 1.5 wt. %; from about 0.01 wt. % to about 1 wt. %; from about
0.01 wt. % to about 0.5 wt. %; from 0.1 wt. % to about 10 wt. %; from 0.1 wt. % to about
9 wt. %; from 0.1 wt. % to about 8 wt. %; from 0.1 wt. % to about 7 wt. %; from 0.1 wt.
% to about 6 wt. %; from 0.1 wt. % to about 5 wt. %; from 0.1 wt. % to about 4.5 wt. %;
from 0.1 wt. % to about 4 wt. %; from 0.1 wt. % to about 3.5 wt. %; from 0.1 wt. % to
about 3 wt. %; from 0.1 wt. % to about 2.5 wt. %; from 0.1 wt. % to about 2.25 wt. %;
from 0.1 wt. % to about 2 wt. %; from about 0.1 wt. % to about 4 wt. %; from about 0.1
wt. % to about 3 wt. %; from about 0.1 wt. % to about 2.5 wt. %; from about 0.1 wt. % to
about 2.25 wt. %; from about 0.1 wt. % to about 2 wt. %; from about 0.1 wt. % to about
1.5 wt. %; from about 0.1 wt. % to about 1 wt. %; from about 0.1 wt. % to about 0.5 wt.
%; from 0.25 wt. % to about 10 wt. %; from 0.25 wt. % to about 9 wt. %; from 0.25 wt. %
to about 8 wt. %; from 0.25 wt. % to about 7 wt. %; from 0.25 wt. % to about 6 wt. %;
from 0.25 wt. % to about 5 wt. %; from 0.25 wt. % to about 4.5 wt. %; from 0.25 wt. % to
about 4 wt. %; from 0.25 wt. % to about 3.5 wt. %; from 0.25 wt. % to about 3 wt. %;
from 0.25 wt. % to about 2.5 wt. %; from 0.25 wt. % to about 2.25 wt. %; from 0.25 wt.
% to about 2 wt. %; from 0.25 wt. % to about 1.75 wt. %; from 0.7 wt. % to about 10 wt.
%; from 0.7 wt. % to about 9 wt. %; from 0.7 wt. % to about 8 wt. %; from 0.7 wt. % to
about 7 wt. %; from 0.7 wt. % to about 6 wt. %; from 0.7 wt. % to about 5 wt. %; from
0.7 wt. % to about 4.5 wt. %; from 0.7 wt. % to about 4 wt. %; from 0.7 wt. % to about
3.5 wt. %; from 0.7 wt. % to about 3 wt. %; from 0.7 wt. % to about 2.5 wt. %; from 0.7
wt. % to about 2.25 wt. %; from 0.7 wt. % to about 2 wt. %; from about 0.7 wt. % to
about 4 wt. %; from about 0.7 wt. % to about 3 wt. %; from about 0.7 wt. % to about 2.5
wt. %; from about 0.7 wt. % to about 2.25 wt. %; from about 0.7 wt. % to about 2 wt. %;
from about 0.7 wt. % to about 1.5 wt. %; from about 0.7 wt. % to about 1 wt. %; from 0.9
wt. % to about 10 wt. %; from 0.9 wt. % to about 9 wt. %; from 0.9 wt. % to about 8 wt.
%; from 0.9 wt. % to about 7 wt. %; from 0.9 wt. % to about 6 wt. %; from 0.9 wt. % to
about 5 wt. %; from 0.9 wt. % to about 4.5 wt. %; from 0.9 wt. % to about 4 wt. %; from
0.9 wt. % to about 3.5 wt. %; from 0.9 wt. % to about 3 wt. %; from 0.9 wt. % to about
2.5 wt. %; from 0.9 wt. % to about 2.25 wt. %; from 0.9 wt. % to about 2 wt. %; from
about 0.9 wt. % to about 4 wt. %; from about 0.9 wt. % to about 3 wt. %; from about 0.9
wt. % to about 2.5 wt. %; from about 0.9 wt. % to about 2.25 wt. %; from about 0.9 wt.
% to about 2 wt. %; from about 0.9 wt. % to about 1.5 wt. %; from about 0.9 wt. % to
about 1 wt. %; from 1 wt. % to about 10 wt. %; from 1 wt. % to about 9 wt. %; from 1 wt.
% to about 8 wt. %; from 1 wt. % to about 7 wt. %; from 1 wt. % to about 6 wt. %; from 1
wt. % to about 5 wt. %; from 1 wt. % to about 4.5 wt. %; from 1 wt. % to about 4 wt. %;
from 1 wt. % to about 3.5 wt. %; from 1 wt. % to about 3 wt. %; from 1 wt. % to about
2.5 wt. %; from 1 wt. % to about 2.25 wt. %; from 1 wt. % to about 2 wt. %; from about
1% to about 4 wt. %; from about 1 wt. % to about 3 wt. %; from about 1 wt. % to about
2.5 wt. %; from about 1 wt. % to about 2.25 wt. %; from about 1 wt. % to about 2 wt. %;
from about 1 wt. % to about 1.5 wt. %; from about 1.5 wt. % to about 10 wt. %; from
about 1.5 wt. % to about 9 wt. %; from about 1.5 wt. % to about 8 wt. %; from about 1.5
wt. % to about 7 wt. %; from about 1.5 wt. % to about 6 wt. %; from about 1.5 wt. % to
about 5 wt. %; from about 1.5 wt. % to about 4.5 wt. %; from about 1.5 wt. % to about 4
wt. %; from about 1.5 wt. % to about 3.5 wt. %; from about 1.5 wt. % to about 3 wt. %;
from about 1.5 wt. % to about 2.5 wt. %;from about 1.5 wt. % to about 2.25 wt. %; from
about 1.5 wt. % to about 2 wt. %; from about 3 wt. % to about 10 wt. %; or in any other
amount within any of the above ranges.
The topical compositions may also include one or more carrier/solvents as
described and defined above. The carrier/solvent may be present in the topical
compositions in an amount of from about 30 wt. % to about 90 wt. %; from about 40 wt.
% to about 80 wt. %; from about 40 wt. % to about 50 wt. %; 45 wt. % to about 47 wt.
%; from about 60 wt. % to about 80 wt. %; from about 65 wt. % to about 75 wt. %; from
about 67 wt. % to about 73 wt. %; about 46%, about 70% or about 72 wt. %; or in any
other amount within any of the above ranges.
The topical compositions may also include one or more chelating agents as
described and defined above. The chelating agent may be present in the present
compositions in an amount of from < 0.01 wt. % to about 5 wt. %; from 0.01 wt. % to
about 5 wt. %; from 0.01 wt. % to about 4.5 wt. %; from 0.01 wt. % to about 4 wt. %;
from 0.01 wt. % to about 3.5 wt. %; from 0.01 wt. % to about 3 wt. %; from 0.01 wt. % to
about 2.5 wt. %; from 0.01 wt. % to about 2.25 wt. %; from 0.01 wt. % to about 2 wt. %;
from about 0.01% to about 4 wt. %; from about 0.01 wt. % to about 3 wt. %; from about
0.01 wt. % to about 2.5 wt. %; from about 0.01 wt. % to about 2.25 wt. %; from about
0.01 wt. % to about 2 wt. %; from about 0.01 wt. % to about 1.5 wt. %; from about 0.01
wt. % to about 1 wt. %; from about 0.01 wt. % to about 0.5 wt. %; from 0.1 wt. % to
about 5 wt. %; from 0.1 wt. % to about 4.5 wt. %; from 0.1 wt. % to about 4 wt. %; from
0.1 wt. % to about 3.5 wt. %; from 0.1 wt. % to about 3 wt. %; from 0.1 wt. % to about
2.5 wt. %; from 0.1 wt. % to about 2.25 wt. %; from 0.1 wt. % to about 2 wt. %; from
about 0.1 wt. % to about 4 wt. %; from about 0.1 wt. % to about 3 wt. %; from about 0.1
wt. % to about 2.5 wt. %; from about 0.1 wt. % to about 2.25 wt. %; from about 0.1 wt.
% to about 2 wt. %; from about 0.1 wt. % to about 1.5 wt. %; from about 0.1 wt. % to
about 1 wt. %; from about 0.1 wt. % to about 0.5 wt. %; from 0.25 wt. % to about 5 wt.
%; from 0.25 wt. % to about 4.5 wt. %; from 0.25 wt. % to about 4 wt. %; from 0.25 wt.
% to about 3.5 wt. %; from 0.25 wt. % to about 3 wt. %; from 0.25 wt. % to about 2.5 wt.
%; from 0.25 wt. % to about 2.25 wt. %; from 0.25 wt. % to about 2 wt. %; from 0.25 wt.
% to about 1.75 wt. %; from 0.7 wt. % to about 5 wt. %; from 0.7 wt. % to about 4.5 wt.
%; from 0.7 wt. % to about 4 wt. %; from 0.7 wt. % to about 3.5 wt. %; from 0.7 wt. % to
about 3 wt. %; from 0.7 wt. % to about 2.5 wt. %; from 0.7 wt. % to about 2.25 wt. %;
from 0.7 wt. % to about 2 wt. %; from about 0.7 wt. % to about 4 wt. %; from about 0.7
wt. % to about 3 wt. %; from about 0.7 wt. % to about 2.5 wt. %; from about 0.7 wt. % to
about 2.25 wt. %; from about 0.7 wt. % to about 2 wt. %; from about 0.7 wt. % to about
1.5 wt. %; from about 0.7 wt. % to about 1 wt. %; from 0.9 wt. % to about 5 wt. %; from
0.9 wt. % to about 4.5 wt. %; from 0.9 wt. % to about 4 wt. %; from 0.9 wt. % to about
3.5 wt. %; from 0.9 wt. % to about 3 wt. %; from 0.9 wt. % to about 2.5 wt. %; from 0.9
wt. % to about 2.25 wt. %; from 0.9 wt. % to about 2 wt. %; from about 0.9 wt. % to
about 4 wt. %; from about 0.9 wt. % to about 3 wt. %; from about 0.9 wt. % to about 2.5
wt. %; from about 0.9 wt. % to about 2.25 wt. %; from about 0.9 wt. % to about 2 wt. %;
from about 0.9 wt. % to about 1.5 wt. %; from about 0.9 wt. % to about 1 wt. %; from 1
wt. % to about 5 wt. %; from 1 wt. % to about 4.5 wt. %; from 1 wt. % to about 4 wt. %;
from 1 wt. % to about 3.5 wt. %; from 1 wt. % to about 3 wt. %; from 1 wt. % to about
2.5 wt. %; from 1 wt. % to about 2.25 wt. %; from 1 wt. % to about 2 wt. %; from about
1% to about 4 wt. %; from about 1 wt. % to about 3 wt. %; from about 1 wt. % to about
2.5 wt. %; from about 1 wt. % to about 2.25 wt. %; from about 1 wt. % to about 2 wt. %;
from about 1 wt. % to about 1.5 wt. %; from about 1.5 wt. % to about 5 wt. %; from
about 1.5 wt. % to about 4.5 wt. %; from about 1.5 wt. % to about 4 wt. %; from about
1.5 wt. % to about 3.5 wt. %; from about 1.5 wt. % to about 3 wt. %; from about 1.5 wt.
% to about 2.5 wt. %;from about 1.5 wt. % to about 2.25 wt. %; from about 1.5 wt. % to
about 2 wt. %; from about 3 wt. % to about 5 wt. %; or in any other amount within any of
the above ranges.
The topical compositions may also include one or more humectants as described
and defined above. The humectant may be present in the topical compositions in an
amount of from < 0.01 wt. % to about 15 wt. %; from < 0.01 wt. % to about 10 wt. %;
from 0.01 wt. % to about 9 wt. %; from 0.01 wt. % to about 8 wt. %; from 0.01 wt. % to
about 7 wt. %; from 0.01 wt. % to about 6 wt. %; from 0.01 wt. % to about 5 wt. %; from
0.01 wt. % to about 4.5 wt. %; from 0.01 wt. % to about 4 wt. %; from 0.01 wt. % to
about 3.5 wt. %; from 0.01 wt. % to about 3 wt. %; from 0.01 wt. % to about 2.5 wt. %;
from 0.01 wt. % to about 2.25 wt. %; from 0.01 wt. % to about 2 wt. %; from about
0.01% to about 4 wt. %; from about 0.01 wt. % to about 3 wt. %; from about 0.01 wt. %
to about 2.5 wt. %; from about 0.01 wt. % to about 2.25 wt. %; from about 0.01 wt. % to
about 2 wt. %; from about 0.01 wt. % to about 1.5 wt. %; from about 0.01 wt. % to about
1 wt. %; from about 0.01 wt. % to about 0.5 wt. %; from 0.1 wt. % to about 10 wt. %;
from 0.1 wt. % to about 9 wt. %; from 0.1 wt. % to about 8 wt. %; from 0.1 wt. % to
about 7 wt. %; from 0.1 wt. % to about 6 wt. %; from 0.1 wt. % to about 5 wt. %; from
0.1 wt. % to about 4.5 wt. %; from 0.1 wt. % to about 4 wt. %; from 0.1 wt. % to about
3.5 wt. %; from 0.1 wt. % to about 3 wt. %; from 0.1 wt. % to about 2.5 wt. %; from 0.1
wt. % to about 2.25 wt. %; from 0.1 wt. % to about 2 wt. %; from about 0.1 wt. % to
about 4 wt. %; from about 0.1 wt. % to about 3 wt. %; from about 0.1 wt. % to about 2.5
wt. %; from about 0.1 wt. % to about 2.25 wt. %; from about 0.1 wt. % to about 2 wt. %;
from about 0.1 wt. % to about 1.5 wt. %; from about 0.1 wt. % to about 1 wt. %; from
about 0.1 wt. % to about 0.5 wt. %; from 0.25 wt. % to about 15 wt. %; from 0.25 wt. %
to about 10 wt. %; from 0.25 wt. % to about 9 wt. %; from 0.25 wt. % to about 8 wt. %;
from 0.25 wt. % to about 7 wt. %; from 0.25 wt. % to about 6 wt. %; from 0.25 wt. % to
about 5 wt. %; from 0.25 wt. % to about 4.5 wt. %; from 0.25 wt. % to about 4 wt. %;
from 0.25 wt. % to about 3.5 wt. %; from 0.25 wt. % to about 3 wt. %; from 0.25 wt. % to
about 2.5 wt. %; from 0.25 wt. % to about 2.25 wt. %; from 0.25 wt. % to about 2 wt. %;
from 0.25 wt. % to about 1.75 wt. %; from 0.7 wt. % to about 10 wt. %; from 0.7 wt. % to
about 9 wt. %; from 0.7 wt. % to about 8 wt. %; from 0.7 wt. % to about 7 wt. %; from
0.7 wt. % to about 6 wt. %; from 0.7 wt. % to about 5 wt. %; from 0.7 wt. % to about 4.5
wt. %; from 0.7 wt. % to about 4 wt. %; from 0.7 wt. % to about 3.5 wt. %; from 0.7 wt.
% to about 3 wt. %; from 0.7 wt. % to about 2.5 wt. %; from 0.7 wt. % to about 2.25 wt.
%; from 0.7 wt. % to about 2 wt. %; from about 0.7 wt. % to about 4 wt. %; from about
0.7 wt. % to about 3 wt. %; from about 0.7 wt. % to about 2.5 wt. %; from about 0.7 wt.
% to about 2.25 wt. %; from about 0.7 wt. % to about 2 wt. %; from about 0.7 wt. % to
about 1.5 wt. %; from about 0.7 wt. % to about 1 wt. %; from 0.9 wt. % to about 10 wt.
%; from 0.9 wt. % to about 9 wt. %; from 0.9 wt. % to about 8 wt. %; from 0.9 wt. % to
about 7 wt. %; from 0.9 wt. % to about 6 wt. %; from 0.9 wt. % to about 5 wt. %; from
0.9 wt. % to about 4.5 wt. %; from 0.9 wt. % to about 4 wt. %; from 0.9 wt. % to about
3.5 wt. %; from 0.9 wt. % to about 3 wt. %; from 0.9 wt. % to about 2.5 wt. %; from 0.9
wt. % to about 2.25 wt. %; from 0.9 wt. % to about 2 wt. %; from about 0.9 wt. % to
about 4 wt. %; from about 0.9 wt. % to about 3 wt. %; from about 0.9 wt. % to about 2.5
wt. %; from about 0.9 wt. % to about 2.25 wt. %; from about 0.9 wt. % to about 2 wt. %;
from about 0.9 wt. % to about 1.5 wt. %; from about 0.9 wt. % to about 1 wt. %; from 1
wt. % to about 10 wt. %; from 1 wt. % to about 9 wt. %; from 1 wt. % to about 8 wt. %;
from 1 wt. % to about 7 wt. %; from 1 wt. % to about 6 wt. %; from 1 wt. % to about 5 wt.
%; from 1 wt. % to about 4.5 wt. %; from 1 wt. % to about 4 wt. %; from 1 wt. % to about
3.5 wt. %; from 1 wt. % to about 3 wt. %; from 1 wt. % to about 2.5 wt. %; from 1 wt. %
to about 2.25 wt. %; from 1 wt. % to about 2 wt. %; from about 1% to about 4 wt. %;
from about 1 wt. % to about 3 wt. %; from about 1 wt. % to about 2.5 wt. %; from about
1 wt. % to about 2.25 wt. %; from about 1 wt. % to about 2 wt. %; from about 1 wt. % to
about 1.5 wt. %; from about 1.5 wt. % to about 10 wt. %; from about 1.5 wt. % to about
9 wt. %; from about 1.5 wt. % to about 8 wt. %; from about 1.5 wt. % to about 7 wt. %;
from about 1.5 wt. % to about 6 wt. %; from about 1.5 wt. % to about 5 wt. %; from
about 1.5 wt. % to about 4.5 wt. %; from about 1.5 wt. % to about 4 wt. %; from about
1.5 wt. % to about 3.5 wt. %; from about 1.5 wt. % to about 3 wt. %; from about 1.5 wt.
% to about 2.5 wt. %;from about 1.5 wt. % to about 2.25 wt. %; from about 1.5 wt. % to
about 2 wt. %; from about 3 wt. % to about 10 wt. %; or in any other amount within any
of the above ranges.
The topical compositions may also include one or more thickeners as described
and defined above. The thickener may be present in the topical compositions in an
amount of from < 0.01 wt. % to about 30 wt. %; from < 0.01 wt. % to about 20 wt. %;
from < 0.01 wt. % to about 10 wt. %; from 0.01 wt. % to about 9 wt. %; from 0.01 wt. %
to about 8 wt. %; from 0.01 wt. % to about 7 wt. %; from 0.01 wt. % to about 6 wt. %;
from 0.01 wt. % to about 5 wt. %; from 0.01 wt. % to about 4.5 wt. %; from 0.01 wt. % to
about 4 wt. %; from 0.01 wt. % to about 3.5 wt. %; from 0.01 wt. % to about 3 wt. %;
from 0.01 wt. % to about 2.5 wt. %; from 0.01 wt. % to about 2.25 wt. %; from 0.01 wt.
% to about 2 wt. %; from about 0.01% to about 4 wt. %; from about 0.01 wt. % to about
3 wt. %; from about 0.01 wt. % to about 2.5 wt. %; from about 0.01 wt. % to about 2.25
wt. %; from about 0.01 wt. % to about 2 wt. %; from about 0.01 wt. % to about 1.5 wt.
%; from about 0.01 wt. % to about 1 wt. %; from about 0.01 wt. % to about 0.5 wt. %;
from 0.1 wt. % to about 10 wt. %; from 0.1 wt. % to about 9 wt. %; from 0.1 wt. % to
about 8 wt. %; from 0.1 wt. % to about 7 wt. %; from 0.1 wt. % to about 6 wt. %; from
0.1 wt. % to about 5 wt. %; from 0.1 wt. % to about 4.5 wt. %; from 0.1 wt. % to about 4
wt. %; from 0.1 wt. % to about 3.5 wt. %; from 0.1 wt. % to about 3 wt. %; from 0.1 wt.
% to about 2.5 wt. %; from 0.1 wt. % to about 2.25 wt. %; from 0.1 wt. % to about 2 wt.
%; from about 0.1 wt. % to about 4 wt. %; from about 0.1 wt. % to about 3 wt. %; from
about 0.1 wt. % to about 2.5 wt. %; from about 0.1 wt. % to about 2.25 wt. %; from
about 0.1 wt. % to about 2 wt. %; from about 0.1 wt. % to about 1.5 wt. %; from about
0.1 wt. % to about 1 wt. %; from about 0.1 wt. % to about 0.5 wt. %; from 0.25 wt. % to
about 30 wt. %; from 0.25 wt. % to about 25 wt. %; from 0.25 wt. % to about 20 wt. %;
from 0.25 wt. % to about 15 wt. %; from 0.25 wt. % to about 10 wt. %; from 0.25 wt. %
to about 9 wt. %; from 0.25 wt. % to about 8 wt. %; from 0.25 wt. % to about 7 wt. %;
from 0.25 wt. % to about 6 wt. %; from 0.25 wt. % to about 5 wt. %; from 0.25 wt. % to
about 4.5 wt. %; from 0.25 wt. % to about 4 wt. %; from 0.25 wt. % to about 3.5 wt. %;
from 0.25 wt. % to about 3 wt. %; from 0.25 wt. % to about 2.5 wt. %; from 0.25 wt. % to
about 2.25 wt. %; from 0.25 wt. % to about 2 wt. %; from 0.25 wt. % to about 1.75 wt.
%; from 0.7 wt. % to about 10 wt. %; from 0.7 wt. % to about 9 wt. %; from 0.7 wt. % to
about 8 wt. %; from 0.7 wt. % to about 7 wt. %; from 0.7 wt. % to about 6 wt. %; from
0.7 wt. % to about 5 wt. %; from 0.7 wt. % to about 4.5 wt. %; from 0.7 wt. % to about 4
wt. %; from 0.7 wt. % to about 3.5 wt. %; from 0.7 wt. % to about 3 wt. %; from 0.7 wt.
% to about 2.5 wt. %; from 0.7 wt. % to about 2.25 wt. %; from 0.7 wt. % to about 2 wt.
%; from about 0.7 wt. % to about 4 wt. %; from about 0.7 wt. % to about 3 wt. %; from
about 0.7 wt. % to about 2.5 wt. %; from about 0.7 wt. % to about 2.25 wt. %; from
about 0.7 wt. % to about 2 wt. %; from about 0.7 wt. % to about 1.5 wt. %; from about
0.7 wt. % to about 1 wt. %; from 0.9 wt. % to about 10 wt. %; from 0.9 wt. % to about 9
wt. %; from 0.9 wt. % to about 8 wt. %; from 0.9 wt. % to about 7 wt. %; from 0.9 wt. %
to about 6 wt. %; from 0.9 wt. % to about 5 wt. %; from 0.9 wt. % to about 4.5 wt. %;
from 0.9 wt. % to about 4 wt. %; from 0.9 wt. % to about 3.5 wt. %; from 0.9 wt. % to
about 3 wt. %; from 0.9 wt. % to about 2.5 wt. %; from 0.9 wt. % to about 2.25 wt. %;
from 0.9 wt. % to about 2 wt. %; from about 0.9 wt. % to about 4 wt. %; from about 0.9
wt. % to about 3 wt. %; from about 0.9 wt. % to about 2.5 wt. %; from about 0.9 wt. % to
about 2.25 wt. %; from about 0.9 wt. % to about 2 wt. %; from about 0.9 wt. % to about
1.5 wt. %; from about 0.9 wt. % to about 1 wt. %; from 1 wt. % to about 10 wt. %; from 1
wt. % to about 9 wt. %; from 1 wt. % to about 8 wt. %; from 1 wt. % to about 7 wt. %;
from 1 wt. % to about 6 wt. %; from 1 wt. % to about 5 wt. %; from 1 wt. % to about 4.5
wt. %; from 1 wt. % to about 4 wt. %; from 1 wt. % to about 3.5 wt. %; from 1 wt. % to
about 3 wt. %; from 1 wt. % to about 2.5 wt. %; from 1 wt. % to about 2.25 wt. %; from 1
wt. % to about 2 wt. %; from about 1% to about 4 wt. %; from about 1 wt. % to about 3
wt. %; from about 1 wt. % to about 2.5 wt. %; from about 1 wt. % to about 2.25 wt. %;
from about 1 wt. % to about 2 wt. %; from about 1 wt. % to about 1.5 wt. %; from about
1.5 wt. % to about 10 wt. %; from about 1.5 wt. % to about 9 wt. %; from about 1.5 wt.
% to about 8 wt. %; from about 1.5 wt. % to about 7 wt. %; from about 1.5 wt. % to
about 6 wt. %; from about 1.5 wt. % to about 5 wt. %; from about 1.5 wt. % to about 4.5
wt. %; from about 1.5 wt. % to about 4 wt. %; from about 1.5 wt. % to about 3.5 wt. %;
from about 1.5 wt. % to about 3 wt. %; from about 1.5 wt. % to about 2.5 wt. %;from
about 1.5 wt. % to about 2.25 wt. %; from about 1.5 wt. % to about 2 wt. %; from about
3 wt. % to about 10 wt. %; or in any other amount within any of the above ranges.
The topical compositions may also include one or more emollients as described
and defined above. The emollient may be present in the topical compositions in an
amount of from < 0.01 wt. % to about 30 wt. %; from < 0.01 wt. % to about 20 wt. %;
from < 0.01 wt. % to about 10 wt. %; from 0.01 wt. % to about 9 wt. %; from 0.01 wt. %
to about 8 wt. %; from 0.01 wt. % to about 7 wt. %; from 0.01 wt. % to about 6 wt. %;
from 0.01 wt. % to about 5 wt. %; from 0.01 wt. % to about 4.5 wt. %; from 0.01 wt. % to
about 4 wt. %; from 0.01 wt. % to about 3.5 wt. %; from 0.01 wt. % to about 3 wt. %;
from 0.01 wt. % to about 2.5 wt. %; from 0.01 wt. % to about 2.25 wt. %; from 0.01 wt.
% to about 2 wt. %; from about 0.01% to about 4 wt. %; from about 0.01 wt. % to about
3 wt. %; from about 0.01 wt. % to about 2.5 wt. %; from about 0.01 wt. % to about 2.25
wt. %; from about 0.01 wt. % to about 2 wt. %; from about 0.01 wt. % to about 1.5 wt.
%; from about 0.01 wt. % to about 1 wt. %; from about 0.01 wt. % to about 0.5 wt. %;
from 0.1 wt. % to about 10 wt. %; from 0.1 wt. % to about 9 wt. %; from 0.1 wt. % to
about 8 wt. %; from 0.1 wt. % to about 7 wt. %; from 0.1 wt. % to about 6 wt. %; from
0.1 wt. % to about 5 wt. %; from 0.1 wt. % to about 4.5 wt. %; from 0.1 wt. % to about 4
wt. %; from 0.1 wt. % to about 3.5 wt. %; from 0.1 wt. % to about 3 wt. %; from 0.1 wt.
% to about 2.5 wt. %; from 0.1 wt. % to about 2.25 wt. %; from 0.1 wt. % to about 2 wt.
%; from about 0.1 wt. % to about 4 wt. %; from about 0.1 wt. % to about 3 wt. %; from
about 0.1 wt. % to about 2.5 wt. %; from about 0.1 wt. % to about 2.25 wt. %; from
about 0.1 wt. % to about 2 wt. %; from about 0.1 wt. % to about 1.5 wt. %; from about
0.1 wt. % to about 1 wt. %; from about 0.1 wt. % to about 0.5 wt. %; from 0.25 wt. % to
about 30 wt. %; from 0.25 wt. % to about 25 wt. %; from 0.25 wt. % to about 20 wt. %;
from 0.25 wt. % to about 15 wt. %; from 0.25 wt. % to about 10 wt. %; from 0.25 wt. %
to about 9 wt. %; from 0.25 wt. % to about 8 wt. %; from 0.25 wt. % to about 7 wt. %;
from 0.25 wt. % to about 6 wt. %; from 0.25 wt. % to about 5 wt. %; from 0.25 wt. % to
about 4.5 wt. %; from 0.25 wt. % to about 4 wt. %; from 0.25 wt. % to about 3.5 wt. %;
from 0.25 wt. % to about 3 wt. %; from 0.25 wt. % to about 2.5 wt. %; from 0.25 wt. % to
about 2.25 wt. %; from 0.25 wt. % to about 2 wt. %; from 0.25 wt. % to about 1.75 wt.
%; from 0.7 wt. % to about 10 wt. %; from 0.7 wt. % to about 9 wt. %; from 0.7 wt. % to
about 8 wt. %; from 0.7 wt. % to about 7 wt. %; from 0.7 wt. % to about 6 wt. %; from
0.7 wt. % to about 5 wt. %; from 0.7 wt. % to about 4.5 wt. %; from 0.7 wt. % to about 4
wt. %; from 0.7 wt. % to about 3.5 wt. %; from 0.7 wt. % to about 3 wt. %; from 0.7 wt.
% to about 2.5 wt. %; from 0.7 wt. % to about 2.25 wt. %; from 0.7 wt. % to about 2 wt.
%; from about 0.7 wt. % to about 4 wt. %; from about 0.7 wt. % to about 3 wt. %; from
about 0.7 wt. % to about 2.5 wt. %; from about 0.7 wt. % to about 2.25 wt. %; from
about 0.7 wt. % to about 2 wt. %; from about 0.7 wt. % to about 1.5 wt. %; from about
0.7 wt. % to about 1 wt. %; from 0.9 wt. % to about 10 wt. %; from 0.9 wt. % to about 9
wt. %; from 0.9 wt. % to about 8 wt. %; from 0.9 wt. % to about 7 wt. %; from 0.9 wt. %
to about 6 wt. %; from 0.9 wt. % to about 5 wt. %; from 0.9 wt. % to about 4.5 wt. %;
from 0.9 wt. % to about 4 wt. %; from 0.9 wt. % to about 3.5 wt. %; from 0.9 wt. % to
about 3 wt. %; from 0.9 wt. % to about 2.5 wt. %; from 0.9 wt. % to about 2.25 wt. %;
from 0.9 wt. % to about 2 wt. %; from about 0.9 wt. % to about 4 wt. %; from about 0.9
wt. % to about 3 wt. %; from about 0.9 wt. % to about 2.5 wt. %; from about 0.9 wt. % to
about 2.25 wt. %; from about 0.9 wt. % to about 2 wt. %; from about 0.9 wt. % to about
1.5 wt. %; from about 0.9 wt. % to about 1 wt. %; from 1 wt. % to about 10 wt. %; from 1
wt. % to about 9 wt. %; from 1 wt. % to about 8 wt. %; from 1 wt. % to about 7 wt. %;
from 1 wt. % to about 6 wt. %; from 1 wt. % to about 5 wt. %; from 1 wt. % to about 4.5
wt. %; from 1 wt. % to about 4 wt. %; from 1 wt. % to about 3.5 wt. %; from 1 wt. % to
about 3 wt. %; from 1 wt. % to about 2.5 wt. %; from 1 wt. % to about 2.25 wt. %; from 1
wt. % to about 2 wt. %; from about 1% to about 4 wt. %; from about 1 wt. % to about 3
wt. %; from about 1 wt. % to about 2.5 wt. %; from about 1 wt. % to about 2.25 wt. %;
from about 1 wt. % to about 2 wt. %; from about 1 wt. % to about 1.5 wt. %; from about
1.5 wt. % to about 10 wt. %; from about 1.5 wt. % to about 9 wt. %; from about 1.5 wt.
% to about 8 wt. %; from about 1.5 wt. % to about 7 wt. %; from about 1.5 wt. % to
about 6 wt. %; from about 1.5 wt. % to about 5 wt. %; from about 1.5 wt. % to about 4.5
wt. %; from about 1.5 wt. % to about 4 wt. %; from about 1.5 wt. % to about 3.5 wt. %;
from about 1.5 wt. % to about 3 wt. %; from about 1.5 wt. % to about 2.5 wt. %;from
about 1.5 wt. % to about 2.25 wt. %; from about 1.5 wt. % to about 2 wt. %; from about
3 wt. % to about 10 wt. %; or in any other amount within any of the above ranges.
The topical compositions may also include one or more emulsifiers as described
and defined above. The emulsifier may be present in the topical compositions in an
amount of from < 0.01 wt. % to about 40 wt. %; from < 0.01 wt. % to about 20 wt. %;
from < 0.01 wt. % to about 10 wt. %; from 0.01 wt. % to about 9 wt. %; from 0.01 wt. %
to about 8 wt. %; from 0.01 wt. % to about 7 wt. %; from 0.01 wt. % to about 6 wt. %;
from 0.01 wt. % to about 5 wt. %; from 0.01 wt. % to about 4.5 wt. %; from 0.01 wt. % to
about 4 wt. %; from 0.01 wt. % to about 3.5 wt. %; from 0.01 wt. % to about 3 wt. %;
from 0.01 wt. % to about 2.5 wt. %; from 0.01 wt. % to about 2.25 wt. %; from 0.01 wt.
% to about 2 wt. %; from about 0.01% to about 4 wt. %; from about 0.01 wt. % to about
3 wt. %; from about 0.01 wt. % to about 2.5 wt. %; from about 0.01 wt. % to about 2.25
wt. %; from about 0.01 wt. % to about 2 wt. %; from about 0.01 wt. % to about 1.5 wt.
%; from about 0.01 wt. % to about 1 wt. %; from about 0.01 wt. % to about 0.5 wt. %;
from 0.1 wt. % to about 10 wt. %; from 0.1 wt. % to about 9 wt. %; from 0.1 wt. % to
about 8 wt. %; from 0.1 wt. % to about 7 wt. %; from 0.1 wt. % to about 6 wt. %; from
0.1 wt. % to about 5 wt. %; from 0.1 wt. % to about 4.5 wt. %; from 0.1 wt. % to about 4
wt. %; from 0.1 wt. % to about 3.5 wt. %; from 0.1 wt. % to about 3 wt. %; from 0.1 wt.
% to about 2.5 wt. %; from 0.1 wt. % to about 2.25 wt. %; from 0.1 wt. % to about 2 wt.
%; from about 0.1 wt. % to about 4 wt. %; from about 0.1 wt. % to about 3 wt. %; from
about 0.1 wt. % to about 2.5 wt. %; from about 0.1 wt. % to about 2.25 wt. %; from
about 0.1 wt. % to about 2 wt. %; from about 0.1 wt. % to about 1.5 wt. %; from about
0.1 wt. % to about 1 wt. %; from about 0.1 wt. % to about 0.5 wt. %; from 0.25 wt. % to
about 40 wt. %; from 0.25 wt. % to about 30 wt. %; from 0.25 wt. % to about 25 wt. %;
from 0.25 wt. % to about 20 wt. %; from 0.25 wt. % to about 15 wt. %; from 0.25 wt. %
to about 10 wt. %; from 0.25 wt. % to about 9 wt. %; from 0.25 wt. % to about 8 wt. %;
from 0.25 wt. % to about 7 wt. %; from 0.25 wt. % to about 6 wt. %; from 0.25 wt. % to
about 5 wt. %; from 0.25 wt. % to about 4.5 wt. %; from 0.25 wt. % to about 4 wt. %;
from 0.25 wt. % to about 3.5 wt. %; from 0.25 wt. % to about 3 wt. %; from 0.25 wt. % to
about 2.5 wt. %; from 0.25 wt. % to about 2.25 wt. %; from 0.25 wt. % to about 2 wt. %;
from 0.25 wt. % to about 1.75 wt. %; from 0.7 wt. % to about 10 wt. %; from 0.7 wt. % to
about 9 wt. %; from 0.7 wt. % to about 8 wt. %; from 0.7 wt. % to about 7 wt. %; from
0.7 wt. % to about 6 wt. %; from 0.7 wt. % to about 5 wt. %; from 0.7 wt. % to about 4.5
wt. %; from 0.7 wt. % to about 4 wt. %; from 0.7 wt. % to about 3.5 wt. %; from 0.7 wt.
% to about 3 wt. %; from 0.7 wt. % to about 2.5 wt. %; from 0.7 wt. % to about 2.25 wt.
%; from 0.7 wt. % to about 2 wt. %; from about 0.7 wt. % to about 4 wt. %; from about
0.7 wt. % to about 3 wt. %; from about 0.7 wt. % to about 2.5 wt. %; from about 0.7 wt.
% to about 2.25 wt. %; from about 0.7 wt. % to about 2 wt. %; from about 0.7 wt. % to
about 1.5 wt. %; from about 0.7 wt. % to about 1 wt. %; from 0.9 wt. % to about 10 wt.
%; from 0.9 wt. % to about 9 wt. %; from 0.9 wt. % to about 8 wt. %; from 0.9 wt. % to
about 7 wt. %; from 0.9 wt. % to about 6 wt. %; from 0.9 wt. % to about 5 wt. %; from
0.9 wt. % to about 4.5 wt. %; from 0.9 wt. % to about 4 wt. %; from 0.9 wt. % to about
3.5 wt. %; from 0.9 wt. % to about 3 wt. %; from 0.9 wt. % to about 2.5 wt. %; from 0.9
wt. % to about 2.25 wt. %; from 0.9 wt. % to about 2 wt. %; from about 0.9 wt. % to
about 4 wt. %; from about 0.9 wt. % to about 3 wt. %; from about 0.9 wt. % to about 2.5
wt. %; from about 0.9 wt. % to about 2.25 wt. %; from about 0.9 wt. % to about 2 wt. %;
from about 0.9 wt. % to about 1.5 wt. %; from about 0.9 wt. % to about 1 wt. %; from 1
wt. % to about 10 wt. %; from 1 wt. % to about 9 wt. %; from 1 wt. % to about 8 wt. %;
from 1 wt. % to about 7 wt. %; from 1 wt. % to about 6 wt. %; from 1 wt. % to about 5 wt.
%; from 1 wt. % to about 4.5 wt. %; from 1 wt. % to about 4 wt. %; from 1 wt. % to about
3.5 wt. %; from 1 wt. % to about 3 wt. %; from 1 wt. % to about 2.5 wt. %; from 1 wt. %
to about 2.25 wt. %; from 1 wt. % to about 2 wt. %; from about 1% to about 4 wt. %;
from about 1 wt. % to about 3 wt. %; from about 1 wt. % to about 2.5 wt. %; from about
1 wt. % to about 2.25 wt. %; from about 1 wt. % to about 2 wt. %; from about 1 wt. % to
about 1.5 wt. %; from about 1.5 wt. % to about 10 wt. %; from about 1.5 wt. % to about
9 wt. %; from about 1.5 wt. % to about 8 wt. %; from about 1.5 wt. % to about 7 wt. %;
from about 1.5 wt. % to about 6 wt. %; from about 1.5 wt. % to about 5 wt. %; from
about 1.5 wt. % to about 4.5 wt. %; from about 1.5 wt. % to about 4 wt. %; from about
1.5 wt. % to about 3.5 wt. %; from about 1.5 wt. % to about 3 wt. %; from about 1.5 wt.
% to about 2.5 wt. %;from about 1.5 wt. % to about 2.25 wt. %; from about 1.5 wt. % to
about 2 wt. %; from about 3 wt. % to about 10 wt. %; or in any other amount within any
of the above ranges.
The topical compositions may also include one or more skin conditioning agents
as described and defined above. The skin conditioning agent may be present in the
topical compositions in an amount of from < 0.01 wt. % to about 60 wt. %; from < 0.01
wt. % to about 20 wt. %; from < 0.01 wt. % to about 10 wt. %; from 0.01 wt. % to about
9 wt. %; from 0.01 wt. % to about 8 wt. %; from 0.01 wt. % to about 7 wt. %; from 0.01
wt. % to about 6 wt. %; from 0.01 wt. % to about 5 wt. %; from 0.01 wt. % to about 4.5
wt. %; from 0.01 wt. % to about 4 wt. %; from 0.01 wt. % to about 3.5 wt. %; from 0.01
wt. % to about 3 wt. %; from 0.01 wt. % to about 2.5 wt. %; from 0.01 wt. % to about
2.25 wt. %; from 0.01 wt. % to about 2 wt. %; from about 0.01% to about 4 wt. %; from
about 0.01 wt. % to about 3 wt. %; from about 0.01 wt. % to about 2.5 wt. %; from about
0.01 wt. % to about 2.25 wt. %; from about 0.01 wt. % to about 2 wt. %; from about 0.01
wt. % to about 1.5 wt. %; from about 0.01 wt. % to about 1 wt. %; from about 0.01 wt. %
to about 0.5 wt. %; from 0.1 wt. % to about 10 wt. %; from 0.1 wt. % to about 9 wt. %;
from 0.1 wt. % to about 8 wt. %; from 0.1 wt. % to about 7 wt. %; from 0.1 wt. % to
about 6 wt. %; from 0.1 wt. % to about 5 wt. %; from 0.1 wt. % to about 4.5 wt. %; from
0.1 wt. % to about 4 wt. %; from 0.1 wt. % to about 3.5 wt. %; from 0.1 wt. % to about 3
wt. %; from 0.1 wt. % to about 2.5 wt. %; from 0.1 wt. % to about 2.25 wt. %; from 0.1
wt. % to about 2 wt. %; from about 0.1 wt. % to about 4 wt. %; from about 0.1 wt. % to
about 3 wt. %; from about 0.1 wt. % to about 2.5 wt. %; from about 0.1 wt. % to about
2.25 wt. %; from about 0.1 wt. % to about 2 wt. %; from about 0.1 wt. % to about 1.5 wt.
%; from about 0.1 wt. % to about 1 wt. %; from about 0.1 wt. % to about 0.5 wt. %; from
0.25 wt. % to about 50 wt. %; from 0.25 wt. % to about 30 wt. %; from 0.25 wt. % to
about 25 wt. %; from 0.25 wt. % to about 20 wt. %; from 0.25 wt. % to about 15 wt. %;
from 0.25 wt. % to about 10 wt. %; from 0.25 wt. % to about 9 wt. %; from 0.25 wt. % to
about 8 wt. %; from 0.25 wt. % to about 7 wt. %; from 0.25 wt. % to about 6 wt. %; from
0.25 wt. % to about 5 wt. %; from 0.25 wt. % to about 4.5 wt. %; from 0.25 wt. % to
about 4 wt. %; from 0.25 wt. % to about 3.5 wt. %; from 0.25 wt. % to about 3 wt. %;
from 0.25 wt. % to about 2.5 wt. %; from 0.25 wt. % to about 2.25 wt. %; from 0.25 wt.
% to about 2 wt. %; from 0.25 wt. % to about 1.75 wt. %; from 0.7 wt. % to about 10 wt.
%; from 0.7 wt. % to about 9 wt. %; from 0.7 wt. % to about 8 wt. %; from 0.7 wt. % to
about 7 wt. %; from 0.7 wt. % to about 6 wt. %; from 0.7 wt. % to about 5 wt. %; from
0.7 wt. % to about 4.5 wt. %; from 0.7 wt. % to about 4 wt. %; from 0.7 wt. % to about
3.5 wt. %; from 0.7 wt. % to about 3 wt. %; from 0.7 wt. % to about 2.5 wt. %; from 0.7
wt. % to about 2.25 wt. %; from 0.7 wt. % to about 2 wt. %; from about 0.7 wt. % to
about 4 wt. %; from about 0.7 wt. % to about 3 wt. %; from about 0.7 wt. % to about 2.5
wt. %; from about 0.7 wt. % to about 2.25 wt. %; from about 0.7 wt. % to about 2 wt. %;
from about 0.7 wt. % to about 1.5 wt. %; from about 0.7 wt. % to about 1 wt. %; from 0.9
wt. % to about 10 wt. %; from 0.9 wt. % to about 9 wt. %; from 0.9 wt. % to about 8 wt.
%; from 0.9 wt. % to about 7 wt. %; from 0.9 wt. % to about 6 wt. %; from 0.9 wt. % to
about 5 wt. %; from 0.9 wt. % to about 4.5 wt. %; from 0.9 wt. % to about 4 wt. %; from
0.9 wt. % to about 3.5 wt. %; from 0.9 wt. % to about 3 wt. %; from 0.9 wt. % to about
2.5 wt. %; from 0.9 wt. % to about 2.25 wt. %; from 0.9 wt. % to about 2 wt. %; from
about 0.9 wt. % to about 4 wt. %; from about 0.9 wt. % to about 3 wt. %; from about 0.9
wt. % to about 2.5 wt. %; from about 0.9 wt. % to about 2.25 wt. %; from about 0.9 wt.
% to about 2 wt. %; from about 0.9 wt. % to about 1.5 wt. %; from about 0.9 wt. % to
about 1 wt. %; from 1 wt. % to about 10 wt. %; from 1 wt. % to about 9 wt. %; from 1 wt.
% to about 8 wt. %; from 1 wt. % to about 7 wt. %; from 1 wt. % to about 6 wt. %; from 1
wt. % to about 5 wt. %; from 1 wt. % to about 4.5 wt. %; from 1 wt. % to about 4 wt. %;
from 1 wt. % to about 3.5 wt. %; from 1 wt. % to about 3 wt. %; from 1 wt. % to about
2.5 wt. %; from 1 wt. % to about 2.25 wt. %; from 1 wt. % to about 2 wt. %; from about
1% to about 4 wt. %; from about 1 wt. % to about 3 wt. %; from about 1 wt. % to about
2.5 wt. %; from about 1 wt. % to about 2.25 wt. %; from about 1 wt. % to about 2 wt. %;
from about 1 wt. % to about 1.5 wt. %; from about 1.5 wt. % to about 10 wt. %; from
about 1.5 wt. % to about 9 wt. %; from about 1.5 wt. % to about 8 wt. %; from about 1.5
wt. % to about 7 wt. %; from about 1.5 wt. % to about 6 wt. %; from about 1.5 wt. % to
about 5 wt. %; from about 1.5 wt. % to about 4.5 wt. %; from about 1.5 wt. % to about 4
wt. %; from about 1.5 wt. % to about 3.5 wt. %; from about 1.5 wt. % to about 3 wt. %;
from about 1.5 wt. % to about 2.5 wt. %;from about 1.5 wt. % to about 2.25 wt. %; from
about 1.5 wt. % to about 2 wt. %; from about 3 wt. % to about 10 wt. %; or in any other
amount within any of the above ranges.
The topical composition may also include one or more antioxidant as described
and defined above. The antioxidant may be present in the topical compositions in an
amount of from < 0.01 wt. % to about 30 wt. %; from < 0.01 wt. % to about 20 wt. %;
from < 0.01 wt. % to about 10 wt. %; from 0.01 wt. % to about 9 wt. %; from 0.01 wt. %
to about 8 wt. %; from 0.01 wt. % to about 7 wt. %; from 0.01 wt. % to about 6 wt. %;
from 0.01 wt. % to about 5 wt. %; from 0.01 wt. % to about 4.5 wt. %; from 0.01 wt. % to
about 4 wt. %; from 0.01 wt. % to about 3.5 wt. %; from 0.01 wt. % to about 3 wt. %;
from 0.01 wt. % to about 2.5 wt. %; from 0.01 wt. % to about 2.25 wt. %; from 0.01 wt.
% to about 2 wt. %; from about 0.01% to about 4 wt. %; from about 0.01 wt. % to about
3 wt. %; from about 0.01 wt. % to about 2.5 wt. %; from about 0.01 wt. % to about 2.25
wt. %; from about 0.01 wt. % to about 2 wt. %; from about 0.01 wt. % to about 1.5 wt.
%; from about 0.01 wt. % to about 1 wt. %; from about 0.01 wt. % to about 0.5 wt. %;
from 0.1 wt. % to about 10 wt. %; from 0.1 wt. % to about 9 wt. %; from 0.1 wt. % to
about 8 wt. %; from 0.1 wt. % to about 7 wt. %; from 0.1 wt. % to about 6 wt. %; from
0.1 wt. % to about 5 wt. %; from 0.1 wt. % to about 4.5 wt. %; from 0.1 wt. % to about 4
wt. %; from 0.1 wt. % to about 3.5 wt. %; from 0.1 wt. % to about 3 wt. %; from 0.1 wt.
% to about 2.5 wt. %; from 0.1 wt. % to about 2.25 wt. %; from 0.1 wt. % to about 2 wt.
%; from about 0.1 wt. % to about 4 wt. %; from about 0.1 wt. % to about 3 wt. %; from
about 0.1 wt. % to about 2.5 wt. %; from about 0.1 wt. % to about 2.25 wt. %; from
about 0.1 wt. % to about 2 wt. %; from about 0.1 wt. % to about 1.5 wt. %; from about
0.1 wt. % to about 1 wt. %; from about 0.1 wt. % to about 0.5 wt. %; from 0.25 wt. % to
about 30 wt. %; from 0.25 wt. % to about 25 wt. %; from 0.25 wt. % to about 20 wt. %;
from 0.25 wt. % to about 15 wt. %; from 0.25 wt. % to about 10 wt. %; from 0.25 wt. %
to about 9 wt. %; from 0.25 wt. % to about 8 wt. %; from 0.25 wt. % to about 7 wt. %;
from 0.25 wt. % to about 6 wt. %; from 0.25 wt. % to about 5 wt. %; from 0.25 wt. % to
about 4.5 wt. %; from 0.25 wt. % to about 4 wt. %; from 0.25 wt. % to about 3.5 wt. %;
from 0.25 wt. % to about 3 wt. %; from 0.25 wt. % to about 2.5 wt. %; from 0.25 wt. % to
about 2.25 wt. %; from 0.25 wt. % to about 2 wt. %; from 0.25 wt. % to about 1.75 wt.
%; from 0.7 wt. % to about 10 wt. %; from 0.7 wt. % to about 9 wt. %; from 0.7 wt. % to
about 8 wt. %; from 0.7 wt. % to about 7 wt. %; from 0.7 wt. % to about 6 wt. %; from
0.7 wt. % to about 5 wt. %; from 0.7 wt. % to about 4.5 wt. %; from 0.7 wt. % to about 4
wt. %; from 0.7 wt. % to about 3.5 wt. %; from 0.7 wt. % to about 3 wt. %; from 0.7 wt.
% to about 2.5 wt. %; from 0.7 wt. % to about 2.25 wt. %; from 0.7 wt. % to about 2 wt.
%; from about 0.7 wt. % to about 4 wt. %; from about 0.7 wt. % to about 3 wt. %; from
about 0.7 wt. % to about 2.5 wt. %; from about 0.7 wt. % to about 2.25 wt. %; from
about 0.7 wt. % to about 2 wt. %; from about 0.7 wt. % to about 1.5 wt. %; from about
0.7 wt. % to about 1 wt. %; from 0.9 wt. % to about 10 wt. %; from 0.9 wt. % to about 9
wt. %; from 0.9 wt. % to about 8 wt. %; from 0.9 wt. % to about 7 wt. %; from 0.9 wt. %
to about 6 wt. %; from 0.9 wt. % to about 5 wt. %; from 0.9 wt. % to about 4.5 wt. %;
from 0.9 wt. % to about 4 wt. %; from 0.9 wt. % to about 3.5 wt. %; from 0.9 wt. % to
about 3 wt. %; from 0.9 wt. % to about 2.5 wt. %; from 0.9 wt. % to about 2.25 wt. %;
from 0.9 wt. % to about 2 wt. %; from about 0.9 wt. % to about 4 wt. %; from about 0.9
wt. % to about 3 wt. %; from about 0.9 wt. % to about 2.5 wt. %; from about 0.9 wt. % to
about 2.25 wt. %; from about 0.9 wt. % to about 2 wt. %; from about 0.9 wt. % to about
1.5 wt. %; from about 0.9 wt. % to about 1 wt. %; from 1 wt. % to about 10 wt. %; from 1
wt. % to about 9 wt. %; from 1 wt. % to about 8 wt. %; from 1 wt. % to about 7 wt. %;
from 1 wt. % to about 6 wt. %; from 1 wt. % to about 5 wt. %; from 1 wt. % to about 4.5
wt. %; from 1 wt. % to about 4 wt. %; from 1 wt. % to about 3.5 wt. %; from 1 wt. % to
about 3 wt. %; from 1 wt. % to about 2.5 wt. %; from 1 wt. % to about 2.25 wt. %; from 1
wt. % to about 2 wt. %; from about 1% to about 4 wt. %; from about 1 wt. % to about 3
wt. %; from about 1 wt. % to about 2.5 wt. %; from about 1 wt. % to about 2.25 wt. %;
from about 1 wt. % to about 2 wt. %; from about 1 wt. % to about 1.5 wt. %; from about
1.5 wt. % to about 10 wt. %; from about 1.5 wt. % to about 9 wt. %; from about 1.5 wt.
% to about 8 wt. %; from about 1.5 wt. % to about 7 wt. %; from about 1.5 wt. % to
about 6 wt. %; from about 1.5 wt. % to about 5 wt. %; from about 1.5 wt. % to about 4.5
wt. %; from about 1.5 wt. % to about 4 wt. %; from about 1.5 wt. % to about 3.5 wt. %;
from about 1.5 wt. % to about 3 wt. %; from about 1.5 wt. % to about 2.5 wt. %;from
about 1.5 wt. % to about 2.25 wt. %; from about 1.5 wt. % to about 2 wt. %; or in any
other amount within any of the above ranges.
The topical compositions may also include one or more pH adjusters as
described and defined above. The pH adjuster may be present in the topical
compositions in an amount of from < 0.01 wt. % to about 3 wt. %; from 0.01 wt. % to
about 3 wt. %; from 0.01 wt. % to about 2.5 wt. %; from 0.01 wt. % to about 2.25 wt. %;
from 0.01 wt. % to about 2 wt. %; from about 0.01 wt. % to about 3 wt. %; from about
0.01 wt. % to about 2.5 wt. %; from about 0.01 wt. % to about 2.25 wt. %; from about
0.01 wt. % to about 2 wt. %; from about 0.01 wt. % to about 1.5 wt. %; from about 0.01
wt. % to about 1 wt. %; from about 0.01 wt. % to about 0.5 wt. %; from 0.1 wt. % to
about 3 wt. %; from 0.1 wt. % to about 2.5 wt. %; from 0.1 wt. % to about 2.25 wt. %;
from 0.1 wt. % to about 2 wt. %; from about 0.1 wt. % to about 4 wt. %; from about 0.1
wt. % to about 3 wt. %; from about 0.1 wt. % to about 2.5 wt. %; from about 0.1 wt. % to
about 2.25 wt. %; from about 0.1 wt. % to about 2 wt. %; from about 0.1 wt. % to about
1.5 wt. %; from about 0.1 wt. % to about 1 wt. %; from about 0.1 wt. % to about 0.5 wt.
%; from 0.25 wt. % to about 3 wt. %; from 0.25 wt. % to about 2.5 wt. %; from 0.25 wt.
% to about 2.25 wt. %; from 0.25 wt. % to about 2 wt. %; from 0.25 wt. % to about 1.75
wt. %; from 0.7 wt. % to about 3 wt. %; from 0.7 wt. % to about 2.5 wt. %; from 0.7 wt.
% to about 2.25 wt. %; from 0.7 wt. % to about 2 wt. %; from about 0.7 wt. % to about 3
wt. %; from about 0.7 wt. % to about 2.5 wt. %; from about 0.7 wt. % to about 2.25 wt.
%; from about 0.7 wt. % to about 2 wt. %; from about 0.7 wt. % to about 1.5 wt. %; from
about 0.7 wt. % to about 1 wt. %; from 0.9 wt. % to about 3 wt. %; from 0.9 wt. % to
about 2.5 wt. %; from 0.9 wt. % to about 2.25 wt. %; from 0.9 wt. % to about 2 wt. %;
from about 0.9 wt. % to about 4 wt. %; from about 0.9 wt. % to about 3 wt. %; from
about 0.9 wt. % to about 2.5 wt. %; from about 0.9 wt. % to about 2.25 wt. %; from
about 0.9 wt. % to about 2 wt. %; from about 0.9 wt. % to about 1.5 wt. %; from about
0.9 wt. % to about 1 wt. %; from 1 wt. % to about 3 wt. %; from 1 wt. % to about 2.5 wt.
%; from 1 wt. % to about 2.25 wt. %; from 1 wt. % to about 2 wt. %; from about 1 wt. %
to about 3 wt. %; from about 1 wt. % to about 2.5 wt. %; from about 1 wt. % to about
2.25 wt. %; from about 1 wt. % to about 2 wt. %; from about 1 wt. % to about 1.5 wt. %;
from about 1.5 wt. % to about 3 wt. %; from about 1.5 wt. % to about 2.5 wt. %;from
about 1.5 wt. % to about 2.25 wt. %; from about 1.5 wt. % to about 2 wt. %; or in any
other amount within any of the above ranges.
The topical compositions may also include one or more preservatives as
described and defined above. The preservative may be present in the present
compositions in an amount of from < 0.01 wt. % to about 10 wt. %; from 0.01 wt. % to
about 9 wt. %; from 0.01 wt. % to about 8 wt. %; from 0.01 wt. % to about 7 wt. %; from
0.01 wt. % to about 6 wt. %; from 0.01 wt. % to about 5 wt. %; from 0.01 wt. % to about
4.5 wt. %; from 0.01 wt. % to about 4 wt. %; from 0.01 wt. % to about 3.5 wt. %; from
0.01 wt. % to about 3 wt. %; from 0.01 wt. % to about 2.5 wt. %; from 0.01 wt. % to
about 2.25 wt. %; from 0.01 wt. % to about 2 wt. %; from about 0.01% to about 4 wt. %;
from about 0.01 wt. % to about 3 wt. %; from about 0.01 wt. % to about 2.5 wt. %; from
about 0.01 wt. % to about 2.25 wt. %; from about 0.01 wt. % to about 2 wt. %; from
about 0.01 wt. % to about 1.5 wt. %; from about 0.01 wt. % to about 1 wt. %; from about
0.01 wt. % to about 0.5 wt. %; from 0.1 wt. % to about 10 wt. %; from 0.1 wt. % to about
9 wt. %; from 0.1 wt. % to about 8 wt. %; from 0.1 wt. % to about 7 wt. %; from 0.1 wt.
% to about 6 wt. %; from 0.1 wt. % to about 5 wt. %; from 0.1 wt. % to about 4.5 wt. %;
from 0.1 wt. % to about 4 wt. %; from 0.1 wt. % to about 3.5 wt. %; from 0.1 wt. % to
about 3 wt. %; from 0.1 wt. % to about 2.5 wt. %; from 0.1 wt. % to about 2.25 wt. %;
from 0.1 wt. % to about 2 wt. %; from about 0.1 wt. % to about 4 wt. %; from about 0.1
wt. % to about 3 wt. %; from about 0.1 wt. % to about 2.5 wt. %; from about 0.1 wt. % to
about 2.25 wt. %; from about 0.1 wt. % to about 2 wt. %; from about 0.1 wt. % to about
1.5 wt. %; from about 0.1 wt. % to about 1 wt. %; from about 0.1 wt. % to about 0.5 wt.
%; from 0.25 wt. % to about 10 wt. %; from 0.25 wt. % to about 9 wt. %; from 0.25 wt. %
to about 8 wt. %; from 0.25 wt. % to about 7 wt. %; from 0.25 wt. % to about 6 wt. %;
from 0.25 wt. % to about 5 wt. %; from 0.25 wt. % to about 4.5 wt. %; from 0.25 wt. % to
about 4 wt. %; from 0.25 wt. % to about 3.5 wt. %; from 0.25 wt. % to about 3 wt. %;
from 0.25 wt. % to about 2.5 wt. %; from 0.25 wt. % to about 2.25 wt. %; from 0.25 wt.
% to about 2 wt. %; from 0.25 wt. % to about 1.75 wt. %; from 0.7 wt. % to about 10 wt.
%; from 0.7 wt. % to about 9 wt. %; from 0.7 wt. % to about 8 wt. %; from 0.7 wt. % to
about 7 wt. %; from 0.7 wt. % to about 6 wt. %; from 0.7 wt. % to about 5 wt. %; from
0.7 wt. % to about 4.5 wt. %; from 0.7 wt. % to about 4 wt. %; from 0.7 wt. % to about
3.5 wt. %; from 0.7 wt. % to about 3 wt. %; from 0.7 wt. % to about 2.5 wt. %; from 0.7
wt. % to about 2.25 wt. %; from 0.7 wt. % to about 2 wt. %; from about 0.7 wt. % to
about 4 wt. %; from about 0.7 wt. % to about 3 wt. %; from about 0.7 wt. % to about 2.5
wt. %; from about 0.7 wt. % to about 2.25 wt. %; from about 0.7 wt. % to about 2 wt. %;
from about 0.7 wt. % to about 1.5 wt. %; from about 0.7 wt. % to about 1 wt. %; from 0.9
wt. % to about 10 wt. %; from 0.9 wt. % to about 9 wt. %; from 0.9 wt. % to about 8 wt.
%; from 0.9 wt. % to about 7 wt. %; from 0.9 wt. % to about 6 wt. %; from 0.9 wt. % to
about 5 wt. %; from 0.9 wt. % to about 4.5 wt. %; from 0.9 wt. % to about 4 wt. %; from
0.9 wt. % to about 3.5 wt. %; from 0.9 wt. % to about 3 wt. %; from 0.9 wt. % to about
2.5 wt. %; from 0.9 wt. % to about 2.25 wt. %; from 0.9 wt. % to about 2 wt. %; from
about 0.9 wt. % to about 4 wt. %; from about 0.9 wt. % to about 3 wt. %; from about 0.9
wt. % to about 2.5 wt. %; from about 0.9 wt. % to about 2.25 wt. %; from about 0.9 wt.
% to about 2 wt. %; from about 0.9 wt. % to about 1.5 wt. %; from about 0.9 wt. % to
about 1 wt. %; from 1 wt. % to about 10 wt. %; from 1 wt. % to about 9 wt. %; from 1 wt.
% to about 8 wt. %; from 1 wt. % to about 7 wt. %; from 1 wt. % to about 6 wt. %; from 1
wt. % to about 5 wt. %; from 1 wt. % to about 4.5 wt. %; from 1 wt. % to about 4 wt. %;
from 1 wt. % to about 3.5 wt. %; from 1 wt. % to about 3 wt. %; from 1 wt. % to about
2.5 wt. %; from 1 wt. % to about 2.25 wt. %; from 1 wt. % to about 2 wt. %; from about
1% to about 4 wt. %; from about 1 wt. % to about 3 wt. %; from about 1 wt. % to about
2.5 wt. %; from about 1 wt. % to about 2.25 wt. %; from about 1 wt. % to about 2 wt. %;
from about 1 wt. % to about 1.5 wt. %; from about 1.5 wt. % to about 10 wt. %; from
about 1.5 wt. % to about 9 wt. %; from about 1.5 wt. % to about 8 wt. %; from about 1.5
wt. % to about 7 wt. %; from about 1.5 wt. % to about 6 wt. %; from about 1.5 wt. % to
about 5 wt. %; from about 1.5 wt. % to about 4.5 wt. %; from about 1.5 wt. % to about 4
wt. %; from about 1.5 wt. % to about 3.5 wt. %; from about 1.5 wt. % to about 3 wt. %;
from about 1.5 wt. % to about 2.5 wt. %;from about 1.5 wt. % to about 2.25 wt. %; from
about 1.5 wt. % to about 2 wt. %; or in any other amount within any of the above
ranges.
The presently described topical compositions may be free from a fragrance,
gluten and/or a paraben.
The biocompatible topical compositions may also include known biocompatible
carriers, excipients, fillers, and diluents are well known to those of skill in the art, such
as those described in The Merck Index, Thirteenth Edition, Budavari et al., Eds., Merck
& Co., Inc., Rahway, N.J. (2001); the CTFA (Cosmetic, Toiletry, and Fragrance
Association) International Cosmetic Ingredient Dictionary and Handbook, Tenth Edition
(2004); and the “Inactive Ingredient Guide”, U.S. Food and Drug Administration (FDA)
Center for Drug Evaluation and Research (CDER) Office of Management, the contents
of all of which are hereby incorporated by reference in their entirety.
These additional inactive components, as well as effective formulations and
administration procedures, are well known in the art and are described in standard
textbooks, such as Goodman and Gillman’s: The Pharmacological Bases of
Therapeutics, 8th Ed., Gilman et al. Eds. Pergamon Press (1990) and Remington’s
Pharmaceutical Sciences, 18th Ed., Mack Publishing Co., Easton, Pa. (1990), both of
which are incorporated by reference herein in their entirety.
Methods of Treatment
Also provided herein are methods of using the biocompatible topical
compositions herein for treating, preventing or ameliorating rosacea, a symptom thereof
or a condition related thereto.
The methods of treating, preventing, ameliorating rosacea described herein may
comprise or consist of topically administering one or more of the described
biocompatible topical compositions to skin of a subject in need thereof.
Also provided is a method of treating, preventing or ameliorating a symptom
associated with rosacea that may comprise or consist of topically administering one or
more of the described biocompatible topical compositions to skin of a subject in need
thereof. Symptoms, including signs, as defined herein above that may be treated,
prevented or ameliorated include one or more sign or symptom including, for example,
erythema, telangiectasia, abnormal skin texture, skin discoloration, excess sebum
production, swelling of the skin, skin nodularities, red patches on the skin,
desquamation, skin lesions, stinging/burning, flushing and/or dry/tight skin.
Further provided is a method of treating, preventing or ameliorating one or more
sub-type of rosacea. The methods of treating, preventing or ameliorating one or more
sub-type of rosacea may comprise or consist of topically administering one or more of
the described biocompatible topical compositions to skin of a subject in need thereof.
The sub-types that may be treated, prevented or ameliorated include, for example,
erythematotelangiectatic rosacea, papulopustular rosacea, phymatous rosacea, ocular
rosacea and/or granulomatous rosacea.
In addition all of the methods described herein further comprise or consist of
administering one or more additional composition to the subject. The one or more
additional composition may be a skin cleanser, an oral composition for treating skin, a
sunscreen such as, e.g., an organic sunscreen, a moisturizing composition, an
exfoliating composition such as, e.g., an exfoliating polish, a barrier protecting
composition and/or an additional topical composition for treating, preventing or
ameliorating rosacea, a symptom thereof or a condition related thereto such as, e.g., a
topical formulation comprising salicylic acid or benzoyl peroxide.
The methods may also further comprise or consist of administering or providing
one or more additional therapies, including an at home or office administered
concomitant device or therapies. Examples of at home use devices include hand held
ultrasound, devices for administering light (UV light therapies, red light therapies, laser
therapies, and therapies utilizing intense non-coherent light sources, LLLT (low level
laser or low level light therapy), LILT (low intensity light therapy), photobiostimulation,
biostimulation (BIOS), photobiomodulation, photonic stimulation, photorejuvenation or
the like) and/or electrical therapy based (electrophoresis, electrophoresis or the like).
Non-limiting examples of office-administered therapies include any concomitant therapy
administered under the supervision of a dermatologist or other professional skin care
provider, such as administration of the topical composition utilizing a micro-needle
technique.
Suitable micro-needle therapies include those using arrays of relatively small
structures, sometimes referred to as micro-needles or micro-pins, for delivery and/or
removal of therapeutic agents and other substances through the skin and other
surfaces.
In addition, the methods described herein may also further include administering
one or more homeopathic products to the subject. Homeopathic therapies are those in
which very dilute form of an active substance is used to relieve similar symptoms in
conditions resulting from different etiologies. Non-limiting examples of homeopathic
products include over the counter compositions comprising or consisting of one or more
of topical or oral forms of belladonna, nuxvomica, sulphur, arsenicum alb., arsenicum
bromatum, carbo animalis, causticum, hydrocotyle, kali brom., kali iod., kreosotum,
lycopodium, nux vom., petroleum, rhustoxicodendron, sepia, sulphur, echinacea,
taraxacum, thuja occidentalis leafy twig, pine needle oil (pinus sylvestris) sambucus
nigra flower calendula officinalis flower, abies balsamea leaf oil, echinacea angustifolia
or the like.
Dosage
The presently described biocompatible topical compositions can be topically
administered in any form. A sufficient amount of the topical composition can be applied
onto the affected area and surrounding skin, for example, in an amount sufficient to
cover an affected area plus a margin of healthy skin or tissue surrounding the affected
area, if possible, for example, a margin of about .5 inches. The compositions can be
applied to any skin surface, including for example, facial skin, and the skin of the hands,
neck, chest and/or scalp.
The compositions can be applied in a single, one-time application, once a week,
once a bi-week, once a month, or from one to four times daily, for a period of time
sufficient to alleviate symptoms, for example, for a period of time of one week, from 1 to
12 weeks or more, from 1 to 6 weeks, from 2 to 12 weeks, from 2 to 12 weeks, from 2 to
8 weeks, from 2 to 6 weeks, from 2 to 4 weeks, from 4 to 12 weeks, from 4 to 8 weeks,
or from 4 to 6 weeks. The present compositions can be administered, for example, at a
frequency of once per day or twice per day. The presently described compositions can
be topically administered once per day for a period of time from 1 week to 4 weeks, of
from 1 week to 2 weeks, for 1 week, for 2 weeks, for 3 weeks, for 4 weeks, or for 4
weeks or more.
The presently described topical compositions can be applied in a therapeutically
effective amount, for example, an amount sufficient to cover an affected area plus a
margin of healthy skin or tissue surrounding the affected area, for example, a margin of
about .5 inches. Suitable amounts, for example, per application per affected area or
cumulative daily dosage per affected area (for example two applications in a 24 hour
period), can include, for example, from about .1 grams to about 6 grams; from about .2
grams to about 4.5 grams; from about .3 grams to about 4 grams; from about .4 grams
to about 3.5 grams; from about .4 grams to about 3 grams; from about .4 grams to
about 2.5 grams; from about .4 grams to about 2 grams; from about .4 grams to about
1.5 grams; from about .5 grams to about 1.5 grams; from about .5 grams to about 4.5
grams; 5 grams to about 4 grams; .5 grams to about 3.5 grams; .5 grams to about 3
grams; .5 grams to about 2.5 grams; .5 grams to about 2 grams; .5 grams to about 1
gram; about .5 grams; about 1 gram; about 1.5 grams; about 2 grams; about 2.5 grams;
or about 3 grams.
If desired, other therapeutic agents can be employed in conjunction with those
provided in the above-described compositions. The amount of active ingredients that
may be combined with the carrier materials to produce a single dosage form will vary
depending upon the host treated, the nature of the disease, disorder, or condition, and
the nature of the active ingredients.
The biocompatible compositions may be given in a single or multiple doses per
time period, for example, daily, weekly, bi-weekly, or monthly. In an embodiment, the
biocompatible compositions can be administered from one to four times per period, for
example once daily or twice daily. In another embodiment, the present compositions
may be administered once per week, for a period of from one to six weeks, for example
for one week, for two weeks, for three weeks, for four weeks, five weeks, or for six
weeks.
It is understood, however, that a specific dose level for any particular patient will
vary depending upon a variety of factors, including the activity of the specific active
agent; the age, body weight, general health, sex and diet of the patient; the time of
administration; the rate of excretion; possible drug combinations; the severity of the
particular condition being treated; the area to be treated and the form of administration.
One of ordinary skill in the art would appreciate the variability of such factors and would
be able to establish specific dose levels using no more than routine experimentation.
Pharmacokinetic parameters such as bioavailability, absorption rate constant,
apparent volume of distribution, unbound fraction, total clearance, fraction excreted
unchanged, first-pass metabolism, elimination rate constant, half-life, and mean
residence time are well known in the art.
The optimal topical biocompatible formulations will be determined by one skilled in
the art depending upon considerations such as the particular active agent combination
and the desired dosage. See, for example, “Remington’s Pharmaceutical Sciences”,
18th ed. (1990, Mack Publishing Co., Easton, PA 18042), pp. 1435-1712, the disclosure
of which is hereby incorporated by reference. Such formulations may influence the
physical state, stability, rate of in vivo release, and rate of in vivo clearance of the
essential lipids.
The present biocompatible topical composition in accordance with the subject
matter described herein may be a topical dosage form packaged in, for example, a
multi-use or single-use package, including for example, a tube, a tottle, a pump, a
container or bottle, a vial, a jar, a packet, or a blister package.
Single dosage kits and packages containing a once per day amount of the topical
biocompatible composition may be prepared. Single dose, unit dose, and once-daily
disposable containers of the present biocompatible compositions are contemplated as
within the scope of the present subject matter.
The present topical biocompatible compositions remain stable in storage for
periods including up to about 5 years, between about 3 months and about 5 years,
between about 3 months and about 4 years, between about 3 months and about 3
years, and alternately any time period between about 6 months and about 3 years.
The presently described biocompatible topical composition in accordance with
the subject matter described herein remains stable for up to at least 3 years at a
temperature of less than or equal to 40°C. In an embodiment, the presently described
topical formulation remains stable for at least 2 years at a temperature of less than or
equal to 40°C. In an embodiment, the presently described biocompatible composition
remains stable for at least 3 years at a temperature of less than or equal to 40°C and at
a humidity of up to 75% RH, for at least 2 years at a temperature of less than or equal to
40°C and at a humidity of up to 75% RH, or for at least 3 years at a temperature of less
than or equal to 30°C and at a humidity of up to 75% RH. In a further embodiment, the
presently described biocompatible composition in accordance with the subject matter
described herein remains stable for an extended period of time when packaged in a
multi-use container such as a bottle dispenser or the like, and exhibits equal to or even
greater stability when packaged in a single-use package.
EXAMPLES
The following examples are illustrative of the present topical biocompatible
compositions and are not intended to be limitations thereon.
Example 1:
Table 1, shown below, is one example of a topical composition according to the
present subject matter.
TABLE 1
RAW MATERIAL SUPPLIER INCI % W/W AGENT FUNCTION
Deionized Water In-house Water, Aqua, Eau 69.9700 Carrier/Solvent
Dissolvine Na2P Akzo Disodium EDTA 0.0500 Chelating Agent
Diglycerin 801 US Diglycerin 3.0000 Humectant
Cosmetics
Keltrol CG CP Kelco Xanthan Gum 0.3000 Thickener
Xiameter 200 Fluid, 100 cs Dow Corning Dimethicone 2.0000 Skin Conditioning Agent
Kukui Nut Oil Desert Aleurites Moluccan Seed Oil 0.5000 Emollient
Whale
Safflower Oil Desert Carthamus Tinctorius (Safflower) Seed 0.5000 Emollient
Whale Oil
Lanette 16 Cognis Cetyl Alcohol 2.0000 Emulsifier,Thickener
Simulsol 165 Seppic PEG-100 Stearate (and) 4.0000 Emulsifier,Thickener
Glyceryl Stearate
Permethyl 101A Presperse Isohexadecane 1.7500 Emollient
Beantree Bernel Methylheptyl Isostearate 1.0000 Emollient
Brij O20-SS Croda Oleth-20 0.3000 Emulsifier
BASF Water (and) Carbomer (and) Papain 3.0000 Exfoliating Agent
X-Pressin C (and)
1,2 Hexanediol (and) Caprylyl Glycol ,
(and) Algin
Neurocap Codif/Barrnet Hydrolyzed Algin 2.2500 Neurogenic Agent
Modukine CLR Lactose, Milk Protein 1.2500 Inflammatory Mgmt. Agent
Timecode Seppic Palmitoyl Glycine 1.5000 Vascular Repair Agent
Phytostem Edelweiss Resources of Glycerin (and) Leontopodium Alpinum 1.0000 Antioxidant
Marrubium Si-D Complex Nature Meristem Cell Culture (and) Marrubium
Vulgare Meristem Cell Culture, (and)
Lecithin
Unitrienol T272 WSL Induchem PEG-12 Glyceryl Laurate, PEG-36 2.5000 Sebum Suppression Agent
Castor Oil, Farnesyl Acetate, Farnesol,
Panthenyl Triacetate
Actiphyte of Broccoli Active Brassica Oleracea Italica (Broccoli) 2.0000 Anti-inflammatory Agent
Lipo Sun Special Organics Extract (and)
Helianthus Annuus (Sunflower) Seed Oil
Microkill COS Arch Phenoxyethanol (and) 1.0000 Preservative
Caprylyl Glycol (and)
Chlorphenesin
AMP Ultra PC -200 Angus Aminomethyl Propanol 0.1300 pH Adjuster
=======
100.0000
Example 2:
Table 2, shown below, is another example of a topical composition according to
the present subject matter.
TABLE 2
RAW MATERIAL SUPPLIER INCI % W/W FUNCTION
Deionized Water In-house Water, Aqua, Eau 72.3200 Carrier/Solvent
Veegum Ultra R.T. Magnesium Aluminum Silicate 0.5000 Thickener
Vanderbilt
Glycerine Ashland Butylene Glycol 1.0000 Solvent
Keltrol CG CP Kelco Xanthan Gum 0.3000 Thickener
Panthenol 50L DSM Panthenol 2.0000 Conditioning Agent
Dissolvine Na2P Akzo Disodium EDTA 0.0500 Chelating Agent
Xiameter 200 Fluid, 350 Dow Corning Dimethicone 1.2000 Skin Conditioning Agent
Lanette 16 Cognis Cetyl Alcohol 2.0000 Emulsifier,Thickener
Simulsol 165 Seppic PEG-100 Stearate (and) 2.0000 Emulsifier,Thickener
Glyceryl Stearate
Amphisol K DSM Potassium Cetyl Phosphate 1.0000 Emulsifier
Minno 21 Alzo/Bernel Neopentyl Glycol Diethylhexanoate, 1.5000 Emollient, Skin-Conditioning
Neopentyl Glycol Diisostearate Agent
Finsolv TN Innospec C12-15 Alkyl Benzoate 1.5000 Emollient
BASF Water (and) Carbomer (and) Papain 3.0000 Exfoliating Agent
X-Pressin C (and)
1,2 Hexanediol (and) Caprylyl Glycol ,
(and) Algin
Neurocap Codif/Barrnet Hydrolyzed Algin 2.2500 Neurogenic Agent
Modukine CLR Lactose, Milk Protein 1.2500 Inflammatory Mgmt. Agent
Timecode Seppic Palmitoyl Glycine 1.5000 Vascular Repair Agent
Phytostem Edelweiss Resources of Glycerin (and) Leontopodium Alpinum 1.0000 Antioxidant
Marrubium Si-D Complex Nature Meristem Cell Culture (and) Marrubium
Vulgare Meristem Cell Culture, (and)
Lecithin
Unitrienol T272 WSL Induchem PEG-12 Glyceryl Laurate, PEG-36 2.5000 Sebum Suppression
Castor Oil, Farnesyl Acetate, Farnesol,
Panthenyl Triacetate
Actiphyte of Broccoli Active Brassica Oleracea Italica (Broccoli) 2.0000 Anti-inflammatory Agent
Lipo Sun Special Organics Extract (and)
Helianthus Annuus (Sunflower) Seed Oil
Microkill COS Arch Phenoxyethanol (and) 1.0000 Preservative
Caprylyl Glycol (and)
Chlorphenesin
AMP Ultra PC-2000 Angus Aminomethyl Propanol 0.1300 pH Adjuster
Chemical
=======
100.0000
Example 3:
Table 3, shown below, is yet another example of a topical composition according
to the present subject matter.
TABLE 3
RAW MATERIAL SUPPLIER INCI % W/W FUNCTION
Deionized Water In-house Water, Aqua, Eau 46.3100 Carrier/Solvent
Dissolvine Na2P Akzo Disodium EDTA 0.0500 Chelating Agent
Diglycerin 801 US Diglycerin 3.0000 Humectant
Cosmetics
Keltrol CG CP Kelco Xanthan Gum 0.3000 Thickener
Xiameter 200 Fluid, 100 Dow Corning Dimethicone 4.5000 Skin Conditioning Agent
Kukui Nut Oil Desert Aleurites Moluccan Seed Oil 0.5000 Emollient
Whale
Safflower Oil Desert Carthamus Tinctorius (Safflower) Seed 1.0000 Emollient
Whale Oil
Lanette 16 Cognis Cetyl Alcohol 3.7500 Emulsifier,Thickener
Simulsol 165 Seppic PEG-100 Stearate (and) 4.0000 Emulsifier,Thickener
Glyceryl Stearate
Permethyl 101A Presperse Isohexadecane 1.7500 Emollient
Beantree Bernel Methylheptyl Isostearate 4.0000 Emollient
Brij O20-SS Croda Oleth-20 0.3000 Emulsifier
Dow Corning 9040 Dow Corning Cyclopentasiloxane (and) 10.0000 Skin Conditioning Agent
Dimethicone Crosspolymer
Dow Corning 1501 Dow Corning Cyclopentasiloxane (and) 6.0000 Skin Conditioning Agent
Dimethiconol
BASF Water (and) Carbomer (and) Papain 3.0000 Exfoliating Agent
X-Pressin C (and)
1,2 Hexanediol (and) Caprylyl Glycol,
(and) Algin
Neurocap Codif/Barrnet Hydrolyzed Algin 2.2500 Neurogenic Agent
Modukine CLR Lactose, Milk Protein 1.2500 Inflammatory Mgmt. Agent
Timecode Seppic Palmitoyl Glycine 1.5000 Vascular Repair Agent
Phytostem Edelweiss Resources of Glycerin (and) Leontopodium Alpinum 1.0000 Antioxidant
Marrubium Si-D Complex Nature Meristem Cell Culture (and) Marrubium
Vulgare Meristem Cell Culture, (and)
Lecithin
Unitrienol T272 WSL Induchem PEG-12 Glyceryl Laurate, PEG-36 2.5000 Sebum Suppression
Castor Oil, Farnesyl Acetate, Farnesol,
Panthenyl Triacetate
Actiphyte of Broccoli Active Brassica Oleracea Italica (Broccoli) 2.0000 Anti-inflammatory Agent
Lipo Sun Special Organics Extract (and)
Helianthus Annuus (Sunflower) Seed Oil
Sodium Hydroxide Univar Sodium Hydroxide 0.0400 pH Adjuster
Microkill COS Arch Phenoxyethanol (and) 1.0000 Preservative
Caprylyl Glycol (and)
Chlorphenesin
=======
100.0000
Example 4:
In order to evaluate the effectiveness of present compositions a proof of principle
clinical study was conducted on nine patients having varying skin types, of which were
female and four of which were male. The study participants were between the ages of
32 and 78 years of age.
The participants each suffered from one or more sub-type of rosacea as
described by Wilken et al. and characterized as shown in Table 4 below:
TABLE 4
The number of patients with diagnosed with each sub-type, as well as a
breakdown of which patients suffered from each sub-type is as follows:
Erythematotelangiectatic = 4 total, including Patient 2, Patient 3, Patient 4,
and Patient 7;
Papulopustular = 5 total, including: Patient 1, Patient 5, Patient 6, Patient 8,
and Patient 9;
Phymatous = 1 total--Patient 2;
Ocular = 5 total, i.e., Patient 1, Patient 2, Patient 3, Patient 4, and Patient 8;
Granulomatous = 0.
In addition to the above, the presence of flushing was observed in six patients,
i.e., Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, and Patient 6.
Study participants administered a topical composition according to Example 1-3
once-daily, for a period of 6 weeks. Patients were reviewed on a weekly basis.
Clinical photographs (frontal, oblique) were obtained weekly and compared with
baseline. Certain signs and symptoms specific to rosacea were graded by a
physician weekly according to their change (-1 = disimprovement, 0 = no
improvement, 1 = minimal improvement, 2 = moderate improvement, 3 =
significant improvement). An overall score was then generated for the observed
changes in signs each week. The patient was simultaneously asked to grade
changes in certain symptoms weekly. These were scored by the patient
according to change (-1 = disimprovement, 0 = no improvement, 1 = minimal
improvement, 2 = moderate improvement, 3 = significant improvement). A total
figure was generated for the changes in symptoms each week.
Over the course of the six-week period, all of the patients showed
significant improvement in their rosacea. Physician graded signs improved to an
overall score of 2.5/3, and patient graded symptoms to 2.9/3. The physician
graded signs with the greatest improvement were texture (2.9/3), nodularities (2.8/3),
sebum (2.7/3), erythema (2.5/3), telangiectasia (2.5/3), red patches / seborrheic
dermatitis (2.3/3), desquamation (2/3), discoloration (1.4/3), and swelling (1.2/3).
The patient graded symptoms with the greatest improvement included stinging / burning
(2.8/3), flushing (2.3/3), and dryness / tightness (2.0/3).
Of particular note, the compositions yielded a dramatic improvement in
overall lesion count. At baseline, there were 40 lesions tallied amongst all
patients. By week 6, this has reduced to 13, representing a 68% improvement.
With regard to patients suffering from ocular rosacea, the patients with this
disease subtype showed improvements in their patient graded signs symptoms (2.9/3)
and physician graded signs (2.4/3). These included conjunctival hyperemia, pruritus,
burning, dryness, lid inflammation, and peri-orbital edema. Of note, no signs or
symptoms of rosacea deteriorated throughout the clinical study.
In addition, it should be noted that the environmental setting for the
clinical trial afforded near 100% humidity levels. Of note, no patient complained
of dryness, exfoliation, or discomfort while using the topical composition.
Furthermore, no patient requested a “moisturizer” be added.
Remembering that rosacea occurs along a spectrum, patients who
displayed more erythematotelangiectatic, phymatous, and ocular features
received unexpectedly substantial benefits. Where the patient had a greater
tendency towards the papulopustular subtype, improvement was clear, albeit not
to as great a degree of patients suffering from erythematotelangiectatic,
phymatous, and ocular subtypes.
Also of note, it is well documented that UV radiation is the premier trigger of
rosacea in 81% of patients. Not unexpectedly, 88% of rosacea patients report a
decrease in flares when they apply sunscreen. Sunscreen use was mindfully
omitted from this Proof of Principle study, so as not to skew the results. It is however
worth remembering, that the trial was carried out in Trinidad, the warmest
Caribbean island. Furthermore, it was executed during the islands most arid
period, the Dry Season. Surprisingly, while administration of the topical
composition demonstrated superb results, all patients were still exposed to
significant amounts of daily UV radiation throughout the study. This generated
ongoing inflammation, barrier function disruption, and melanocyte activation
amongst others. Naturally, this can limit the cumulative benefits of the
composition, as the treatment was continually playing “catch-up” to the sun’s ill-
effects.
As described above and shown in Tables A-J below, administration of the
topical compositions described herein yielded an excellent ability to treat,
control, prevent and ameliorate of rosacea, a symptom thereof or a condition
related thereto, over the six-week period. Tables A-J shown below includes the
raw scores for each patient in the 9-patient cohort.
TABLE A
0 Equals No Change
1 Equals Minimal Change
2 Equals Moderate Change
3 Equals Significant Change
4 Equals Not Applicable
Equals Incomplete Data
TABLE B
Patient 1 Week Number
0 1 2 3 4 6 7
Signs/Symptom Physician Graded
Erythema 4 1 2 2 3 3 3
Telangiectasia 4 0 1 2 3 3 3
Texture 4 2 3 2 2 3 3
Discoloration 4 2 2 1 1 1 1
Sebum 4 2 2 2 2 3 3
Swelling 4 2 0 4 1 1 1
Nodularities 4 0 3 2 3 3
Up by 2
Red Patches 4 0 4 4 4 4 4
Desquamation 4 0 4 4 4 4 4
Lesion Count 14 lesions 6 lesions 3 lesions 3 lesions 1 lesion 4 2
Patient Graded
Stinging/Burning 4 0 4 4 4 4 4
Flushing 4 1 2 3 3 3 3
Dryness/Tightne 4 0 4 4 4 4 4
TABLE C 3
Patient 2 Week Number
0 1 2 3 4 6 7
Signs/Symptom Physician Graded
Erythema 4 2 2 5 3 3 3
Telangiectasia 4 1 1 5 3 3 3
Texture 4 3 2 5 3 3 3
Discoloration 4 2 2 5 2 2 2
Sebum 4 2 2 5 3 3 3
Swelling 4 1 2 5 3 3 3
Nodularities 4 0 0 5 4 4 4
Red Patches 4 2 2 5 3 3 3
Desquamation 4 1 2 5 3 3 3
Lesion Count 4 4 4 5 4 4 4
Patient Graded
Stinging/Burning 4 4 0 5 3 3 3
Flushing 4 2 2 5 3 3 3
Dryness/Tightne 4 4 0 5 3 3 3
TABLE D 3
Patient Grade
Patient 3 Week Number
0 1 2 3 4 6 7
Signs/Symptom Physician Grade
Erythema 4 0 1 2 2 3 5
Telangiectasia 4 0 1 2 2 3 5
Texture 4 2 2 2 3 3 5
Discoloration 4 1 2 1 1 1 5
Sebum 4 2 2 2 3 3 5
Patient Grade
Swelling 4 0 1 1 0 0 5
Nodularities 4 0 0 4 4 4 5
Red Patches 4 0 0 2 3 3 5
Desquamation 4 0 2 2 3 3 5
Lesion Count 3 lesions 4 1 Lesion 1 Lesion 0 lesions 0 5
Patient 3 Grade
Stinging/Burning 4 3 1 3 4 4 5
Flushing 4 1 2 2 3 3 5
Dryness/Tightne 4 4 2 2 3 3 5
TABLE E
Patient 4 Week Number
0 1 2 3 4 6 7
Signs/Symptom Physician Graded
Erythema 4 0 5 3 2 2 3
Telangiectasia 4 0 5 2 3 3 3
Texture 4 3 5 3 3 3 3
Discoloration 4 2 5 2 1 1 1
Sebum 4 2 5 2 2 3 2
Swelling 4 0 5 2 4 4 4
Nodularities 4 0 5 2 4 3 3
Red Patches 4 0 5 4 4 4 4
Desquamation 4 0 5 4 4 4 4
Lesion Count 4 lesions 4 5 1 lesion 1 lesion 3 2
Patient Graded
Stinging/Burning 4 1 2 3 3 3 3
Flushing 4 0 0 2 1 3 2
Dryness/Tightne 4 1 4 4 4 4 4
TABLE F 3
Patient 5 Week Number
0 1 2 3 4 6 7
Signs/Symptom Physician Graded
Erythema 4 1 2 5 2 1 3
Telangiectasia 4 0 2 5 2 1 3
Texture 4 2 2 5 3 3 3
Discoloration 4 1 1 5 0 0 0
Sebum 4 2 2 5 3 3 3
Swelling 4 1 0 5 0 4 4
Nodularities 4 Worse 0 5 3 3 3
Red Patches 4 1 0 5 3 3 3
Desquamation 4 1 0 5 2 2 2
Lesion Count 3 lesions 1 Nodule 1 lesion 5 4 1 1
Patient Graded
Stinging/Burning 4 1 1 5 2 3 2
Flushing 4 1 1 5 0 1 2
Dryness/Tightne 4 1 1 5 2 2 2
TABLE G 3
Patient 6 Week Number
0 1 2 3 4 6 7
Signs/Symptoms
Erythema 4 Worse 2 2 2 2 2
Physician Grade
Telangiectasia 4 0 0 2 2 2 2
Texture 4 2 2 3 3 3 3
Discoloration 4 2 2 2 2 2 2
Sebum 4 2 2 2 2 2 2
Swelling 4 2 2 1 1 1 1
Nodularities 4 0 2 2 3 2 2
Red Patches 4 Worse 2 1 2 1 2
Desquamation 4 0 0 0 0 0 0
Lesion Count 9 lesions 7 4 Lesions 4 1 lesion 2 6
Patient Grade
Stinging/Burning 4 0 4 2 4 4 4
Flushing 4 0 2 2 2 2 2
Dryness/Tightne 4 0 4 4 4 4 4
TABLE H 3
Patient 7 Week Number
0 1 2 3 4 6 7
Signs/Symptom Physician Grade
Erythema 4 1 2 2 5 3 3
Telangiectasia 4 0 2 2 5 2 2
Texture 4 2 2 2 5 2 2
Discoloration 4 1 2 1 5 1 1
Sebum 4 2 2 2 5 2 2
Swelling 4 0 0 0 5 1 1
Nodularities 4 0 0 4 5 4 4
Red Patches 4 0 0 4 5 4 4
Desquamation 4 0 0 4 5 4 4
Lesion Count 4 0 4 4 5 0 0
Patient Grade
Stinging/Burning 4 0 2 2 5 2 3
Flushing 4 0 0 4 5 0 0
Dryness/Tightne 4 0 0 4 5 0 0
TABLE I 3
Patient 8 Week Number
0 1 2 3 4 6 7
Signs/Symptom Physician Grade
Erythema 4 1 5 2 5 3 3
Telangiectasia 4 1 5 2 5 3 3
Texture 4 1 5 2 5 3 3
Discoloration 4 1 5 2 5 3 3
Sebum 4 0 5 2 5 3 3
Swelling 4 0 5 2 5 4 4
Nodularities 4 0 5 3 5 3 3
Red Patches 4 0 5 1 5 2 2
Desquamation 4 0 5 1 5 2 2
Lesion Count 7 lesions 6 lesions 5 4 Lesions 5 3 1
Patient Grade
Stinging/Burning 4 0 5 4 5 4 4
Flushing 4 0 5 2 5 3 3
Dryness/Tightne 4 0 5 4 5 4 4
TABLE J 3
Patient 9 Week Number
0 1 2 3 4 6 7
Physician Grade
Signs/Symptom
Erythema 4 5 1 5 2 5 5
Telangiectasia 4 5 0 5 1 5 5
Texture 4 5 3 5 2 5 5
Discoloration 4 5 4 5 4 5 5
Sebum 4 5 3 5 2 5 5
Swelling 4 5 4 5 4 5 5
Nodularities 4 5 3 5 1 5 5
Red Patches 4 5 4 5 4 5 5
Desquamation 4 5 4 5 4 5 5
Lesion Count 38 5 5 5 16 5 5
Patient Grade
Stinging/Burning 4 5 1 5 4 5 5
Flushing 4 5 4 5 4 5 5
Dryness/Tightnes 4 5 2 5 4 5 5
As a discussed, photographs were taken of all the patients during the study. The
photographic evidence shows drastic improvement in all patients. For example, Figure
1 is a side-by-side photographic comparison of Patient 4 prior to treatment, i.e., a
baseline, and after six weeks of treatment. As shown, the patient’s condition was
markedly improved. Likewise Figure 2, is a side-by-side photographic comparison of
Patient 1 prior to treatment, i.e., a baseline, and after six weeks of treatment. As
shown, the patient’s condition was markedly improved.
All publications cited in the specification are indicative of the level of skill of those
skilled in the art to which the presently described subject matter pertains. All of these
publications are hereby incorporated by reference herein to the same extent as if each
individual publication were specifically and individually indicated as being incorporated
by reference.
The present subject matter being thus described, it will be apparent that the
same may be modified or varied in many ways. Such modifications and variations are
not to be regarded as a departure from the spirit and scope of the present subject
matter, and all such modifications and variations are intended to be included within the
scope of the following claims.
Claims (18)
1. A topical composition, comprising: an inflammatory management agent comprising lactose and/or milk protein, the inflammatory management agent being present in an amount of from about 0.01 wt. % to about 12.5 wt. % based on the weight of the topical composition; a vascular repair agent comprising palmitoyl glycine, the vascular repair agent being present in an amount of from about 0.01 wt. % to about 15 wt. % based on the weight of the topical composition; a neurogenic agent comprising an oligosaccharide, the neurogenic agent being present in an amount of from about 0.01 wt. % to about 22.5 wt. % based on the weight of the topical composition; a sebum suppression agent comprising Panthenyl Triacetate, farnesol and farnesyl acetate, the sebum suppression agent being present in an amount of from about 0.01 wt. % to about 25 wt. % based on the weight of the topical composition; and an exfoliating agent comprising at least one plant derived cysteine protease enzyme, the exfoliating agent being present in an amount of from about 0.01 wt. % to about 10 wt. % based on the weight of the topical composition.
2. The topical composition according to claim 1, further comprising one or more agent selected from the group consisting of a solvent, a chelating agent, a humectant, a thickener, emollient, an emulsifier, a skin conditioning agent, an antioxidant, an anti- inflammatory agent, pH adjuster and a preservative.
3. The topical composition of claim 1, wherein the inflammatory management agent is present in an amount of from about 0.25 wt. % to about 10.0 wt. % based on the weight of the topical composition.
4. The topical composition of claim 1, wherein the vascular repair agent is present in an amount of from about 0.25 wt. % to about 5.0 wt. % based on the weight of the topical composition.
5. The topical composition of claim 1, wherein the neurogenic agent is present in an amount of from about 0.1 wt. % to about 5.0 wt. % based on the weight of the topical composition.
6. The topical composition of claim 1, wherein the sebum suppression agent is present in an amount of from about 0.1 wt. % to about 5.0 wt. % based on the weight of the topical composition.
7. The topical composition of claim 1, wherein the exfoliating agent is present in an amount of from about 0.1 wt. % to about 10.0 wt. % based on the weight of the topical composition.
8. A topical dosage form selected from the group consisting of a cream, a lotion, an ointment, a foam, an aerosol, a powder, a solution, an emulsion, and a serum, comprising the topical composition according to claim 1.
9. The topical dosage form of claim 8, wherein the topical composition does not comprise a fragrance.
10. The topical dosage form of claim 8, wherein topical dosage form is a lotion.
11. A kit, comprising the topical composition of claim 1.
12. Use of an inflammatory management agent comprising lactose and/or milk protein, a vascular repair agent comprising palmitoyl glycine, a neurogenic agent comprising an oligosaccharide, a sebum suppression agent comprising Panthenyl Triacetate, farnesol and farnesyl acetate, and an exfoliating agent comprising at least one plant derived cysteine protease enzyme for the manufacture of a medicament effective in the treatment of rosacea.
13. The use of claim 12, wherein the medicament is a lotion.
14. The use of claim 12, wherein the medicament is formulated for twice daily application.
15. The use according to claim 12, wherein the medicament is formulated for co- administration with a topical formulation comprising salicylic acid.
16. The use according to claim 12, wherein the medicament is formulated for co- administration with an organic or an inorganic sunscreen.
17. The kit of claim 11, further comprising one or more additional composition selected from the group consisting of a skin cleanser, an organic or an inorganic sunscreen, an exfoliating polish, a topical formulation comprising salicylic acid.
18. A topical composition, consisting essentially of: an inflammatory management agent comprising lactose and milk protein, the inflammatory management agent being present in an amount of from about 0.01 wt. % to about 12.5 wt. % based on the weight of the topical composition; a vascular repair agent comprising palmitoyl glycine, the vascular repair agent being present in an amount of from about 0.01 wt. % to about 15 wt. % based on the weight of the topical composition; a neurogenic agent comprising an oligosaccharide, the neurogenic agent being present in an amount of from about 0.01 wt. % to about 22.5 wt. % based on the weight of the topical composition; a sebum suppression agent comprising Panthenyl Triacetate, farnesol and farnesyl acetate, the sebum suppression agent being present in an amount of from about 0.01 wt. % to about 25 wt. % based on the weight of the topical composition; an exfoliating agent comprising at least one plant derived cystein protease enzyme, the exfoliating agent being present in an amount of from about 0.01 wt. % to about 10 wt. % based on the weight of the topical composition; and optionally one or more agent selected from the group consisting of a solvent, a chelating agent, a humectant, a thickener, emollient, an emulsifier, a skin conditioning agent, an antioxidant, an anti-inflammatory agent, pH adjuster and a preservative. ZO Skin Health, Inc. By the Attorneys for the Applicant SPRUSON & FERGUSON Per:
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
NZ739287A NZ739287B (en) | 2016-08-02 | 2017-08-01 | Composition and method for treating skin conditions |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US15/226349 | 2016-08-02 |
Publications (1)
Publication Number | Publication Date |
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NZ734222A true NZ734222A (en) |
Family
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