Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
  • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
  • A61K31/737—Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/66—Phosphorus compounds
  • A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
  • A61K31/685—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
  • A61K31/7012—Compounds having a free or esterified carboxyl group attached, directly or through a carbon chain, to a carbon atom of the saccharide radical, e.g. glucuronic acid, neuraminic acid
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/06—Fungi, e.g. yeasts
  • A61K36/07—Basidiomycota, e.g. Cryptococcus
  • A61K36/076—Poria
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/185—Magnoliopsida (dicotyledons)
  • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
  • A61K36/736—Prunus, e.g. plum, cherry, peach, apricot or almond
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
  • A61K8/41—Amines
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
  • A61K8/4973—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with oxygen as the only hetero atom
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/60—Sugars; Derivatives thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/63—Steroids; Derivatives thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
  • A61K8/73—Polysaccharides
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
  • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
  • A61K8/9728—Fungi, e.g. yeasts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
  • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
  • A61K8/9783—Angiosperms [Magnoliophyta]
  • A61K8/9789—Magnoliopsida [dicotyledons]
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P17/00—Drugs for dermatological disorders
  • A61P17/10—Anti-acne agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
  • A61Q19/00—Preparations for care of the skin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
  • A61K2800/74—Biological properties of particular ingredients
  • A61K2800/75—Anti-irritant
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
  • A61Q19/00—Preparations for care of the skin
  • A61Q19/008—Preparations for oily skin

Definitions

• the present invention relates to cosmetic or pharmaceutical compositions for treating acne with specific combinatorial components active against the various aspects of the acne condition. More specifically, the invention relates to substantially non-irritating topical compositions free of benzoyl peroxide for the treatment of acne.
• acne is characterized by a multifacto ⁇ al pathogenesis including factors of increased sebum production, follicular keratimzation, Propionibacterium acnes (P acnes) proliferation, and inflammation.
• acne is an androgen dependent disorder. Endoc ⁇ nological factors effect the secretory activity of sebaceous glands.
• 5 ⁇ -reductase catalyzes testosterone to 5 ⁇ -d ⁇ hydrotestosterone (DHT), a large amount of which is found in sebaceous glands.
• DHT 5 ⁇ -d ⁇ hydrotestosterone
• 5 ⁇ -reductase is considered to be the principal mediator of local androgemc activity.
• the role of 5 ⁇ -reductase, and in particular, 5 ⁇ -reductase inhibitors in being able to treat acne is uncertain.
• a recent report suggests, based on studies, that 5 ⁇ -reductase inhibitors may not be valuable in acne therapy. Webster, G. F., "Acne Vulga ⁇ s: State of the Science", Arch Dermatol, vol. 135 (Sep.
• Sebum is one of the major factors contributing to the development of the acne condition. Other contributors include colonization by P. acnes, and abnormal keratimzation of the follicular epithelium.
• P acnes the major organism responsible for acne, is a gram-positive microaerophihc diphtheroid and it is dominant in the sebaceous follicles.
• the nutritional needs of P. acnes are provided by the t ⁇ glyce ⁇ de fraction of sebum
• the glycerol moiety of sebaceous triglyce ⁇ des are necessary for nutrition and P acnes gains access to it by an extracellular lipase.
• P acnes within a comedo produces toxic substances which can attack the follicular epithelium and cause rupturing of the comedo.
• neutrophils congregate around the area of the comedo.
• Neutrophils contain enzymes which are capable of digesting the follicular epithelium and collagen.
• P. acnes is very resistant to degradation by neutrophils or monocytes. Therefore, other treatments are sought to combat the difficult P. acnes Retinoids, such as, for example, 13-c ⁇ s retmoic acid (lsotretmoin) cause a reduction in sebum production and cause the glands to shrink by about 90 percent.
• a widely used treatment regimen is topically applied benzoyl peroxide
• benzoyl peroxide A widely used treatment regimen is topically applied benzoyl peroxide
• the advantage to using benzoyl peroxide in treating acne is its strong antibacterial activity against P acnes.
• Application of 5 percent benzoyl peroxide two times daily for five days has been found to reduce P acnes population by more than 95 percent.
• P. acnes has not been found to become resistant to benzoyl peroxide.
• benzoyl peroxide has little effect on sebum production in acne
• Some users of benzoyl peroxide as a topical therapeutic treatment may also experience skin reactions such as irritation and redness.
• benzoyl peroxide is unstable and incompatible with other treatment compounds. Therefore, it is difficult to combine benzoyl peroxide with other actives when treating acne.
• An anti-acne composition free of benzoyl peroxide is desirable because it can contain many actives to treat the multifactorial sub-conditions associated with acne.
• Other anti-acne agents include sialyl sugars as described in PCT International Publication No. WO 00/06115, manuka oil as reported in "Coast Manuka Oil” on website http://www.coastbio co.nz/manuka htm (June 12, 2001), and Acnacidol Biopeptide Base (Acnacidol 101) as reported in "BioSelect Innovations: Products" on website http : / / www . bioselectinnovations . com/designer . html (April 17, 2001).
• the present invention relates to topical combinatorial component containing anti-acne compositions comprising an anti-acne effective amount of 1) an adhesion blocking component comprising at least a polysaccha ⁇ de, 2) a sebum reducing component comprising at least soft pygeum, 3) an anti-irritating component comprising at least a phytosphmgosine, 4) an anti-mflammatory component comprising at least hoelen mushroom extract, and 5) a sclareolide component m a cosmetic or pharmaceutical acceptable vehicle.
• the present invention achieves superior results with the specific combination of five natural components as they have been found to significantly reduce the severity of the acne condition with substantially no discomfort or irritation.
• the penta- combinatorial acne treatment of the present invention eliminates known anti-bacterial compounds which are occasionally found to be too strong for the sensitive skin suffering from acne, and which, further provokes discomfort, redness and inflammation of the acne inflicted skm.
• the combinatorial anti-acne treatment of the present invention is effective against acne alone. In addition, combinations of less than all of the actives used in the present invention fail to achieve the full benefits of the present invention.
• the combination of natural anti-acne components in the present invention reduces inflamed lesions by greater than about 20 percent after the second week of treatment, greater than about 30 percent after four weeks of treatment, and greater than 40 percent after six weeks of treatment. With respect to non-inflamed lesions, the combinatorial anti-acne treatment of the present invention results in a reduction by greater than about 10 percent after the second week of treatment, greater than about 15 percent after four weeks of treatment, and greater than about 20 percent after six weeks of treatment. All results in reducing lesions of any type are accompanied by a substantial lack of discomfort or irritation. These results heretofore have not been seen with the individual natural actives themselves or with smaller combinations of the individual actives of the present invention.
• the anti-acne effect achieved by the present compositions is mild and substantially non-irritatmg. Consumers feel better about using products that contain natural ingredients because they perceive those ingredients as being milder, safer and healthier.
• the network of anti-acne activities is derived from specific sclareolide, adhesion blocking, sebum reducing, anti-inflammatory and anti-irritant components
• the present invention also relates to a method of preventing or protecting the skin against the damaging effects of acne and the appearance of comedones on the skm, which comprises applying to the skin the sclareolide, adhesion blocking component, the sebum reducing component, and the anti-irritant and anti-inflammatory components in anti-acne effective amounts
• the compositions of the present invention provide a natural treatment for the acne condition
• the combination of five components namely, the sclareolide component, the adhesion blocking component, the sebum reducing component, the anti- lnflammatory component, and the anti-irritant component are effective in treating the acne condition without the use of benzoyl peroxide or salicylic acid
• the five components of the present invention in combination with each other reduce the severity of the acne condition by combating a variety of aspects associated with acne
• the primary activity of the present compositions while not wishing to be bound to any particular theory, is believed to be that a polysaccharide, when applied topically to the skin, inhibits the adhesion of Propwnibacterium acnes (P acnes) to the mfundibulum, the region above insertion where the sebaceous gland deposits its contents into the follicular canal via a short duct Therefore, the P acnes responsible for the unsightly and damaging symptoms of acne is not able to survive, and its damaging effects to the
• the terminal follicles contain the mfundibulum, and provide the follicular canal where sebaceous glands empty their contents
• Epithelium lines the mfundibulum and produces a sturdy, well- differentiated horny layer of cells similar to the epidermis Further, like the epidermis, the horny layer of the mfundibulum has barrier function
• the acne condition can be treated on a holistic basis by topical application of polysaccharide in combination with the sclareolide component, the sebum reducing component of at least pygeum extract, the anti-inflammatory component of at least the hoelen mushroom extract, and the anti- lr ⁇ tation component can effectively enhance the treatment of the acne condition
• many polysaccha ⁇ des may be used in the present invention, preferably, the polysaccharide is a sulfated polysaccharide
• algal polysaccha ⁇ des inhibit the activity of viruses such as human immunodeficiency virus reverse transcnptase enzyme and herpes simplex virus, as described in U S Patent 5,089,481 and International Patent Application WO 97/00689. Both of these references are incorporated herein by reference.
• an anti-acne effective amount is an amount of polysaccharide sufficient to reduce inflamed or non-mflamed lesions caused by or attributable to P acnes by an amount comparable to or better than the reduction observed using benzoyl peroxide.
• the polysaccharide is present in an amount of from about 0 05 to about 10%, more preferably from about 0.1 to about 5%, most preferably about 0 5 to about 2%, all by weight of the total composition.
• the polysaccharide in combination with only the anti-inflammatory component and the anti-ir ⁇ tant component is less effective in treating the lesions, both inflamed and non-inflamed, associated with acne than the polysaccharide in combination with the other four components of the present invention.
• the red microalgae polysaccharide can be included in any type of cosmetically or pharmaceutically acceptable vehicle for topical application with which it is compatible, e.g , a gel, a cream, a lotion, an ointment, a mousse, a spray, a solid stick, a powder, a suspension, a dispersion, and the like.
• the polysaccharide can also be provided in a hposome formulation Techniques for formulating various types of vehicles are well known to those skilled in the art.
• compositions of the present invention also include a sebum reducing component which can be any compound known to have sebum reducing activity.
• the sebum reducing component is pygeum extract which is generally known for treating prostate cancer. Extracts of Pygeum africanum have been desc ⁇ bed by Cum, S.B., et al , in "The Lipid-Sterol Fraction of Pygeum Africanum xxx Cosmetics", Chim. Oggi (1), 17-19 (1983), and by Piermi, N., et al., in "Identification and Determination of 1-Docosanol in Extracts of Pygeum Africanum bark and in Pharmaceuticals Containing the Extract", Boll. Chim.
• the pygeum extract is present in an anti-acne effective amount, and the definition of this term as it is described above with respect to the polysaccharide applies to pygeum extract.
• the pygeum extract is available commercially, as Soft Pygeum Extract, from Actives International, Norwood, New Jersey 0 (Alchem International Ltd., Ballabgarh, India).
• the amount of pygeum extract used in combination with the polysaccharide is about 0.05 to about 5.0 percent, more preferably about 0.2 to 2.0 percent, and most preferably about 0.2 to 1.0 percent, all by weight of the composition.
• sebum reducing component Another preferred compound used as the sebum reducing component is IsolutrolTM (tradename for scymnol sulfate) which can be used alone or in combination with the pygeum extract.
• the sebum reducing component is a combination of isolutrol and pygeum extract.
• An additional advantage may be experienced with isolutrol because scymnol, a shark bile steroid, according to a research project group, is believed to have dermatological cleansing properties which are considered to be anti-acne in nature Organic Synthesis Group 1996 Projects, RMIT University, Department of Applied Chemistry, Melbourne, Australia.
• the specific activity in treating acne is not o known, and the ability to treat the whole acne condition in combination with the other components of the present invention are not known.
• the scymnol sulfate is present in an amount of about 0.001 to about 0.05 percent by weight of the present invention.
• the sebum reducing component can also be a combination of sebum reducing actives and is present in an amount of about 0.02 to about 2.0 when it contains a combination of actives for reducing sebum. 5 Because acne is inherently an irritating condition associated with inflammation, two requisite components of the present invention are the anti-inflammatory component and the anti-ir ⁇ tant component.
• the formulation for the present anti-acne composition contains an anti-inflammatory component.
• the an ti -inflammatory 0 component can include topical agents, such as, for example, non-steroidal anti-inflammatory drugs, and naturally derived anti-mflammatory agents including but not limited to hoelen mushroom, manuka oil, emu oil, echinacea, chamomile (matrica ⁇ a oil), soybean protein, calendula, cayenne, tume ⁇ c, white willow, sialyl sugars (e.g., 3 ' sialyl lactose) and the like.
• the anti-inflammatory component is naturally derived.
• naturally derived 5 agents are those found in nature in animals or plants where natural plant derived agents are referred to as botanicals.
• the anti-inflammatory component can include known anti-mflammatory agents, a particular beneficial result in treating acne lesions is found using a hoelen mushroom extract in combination with the other components of the present invention.
• Hoelen mushroom, or Poria cocos is an herb used in traditional Chinese and Japanese medicine, and is known as a diuretic, antiviral agent, 5 sedative, fever reducer, and spleen/kidney tonic.
• An organic or hydro-organic extract of Poria cocos is used in an anti-acne composition in U.S. Patent No.
• the present invention incorporating Poria cocos in combination with the four other components of the present invention is surprisingly more effective against acne lesions, both inflamed and non-mflamed, than Poria cocos with only two of the other components of the present invention.
• the Hoelen mushroom is available 0 from Premier Specialties, Middlesex, NJ.
• the hoelen mushroom is present in an amount of about 2.0 percent or less, and preferably about 1.0 percent or less.
• the anti-irritant component are those which are capable of minimizing the irritation (i.e., responses that are not primarily an inflammatory response) experienced with anti-acne treatment.
• irritation include, but are not limited to, itching, redness, flakmess, pam, and the like.
• Suitable known anti -irritants that can be utilized in the present invention include, but are not limited to, for example, sucrose, green tea extract, hmokitiol, polysaccharide, phytosphingosine, gorgoman extract, sialyl sugars and combinations thereof.
• the anti-irritant component is present in an amount of about 0.1 to about 5.0 percent by weight of the composition.
• the phytosphingosine component is known as an added active ingredient in cosmetic and pharmaceutical compositions, as explained m 0 WO 00/01839 and in WO 99/29293, for their anti-inflammatory and antimicrobial activity, and as described in JP 2000109409, for its use in preventing acne comedones.
• WO 00/01839 describes an enhanced method of producing sphingoid bases and derivatives such as phytosphingosines and
• WO 99/29293 teaches a combination of a ceramide and a free sphmgoid base which, when topically applied, allegedly benefit bacterial, fungal, yeast and viral infections.
• the anti-irritant component is a combination of about 0.1 to about 0.5 percent phytosphingosine, about 0.05 to about 0.2 sialyl sugar, and about 0.2 to about 1.0 percent sucrose.
• the compositions of the present invention also contain the sclareolide component. Its use is described in U.S. Application Serial No. 09/773351 in combination with pygeum extract and ammo sugars. It has been reported m U.S. Patent No.
• Sclareol is an important bioactive diterpene obtained from clary sage (Salvia sclarea Labiatae.) The clary sage extract is believed to contain about 5 70 percent sclareol.
• another useful species of the genus Salvia is Salvia officinahs L. Methods of using Salvia officinahs m an external ointment have been disclosed in U.S. Patent No. 5,660,831 for controlling high blood-pressure, circulatory problems, and incomplete cicatrization of wounds.
• Salvia officinalis The characteristic constituents of Salvia officinalis (Dalmation sage) are believed to be alpha- (about 30 to 40 percent) and beta- thujone (about 10 percent).
• the source of sclareolide can be derived (extracted) naturally from either species of the Salvia genus, or can be synthetically obtained as substantially pure sclareolide.
• substantially pure sclareolide contains greater than 70 percent sclareolide.
• sclareolide is effective in an amount of about 0.01 to about 2.0 percent by weight of the total composition. It is believed to function as an effective desquamation agent when treating acne and in combination with the other components of the present invention.
• compositions of the invention are applied to the skin in a manner appropriate to achieve the intended end result of reducing or eliminating inflamed and non-mflamed lesions associated with the general acne condition as a whole.
• topical application of the composition in an amount of from about 0.1 mg/cm 2 to 2 mg/cm 2 of skin, be performed from about once per week to about 4 or 5 times daily, preferably from about 3 times a week to about 3 times daily, most preferably about once or twice per day.
• the period of topical application may be for a period of at least about two weeks, more preferably from about two weeks to about two years, more preferably from about two weeks to about two months, more preferably still from about two weeks to about six weeks, thereby resulting in the treatment or prevention of the external signs of the acne condition.
• the period of time which may be necessary to treat individual acne conditions will vary, and therefore, repeat applications may ultimately be required
• the present invention has the added benefit of being substantially non- lr ⁇ tating, and therefore, treatment can endure as long as necessary to diminish the acne condition without discontinuing its use because of discomfort and the development of irritation.
• the methods of the present invention are for treating the acne condition and specifically, treating or preventing the adhesion of P acnes to keratmocytic cells on the skin.
• the present invention prevents and protects the skm against the appearance of unattractive, and even in some cases, disfiguring effects caused by the acne condition by topically applying the compositions of the present invention to the skin.
• the compositions can be applied to the entire facial area to treat acne and any area of skin on the body which is afflicted with the acne condition, as for example, the back, without causing substantial irritation on the healthy and/or normal areas of the skin surrounding the plagued areas.
• the method treating the acne condition is achieved by topically applying the sclareolide component, the adhesion blocking component, the sebum reducing component, along with the anti-inflammatory component and the anti-irritant component.
• the invention is further illustrated by the following non-limiting examples:
• composition according to the present invention ANTI-ACNE COMPOSITION
• the lesions inflamed and non-mflamed, as measured by physical observation, indicate that the 2 o skin treated with the compositions of the present invention results in a reduction of both types of lesions.
• a decrease in 18% of the lesions is found at two weeks, and at 6 weeks there is a 56% decrease.
• the decrease in inflamed lesions is believed to be due to the effect the combination of polysaccharide and pygeum extract has 5 on P acnes.
• the first type is the present invention containing an adhesion blocking component of polysaccharide, a sebum reducing component comprising pygeum extract, Acnacidol-pTM, and scymnol sulfate, an anti-inflammatory component comprising hoelen mushroom extract, and manuka oil, an anti-irritant component comprising sucrose, sialyl sugar, phytosphingosine, and a sclareolide component, II.
• an adhesion blocking component of polysaccharide a sebum reducing component comprising pygeum extract, Acnacidol-pTM, and scymnol sulfate
• an anti-inflammatory component comprising hoelen mushroom extract
• manuka oil an anti-irritant component comprising sucrose, sialyl sugar, phytosphingosine
• a sclareolide component II.
• the second type is a 3 component cream containing polysaccharide, hoelen mushroom extract, and sucrose, and HI.
• the third type is a 2 component cream containing Acnacidol-pTM and phytosphingosine.
• Each acne treatment cream is applied to the full face twice daily, once in the morning and once in the evening for 6 weeks. Participants are instructed not to use any other topical or systemic acne treatment product during the course of the study.
• Compositions containing polysaccharide in an amount of 1.0 percent, hoelen mushroom extract in an amount of 0.5 percent, and anti-irritation component in an amount of 0.5 percent without the sebum reducing component (3 components) are less effective against the acne condition than the present invention.
• compositions containing an anti-ir ⁇ tant in an amount of 0.2 percent, and a sebum reducing component in an amount of 1.0 percent without polysaccharide and without the anti-mflammatory component (2 components) are less effective against the acne condition than the compositions of the present invention.
• Results are shown m Table 3 below and demonstrate that the components of the present invention are not cumulative.

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• 2001
  • 2001-10-05 US US09/971,498 patent/US20030072777A1/en not_active Abandoned
• 2002
  • 2002-10-01 WO PCT/US2002/031366 patent/WO2003030816A2/en not_active Ceased
  • 2002-10-01 JP JP2003533850A patent/JP2005507903A/ja active Pending
  • 2002-10-01 CA CA002461960A patent/CA2461960A1/en not_active Abandoned
  • 2002-10-01 AU AU2002334785A patent/AU2002334785B2/en not_active Ceased
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