MXPA97007482A - Skin care products containing anti-irritating agents / against the come - Google Patents

Abstract

The present invention relates to mild aqueous detergent compositions, for example shampoos, based on a mixture comprising anionic surfactant and amphoteric surfactant, such as betaines, present in the composition at a level of from about 0.75 to 1.25 parts by weight per part by weight of anionic surfactant. The compositions also contain one or a mixture of climbazole and one or more co-therapeutics such as salicylic acid. The combination of the mild surfactant system and said therapeutic agent serves to prevent or treat mild skin disorders such as itching of the scalp and scalp irritation when applied to the scalp like a shampoo. The shampoo compositions also preferably contain one or more conditioning agents and suitable suspending agents. The invention also provides a method for treating dry skin comprising applying certain of the therapeutic agents to dry skin to promote natural secretion of the skin.

Description

SKIN CARE PRODUCTS CONTAINING ANTI-IRRITATING AGENTS / AGAINST THE COMEZON Field of the Invention The invention relates to skin care compositions which exhibit a therapeutic effect in the treatment of skin disorders such as itching, irritation and dryness of the skin.

Description of Related Art There are a large number of shampoo products on the market today which are specifically formulated as shampoos against dandruff. These products generally contain one or a mixture of surfactants, with the primary surfactant being an anionic surfactant such as an alkyl or aryl sulfate or a sulfonate. One hypothesis is that dandruff problems are thought to be linked to the presence of a yeast-type fungus on the skin and to an acceleration of the normal process of skin production. Conventional dandruff shampoos generally contain effective amounts of an active agent which inhibits the growth of fungi and / or delays the growth of cells on the scalp. Examples of these agents include zinc pyrithione, selenium sulfide, salicylic acid, coal tar, sulfur, ketoconazole and climbazole. Examples of shampoo formulations against dandruff are described in U.S. Patent Nos. 4,089,945; 4,329,334; 4,329,335; and 4,329,336 and 4,835,148.

However, experience has shown that excessive dandruff is largely a problem associated with cold and dry climates and usually does not occur until after puberty. In the more humid tropical regions, dandruff is a much less common problem. However, the inhabitants of these regions are generally more susceptible to mild forms of scalp dermatitis with such symptoms as excessive scalp itching, irritation of the scalp, inflammation, scalp dryness and redness of the scalp. These symptoms can also occur during the hot summer months in non-tropical regions. Even though many of these symptoms must be alleviated by the use of anti-fungal agents present in some shampoos against dandruff, for example, climbazole, zinc periotione or selenium sulfide, experience has shown that these symptoms do not They are relieved, and in fact, are still made worse by the irregular use of many commercial dandruff hair shampoos.

Therefore, it is a primary object of this invention to provide a mild and aqueous skin care detergent composition, for example a scalp care shampoo or a shower cleansing composition that exhibits a therapeutic effect on the skin. skin disorders, particularly scalp disorders, particularly as they are found in warm climate and in tropical regions.

It is another object of the invention to provide a skin care product for the treatment of dry skin, other than the skin of the scalp, which promotes the natural secretion of sebum.

Synthesis of the Invention The present invention provides a mild aqueous detergent composition, for example, a shampoo composition, having a therapeutic effect on the skin and scalp disorders comprising an aqueous dispersion of: (a) from about 5 to about 12 % by weight of an anionic surfactant; (b) an amphoteric surfactant present in said composition at a level of at least about 0.075 parts by weight per part by weight of said anionic surfactant; and (c) from about 0.10 to about 4% by weight of a therapeutic agent selected from the group consisting of 1-imidazolyl-1- (4-chlorophenoxy) -3,3-dimethylbutane-2-one, (climbazole ) acetylsalicylic acid, salicylic acid, 2,4,4, '- trichloro-2'-hydroxy diphenyl ether (triclosan); l-acetyl-4- (4- ((2- (2,4-dichlorophenyl) -2- (lH-imidazolyl-1-methyl) -1, 3-dioxolan-4-yl) methoxy) phenyl) -piperazine ( Cetoconazole); l-hydroxy-4-methyl-6- (2,4,4-trimethylpentyl) -2-monoetholamine pyridine salt (picrotone olamine); selenium sulfide; zinc pyrithione; coal tar; sulfide; 2- (4'-isobutylphenyl) propionic acid (ibuprofen); and mixtures thereof.

The invention also provides a method for treating scalp disorders such as scalp irritation and / or itching which comprises applying to the hair and scalp compositions of the invention such as shampoo and rinsing the hair shampoo after having washed it with shampoo Therapeutic testing of individuals living in tropical climates has shown that the detergent compositions of the invention, particularly in the form of shampoos, serve to prevent the onset of minor scalp disorders in individuals previously free of disorders and provide therapeutic healing of such disorders in the individuals who are presented with such disorders.

Detailed description of the invention The anionic surfactants normally present in mild detergent compositions, especially shampoo formulas, are used not only for the detersive or cleansing operation, but because they impart a high degree of foaming characteristics to the detergent or chammpu composition which improve the attraction to the consumer. However, anionics are generally much more irritating to the skin than are amphoteric or non-ionic surfactants. On the other hand, these latter types of surfactant are considerably less foaming than anionic and therefore less attractive when used as a single or main surfactant component in a detergent composition or in a shampoo.

The present invention is based on the discovery that the use of a specific combination of anionic and amphoteric surfactants provides a mild surfactant base for a therapeutic aqueous body cleansing composition particularly in the form of a shampoo so that the surfactant system does not tend to counterattack or deny the therapeutic benefits provided by the therapeutic agents present in the body cleansing composition or shampoo.

Suitable anionic surfactants which may be used include the water-soluble ammonium or alkali metal salts having alkyl radicals containing from about 8 to about 22 carbon atoms, the term "alkyl" being used to include the alkyl portion of the higher acyl radicals. Examples of suitable synthetic anionic surfactants are sodium or ammonium alkyl sulphates, especially those obtained by sulfating the higher alcohols (C8-C18) produced for example from tallow or from coconut oil; the alkyl benzene sulfonates (C9-C20) particularly the linear secondary sodium (C10-C15) benzene sulphonates; sulfates of alkyl glycerol ether, especially those ethers of higher alcohols derived from tallow or coconut oil and synthetic alcohols derived from petroleum; the fatty monoglyceride sulphates and sulphonates of coconut oil; salts of sulfuric acid esters of alkylene oxide-higher fatty alcohol (Cß-C18), particularly reaction products of ethylene oxide; the reaction products of fatty acids such as coconut fatty acids esterified with isethionic acid and neutralized with sodium hydroxide; sodium and potassium salts of methyl taurine fatty acid amides; alkene monosulfonates such as those derived from reacting alpha-olefins (C8-C20) with sodium bisulfite and those derived from reacting paraffins with S02 and Cl2 and then hydrolyzing with a base to produce a sulfonate at random; and olefin sulphonates whose term is used to describe the material made by reacting olefins, particularly C10-C20 alpha olefins, with So3 and then neutralizing and hydrolyzing the reaction product. Preferred anionic surfactants are the sodium (C 10 -C 1 B) alkyl or ammonium sulfates and the (C 10 -C 18) alkyl polyethoxy (1-11 Eo) sulfates and mixtures thereof having different solubilities in water.

The particularly preferred anionic surfactant comprises a mixture of a sodium or ammonium sulfate or ammonium of C10 to C18 alkyl or a sodium or ammonium sulphonate C14-C18 alpha olefin (AOS) and a sodium or ammonium sulfate (2-4 EO) ) C8 to C12 alkyl polyethoxy. Mixtures containing a major amount of the alkyl sulfates, olefin sulfonates or alkoxy alkyl sulfates with aryl sulfonates such as sodium eumenium sulfonate, sodium xylene sulfonate and sodium benzene sulfonate are also preferred.

The amount of anionic surfactant present in the composition will generally vary from about 4 to about 12% by weight (active ingredient), more preferably from about 6 to 10% by weight.

The second essential component of the formula is an amphoteric surfactant, present at a level of at least about 0.075 parts by weight per part by weight of the content of anionic surfactant present in the composition. The preferred level of amphoteric surfactant is in the range of from about 0.075 to 1.25 parts by weight, more preferably from about 0.9 to 1.1 parts by weight per part by weight of anionic surfactant. It has been found that the presence of one or more amphoteric surfactants at these levels tends to cancel the tendency of most anionic surfactants to cause irritation when they come in contact with the skin or the scalp.

Examples of amphoteric surfactants which can be used in the compositions of the invention include betaines and compounds which can be broadly described as derivatives of aliphatic secondary and tertiary amines in which the aliphatic radical can be straight or branched chain and wherein one of the aliphatic substituents contains from about 8 to about 18 carbon atoms and one contains an anionic water solubilizing group, for example, carboxy, sulfonate, sulfate, phosphate, or phosphonate. Examples of the compounds falling within this definition are sodium 3-dodecylaminopropionate, sodium 3-dodecylaminopropane sulfonate, N-alkyl taurines, as prepared by reacting dodecylamine with sodium isethionate, N-higher alkyl aspartic acids and the products sold under the trademark "Miranol".

Examples of the betaines useful herein include the higher alkyl betaines such as cocodimethyl carboxymethyl betaine, lauryl dimethyl carboxymethyl betaine, lauryl dimethyl alpha-carboxymethyl betaine, cetyl dimethyl carboxymethyl betaine, lauryl bis (2-hydroxypropyl) carboxymethyl betaine, oleyl dimethyl gamma- carboxypropyl betaine, lauryl bis- (2-hydroxypropyl) alpha-carboxymethyl betaine and the like.

Other suitable sulfobetaines include 1- (lauryl, dimethylammonium) acetate-1- (myristyl dimethylammonium) propane-3-sulfonate and 1- (myristyl dimethylamino) -2-hydroxypropane-3-sulfonate.

Particularly preferred betaines are those having the following general formula: R3 Wherein is an alkyl group having from about 10 to 20 carbon atoms, preferably from 12 to 16 carbon atoms or the amino radical: R-C- (0) -N (H) - (CH 2) n- Where is an alkyl group having about 10 to 20 carbon atoms and n is the integer from 1 to 4; R2 and R3 are each alkyl groups having from 1 to 3 carbon atoms and preferably one carbon; R 4 is an alkylene or hydroxyalkylene group having from 1 to 4 carbon atoms and optionally, a hydroxyl group; and X is an anion selected from the group consisting of S03 = and COO =. Typical alkyl dimethyl betaines include decyl dimethyl betaine or 2- (N-decyl-N, N-dimethylammonium) acetate, coconut dimethyl betaine or 2- (N-coco-N, N-dimethyl-ammonium) acetate, myristyl dimethyl betaine , cetyl dimethyl betaine, stearyl dimethyl betaine, and so on. Typical sulfabetaines or sulfains similarly include cocodimethyl sulphobetaine, or 3- (N-coco-N, N-dimethyl ammonium) propane-1 sulfonate, myristyl dimethyl sulphobetaine, or 3- (N-coco-N, N-dimethyl ammonium) propane -1 sulfonate, myristyl dimethyl sulfobetaine, palmityl dimethyl sulphobetaine, lauryl dimethyl sulfobetaine, and so on. Amidobetaine and amidosulfobetaines similarly include cocoamidoethyl betaine, cocoamidoethyl sulfobetaine, cocoamidopropyl betaine, cocoamidopropyl sulfobetaine and similar materials.

Shampoo formulas containing a combination of anionic and amphoteric surfactants such as betaines present at a level of at least about 0.065 parts by weight of betaine per part by weight of anionic surfactant are described in the United States patent application. of North American co-pending series No. 08 / 155,251, the complete description of which is incorporated herein by reference.

The composition may also contain one or more nonionic surfactants which aid in the formation of more stable aqueous compositions, which compositions may be in the form of solutions or dispersions, particularly suspensions or emulsions. Nonionics, which were used, are generally present as a minor surfactant, generally at levels below 10% by weight, more preferably below 5% by weight of the composition.

Suitable nonionic surfactants include, in particular, the reaction products of the compounds having a hydrophobic group and a reactive hydrogen atom, for example, aliphatic alcohols, acids, amides and alkyl phenols with alkylene oxides, especially ethylene oxide. , either alone or with propylene oxide. The compounds of specific nonionic surfactants are branched or linear primary or secondary alcohols (C6-C18) condensed with ethylene oxide, and products made by condensation of ethylene oxide with the reaction products of propylene oxide and ethylene diamine. Other so-called non-ionic surfactant compounds include the long chain tertiary amine oxides, the long chain tertiary phosphine oxides, the alkyl sulfoxides, the fatty esters (C8-C18) of glycerol, sorbitan and the like, the polyglycosides of alkyl, the ethoxylated glycerol esters, the ethoxylated sorbitans and the ethoxylated phosphate esters.

A more detailed illustration of the various surfactants and surfactant classes mentioned can be found in the text "Active Surface Agents", Volume II by Schwartz, Perry and Berch (Interscience Publishers, 1958), in a series of annual publications entitled Detergents and Emulsifiers of McCutcheon, which went into circulation in 1969, or in Tenside-Taschenbuch. H. Stache, 2a. Edition, Cari Hanser Verlag, Munich and Vienna, 1981.

The present therapeutic agent in the composition is selected from the group consisting of climbazole, acetylsalicylic acid, salicylic acid, triclosan, ketoconazole, pyrotone or lamina, selenium sulfide, zinc pyrithione, coal tar, sulfur, ibubropen and mixtures of the same, present at a level of from about 0.10 to about 4% by weight.

The therapeutic agent preferably present in the composition of the invention is climbazole which is known chemically as 1-imidazolyl-1- (4-chlorophenoxy) -3,3-dimethylbutane-2-one or equivalent imidazolyl compounds. This agent can be prepared by reacting 1-bromo-l- (4-chlorophenoxy) -3-dimethylbutane-2-one with the imidazole dissolved in acetonitrile as described in US Pat. Nos. 3,812,142 and 3,903,287. This imidazolyl ketone is a water-insoluble crystalline powder having a melting point of 94.5 ° -97.8 ° C and can be obtained from the Bayer Company.

Climbazole has proven to be a more effective therapeutic in compositions having a pH on the acid side, for example, from about 4.0 to about 6.9, more preferably from about 4.5 to 6.5. It may be necessary to adjust the pH of the shampoo formula with a suitable acid, for example, citric acid. Suitable acid buffers such as boric acid, and phosphoric acid can also be used.

A combination of climbazole with one or more anti-inflammatory or ceratolytic agents such as acetylsalicylic acid (aspirin), salicylic acid, 2,4,4'-trichloro-2-hydroxy diphenyl ether (triclosan); 2- (4'-isobutylphenyl) propionic acid (ibuprofen), l-acetyl-4- (4- ((2- (2,4-dichlorophenyl) -2- (lH-imidazolyl-1-methyl) -1,3 - dioxolan-4-yl) methoxy) phenyl) -piperazine (Cetoconazole); l-hydroxy-4-methyl-6- (2,4,4-trimethylpentyl) -2-monoethanolamine pyridone salt (piroctone olamine); coal tar; selenium sulfide; Sulfur or zinc pyrithione are also within the scope of the invention. The addition of one or more of these therapeutics serves the dual roles of pH adjustment (where the additive is acidic) as described above, and as a co-therapeutic along with climbazole. The use of the combination can also impart improved hair conditioning effects for the shampoo as will be described hereafter. Climbazole will normally be present in the shampoo at an effective level to provide therapeutic relief of the scalp disorders described therein. Preferred levels are in the range of from about 0.1 to about 4% by weight, more preferably from about 0.25 to 2.5% by weight and more preferably from about 0.5 to 1.5% by weight. When used with a co-therapeutic, for example, salicylic acid, the co-therapeutic may be present at a level of from about 0.1 to about 10% by weight, more preferably from about 0.25 to about 4%. by weight and more preferably from about 0.25 to 2.5% by weight.

The body cleansing composition of the present invention may also be formulated as a hair conditioning shampoo and therefore may contain one or more hair conditioning agents and suspending agents.

Hair conditioning agents include organosilicon compounds, for example, non-volatile silicones and aminosilicones, such as dimethicone. The conditioner may also comprise water insoluble polyethylenes; paraffins, petrolatum; microcrystalline waxes; C18-C36 mixed fatty acids and the corresponding triglycerides; stearyl stearate and similar known conditioners.

The conditioners may also include various cationic quaternary ammonium salts or polymers. Preferred quaternary ammonium salts include materials such as tricholyl methyl ammonium chloride, dicetyl dimethyl ammonium chloride, distearyl dimethyl ammonium chloride, tristearyl methyl ammonium chloride and other quaternary such as: guar hydroxypropyl trimethyl ammonium chloride (Cosmedia GUAR-C261) available from Hoechst Celanese Corp.); polyethylene glycol (PEG 15) coco-polyamine ® (Polyquat H81, available from Henkel G.m.b.H.); quaternized hydroxyethylcellulose, available from Amerchol as polymers JR and LR; dimethyldiallylammonium chloride polymers or copolymers thereof with acrylamide, available as Merquats 100 and 550 (also known as polyquaternium 10 and 7 respectively); vinyl imidazole vinyl pyrrolidone copolymers, available as Luviquats from BASF Corporation; copolymers of polyvinyl pyrrolidone-dimethylaminoethyl methacrylate, available as GAFQUATS from GAF Corporation; and similar materials. Quaternary conditioners are normally present in the composition at levels of from about 0.2 to about 5% by weight.

Hair conditioning shampoos also contain one or more suspending agents or lipids which help maintain a stable dispersion of ingredients not soluble in water and also impart improved hair conditioning effects, generally present at a level of from about 1 to 15. % by weight. Suitable agents include the long chain acyl derivatives such as the C16 to C50 fatty acid esters of polyols such as glycerol, ethylene glycol or sorbitol. Preferred agents of this class include glycerol distearate and Isosteareth (2 or 10), as well as the long chain alkanolamides such as distearate DEA stearamide. Suspension agents of this type are normally present in the composition at a level of from about 0.5 to about 5% by weight of the composition.

Other useful suspension stabilizers are the long chain primary alcohols or the ethoxylated alcohols averaging about 26 to 40 carbon atoms in the chain. These alcohols are mixed alcohols wherein at least about 80% of the chain lengths are 18-44 carbon atoms for the alcohols averaging 30 carbon atoms and at least 80% of the chain lengths are 30- 54 carbon atoms for the alcohols averaging 40 carbon atoms. These materials are available from Petrolite Corporation under the trade name UNILIN alcohols * 1 * 1"* The preferred materials are alcohol UnilinMARCA 425 (average chain of 30 carbons), alcohol Unilin" * 0 * 550 (average chain of 40 carbons) and alcohol Unilin "* 01 350 (average chain of 26 carbons.) A suitable derivative is Unithox * 1 * 0 * 550 which is an ethoxylated alcohol (13 Eo) averaging 40 carbon atoms in the alkyl chain These alcohols are normally present in the composition at levels of from about 1 to about 7% by weight.

The shampoo composition also contains water, preferably deionized or irradiated water. The amount of water present in the composition as added water plus water present in the ingredients used in the formula will generally vary from about 50 to about 85% by weight, more preferably from about 60 to about 80% by weight .

In addition to the above-mentioned constituents of the liquid shampoo, normal and conventional auxiliaries may be present, provided that these do not adversely affect the properties of the shampoo. Thus, various coloring agents and perfumes, ultraviolet light absorbers such as Uvinols, which are products of GAF Corporation, preservatives such as formaldehyde or hydrogen peroxide; pearlescent and opacifying agents, solvents, such as ethanol, glycerin and glycols (ethylene glycol is useful as a clarifying agent, to prevent high and low temperature clouding of desirably clear shampoos); lubricants, such as mineral oil and higher fatty alcohols, for example cetyl alcohol, stearyl alcohol, sequestering agents, such as EDTA tetrasodium salt, thickeners, such as hydroxypropyl methyl cellulose (Methocek 34M) and salts like sodium chloride, and so on. The proportion of such auxiliary material in total will normally not exceed 5% of the shampoo.

Shampoos are easily made by simple mixing methods of readily available components such as, in storage, that do not adversely affect the entire composition. However, it is preferred that the imidazolyl compound is first mixed with a nonionic component before the addition of the amphoteric and anionic surfactants. However, in the absence of a non-ionic surfactant, the climbazole can also be mixed with an aqueous solution of the amphoteric betaine before the addition of the anionic surfactant. Therefore, the products are capable of being made in a desired transparent form or in an opaque or opalescent form. The viscosities are adjusted by changing the total percentage of the active ingredients and by modifying the percentages of the thickening agent, sodium chloride and other auxiliaries. The viscosity of the shampoo will normally be around that of glycerin at room temperature, for example, of about 1,000 centipoise, but the viscosity may be in wider ranges of 250-1,500 centipoise. Its viscosity can approximate those of commercially available shampoos now on the market. Instead of measuring viscosity directly, such as using a Brookfield LVF viscometer, one can use standard laboratory flow tests in which flow times can be measured in seconds through a restriction or length of tube under a reproducible head, using a Raymond tube. The viscosities may preferably vary from 10-135 seconds and up to 300 or 400 seconds. The shampoo itself remains stable in storage for extended periods of time, without color changes or settling of any insoluble materials.

The following examples are illustrative of the invention.

Example 1 A shampoo composition was prepared by the general mixing procedure described above. The formula of this shampoo is as follows in percent by weight: COMPONENT AS IT IS% ACTIVE Cocoamidopropyl betaine No. 3 30.0 9.0 Deionized water (irradiated) 25.0 - Deceth Sodium Sulphate (3 Eo) 15.0 4.5 Ammonium Lauryl Sulfate 12.0 3.0 Sodium sulfonate sodium 5.0 2.3 Fatty Alcohol C30-C40 (UNILINMARCA) 4.0 4.0 Dimethyl polysiloxane 3.5 3.5 Distearyl Methylammonium Chloride 1.0 1.0 Condom 1.0 1.0 Isosteareth (2 Eo) 0.8 0.8 Perfume 0.75 0.75 Hydroxyethyl cellulose 0.6 0.6 Climbazole 0.5 0.5 Poliquaternium 10 0.35 0.35 Sodium Phosphate (dibasic) 0.2 0.2 EDTA 0.1 0.06 Coloring 0.013 0.013 This shampoo was designated as Formula A.

Example 2 A second shampoo having the formula of Example 1 was prepared except that the amount of climbazole was raised to 1.5% by weight and 1.5% by weight less water was added to the formula. This formula was designated as Formula B.

The effectiveness of the shampoo formulas of the present invention for curing and preventing scalp disorders was evaluated using the following protocol. 90 residents of the Dominican Republic who were free of scalp disease (as determined by a dermatologist), but which complained regularly of irritation of the scalp and itching caused by the use of the shampoo were selected by means of a questionnaire. The group was arbitrarily divided into six groups of fifteen people each.

Four groups were used to evaluate the effectiveness of formulas A and B given above to reduce discomfort of the scalp (itching) for those complaining of discomfort after shampooing with a control formula containing a high content of anionic surfactant. The control formula used was a formula containing no therapeutic agent and a high surfactant mixture in anionic content. The combination of surfactant (active) in the control was: Ammonium lauryl sulfate - 19% by weight Cocamide DEA * - 4.5% by weight Sodium eumenium sulphonate - 1.4% by weight laureth Na -13 carboxylate - 2.5% by weight * CTFA is the adopted name for coconut diethanolamide Each of the four panels was shampooed with the control product one day and one day not for two weeks for a total of seven washes. The shampoo procedure involved the application of 10 grams of control directly to the moist scalp followed by a minute massage to the scalp. The hair is then washed and rinsed free of foam and dried.

The evaluations of the scalp were made by the subjects themselves and a dermatologist after six, ten and fourteen days to determine the degree of discomfort of the scalp caused by the shampooing using the control. The ratings of itching, irritation (redness of the skin), dryness and scales were made on a scale of 1 to 10 with the number 1 not representing a problem and the 10 representing the maximum problem.

The average rating for each of the four groups at the end of the control washout for each of the four scalp discomfort factors was plotted as a baseline value.

The four control groups were then subjected to seven additional shampoos using the protocol described above over the next two weeks using the following shampoos: Group A - Formula A Group B - Formula B Group C - Commercial product HEAD AND SHOULDERSMARK obtained in Mexico (H &S) * Group D - Commercial product PANTENE "** '* For the care of the scalp / against dandruff obtained in the Philippines * * The main surfactant is anionic.

The evaluations of the scalp for each group were made after the third, fifth and seventh washings, were graded on a scale of 1 to 10 as described above and plotted as a regression line adjusted for each group against the values of baseline obtained after the control washes.

Scalp changes are shown in Table 1. The more negative the change, the better the condition of the scalp is.

TABLE 1 PANTENE -0.28 -0.35 -0.28 -1.75 Mcuginally Effective H &S 0.18 -0.28 1.05 -2.05 Marginally Effective Form B -2.10 -0.15 -3.93 -5.30 More Cash Form A -1.25 -1.00 -1.00 -3.72 Cash These results show that the products of the present invention are considerably more effective than commercial anti-dandruff shampoos (which contain an anionic surfactant as the main surfactant component) in order to reduce or eliminate essentially the disorder factors of leather scalp caused by the use of an irritating high anionic shampoo.

The rest of the two groups of fifteen panelists each (group E and F) underwent a different protocol. In this protocol, there were no control washes, but instead the hair of each panelist was washed every third day by the washing procedure described above (for a total of fourteen washes) with the Head & Shoulders "** 0 * (Group E) and with formula B (Group F) The objective of this protocol was to determine the effectiveness of each product in preventing the onset of dandruff disorders. Baseline of the scalp disorder for each panelist before the fourteen washes was established by dermatological observation and panelist information.

Changes in scalp characteristics after fourteen washes rated on a scale of 1-10 were drawn as indicated above. Results are shown in table 2.

TABLE 2 CHAMPÚ COMEZÓN IRRITATION SEQUEDAD ESCAMAS CONCLUSIÓN H & S -2 .42 - 0. 07 0. 08 -2. 98 Marginalroente Cash Form B -2. 69 - 1. 49 -4. 93 -4.84 Cash The results show that the product of the invention is considerably more effective in preventing the onset of scalp disorder problems than a leading trademark.

Again, it is believed that the main factor contributing to this efficiency is the mild surfactant system present in the formula of this invention.

A further feature of the invention is based on the discovery that the mild conditioning shampoos of the invention will contain an alkyl, alkaryl or alpha olefin sulfonate as the main anionic surfactant and a combination of climbazole and salicylic acid or acetylsalicylic acid will also provide Improved conditioning effects in an acidic shampoo (pH 4.0-5.0). Two shampoo formulas containing the following compositions of therapeutic ingredient and surfactant were prepared: Example 3 Example 4 Climbazole 1.5 Salicylic Acid 2.0 AOS Sodium (40%) 22.5 22.5 Natrium sulfonate Na (43.3%) 7.0 7.0 Cocoamidopropylbetaine (30%) 30.0 30.0 The remainder of each formula was identical and essential as described in Examples 1 and 2. The pH of each formula was adjusted to 4.0 using citric acid.

Hair washing with the shampoo of Example 3 exhibited an improved hairstyle compared to washed hair using the formula of Example 4. This is indicative of an increased deposition on the hair of the cationic hair conditioning components present in the formula of Example 3 as a result of the presence of the therapeutic agents climbazole and salicylic acid.

In another embodiment of the invention skin care products in the form of gels, lotions, creams, foams, bars and liquid soaps containing one or more tallow-promoting active ingredients are provided which are adapted to be applied to the areas of the skin other than the scalp as skin moisturizers. It has been found that the active ingredients climbazole, selenium sulphide and zinc pyrithione tend to stimulate the sebaceous glands when rubbed into the skin; thus promoting the natural production of oily body sebum. The excess sebum generated in the skin acts as a natural skin softener and moisturizer. These products and similar products such as triclosan, ketoconazole, pyroctone or amine and mixtures thereof can be formulated to contain from about 0.1 to about 5% by weight, more preferably from about 0.25 to 2.5% by weight. weight, of the active ingredient, dispersed or dissolved in a suitable carrier medium which may comprise water, lower Cx to C4 alcohols such as ethanol or isopropanol, polyalcohols such as glycerin or propylene glycol, and mixtures thereof.

These carrier compositions may also contain one or more surfactants, for example, the anionic, cationic, nonionic or amphoteric surfactants such as to form a cleansing lotion; one or more soap materials such as sodium cebutoate, sodium cocoate, sodium palm kernel, or sodium palmitate as used to formulate a bar of soap; thickening agents such as carboxymethyl cellulose used to form a gel; and softeners, emollients, fatty acids, fatty alcohols, fatty acid esters, natural or synthetic oils or waxes and suspending agents as used to formulate skin creams, lotions and emulsions. These products may also contain dyes, perfumes, preservatives and pH regulating agents.

The tests were carried out using two different skin cleansing creams, one containing 1.0% by weight of climbazole and the other containing 2.0% by weight of zinc pyrithione. These products were rubbed into the dry skin areas of two groups of panelists, each of whom complained of dryness of the skin for one minute once a day for seven days. The sebum meter readings taken at the end of the test period showed an increase in the sebum content of the skin. A consequent decrease in skin dryness and cracking was also observed in the panelists.

Claims (44)

R E I V I N D I C A C I O N S

1. A mild aqueous detergent composition having a therapeutic effect on skin disorders comprising: (a) from about 4 to about 12% by weight of an anionic surfactant; (b) an amphoteric surfactant present in said composition at a level of at least about 0.75 parts by weight per part by weight of said anionic surfactant; Y (c) an effective amount of a therapeutic agent selected from the group consisting of 1- imidazolyl-1- (4-chlorophenoxy) -3,3-dimethylbutane-2-one, (climbazole); acetylsalicylic acid; salicylic acid, 2,4,4, '-trichloro-2'-hydroxy diphenyl ether (triclosan); l-acetyl-4- (4- (2- (2,4-dichlorofenyl) -2- (1H-imidazolyl-1-methyl) -1,3-dioxolan-4-yl) methoxy) phenyl) -piperazine ( Cetoconazole); 1-Hydroxy-4-methyl-6- (2,4,4-trimethylpentyl) -2 -salt of monoe taolate pyridone (pyroctone olamine); selenium sulfide; zinc pyrithione; coal tar; sulfide; 2- (4'-isobutylphenyl) propionic acid (ibuprofen); and mixtures thereof.

2. The composition, as claimed in clause 1, characterized in that it contains from about 0.75 to 1.25 parts by weight of an amphoteric surfactant per part by weight of the anionic surfactant.

3. The composition, as claimed in clause 2, characterized in that it contains from about 0.9 to 1.1 parts by weight of said amphoteric surfactant per part by weight of the anionic surfactant.

4. The composition, as claimed in clause 1, characterized in that said detergent composition is a shampoo.

5. The composition, as claimed in clause 4, characterized in that said therapeutic agent is climbazole present at a level of from about 0.1 to about 4% by weight.

6. The composition, as claimed in clause 5, characterized in that said climbazole is present at a level of from about 0.25 to about 2.5% by weight.

7. The composition, as claimed in clause 5, characterized in that the therapeutic agent comprises a mixture of climbazole and salicylic acid wherein the salicylic acid is present at a level of from about 0.1 to about 10% by weight.

8. The composition, as claimed in clause 7, characterized in that said salicylic acid is present at a level of from about 0.25 to about 2. 5% by weight.

9. The composition, as claimed in clause 4, characterized in that said amphoteric surfactant is a betaine or sulfobetaine.

10. The composition, as claimed in clause 9, characterized in that said betaine is cocoamidoethyl betaine or cocoamidopropyl betaine.

11. The composition, as claimed in clause 4, characterized in that said anionic surfactant is selected from the group consisting of sodium or ammonium C10 to C18 alkyl sulfates or sulphonates, C14 to C18 alpha olefin sulphonates, sulfates C 8 to C 12 alkyl polyethoxy and mixtures thereof, and combinations thereof with an aryl sulfonate.

12. The composition, as claimed in clause 2, characterized in that said anionic surfactant is present at a level of from about 6 to 10% by weight.

13. The composition, as claimed in clause 4, characterized in that it contains a hair conditioning agent selected from the group consisting of organosilicone compounds, aminosilicones, water insoluble hydrocarbons, water insoluble fatty acid esters, quaternary ammonium salts and combinations thereof, present at a level of from about 0.2 to 5% by weight.

14. The composition, as claimed in clause 13, characterized in that said hair conditioner comprises a quaternary ammonium salt.

15. The composition, as claimed in clause 14, characterized in that said therapeutic agent comprises a mixture of climbazole and acetylsalicylic acid.

16. The composition, as claimed in clause 14, characterized in that said quaternary ammonium salt is selected from the group consisting of tricethyl methyl ammonium chloride, dicetyl methyl ammonium chloride, distearyl dimethyl ammonium chloride, tristearyl methyl ammonium chloride and mixtures thereof .

17. The composition, as claimed in clause 13, characterized in that said conditioner is a polysiloxane or an aminopolysiloxane.

18. The composition, as claimed in clause 13, characterized in that said quaternary ammonium salt is the salt of a dimethylammonium chloride polymer or copolymers thereof with acrylamide.

19. The composition, as claimed in clause 4, characterized in that it also contains one or a mixture of suspending agents present at a level of from about 0.5 to 7% by weight.

20. The composition, as claimed in clause 19, characterized in that said suspending agent is a long chain alcohol or an ethoxylated alcohol averaging about 26 to 40 carbon atoms.

21. A method for treating or preventing scalp disorders such as irritation, inflammation, dryness and redness and itching comprising applying to the hair and scalp an aqueous composition comprising: (a) from about 4 to about 12% by weight of an anionic surfactant; (b) an amphoteric surfactant present in said composition at a level of at least about 0.75 parts by weight per part by weight of said anionic surfactant; Y (c) an effective amount of a therapeutic agent selected from the group consisting of 1-imidazolyl-1- (4-chlorophenoxy) -3,3-dimethylbutane-2-one, (climbazole); acetylsalicylic acid; salicylic acid, 2,4,4, '-trichloro-2'-hydroxy diphenyl ether (triclosan); l-acetyl-4- (4- (2- (2,4-dichlorophenyl) -2- (1H-imidazolyl-1-methyl) -1, 3-dioxolan-4-yl) methoxy) phenyl) -piperazine (Cetoconazole ); l-hydroxy-4-methyl-6- (2,4,4-trimethylpentyl) -2 -salt of monoethanolamine pyridone (pyroctone olamine); selenium sulfide; zinc pyrithione; coal tar; sulfide; 2- (4'-isobutylphenyl) propionic acid (ibuprofen); and mixtures thereof.

22. The method, as claimed in clause 21, characterized in that the composition contains from about 0.75 to 1.25 parts by weight of the amphoteric surfactant per part by weight of the anionic surfactant.

23. The method, as claimed in clause 22, characterized in that the composition contains from about 0.9 to 1.1 parts by weight of said amphoteric surfactant per part by weight of said anionic surfactant.

24. The method, as claimed in clause 21, characterized in that said therapeutic agent is climbazole present at a level of from about 0.1 to about 4% by weight.

25. The method, as claimed in clause 23, characterized in that said climbazole is present at a level of from about 0.25 to about 2.5% by weight.

26. The method, as claimed in clause 24, characterized in that said therapeutic agent comprises a mixture of climbazole and salicylic acid wherein said salicylic acid is present at a level of from about 0.1 to about 10% by weight.

27. The method, as claimed in clause 26, characterized in that said salicylic acid is present at a level of from about 0.25 to about 2.5% by weight.

28. The method, as claimed in clause 21, characterized in that said amphoteric surfactant is a betaine or sulfobetaine.

29. The method, as claimed in clause 28, characterized in that said betaine is cocoamidoethyl betaine or cocoamidopropyl betaine.

30. The method, as claimed in clause 21, characterized in that said anionic surfactant is selected from the group consisting of sodium or ammonium C10 to C18 alkyl sulfates or sulphonates, C14 to C18 alpha olefin sulphonates, alkyl polyethoxy sulfates C8 to C12 and mixtures thereof, and combinations thereof with an aryl sulfonate.

31. The method, as claimed in clause 22, characterized in that said anionic surfactant is present at a level of from about 6 to 10% by weight.

32. The method, as claimed in clause 21, characterized in that the composition also contains a hair conditioning agent selected from the group consisting of organosilicon compounds, aminosilicones, water insoluble hydrocarbons, water insoluble fatty acid esters, salts of quaternary ammonium and combinations thereof, present at a level of from about 0.2 to 5% by weight.

33. The method, as claimed in clause 32, characterized in that said hair conditioner comprises a quaternary ammonium salt.

34. The method, as claimed in clause 33, characterized in that said therapeutic agent comprises a mixture of climbazole and salicylic acid.

35. The method, as claimed in clause 33, characterized in that said quaternary ammonium salt is selected from the group consisting of tricethyl methyl ammonium chloride, dicetyl dimethyl ammonium chloride, distearyl dimethyl ammonium chloride, tristearyl methyl ammonium chloride and mixtures thereof .

36. The method, as claimed in clause 32, characterized in that said conditioner is a polysiloxane or an aminopolysiloxane.

37. The method, as claimed in clause 33, characterized in that said quaternary ammonium salt is the salt of a dimethylammonium chloride polymer or copolymers thereof with acrylamide.

38. The method, as claimed in clause 21, characterized in that the composition further contains one or a mixture of suspending agents present at a level of from about 0.5 to 7% by weight.

39. The method, as claimed in clause 38, characterized in that said suspending agent is a long chain alcohol or an ethoxylated alcohol averaging about 26 to 40 carbon atoms.

40. A method for treating dry skin conditions comprising rubbing on the affected skin areas other than the scalp a skin care composition containing a carrier having there dispersed an agent that stimulates the sebaceous glands to promote the oily sebum production selected from the group consisting of 1-imidazolyl-1- (4-chlorophenoxy) -3,3-dimethylbutane-2-one; 2,4,4, '-trichloro-2'-hydroxy diphenyl ether; 1-Acetyl-4- (4- (2- (2,4-dichlorophenyl) -2- (1H-imidazolyl-1-methyl) -1,3-dioxolan-4-yl) methoxy) phenyl) -piperazine; 1-hydroxy-4-methyl-6- (2,4,4-trimethylpentyl) -2-monoethanolamine pyridone salt; selenium sulfide and zinc pyrithione, said wetting agent is present in said composition in an amount effective to promote the natural secretion of sebum on the skin.

41. The method, as claimed in clause 40, characterized in that said skin care composition contains from about 0.1 to about 5% by weight of said agent.

42. The method, as claimed in clause 41, characterized in that said agent is zinc pyrithione or 1-imidazol-1- (4-chlorophenoxy) -3,3-dimethylbutane-2-one.

43. The method, as claimed in clause 42, characterized in that said skin care composition contains from about 0.25 to 2.5% by weight of said wetting agent.

44. The method, as claimed in clause 40, characterized in that said skin care composition is in the form of a cleansing lotion, gel, bar soap, liquid soap, foam, skin cream or cleansing liquid . SUMMARY Gentle aqueous detergent compositions, for example shampoos, are described based on a mixture comprising anionic surfactant and amphoteric surfactant, such as betaines, present in the composition at a level of from about 0.75. to 1.25 parts by weight per part by weight of anionic surfactant. The compositions also contain one or a mixture of climbazole and one or more co-therapeutics such as salicylic acid. The combination of the mild surfactant system and said therapeutic agent serves to prevent or treat mild skin disorders such as itching of the scalp and scalp irritation when applied to the scalp like a shampoo. The shampoo compositions also preferably contain one or more conditioning agents and suitable suspending agents. The invention also provides a method for treating dry skin comprising applying certain of the therapeutic agents to dry skin to promote natural sebum secretion.