Composition for the treatment of androgenetic alopecia

Abstract

A composition for topical use in the treatment of androgenetic alopecia comprises a nanoemulsion, said nanoemulsion comprising a mixture of oils, at least one surfactant, finasteride and minoxidil. The mixture of oils comprises sandalwood oil, rosemary oil and sweet almond oil.

Description

Composition for the treatment of androgenetic alopecia

[0001] The invention relates to a composition for the therapeutic treatment of the scalp, in particular for topical use in the treatment of androgenetic alopecia.

[0002] Compositions that are usable in the pharmacological treatment of androgenetic alopecia and contain minoxidil and finasteride as active principles are known, as well as approved by agencies like EMA in Europe and FDA in the United States. In particular, the topical administration of minoxidil to subjects of male and female gender and the oral and topical administration of finasteride only to subjects of male gender are known.

[0003] Numerous hydroalcoholic compositions are currently available commercially for topical use containing minoxidil or finasteride.

[0004] A drawback of known hydroalcoholic compositions for topical use consists of the fact that the alcohol used for the solubilization of the active principles, consisting of lipophilic molecules, can cause local symptoms like burning, dryness of the skin and increased desquamation.

[0005] Another drawback of the aforesaid compositions, which is found above all in the case of compositions containing finasteride, consists of the possibility that the active principle will breach the skin barrier (transdermic absorption induced by alcohol) and be absorbed systemically, with consequent onset of important side effects, in particular sexual and / or psychiatric disorders.

[0006] A further drawback of known hydroalcoholic compositions for topical use is that - due to problems of both solubility and formulation - known compositions do not enable minoxidil and finasteride to be conveyed in combination, although these two active principles would be able to act synergically on the scalp, in particular at the hair follicle level.

[0007] Accordingly, the need is strongly felt among the skilled persons for compositions for topical use, that are usable in the treatment of androgenetic alopecia and enable the drawbacks described above to be overcome.

[0008] Objects of the invention

[0009] An object of the invention is to improve the known compositions for topical use that are usable for the treatment of androgenetic alopecia.

[0010] Another object is to provide a composition for topical use, which is usable in the treatment of androgenetic alopecia, which avoids the possible onset of local symptoms like burning, dryness of the skin and increased desquamation.

[0011] A further object is to provide a composition for topical use, which is usable in the treatment of androgenetic alopecia, which avoids, or at least significantly reduces, the side effects due to the possible systemic absorption of the active principles.

[0012] Yet another object is to provide a composition for topical use, which is usable in the treatment of androgenetic alopecia, which enables two active principles to be conveyed and administered simultaneously, in particular minoxidil and finasteride, so as to enable these latter to act synergically on the scalp, in particular on the hair follicle.

[0013] A still further object is to provide a composition for topical use, which is usable in the treatment of androgenetic alopecia, in which, instead of organic solvents, functional components are comprised that are able not only to solubilize the active principles, but also to enhance the effect thereof by acting on the suppression of specific receptors involved in the apoptosis of the cells and by increasing the production of IGF-1, a growth factor that is able to extend the anagen phase.

[0014] Short description of the invention

[0015] According to the invention, a composition is provided for use in the topical treatment of androgenetic alopecia, as defined in claim 1.

[0016] Owing to the invention, a composition for topical use is made available that is usable in the treatment of androgenetic alopecia and enables the drawbacks of known compositions, in particular hydroalcoholic compositions, to be overcome.

[0017] In fact, the composition according to the invention is based on a nanoemulsion devoid of alcohols, which avoids the onset of uncomfortable local symptoms - such as burning, dryness of the skin and increased desquamation - when the aforesaid composition is applied to the scalp of a subject to be treated.

[0018] Furthermore, as ascertained experimentally by the Applicant, the composition according to the invention enables the systemic absorption of the active principles, in particular finasteride, to be reduced, reducing the corresponding side effects accordingly.

[0019] Lastly, the composition according to the invention enables two active principles, namely minoxidil and finasteride, to be conveyed and administered simultaneously, thus permitting the synergic and selective action thereof on the hair follicles of scalp.

[0020] Short description of the drawings

[0021] The invention can be better understood and implemented with reference to the attached drawings that illustrate an embodiment by way of non-limiting example, in which:

[0022] Figure la is a photograph showing the scalp of a human subject before the start of treatment (t = 0 months) with the composition according to the invention.

[0023] Figure lb is a photograph showing the scalp of the human subject of Figure la after three months of treatment (t = 3 months) with the composition according to the invention.

[0024] Figure 1c is a photograph showing the scalp of the human subject of Figure la after six months of treatment (t = 6 months) with the composition according to the invention.

[0025] Figure 2a is a photograph showing the scalp of another human subject before the start of treatment (t = 0 months) with the composition according to the invention.

[0026] Figure 2b is a photograph showing the scalp of the human subject of Figure 2a after six months of treatment (t = 6 months) with the composition according to the invention.

[0027] Figure 3 shows three electronic microphotographs of samples of the composition according to the invention.

[0028] Figure 4 is a ternary phase diagram based on a mixture of oils, HEPES and surfactant.

[0029] Figure 5 is a graph illustrating the outcomes of a test of stability over time, to which test samples of the composition according to the invention were subjected.

[0030] Figure 6 is a graph illustrating the outcomes of a test of evaluation of the antioxidating activity of the nanoemulsion according to the invention.

[0031] Detailed description of the invention

[0032] In the description and / or in the attached claims:- the terms “nanoemulsion / nanoemulsions” and “NE / NEs” are considered to be synonyms and thus can be used interchangeably;- the indicated percentages (%) are meant as weight on weight (w / w) percentages with respect to the total of the composition.

[0033] The Applicant ascertained experimentally a new and surprisingly unexpected technical effect, namely the possibility of obtaining a composition, which is usable in the treatment of androgenetic alopecia, which is able to overcome the aforesaid drawbacks of known compositions and the components of which are able to act synergically in the topical treatment of androgenetic alopecia.

[0034] The aforesaid technical effect was obtained by replacing the hydroalcoholic formulation of the known compositions with a mixture of oils, selected on the basis of the properties thereof. The aforesaid mixture was then combined with surfactants and with activeprinciples for the treatment of androgenetic alopecia, i.e. finasteride and minoxidil. The two active principles (in solid form) are solubilized in the mixture of oils.

[0035] More exactly, the mixture of oils, the surfactants and the two active principles are combined together physically in the form of a nanoemulsion (NE) having an average dimension of the particles comprised between 230 nm and 280 nm (see Example 5 below). In the nanoemulsion, the mixture of oils and the surfactants act synergically with finasteride and minoxidil.

[0036] In one embodiment, the mixture of oils comprises sandalwood oil, rosemary oil and sweet almond oil.

[0037] In another embodiment, the mixture of oils consists of, namely comprises only, sandalwood oil, rosemary oil and sweet almond oil.

[0038] Sandalwood oil is an essential oil that is able to reduce hair loss and increase the volume thereof. Rosemary oil is an essential oil that is rich in rosmarinic acid, which is a powerful antioxidant and anti-inflammatory. Sweet almond oil is a hydrating and emollient agent.

[0039] The surfactants have been selected in such a way as to ensure that the nanoemulsion is stable and is effectively retained in the dermis. In particular, the surfactant can be a nonionic surfactant, an anionic surfactant, a cationic surfactant, or a mixture thereof.

[0040] The non-ionic surfactant can be selected, for example, from: sorbitan esters (Span), sorbitan esters with ethylene oxide (Tween), polyoxyethylene ethers, polyoxyethylene glycol ethers, polyoxyethylene and polyoxypropylene copolymers (Poloxamer), lauryl ether polyethoxylates and mixtures thereof.

[0041] The anionic surfactant can be selected, for example, from: alkyl sulphates, mono and divalent salts of long chain fatty acids, and mixtures thereof.

[0042] The cationic surfactant can be selected, for example, from: mono alkyl quaternary systems, surfactants of natural origin, such as for example lecithin and bile salts, and mixtures thereof.

[0043] In one embodiment, the surfactant comprises at least one of Span 20, Tween 20, Tween 21, Span 60, Tween 60, Tween 80, Tween 85, Span 80, Span 85, Brij 72, Brij 96, Brij O10, Pluronic F10, soya lecithin or mixtures thereof.

[0044] In one embodiment, the composition according to the invention consists of, namely comprises only, the nanoemulsion and corresponds to a lotion. In this embodiment, thecomposition, namely the nanoemulsion, according to the invention has the qualitative / quantitative formulation set out in Table 1 below:

[0045] Table 10046] In the formulation of Table 1, the aqueous phase consists of HEPES buffer (0.02 M pH 7.4) or water, in particular purified water. In another embodiment, in which the composition according to the invention consists of the nanoemulsion (composition made in the form of a lotion), the latter has the qualitative / quantitative formulation set out in the following Table 2:

[0047] Table 2

[0048] In the formulation of Table 2, the aqueous phase consists of HEPES buffer (0.02 M pH 7.4) or water, in particular purified water. The formulation of Table 2 will be indicated below by the acronym “NspMF” (Nanoemulsion Special Minoxidil Finasteride). In another embodiment, the composition according to the invention is made in the form of a gel, semisolid preparation for cutaneous application or medicated foam.

[0049] In the embodiment in which substances that are useful for the formation of a gel are incorporated into the aqueous phase of the nanoemulsion, the composition according to the invention has the qualitative / quantitative formulation set out in the following Table 3:

[0050] Table 3formulation of the nanoemulsion is the one set out in Table 1 or in Table 2, the pre-dispersed gelling base can be Sepigel 305 and the surfactant can be Poloxamer 407.

[0052] As will be illustrated in the Examples disclosed below, the composition according to the invention has a good entrapment efficiency for the active principles, i.e. finasteride and minoxidil (see the encapsulation efficiency set out in Example 4 below), and it is stable over time in terms of dimensions and surface charge (see Example 8). Studies of in vitro permeation on synthetic membrane have also shown that the active principle conveyed through the composition according to the invention remains substantially localised in the aforesaid membrane (see Example 7). Both cytological and chemical tests have also been run to evaluate the antioxidant activity of the nanoemulsion according to the invention (see Example 6).

[0053] In vivo tests have been run on human subjects by administering the composition according to the invention to some patients at the Centre of Physiopathology of Skin Appendages at the Policlinico Umberto I of Sapienza University in Rome and the results were assessed very positively (see Example 9). Moreover, the blood of the patients treated with the composition according to the invention was analysed, confirming a significantly reduced systemic absorption of the administered active principles (see Example 10).

[0054] By way of non-limiting example, the following Examples are disclosed below: ternary phase diagram based on a mixture of oils, HEPES and surfactant (Example 1); preparation of a nanoemulsion according to the invention (Example 2); preparation of a gel incorporating the nanoemulsion according to the invention (Example 3); chemical-physical features of the nanoemulsion according to the invention (Example 4); TEM analysis of samples of nanoemulsion according to the invention (Example 5); in vitro permeation test on synthetic membrane (Example 6); stability in terms of dimensions and potential C, in Nsp and NspMF samples at 25°C and 4°C in a time interval of 90 days (Example 7); in vivo test of topical administration of the composition according to the invention (Example 8); in vivotest for the evaluation of the systemic absorption of active principle (finasteride) (Example 9).

[0055] Example 1 - Ternary phase diagram based on mixture of oils, HEPES and surfactant

[0056] Figure 4 shows a ternary phase diagram of a composition comprising the following ingredients: a mixture of the oils according to the invention (indicated by “Oil” in Figure 4); HEPES (2-[4-(2-hydroxyethyl)piperazin-l-yl]ethanesulfonic acid), buffer for biological use (indicated by “H” in Figure 4); a surfactant (indicated by “Tens” in Figure 4).

[0057] The aforesaid diagram enables the appropriate quantities of oils, HEPES and surfactants to be identified with which to obtain a homogeneous nanoemulsion that does not give rise to the formation of aggregates and phase separation.

[0058] Example 2 - Preparation of a nanoemulsion according to the invention (lotion)

[0059] A quantity conforming to the formulation of Table 1 (or Table 2) is weighed for each of the three oils. The aforesaid quantity is weighed directly in a test tube placed on analytical scales, by using a Gilson pipette. The two active principles (minoxidil and finasteride) are weighed in quantities conforming to the formulation of Table 1 (or Table 2) and solubilized in the mixture of the three previously weighed oils. A quantity of surfactant conforming to the formulation of Table 1 (or Table 2) is then added to the test tube by using a metal spatula. The so obtained mixture of oils, active principles and surfactant is subjected to mechanical stirring by a Vortex stirrer for 1 minute at 35 Hertz, in order to facilitate an optimal homogenization of the phases. A suitable quantity (q.s. at 100) of HEPES buffer is lastly added. The nanoemulsion is obtained by subjecting the mixture consisting of oils, surfactant, active principles and HEPES to the action of an ultrasonic disintegrating apparatus (sonicator) of known type, by setting suitable parameters (3 minutes, 20%, 25 °C) in order to supply energy to the system.

[0060] Example 3 - Preparation of a gel incorporating the nanoemulsion according to the invention

[0061] A quantity conforming to the formulation of Table 1 (or Table 2) is weighed for each of the three oils. The aforesaid quantity is weighed directly in a test tube placed on analytical scales, by using a Gilson pipette. The two active principles (minoxidil and finasteride) are weighed in quantities conforming to the formulation of Table 1 (or Table 2) and solubilized in the mixture of the three previously weighed oils. A quantity of surfactant conforming to the formulation of Table 1 (or Table 2) is then added to the test tube by using a metal spatula. The so obtained mixture of oils, active principles and surfactant is subjectedto mechanical stirring by Vortex agitator for 1 minute at 35 Hertz, in order to facilitate an optimal homogenization of the phases. A suitable quantity (q.s. at 100) of HEPES buffer is lastly added. The nanoemulsion is obtained by subjecting the mixture consisting of oils, surfactant, active principles and HEPES to the action of an ultrasonic disintegrating apparatus (sonicator) of known type, by setting suitable parameters (3 minutes, 20%, 25 °C) in order to supply energy to the system. A gelling base and hydroxyethyl cellulose are then added (in conformity to Table 3) to the so obtained nanoemulsion and the resulting mixture is stirred until the gel is formed completely.

[0062] Example 4 - Chemical-physical features of the nanoemulsion according to the invention

[0063] The following parameters were determined in the nanoemulsions according to the invention: hydrodynamic diameter, poly dispersity index (PDI), potential C, (electrokinetic potential) and encapsulation efficiency (e.e.%).

[0064] In particular, nanoemulsion samples without active principles (Nsp), nanoemulsion samples containing only minoxidil (NspM), nanoemulsion samples containing only finasteride (NspF) and nanoemulsion samples containing both minoxidil and finasteride (NspMF) were tested.

[0065] The hydrodynamic diameter, the PDI and the electrokinetic potential were determined by Dynamic Light Scattering (DLS) with a Zetasizer Pro instrument (Malvern, UK), while the encapsulation efficiency was determined by spectrometry UV-Vis, with a Perkin Elmer spectrophotometer.

[0066] The obtained results are set out in Table 4 below:

[0067] Table 40068] From the values set out in Table 5 it is clear that the nanoemulsions have dimensions that are suitable for the hypothesised (topical) administration route, the sample ismonodispersed, the potential C, is sufficiently negative as to ensure good stability of the sample over time and the e.e. % is extremely high.

[0069] Example 5 - TEM analysis of nanoemulsion samples according to the invention

[0070] Samples of the nanoemulsions of Example 5, in particular the samples Nsp, NspM and NspF, were analysed by TEM (transmission electron microscopy). Figure 3 shows three electronic microphotographs, in which the sample Nsp is indicated by “A”, the sample NspM is indicated by “B” and the sample NspF is indicated by “C”. The TEM analysis shows that the three samples have comparable dimensions, a good mono-dispersion of the dimensions and regular morphology.

[0071] Example 6 - Analysis of the antioxidant activity of single oils, mixture of oils and oil nanoemulsion

[0072] Tests of evaluation of the antioxidant activity (Experiment 1; Experiment 2) were run as disclosed below.

[0073] Experiment 1

[0074] Caco-2 cells were sown in 96-well plates at a density of 1 x 104cells / well. After 24 hours of incubation, the cells were treated with the following five compounds: rosemary oil (OR), almond oil (OM), sandalwood oil (OS), a mixture of the three oils (MIX) and a nanoemulsion of the three oils (NEs = Nsp). All the compounds were initially dissolved in DMSO (dimethylsulphoxide) and taken to a mother concentration of 1%. Subsequently, from these stock solutions 0.1%, 0.01%, 0.001% and 0.0001% dilutions in DMEM (Dulbecco's Modified Eagle Medium) were prepared that were used for the 24-hour treatment.

[0075] 3 hours after adding the five compounds, the cells were exposed to 1 mM H2O2. 24 hours after adding the five compounds, a cell count was run to determine the protective capacity against the induced oxidative stress. A control with DMSO at the same final concentration was included for each tested concentration. The greater capacity of the oil nanoemulsion (NEs = Nsp) in protecting the cells from induced oxidative damage, in comparison with the oils alone or the mixture of the three oils, emerges from the data set out in the graph in Figure 6.

[0076] Experiment 2

[0077] The antioxidant capacity of the oil samples was evaluated through the DPPH radical scavenging assay. A mother solution was prepared by dissolving 24 mg of DPPH (2,2- phenyl-l-picrylhydrazyl) in 100 ml of methanol and stored at -20 °C until the time ofanalysis. The working solution was obtained by diluting 10 ml of mother solution with 45 ml of methanol, obtaining 1.17 ± 0.02 absorbance at 515 nm, determined by a UV-vis spectrophotometer. Each oil sample (150 pl) was mixed with 2850 pl of DPPH solution and incubated in the dark at ambient temperature for 30 minutes. After incubation, absorbance was measured at 515 nm with respect to a blank (methanol). The results were expressed in Trolox (6-hydroxy-2,5,7,8-tetramethyl-chroman-2-carboxylic acid) equivalent millimoles per millilitre of oil (mM TE / ml). In the cases in which the absorbance values exceeded the linear interval of the calibration curve, appropriate dilutions were made to ensure accuracy.

[0078] The antioxidant activity of the oil samples was evaluated by using the DPPH assay and expressed in Trolox equivalent millimoles per millilitre of oil (mM TE / ml). The results are set out in the following Table 5 and have shown significant differences among the various samples tested:

[0079] Table 50080] Sandalwood oil (OS) showed the highest antioxidant activity (1.03 ± 0.04 mM TE / ml), showing a greater capacity to neutralize the free DPPH radicals. Rosemary oil (OR) followed, which also has a high value (0.87 ± 0.03 mM TE / ml), in line with what is reported in literature, which emphasises the high concentration of phenol compounds in essential rosemary oil. Almond oil (OA), on the contrary, showed the lowest antioxidant capacity (0.50 ± 0.02 mM TE / ml), suggesting a composition that is less rich in active antioxidants, at least in the context of the DPPH assay. The mixture of oils (MIX) showed intermediate activity (0.65 ± 0.02 mM TE / ml), indicating a possible synergic, even if not completely additive, effect between the combined components. The nanoemulsion (NEs = Nsp) composed of almond, sandalwood and rosemary oils was found to have an antioxidant capacity of 0.60 ± 0.02 mM TE / ml, which is thus comparable to the antioxidant capacity of the mixture of the three oils.

[0081] From experimental evidence it emerges that rosemary and sandal oils have a good antioxidant activity (see Experiment 2), but that the protection of the cells from the oxidativedamage is greater (see Experiment 1) when the almond, sandalwood and rosemary oils are in the form of a nanoemulsion.

[0082] Example 7 - In vitro permeation test on synthetic membrane

[0083] An in vitro permeation test was run by using an apparatus of known type that is able to simulate the diffusion of active principles through the human skin, i.e. Franz cells (vertical diffusion) in combination with a lipophilic synthetic membrane (StratM®). The results of the test are set out in Table 5 below, in which “NspM” is a nanoemulsion containing minoxidil and “NspF” is a nanoemulsion containing finasteride:

[0084] Table 50085] The results of the test have highlighted that both the active principles (minoxidil; finasteride) contained in the composition according to the invention and conveyed through the latter remain substantially localized in a structure (lipophilic synthetic membrane) simulating the human skin.

[0086] Example 8 - Stability in terms of dimensions and potential C in samples Nsp and NspMF at 25°C and 4°C in a time interval of 90 days

[0087] Samples of nanoemulsion without active principles (Nsp) and of nanoemulsion containing minoxidil and finasteride (NspMF) were subjected to a 90-day stability test conducted at 25°C and at 4°C. In order to evaluate the stability of the nanoemulsions over time, the variations of hydrodynamic diameter and potential C, were measured, which were determined as disclosed in Example 5. The stability test results are illustrated in the graph of Figure 5 and show that the composition (nanoemulsion) according to the invention keeps substantially stable over time in terms of dimensions and electrokinetic potential, especially if stored at ambient temperature.

[0088] Example 9 - In vivo test of topical administration of the composition according to the invention

[0089] The composition according to the invention was administered to some patients at the Centre of Physiopathology of Skin Appendages, Sapienza University in Rome, Policlinico Umberto I. The topical administration of the composition according to theinvention induced an improvement in the density and thickness of the hair shaft with a consequent improvement of the general appearance.

[0090] Figures la, lb, 1c are photographs showing the effects of the composition according to the invention on the scalp of a patient at 0, 3 and 6 months (situations designated respectively by “T 0”, “T 3” and “T 6” in Figures la, lb and 1c) from the start of the treatment. In particular, at t = 3 and t = 6 a clear improvement in the density of the hair is noted.

[0091] Figures 2a and 2b are photographs showing the effects of the composition according to the invention on the scalp of another patient at 0 months (2a) and 6 months (2b). Also in this case, a certain improvement can be pointed out at t = 6.

[0092] Moreover, as reported by the treated patients, the formulations are agreeable to the touch and smell and do not weigh the hair down.

[0093] Example 10 - In vivo test for the evaluation of the systemic absorption of active principle (finasteride)

[0094] Blood samples were taken from two patients subj ected to the topical administration disclosed in Example 7. The samples were taken at the start of the treatment (t = 0) and at the end of the treatment (t = 3 months). The blood samples were centrifuged and the so obtained corresponding plasma samples were subjected to HPLC analysis to determine the concentration of finasteride in the plasma. The results of the analyses are set out in Table 6 below:

[0095] Table 60096] The obtained results show that at 3 months from the start of the topical treatment, the systemic absorption of finasteride was nil in the treated patients.

[0097] From what has been previously disclosed and exemplified, it can be affirmed that the composition according to the invention enables to overcome efficiently the drawbacks that are detectable in known compositions for the topical treatment of androgenetic alopecia.

[0098] Variations on and / or additions to what has been disclosed above are also possible. For example, although the previously disclosed compositions were prepared on thelaboratory scale, the skilled person is able to select and apply preparation procedures that are suitable for production on an industrial scale.

Claims

CLAIMS1. Composition for topical use in the treatment of androgenetic alopecia comprising a nanoemulsion, said nanoemulsion comprising a mixture of oils, at least one surfactant, finasteride and minoxidil, wherein said mixture of oils comprises sandalwood oil, rosemary oil and sweet almond oil.

2. Composition for the use according to claim 1, wherein said mixture of oils consists of said sandalwood oil, said rosemary oil and said sweet almond oil.

3. Composition for the use according to claim 1 or 2, wherein said composition consists of said nanoemulsion.

4. Composition for the use according to any one of claims 1 to 3, wherein said nanoemulsion consists of said mixture of oils, of said at least one surfactant, of said finasteride, of said minoxidil and of an aqueous phase.

5. Composition for the use according to any one of claims 1 to 4, wherein said nanoemulsion has the following formulation: Sandalwood oil 1.1 - 5.5%Rosemary oil 1.1 - 5.5% Sweet almond oil 7.8 - 39% Surfactant 1 - 10% Finasteride 0.1 -0.5% Minoxidil 1 - 5% Aqueous phase q.s. at 1006. Composition for the use according to claimwherein said nanoemulsion has the following formulation:Sandalwood oil 4.95% Rosemary oil 4.95% Sweet almond oil 35.1% Surfactant 5%Finasteride 0.25%Minoxidil 5%Aqueous phase q.s. at 1007. Composition for the use according to claim 5, or 6, wherein said aqueous phase consists of HEPES (0.02 M pH 7.4) buffer or purified water.

8. Composition for the use according to any one of claims 1 to 7, wherein said surfactantcomprises a non-ionic surfactant and is selected from the group consisting of sorbitan esters, sorbitan esters with ethylene oxide, polyoxyethylene ethers, polyoxyethylene glycol ethers, polyoxyethylene and polyoxypropylene copolymers, lauryl ether polyethoxylates, and mixtures thereof.

9. Composition for the use according to any one of claims 1 to 8, wherein said surfactant comprises an anionic surfactant and is selected from the group consisting of alkyl sulphates, mono and divalent salts of long chain fatty acids, and mixtures thereof.

10. Composition for the use according to any one of claims 1 to 9, wherein said surfactant comprises a cationic surfactant and is selected from the group consisting of mono alkyl quaternary systems, lecithins, bile salts, and mixtures thereof.

11. Composition for the use according to any one of claims 1 to 10, wherein said composition is made in the form of lotion, gel, semi-solid preparation for skin application or medicated foam.

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