Composition for use in the treatment of an excess of malassezia and / or staphylococcus on the skin

Abstract

The present invention primarily relates to compositions comprising piroctone olamine and at least one 1,2-alkanediol for use in the treatment of an excess of Malassezia and / or Staphylococcus on the skin surface of mammals, preferably of humans. The present invention further relates to products, and to the cosmetic, non-therapeutic use of a composition comprising a particular amount of piroctone olamine and 1,2-alkanediol or of products comprising such compositions to reduce the amount of Malassezia and / or Staphylococcus on the skin surface of mammals, preferably of humans.

Description

[0001] Eisenfuhr Speiser

[0002] Munich, 15 October 2024

[0003] Our Ref.: SM 7004-01 WO SOE / HGR

[0004] Applicant: Symrise AG

[0005] Serial Number: New Application

[0006] Symrise AG

[0007] MiihlenfeldstraBe 1 , 37603 Holzminden, Germany

[0008] Compositions with anti-Ma / assez / a and anti-Staphylococcus effect

[0009] The present invention primarily relates to compositions comprising piroctone olamine and at least one 1 ,2-alkanediol for use in the treatment of an excess of Malassezia and / or Staphylococcus on the skin surface of mammals, preferably of humans. The present invention further relates to products, and to the cosmetic, non-therapeutic use of a 5 composition comprising a particular amount of piroctone olamine and 1 ,2-alkanediol or of products comprising such compositions to reduce the amount of Malassezia and / or Staphylococcus on the skin surface of mammals, preferably of humans.

[0010] Further aspects of the present invention will arise from the description below, in particular from the examples, as well as from the attached patent claims. 0 Malassezia is a genus of fungi and is naturally found on the skin surfaces of many animals, including humans. It is involved in the pathogenesis of a variety of diseases, in particular skin diseases, and undesired conditions such as, for example, in pityriasis versicolor (tinea versicolor), seborrheic dermatitis and dandruff.

[0011] Staphylococcus is a genus of bacteria commonly found on the skin, with Staphylococcus5 aureus being the most notable species. While some, like S. epidermidis, are harmless and part of the skin’s normal flora, S. aureus can cause infections if the skin is damaged or the immune system is weakened. Common skin infections include impetigo, boils, cellulitis, and folliculitis. In some cases, it can lead to more severe conditions like Staphylococcal Scalded Skin Syndrome (SSSS).

[0012] *20240580613* Piroctone olamine, chemically known as 1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)- 2(1 H)-pyridone ethanolamine salt, is an organic salt with antifungal and antimicrobial properties. The compound consists of a pyridone ring (a type of nitrogen-containing heterocycle) and an ethanolamine moiety, which enhances its solubility in water. Piroctone olamine has the ability to penetrate the cell membrane and form complexes with irons, which negatively impacts a variety of different processes in the cell (e.g. disruption of the cell membranes of fungi like Malassezia). This results in growth inhibition and prevention of the formation of dandruff. Its ability to balance the scalp's microbial composition makes it effective in reducing symptoms like flaking, itching, and irritation.

[0013] The use of piroctone olamine as anti-dandruff agent is known in the state of the art. Also the use of 1 ,2-alkanediols in the treatment of dandruff is known.

[0014] The international application WO 2008 / 046795 A1 describes the use of C10- to C14- alkanediols for the treatment of dandruff. An effect on Malassezia species is also disclosed. Piroctone olamine can be used as further anti-fungal compound.

[0015] Furthermore, the international application WO 2022 / 122137 A1 discloses mixtures of (Bio)- alkanediols and antimicrobial agents (e.g. piroctone olamine) for skin protection. The effect on Malassezia species is also named. Especially compositions with 1 ,2-nonanediol and 2,3-nonanediol are disclosed.

[0016] The patent application EP 3 944 852 A1 discloses the use of 1 ,2-decanediol for enhancing the efficacy of piroctone olamine.

[0017] Even though the general concept of combining 1 ,2-alkanediols with piroctone olamine is well known in the art, the general need for improved anti-dandruff and skin protection compositions is constantly high.

[0018] Thus, the primary task of the present invention was to provide an anti-dandruff composition and / or skin protection composition, which has an improved efficacy compared to compositions known from the state of the art.

[0019] The primary task of the present invention was solved by providing a composition comprising or consisting of: piroctone olamine, 1 ,2-decanediol, at least one additional 1 ,2-alkanediol selected from the group consisting of 1 ,2- pentanediol, 1 ,2-hexanediol, 1 ,2-heptanediol and 1 ,2-octanediol, preferably 1 ,2- pentanediol or 1 ,2-hexanediol, especially preferably 1 ,2-hexanediol, optionally a cosmetically acceptable carrier, preferably glycerol for use in the treatment of an excess of Malassezia and / or Staphylococcus on the skin, preferably on the scalp, of mammals, preferably of humans.

[0020] Within the framework of the present text, the term “Malassezia” refers to one or more species of the genus Malassezia, preferably to one, two, three, four, five or more species of the genus Malassezia (as defined further below).

[0021] Within the framework of the present text, the term “Staphylococcus" refers to one or more species of the genus Staphylococcus, preferably to one, two, three, four, five or more species of the genus Staphylococcus (as defined further below).

[0022] Malassezia and Staphylococcus species are naturally found on the skin surfaces of many animals, including humans. As Malassezia requires fatty acids to grow, it is most common in areas with many sebaceous glands, i.e. on the scalp, face, and upper part of the body. However, when the microorganisms grow too rapidly, the natural renewal of cells is disturbed and, for example, dandruff appears on the scalp along with an itching sensation.

[0023] Within the framework of the present text, an excess of Malassezia and / or Staphylococcus on the skin surface, preferably on the scalp, of mammals, preferably of humans, thus relates to a situation where the total amount of Malassezia and / or Staphylococcus cells present on said skin surface leads to symptoms of skin disease such as, for example, redness, itching, dryness, flaking, greasiness, hypopigmentation and / or hyperpigmentation of the skin. The treatment of an excess of Malassezia and / or Staphylococcus on the skin surface preferably relates to an action that leads to a situation where the total amount of Malassezia and / or Staphylococcus cells present on said skin surface does not result in said symptoms of skin condition or wherein one, more or preferably all said symptoms are at least reduced. Thus, preferably a use according to the present invention (as described herein) is selected from or comprises the treatment and / or the prevention of one, more or all symptoms from the group consisting of redness, itching, dryness, flaking, greasiness, hypopigmentation and hyperpigmentation of the skin.

[0024] Within the framework of the present text, the term “on the skin surface” also includes the areas of the hair infundibulum, the junctional zone and / or the sebaceous glands, if applicable, where an excess of Malassezia and / or Staphylococcus may be present.

[0025] 1 ,2-alkanediols are straight chained alkanediols. They have a carbon chain and the two functional OH groups of the 1 ,2-alkanediol are in alpha, beta position and chemically bonded to the Ci and C2 carbon atoms in the alkanediol chain two OH groups of the alkanediol are chemically bonded to the Ci and C2 carbon atoms in the alkanediol chain.

[0026] Piroctone olamine chemically known as 1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)- 2(1 H)-pyridone ethanolamine salt, is an organic salt with antifungal and antimicrobial properties. It has the general structure according to formula (I).

[0027] It is preferred in terms of the present invention that piroctone olamine is present in an amount of from 1 to 15 wt.-%, preferably 4 to 6 wt.-%, of the total weight of the composition. An especially preferred piroctone olamine content was found to be 5 wt.-%.

[0028] Moreover, it is preferred that 1 ,2-decanediol is present in an amount of from 20 to 50 wt.- %, preferably 30 to 40 wt.-%, in relation to the total weight of the composition. An especially preferred 1 ,2-decanediol content was found to be 35 wt.-%. 1 .2-decanediol is an 1 ,2-alkanediol having a linear carbon chain with ten carbon atoms. Preferably, the term 1 ,2-decanediol also incorporates mixtures of 1 ,2- and 2,3-decanediol.

[0029] Furthermore, a composition according to the invention for use in the treatment of an excess of Malassezia and / or Staphylococcus on the skin comprises at least one additional 1 ,2- alkanediol selected from the group consisting of 1 ,2-pentanediol, 1 ,2-hexanediol, 1 ,2- heptanediol and 1 ,2-octanediol, preferably 1 ,2-pentanediol or 1 ,2-hexanediol, especially preferably 1 ,2-hexanediol is present in an amount of from 30 to 70 wt.-%, more preferably 40 to 60 wt.-%, in relation to the total weight of the composition. An especially preferred

[0030] 1 .2-hexanediol content was found to be 50 wt.-%.

[0031] According to another preferred embodiment, the weight ratio of piroctone olamine to the sum of 1 ,2-alkanediols present in the composition or in the product for use in the treatment of an excess of Malassezia and / or Staphylococcus on the skin as defined herein is from 1 : 5 to 1 : 25, more preferably from 1 : 7.5 to 1 : 20 and most preferably from 1 : 10 to 1 : 18. Especially preferably, the ratio of piroctone olamine to 1 ,2-decanediol and the at least one additional 1 ,2-alkanediol is 1 :17.

[0032] It is preferred in terms of the present invention that the cosmetically acceptable carrier, preferably glycerol, is present and is preferably present in an amount of from 1 to 20 wt.- %, preferably 5 to 15 wt.-%, in relation to the total weight of the composition. An especially preferred glycerol content was found to be 10 wt.-%.

[0033] The term “cosmetic carrier” relates in terms of the present invention to a substance, which provides e.g. an improved applicability of the composition or of the cosmetic product the composition is incorporated in. Preferred cosmetic carrier materials are solid or liquid at 25°C and 1013 mbar (including highly viscous substances) as for example glycerol, 1 ,2- propylene glycol, 1 ,2-butanediol, 1 ,3-propanediol, 1 ,3-butylene glycol, ethanol, water, and mixtures of two or more of said liquid carrier materials with water.

[0034] Other preferred liquid carrier substances, which may be a component of a composition or cosmetic product according to the invention are selected from the group consisting of oils such as vegetable oil or neutral.

[0035] In terms of the present invention, the presence of glycerol as cosmetic carrier is preferred. The composition according to the present invention has several advantages:

[0036] 1 . The compound piroctone olamine is difficult to solubilize. In terms of the composition according to the invention, the solution of piroctone olamine was improved.

[0037] 2. The compound piroctone olamine is an economically intensive raw material. In terms of the composition according to the invention, the amount of piroctone olamine was decreased compared to compositions known from the state of the art while maintaining the same efficiency or even having an improved efficacy.

[0038] 3. The preservation of a cosmetic composition is challenging and usually requires the addition of more preservatives. In terms of the composition according to the invention, the composition exhibits a dual effect: a preservation of the composition and the simultaneous growth inhibiting effect on Malassezia and Staphylococcus species can be achieved.

[0039] It was surprisingly found that the combination of piroctone olamine and 1 ,2-decanediol in the defined amounts and at least one additional 1 ,2-alkanediol as defined herein leads to a synergistic increase in antimicrobial activity against Malassezia and / or Staphylococcus. Thus, the mixtures or products as defined herein display particularly high antimicrobial activity against Malassezia and / or Staphylococcus (as will be demonstrated further below in the examples section).

[0040] The composition according to the invention is effective against a broad spectrum of Malassezia and Staphylococcus strains. It is preferred in terms of the present invention that the Malassezia is / are one or more species selected from the group consisting of M. furfur, M. pachydermatis, M. sympodialis, M. globosa, M. obtusa, M. restricta, M. slooffiae, M. dermatis, M. japonica, M. nana, M. yamatoensis, M. caprae, M. equina, M. cuniculi, M. brasiliensis, M. psittaci and M. arunalokei, preferably is / are selected from the group consisting of M. restricta, M. globosa, M. furfur, M. sympodialis, M. vespertilionis and M. dermatis and / or wherein Staphylococcus is / are one or more species selected from Staphylococcus aureus, S. capitis, S. chromogenes, S. epidermidis, S. haemolyticus, S. hyicus, S. pseudintermedius, S. lugdunensis and S. saprophyticus.

[0041] Besides the effect on the treatment of an excess of Malassezia and / or Staphylococcus, the composition according to the present invention also has an effect on the naturally occurring microbiome on the skin of mammals, preferably of humans. The human skin microbiome is a diverse community of microorganisms, including bacteria, fungi, viruses, and mites, that live on the skin's surface. It plays a crucial role in maintaining skin health by protecting against harmful pathogens, supporting the immune system, and helping regulate skin pH and moisture. A balanced microbiome fosters healthy skin by preventing infections, reducing inflammation, and contributing to wound healing. Positive effects on the skin microbiome include improving this barrier function, reducing skin irritation and having an overall healthier, more resilient skin.

[0042] The composition according to the invention is a so-called semi-finished product or “blend”, which is incorporated into cosmetic products.

[0043] Thus, another aspect of the present invention relates to a cosmetic product, in which the composition according to the invention is incorporated in, for use in the treatment of an excess of Malassezia and / or Staphylococcus on the skin, preferably on the scalp, of mammals, preferably of humans, wherein the composition is incorporated in an amount ranging from 0.01 to 10 wt.-%, preferably 0.1 to 5 wt.-%, especially preferably 0.1 to 3 wt.- % depending on the total weight of the composition.

[0044] It is preferred that the product is selected from the group consisting of rinse-off personal care products or solid or liquid leave-on personal care products, preferably selected from the group consisting of shampoos, preferably anti-dandruff shampoos, cleansing products, wet wipes, emulsions, preferably o / w emulsions, tonics, leave on and rinse off conditioner, hair butter or hair wax, hair sprays beard care or beard conditioner. Tonics could be aqueous, ethanolic or glycolic solutions and gels.

[0045] It is advantageous to formulate the products as defined herein in a way that enables users to incorporate the treatment of an excess of Malassezia and / or Staphylococcus on their skin surface into their daily hair or skin care routine. This is achieved by, for example, formulating said products as hair or skin care products. By creating hair or skin care products comprising the composition according to the invention, the user can save time, money, and effort by combining the treatment against an excess of Malassezia and / or Staphylococcus on the skin surface with their standard hair or skin care, e.g. washing hair. The rinse-off skin care product as defined herein may also, for example, be a shower gel and the leave-on skin care product may, for example, be a body cream or body lotion. It is also preferred that the cosmetic product comprises one or more additional active agent(s), preferably one or more antimicrobial agent(s), more preferably one or more active agent(s) selected from the group consisting of climbazole, zinc pyrithione, salicylic acid and salts, o-cymen-5-ol, selenium sulfide, coal tar, sulfur, ketoconazole, propanediol caprylate, propanediol undecylenate, propanediol caprate, propylene glycol caprylate, xylityl caprylate, polylysine, tea trea oil, sodium caproyl / lauroyl lactylate, sclareolide, farnesol, capryloyl glycine, undecylenoyl glycine, ethyl lauroyl arginate HCI, usnic acid and salts, copper PCA, zinc PCA, hexamidine diisethionate, morinda citrifolia callus culture lysate, 1 ,10-decanediol and succinic acid.

[0046] Another aspect of the present invention relates to a cosmetic, non-therapeutic use of a composition comprising or consisting of: piroctone olamine,

[0047] 1 ,2-decanediol, at least one additional 1 ,2-alkanediol selected from the group consisting of 1 ,2- pentanediol, 1 ,2-hexanediol, 1 ,2-heptanediol and 1 ,2-octanediol, preferably 1 ,2- pentanediol or 1 ,2-hexanediol, especially preferably 1 ,2-hexanediol, optionally a cosmetic carrier, preferably glycerol, for use in the treatment of an excess of Malassezia and / or Staphylococcus on the skin, preferably on the scalp, of mammals, preferably of humans and / or to avoid dandruff and / or to reduce the amount of dandruff on human skin, preferably on human scalp.

[0048] As defined above, an excess of Malassezia and / or Staphylococcus on the skin surface, preferably on the scalp, of mammals, preferably of humans, relates to a situation where the total amount of Malassezia and / or Staphylococcus cells present on said skin surface leads to symptoms such as, for example, redness, itching, dryness, flaking, greasiness, hypopigmentation and / or hyperpigmentation of the skin.

[0049] In the context of the present invention, the term “avoiding dandruff on human skin, preferably on human scalp” relates to a preventive measure where the first occurrence or reoccurrence of dandruff on a defined area of human skin, preferably of human scalp, is avoided by applying the composition or cosmetic product comprising the composition as defined herein or repeatedly to said defined area of human skin. As a result, no dandruff is visible on said defined area of the human skin when inspected (by a trained professional in the field, such as e.g. a dermatologist) by naked human eye.

[0050] In context of the present invention, the term “reducing the amount of dandruff on human skin, preferably on human scalp” relates to a measure where the total amount of dandruff on a defined area of human skin, preferably of human scalp, as observed (by a trained professional in the field) by naked human eye is reduced by more than 10, 20, 30, 40 50, 60, 70, 80 or 90% after one-off or repeated treatment of said defined area with the composition or cosmetic product comprising the composition as defined herein.

[0051] It is preferred that piroctone olamine is present in an amount of from of from 1 to 15 wt.-%, preferably 4 to 6 wt.-%, of the total weight of the composition. and / or

[0052] 1 ,2-decanediol is present in an amount of from 20 to 50 wt.-%, preferably from 30 to 40 wt.- %, in relation to the total weight of the composition. and / or the at least one additional 1 ,2-alkanediol selected from the group consisting of 1 ,2- pentanediol, 1 ,2-hexanediol, 1 ,2-heptanediol and 1 ,2-octanediol, preferably 1 ,2- pentanediol or 1 ,2-hexanediol, especially preferably 1 ,2-hexanediol is present in an amount of from 30 to 70 wt.-%, preferably 40 to 60 wt.-%, in relation to the total weight of the composition and / or the cosmetic carrier, preferably glycerol, is present and is preferably present in an amount of from 5 to 15 wt.-%, in relation to the total weight of the composition.

[0053] Furthermore, it is preferred in terms of the use of the present invention that Malassezia is / are one or more species selected from the group consisting of M. furfur, M. pachydermatis, M. sympodialis, M. globosa, M. obtusa, M. restricta, M. slooffiae, M. dermatis, M. japonica, M. nana, M. yamatoensis, M. caprae, M. equina, M. cuniculi, M. brasiliensis, M. psittaci and M. arunalokei, preferably is / are selected from the group consisting of M. restricta, M. globosa, M. furfur, M. sympodialis, M. vespertilionis and M. dermatis and / or wherein Staphylococcus is / are one or more species selected from Staphylococcus aureus, S. capitis, S. chromogenes, S. epidermidis, S. haemolyticus, S. hyicus, S. pseudintermedius, S. lugdunensis and S. saprophyticus.

[0054] Furthermore, it is also preferred that the composition is used as part of a cosmetic product as defined herein. Preferably, the product is selected from the group consisting of rinse-off personal care products or solid or liquid leave-on personal care products, preferably selected from the group consisting of shampoos, preferably anti-dandruff shampoos, cleansing products, wet wipes, emulsions, preferably o / w emulsions, tonics, leave on and rinse off conditioner, hair butter or hair wax, hair sprays, beard care or beard conditioner. Tonics could be in aqueous, ethanolic or glycolic solutions and gels.

[0055] Another aspect relates to a composition comprising

[0056] 1 to 15 wt.-%, preferably 4 to 6 wt.-% piroctone olamine,

[0057] 20 to 50 wt.-%, preferably 30 to 40 wt.-% 1 ,2-decanediol,

[0058] 30 to 70 wt.-%, preferably 40 to 60 wt.-% of at least one additional 1 ,2-alkanediol selected from the group consisting of 1 ,2-pentanediol, 1 ,2-hexanediol, 1 ,2- heptanediol and 1 ,2-octanediol, preferably 1 ,2-pentanediol or 1 ,2-hexanediol, especially preferably 1 ,2-hexanediol and optionally 5 to 15 wt.-% cosmetic carrier, preferably glycerol, each based on the total weight of the composition.

[0059] Especially preferably, the composition comprises

[0060] 4.5 to 5.5 wt.-% piroctone olamine,

[0061] 32.5 to 37.5 wt.-% 1 ,2-decanediol,

[0062] 45 to 55 wt.-% 1 ,2-hexanediol and

[0063] 7.5 to 12.5 wt.-% glycerol, each based on the total weight of the composition.

[0064] The invention will now be described in more detail hereinafter with references to selected examples.

[0065] Examples

[0066] Example 1 - Manufacturing of compositions according to the invention The compositions as listed in table 1 have been manufactured fortesting their efficacy on different Malassezia and Staphylococcus species.

[0067] Table 1: List of ingredients of the tested compositions

[0068] Example 2: Determining the minimum inhibitory concentration on different Malassezia species and Staphylococcus aureus

[0069] MIC-testing in liquid medium: For the MIC testing in liquid media, the method including the following general steps was used:

[0070] • Adding the respective growth medium* to each well of the microplate (96-well plate / max volume for one sample 300 pL). • Adding the test-substances (e.g. the composition) or positive and negative controls* in different concentrations.

[0071] • Adding the microorganism in a defined concentration (as standard 106CFU I mL (CFU = colony forming units), adjusted for 10 pL were used).

[0072] • Incubation of the microplates at 37°C (incubation temperature depends on the strain):

[0073] • Aerobic microorganism: optical density is continuously measured (microplate reader) during incubation.

[0074] • Anaerobic microorganism: incubation in an anaerobic chamber, measurement of the optical density at the end of the incubation, comparison of the results with positive and negative controls.

[0075] ‘depending on the microorganism

[0076] MIC-testing on agar:

[0077] For the MIC testing on solid medium (agar), the method including the following general steps was used:

[0078] • Pipetting of the test-substances (e.g., composition, single compound) or positive and negative controls*, in different concentrations into the respective well of the microplate (as standard 5pL volume was used).

[0079] • Adding the respective growth agar* to each well of the microplate (24-well plate I as standard 500 pL volume was used).

[0080] • Waiting until the agar becomes solid.

[0081] • Adding 50 pL liquid growth medium* (the same medium as the agar medium was used).

[0082] • Adding 20 pL of microorganism suspension in a defined concentration**.

[0083] • Incubation of the microplates at 30°C (incubation temperature depends on the strain).

[0084] • Evaluation of the growth.

[0085] * depending on the microorganism

[0086] ** depending on the microorganism; concentrations were defined in Symrise protocols

[0087] Table 2: Minimum inhibitory concentrations of the blends of Table 1 on different Malassezia species and Staphylococcus aureus

[0088] Example 3: Testing the inhibitory efficiency of a composition according to the invention on different Malassezia species.

[0089] Zone of inhibition test (agar diffusion assay):

[0090] For the zone of inhibition testing on solid medium (agar), the method including the following general steps was used:

[0091] • Cultivation of the test microorganism in a 100 mL-Erlenmeyer flask (as standard 20 ml medium* were inoculated with 100 pL glycerol stock and incubated at the suitable temperature* for the used test microorganism; incubation time: 24h)

[0092] • Adding 1 mL of the 24h-culture (the ODeoo was controlled and adjusted*) to 100 ml agar (the temperature of the agar should not exceed 50°C; controlled by using water bath)

[0093] • Pouring plates (20 mL agar was added to each Petri dish)

[0094] • Drying plates (plates were stored under sterile conditions until they became solid)

[0095] • Preparing paper filter discs containing test-substances (e.g., blend, composition, single compound) or positive and negative controls*, in different concentrations (as standard 1 Opl volume was used)

[0096] • Drying the paper filter discs under sterile conditions

[0097] • Placing the paper filter discs (samples) on the respective position on the agar plate

[0098] • Incubation*

[0099] • Measurement of the zone of inhibition and evaluation

[0100] 'depending on the microorganism a) Effect on Malassezia sympodialis HR297

[0101] In this experiment compositions 4 and 5 are tested against each other. The zone diameter describes the efficiency of the inhibition. The larger the zone diameter, the higher the inhibitory effect. As positive control, Crinipan® ADS was used.

[0102] Table 3: Results on the inhibitory zone test on Malassezia sympodialis HR297

[0103] Composition 4, which uses 1 ,2-pentanediol instead of 1 ,2-hexanediol, shows a smaller zone of inhibition compared to composition 5. This means, composition 4 is less effective than composition 5. If the addition of 1 ,2-alkanediols had no impact, both blends would have very similar (the same) zones of inhibition. The observed difference suggests a synergistic effect between 1 ,2-hexanediol and the other components in composition 5. b) Effect on Malassezia furfur HR999

[0104] In this experiment compositions 4 and 5 should be tested against each other. The zone diameter describes the efficiency of the inhibition. The larger the zone diameter, the higher the inhibitory effect.

[0105] Table 4: Results on the inhibitory zone test on Malassezia furfur HR999

[0106] Composition 4, which uses 1 ,2-pentanediol instead of 1 ,2-hexanediol, shows a smaller zone of inhibition compared to composition 5. This means, composition 4 is less effective than composition 5. If the addition of 1 ,2-alkanediols had no impact, both blends would have similar zones (the same) of inhibition. The observed difference suggests a synergistic effect between 1 ,2-hexanediol and the other components in composition 5.

[0107] Furthermore, additional tests were performed with a comparison combination to evaluate the synergism observed in composition 5.

[0108] Table 5: Results on the inhibitory zone test on Malassezia furfur HR999 with composition 5 in comparison to a comparable composition with 5% piroctone olamine, 35 % 1,2- decanediol and 60 % DMSO

[0109] The comparison composition shares the same concentrations of piroctone olamine and

[0110] 1 .2-decanediol as compositions 4 and 5, but it lacks the other ingredients: 1 ,2-pentanediol,

[0111] 1 .2-hexanediol, and glycerol. Since pure DMSO has no efficacy against Malassezia, it is used solely as a solvent. Consistent results were observed in three independent tests, indicating the reproducibility of the findings.

[0112] The significance of the findings was also confirmed using statistical analysis. The analysis confirms with a p-value of 0.025 the significant difference between the blend according to the invention and the comparison composition.

[0113] Example 4: Test of synergism For confirming the synergistic effect present in the composition according to the present invention, MIC tests (as described in example 2) were conducted. The synergy index was calculated based on Kull’s equation (Kull et al., 1961). A synergy index >1 indicates no synergism and a synergy index < 1 a present synergism.

[0114] The following test were conducted:

[0115] Table 6: MIC test and calculated synergy index of a mixture including 1,2-decanediol and piroctone olamine.

[0116] Table 7: MIC test and calculated synergy index of a mixture including 1,2-decanediol, piroctone olamine and 1 ,2-hexanediol.

Claims

Claims1 . Composition comprising or consisting of: piroctone olamine,1 .2-decanediol, at least one additional 1 ,2-alkanediol selected from the group consisting of1 .2-pentanediol, 1 ,2-hexanediol, 1 ,2-heptanediol and 1 ,2-octanediol, preferably 1 ,2-pentanediol or 1 ,2-hexanediol, especially preferably 1 ,2- hexanediol, optionally a cosmetic carrier, preferably glycerol for use in the treatment of an excess of Malassezia and / or Staphylococcus on the skin, preferably on the scalp, of mammals, preferably of humans.

2. Composition for use in the treatment of an excess of Malassezia and / or Staphylococcus according to claim 1 , wherein piroctone olamine is present in an amount of from 1 to 15 wt.-%, preferably 4 to 6 wt.-%, of the total weight of the composition.

3. Composition for use in the treatment of an excess of Malassezia and / or Staphylococcus according to claim 1 or 2, wherein 1 ,2-decanediol is present in an amount of from 20 to 50 wt.-%, preferably 30 to 40 wt.-%, in relation to the total weight of the composition.

4. Composition for use in the treatment of an excess of Malassezia and / or Staphylococcus according to any one of the preceding claim, wherein the at least one additional 1 ,2-alkandiol selected from the group consisting of 1 ,2-pentanediol,1 ,2-hexanediol, 1 ,2-heptanediol and 1 ,2-octanediol, preferably 1 ,2-pentanediol or1 ,2-hexanediol, especially preferably 1 ,2-hexanediol is present in an amount of from 30 to 70 wt.-%, preferably 40 to 60 wt.-%, in relation to the total weight of the composition.

5. Composition for use in the treatment of an excess of Malassezia and / or Staphylococcus according to any one of the preceding claims, wherein the cosmetic carrier, preferably glycerol, is present and is preferably present in an amount of from 1 to 20 wt.-%, preferably 5 to 15 wt.-%, in relation to the total weight of the composition.

6. Composition for use in the treatment of an excess of Malassezia and / or Staphylococcus according to any one of the preceding claims, wherein Malassezia is / are one or more species selected from the group consisting of M. furfur, M. pachydermatis, M. sympodialis, M. globosa, M. obtusa, M. restricta, M. slooffiae, M. dermatis, M. japonica, M. nana, M. yamatoensis, M. caprae, M. equina, M. cuniculi, M. brasiliensis, M. psittaci and M. arunalokei, preferably is / are selected from the group consisting of M. restricta, M. globosa, M. furfur, M. sympodialis, M. vespertilionis and M. dermatis and / or wherein Staphylococcus is / are one or more species selected from Staphylococcus aureus, S. capitis, S. chromogenes, S. epidermidis, S. haemolyticus, S. hyicus, S. pseudintermedius, S. lugdunensis and S. saprophyticus.

7. Cosmetic product, in which the composition as defined in any one of the claims 1 to 6 is incorporated in, for use in the treatment of an excess of Malassezia and / or Staphylococcus on the skin, preferably on the scalp, of mammals, preferably of humans, wherein the composition is incorporated in an amount of from 0.01 to 5 wt.- %, preferably 0.1 to 3 wt.-% depending on the total weight of the composition.

8. Cosmetic product for use in the treatment of an excess of Malassezia and / or Staphylococcus according to claim 7, wherein the cosmetic product is selected from the group consisting of rinse-off personal care products or solid or liquid leave-on personal care products, preferably selected from the group consisting of shampoos, preferably anti-dandruff shampoos, cleansing products, wet wipes, emulsions, preferably o / w emulsions, tonics, leave on and rinse off conditioner, hair butter or hair wax, hair sprays, beard care or beard conditioner.

9. Cosmetic, non-therapeutic use of a composition comprising or consisting of: piroctone olamine,1 ,2-decanediol,at least one additional 1 ,2-alkanediol selected from the group consisting of 1 ,2-pentanediol, 1 ,2-hexanediol, 1 ,2-heptanediol and 1 ,2-octanediol, preferably 1 ,2-pentanediol or 1 ,2-hexanediol, especially preferably 1 ,2- hexanediol, optionally glycerol for use in the treatment of an excess of Malassezia and / or Staphylococcus on the skin, preferably on the scalp, of mammals, preferably of humans and / or to avoid dandruff and / or to reduce the amount of dandruff on human skin, preferably on human scalp.

10. Use according to claim 9, wherein piroctone olamine is present in an amount of from of from 1 to 15 wt.-%, preferably 4 to 6 wt.-%, especially preferably 5 wt.-%, of the total weight of the composition. and / or1 ,2-decanediol is present in an amount of from 20 to 50 wt.-%, preferably from 30 to 40 wt.-%, especially preferably 35 wt.-%, in relation to the total weight of the composition. and / or the at least one additional 1 ,2-alkanediol selected from the group consisting of 1 ,2- pentanediol, 1 ,2-hexanediol, 1 ,2-heptanediol and 1 ,2-octanediol, preferably 1 ,2- pentanediol or 1 ,2-hexanediol, especially preferably 1 ,2-hexanediol is present in an amount of from 30 to 70 wt.-%, preferably 40 to 60 wt.-%, especially preferably in an amount of 50 wt.-%., in relation to the total weight of the composition and / or the cosmetic carrier, preferably glycerol is present and is preferably present in an amount of from 5 to 15 wt.-%, preferably 10 wt.-% in relation to the total weight of the composition.

11. Use according to claim 9 or 10, wherein Malassezia is / are one or more species selected from the group consisting of M. furfur, M. pachydermatis, M. sympodialis, M. globosa, M. obtusa, M. restricta, M. slooffiae, M. dermatis, M. japonica, M. nana, M. yamatoensis, M. caprae, M. equina, M. cuniculi, M. brasiliensis, M. psittaci and M. arunalokei, preferably is / are selected from the group consisting of M. restricta, M. globosa, M. furfur, M. sympodialis, M. vespertilionis and M. dermatis and / or wherein Staphylococcus is / are one or more species selected from Staphylococcus aureus, S. capitis, S. chromogenes, S. epidermidis, S. haemolyticus, S. hyicus, S. pseudintermedius, S. lugdunensis and S. saprophyticus.

12. Use according to claim 9 to 11 , wherein the composition is incorporated in a cosmetic product, wherein the cosmetic composition is present of from 0.01 to 5 wt.-%, preferably 0.1 to 3 wt.-% depending on the total weight of the cosmetic product.

13. Use according to claim 12, wherein the cosmetic product is selected from the group consisting of rinse-off personal care products or solid or liquid leave-on personal care products, preferably selected from the group consisting of shampoos, preferably anti-dandruff shampoos, cleansing products, wet wipes, emulsions, preferably o / w emulsions, tonics, leave on and rinse off conditioner, hair butter or hair wax, hair sprays, beard care or beard conditioner.

14. Composition comprising 1 to 15 wt.-%, preferably 4 to 6 wt.-% piroctone olamine, 20 to 50 wt.-%, preferably 30 to 40 wt.-% 1 ,2-decanediol, 30 to 70 wt.-%, preferably 40 to 60 wt.-% of at least one additional 1 ,2-alkandiol selected from the group consisting of 1 ,2-pentanediol, 1 ,2-hexanediol, 1 ,2-heptanediol and 1 ,2-octanediol, preferably 1 ,2-pentanediol or 1 ,2-hexanediol, especially preferably 1 ,2-hexanediol and optionally 5 to 15 wt.-% cosmetic carrier, preferably glycerol, each based on the total weight of the composition.

15. Composition according to claim 14, comprising 4.5 to 5.5 wt.-% piroctone olamine, 32.5 to 37.5 wt.-% 1 ,2-decanediol, 45 to 55 wt.-% 1 ,2-hexanediol and 7.5 to 12.5 wt.-% glycerol, each based on the total weight of the composition.

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