FR3075040A1 - PEST CONTROL COMPOSITION FOR EXTERNAL USE - Google Patents

Abstract

An antiparasitic composition for external use, administrable to a human or animal individual, comprising more than 50% of an external pest control agent selected from vegetable oils and vegetable oils and its use as an external pest control.

Description

Technical area

The invention relates to an antiparasitic composition for external use, namely intended to prevent, treat and / or regulate infestations in humans or animals with ectoparasites such as ectoparasitic arthropods. In particular, the composition according to the invention is suitable for the prevention, regulation and / or treatment, in a human or animal individual, of a lice infestation, for example, in a human individual, of an infestation by head lice (Pediculus humanus capitis), body lice (Pediculus humanus corporis) or pubic lice (Phtirius pubis).

State of the art

Among the best known ectoparasites are phthirapters (Phthiraptera). These phthirapters today group together in a unique order all the insects classically designated as lice, including human lice. The old classification distinguished as two separate orders the lice of mammals, blood suckers (anoploures), from "bird lice" (or mallophages), with a more varied diet. In all cases, these are ectoparasites without wings. Of these, the head louse (Pediculus humanus capitis) is probably the best known. This is a compulsory ectoparasitic insect affecting human beings, as much as the body louse (Pediculus humanus corporis) and the pubic louse (Phtirius pubis), since Antiquity or even the prehistoric period [Dutra, 2014] [1 ], Head lice infestation is called pediculosis of the scalp (Pediculosis capitis). Pediculosis of the scalp continues to be a global public health problem, with hundreds of millions of people infected worldwide [Combescot-Lang, 2015 [2]; Sangaré, 2016] [3]. Head lice infest the scalp and attach their eggs (slow) to the hair rods. The adult louse is 2 to 4 mm long. Lice do not have powerful wings or legs to jump, so they crawl quickly (23 cm / min) using their six claw-shaped legs to move from one hair to another, one host to another. Usually, head lice infest a new host only through close contact between individuals. During its lifetime on the head, the louse feeds by injecting small amounts of saliva and simultaneously ingesting small amounts of blood from the scalp every 3 to 6 hours. This saliva can cause significant irritation which causes itching / itching [Frankowski, 2002 [4]; Higher Council of Public Health, 2003] [5],

Pediculosis of the scalp is an endemic disease in environments where children are gathered, mainly in groups of children from 3 to 12 years old (preschool and school children). However, this pediculosis also affects family members of children who suffer from head lice infestation. The infestation, mainly transmitted by direct head-to-head contact, can reach endemic proportions. A significant global increase in scalp pediculosis is noted, in particular in primary schools [Conseil Supérieur d'Hygiène Publique, 2003] [5],

The most characteristic symptom of this scalp pediculosis is pruritus of the scalp which can begin one to four weeks after the initial infestation. However, the following infestations can cause itching within a day. If the infestation is not treated within a reasonable time, the itching / scratching cycle can lead to a secondary bacterial skin infection, leading to impetigo or pyoderma. Swelling of local lymph nodes and fever are rare in developed countries but may be common in less developed / poor countries. Generalized allergic dermatitis of the prurigo type due to lice antigens has also been reported [Barker, 2012] [6], Recently, a case of treatment-resistant scalp pediculosis has even been described, leading to diffuse auto-eczematization of the torso and extremities, as well as severe scaling and scaling [Connor, 2016] [7], Pediculosis of the scalp also continues to have a significant negative psychosociological impact due to the false image of lack of hygiene (or poor hygiene) that it conveys. The direct and indirect cost of head lice infestation in the world is considerable (more than a billion dollars in the United States in 2004, more than 38 million euros in France in 2004, according to some estimates) [Barker, 2012 [6]; Izri, 2010] [8],

The scalp irritation is usually localized at the temples, around the ears and the nape of the neck. The endemic situation often persists due to easy contact transmission, repeated treatment failures, frequent secondary infections, cost of treatment and lack of reimbursement.

The final diagnosis of head lice infestation requires the detection of a living louse. The presence of nits may indicate a past infestation which may not be active at present. For the diagnosis, a fine-toothed lice comb is four times more effective than the visual examination of the scalp to detect live head lice and diagnose an infestation [Cummings, 2016] [9],

Head lice breathe through small openings located along their abdomen that they can close tightly, making them resistant to immersion. This was explained by Burgess IF in a famous publication dated 2009 [Burgess, 2009] [10], The respiratory elements, called spiracles, are located on the outer covering of lice, on the chest and abdomen. Most of the water ingested by the louse in the form of blood is excreted by spiracles. In nits, the respiratory openings are called aeropyles.

Effective treatment options for head lice (Pediculus humanus capitis) infestation include the administration of topical or oral synthetic insecticides (also known as "chemical" insecticides) (biocides), and products presented as "non-toxic" -insecticides ", acting locally by physical means.

By way of illustration (and not limitation), the synthetic insecticides traditionally used to treat scalp pediculosis are derivatives of pyrethrum or synthetic pyrethroids (such as pyrethrin or permethrin), malathion, ivermectin, lindane or spinosad. Unfortunately, these synthetic insecticides present numerous toxicity - or even neurotoxicity - problems (as regards, for example, ivermectin and lindane) - which are well documented. In addition, some compounds, such as malathion, are flammable substances, and some are capable of causing eye irritation as well as skin burns (such as ivermectin). In addition, certain synthetic insecticides are capable of emitting a strong, unpleasant odor, and are also considered to be pollutants from an environmental point of view. Furthermore, the ovicide (lenticide) efficacy of these synthetic insecticides is very variable, which represents a major drawback in the prevention of future re-infestations. In addition, head lice develop resistance to these synthetic insecticides, which drastically reduces their effectiveness, thus leading to treatment failure and reinfestation. Indeed, the increasing resistance of insects to pyrethrins and permethrin is documented [Cummings, 2016 [9]; Koch, 2016 [11]; Frankowski, 2002 [4]]. In the first studies, the pediculicide efficacy rate of pyrethroids was around 98%, it was recently estimated to be around 25%.

In addition to these synthetic insecticides (whose ovicidal activity remains imperfect) and to which lice are becoming increasingly resistant, other compounds are available for the treatment of scalp pediculosis. These act mechanically (and not chemically, unlike the above-mentioned synthetic insecticides), which has the effect that lice cannot develop resistance to them.

By way of illustration, it is possible to cite benzyl alcohol. It has no ovicidal activity (against [slow] eggs). In addition, it requires another treatment 9 days from the initial treatment and is not recommended for children under 6 months because associated with neonatal suffocation syndrome potentially fatal, despite poor absorption after topical application. This compound therefore needs to be applied with caution. The majority of the side effects described in connection with the topical administration of benzyl alcohol are irritations at the site of application.

Wet combing is sometimes described as a natural and safe option for the treatment of scalp pediculosis. Wet hair should be combed carefully with a fine-tooth comb every three to four days for two weeks, which is extremely demanding. Respect for this rigorous and restrictive treatment is obviously an element of importance in the failure of treatment (due to poor compliance with it). The literature shows that it is less effective than malathion and that it does not improve the results obtained with permethrin treatment [Cummings, 2016 [9]]. Due to its demonstrated lack of efficacy (this solution only eliminates part of the head lice), and even if it does not cause a side effect, wet combing is not considered to be a first-line treatment for pediculosis of the scalp.

More recently, in the context of the treatment of pediculosis of the scalp, products comprising silicones (polysiloxanes), and in particular dimethicone, have appeared. Dimethicone works mechanically, obstructing the respiratory system of the louse, leading to its death. A second treatment is however recommended after 8 to 10 days. However, such treatments are not recommended for children under 2 years of age [Cummings, 2016 [9]]. The application time is approximately 10 minutes. Serious burns have been reported for some products containing dimethicone, particularly when combined with cylclometicone 5 (decamethylcyclopentasiloxane) [Tang, 2013 [12]].

Another known treatment contains isopropyl myristate and cyclometicone (50% / 50% m / m), with an application time of 10 minutes. Cyclometicone clogs the respiratory system of head lice and isopropyl myristate dissolves their exoskeleton, causing dehydration and then death [Cummings, 2016 [9]]. However, this treatment is not recommended for children under 4 years of age and requires additional treatment one week after the initial treatment. Mild erythema and pruritus of the scalp are reported. A treatment of this type is marketed by the company Aralez Pharmaceuticals, under the brand name Resultz®.

As previously indicated, Tang QO et al. [12] mentions two cases of severe burns on the face and scalp due to inflammation, due to having lit a cigarette after having applied, several hours before, a dimeticone lotion with cylcometicone 5. More generally, the active principles anti-lice, such as dimethicone, phenotrine, malathion and permethrin, are flammable, and cyclometicone 5 volatilizes around the head and scalp. The authors of Tang, 2013 [12] suggest that non-flammable ingredients and formulations should be encouraged. A recent publication also points out that many products on the market are highly flammable, in particular those containing dimethicone, some of them being flammable even after long-term contact with a spark [Dorge, 2017 [13]].

In addition to the problems associated with the flammability of certain anti-lice active ingredients, and in particular with the flammability of silicones, it has been shown that certain high molecular weight silicones (polysiloxanes) are toxic. In particular, studies carried out by Environment Canada have shown that octamethylcyclotetrasiloxane (also known as cyclotetrasiloxane or D4) and decamethylcyclopentasiloxane (also known as cyclopentasiloxane or D5) are toxic, persistent and have the potential to bioaccumulate in aquatic organisms (this which induces an environmental risk).

In addition, some silicones are suspected of being endocrine disruptors. For example, the European Union categorizes D4 as an endocrine disruptor since D4 has been shown to interfere with hormonal functions in humans, and as a potentially toxic substance for reproduction that can impair human fertility.

In February 2017, the European Union transmitted to the WTO a draft regulation intended to limit the use of octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) to 0.1% in rinse-off cosmetic products. A measure decided in the framework of the “REACH” regulation and which will shortly amend its Annex XVII.

In addition, and from a consumer point of view, even if, in the short term, the hair appears supple, smooth, shiny, easy to comb following an anti-lice treatment containing silicones, in the long term, the silicones suffocate , dry and weigh down the hair. What's more, it takes a whole month for the silicones to disappear from treated hair.

In addition, and from an environmental point of view, silicones are compounds derived from petroleum, pollutants to manufacture and very little biodegradable (400 or 500 years); the ecological footprint linked to the use of treatments including silicones is therefore high. The European Chemicals Agency (https://echa.europa.eu/) has pointed out that dimethicone is likely to have long-term harmful effects on "aquatic life".

It is therefore advisable to drastically limit the use of these silicones in anti-lice treatments (pediculicides) and, if possible, to get rid entirely of their presence in these products.

The PCT patent application published under the reference WO 2005/027636 broadly discloses the use of a fluid comprising:

one or more fatty acid esters of a mono-, bi-tri-alcohol or polyol, or a lower alkyl ether of a glycol, as a topical treatment for the eradication and / or the fight against ectoparasites and arthropods. Ectoparasites can be in particular head lice, body lice, pubic lice, scabies mites or ticks. Despite wide disclosure, WO 2005/027636 presents pediculicidal data only with respect to a simple fluid composition comprising, in mixture with isopropanol (solvent), the following four compounds:

caprylcaproyl macrogol-8 glyceride in a concentration of 30% by weight (examples 1, 5, 6 and 7), diethylene glycol monoethyl ether, also in a concentration of 30% by weight (example 2), caprylic / capric triglyceride , also in a concentration of 30% by weight (example 3), and isopropyl myristate (isopropyl myristate), also in a concentration of 30% by weight (example 4).

The procedure used in Examples 1 to 7 of WO 2005/027636 is very brief. Indeed each of the four aforementioned compounds is tested on a small number of lice (about 20), with a single series of tests, following an artificial protocol, not making it possible to conclude that the pediculicidal efficacy that can be expected in vivo (with a late recorded head lice mortality, i.e. at 24 hours).

In addition, WO 2005/027636 is silent as to the possible ovicidal effect of each of these four compounds, while this ovicidal effect is essential in order to prevent any future reinfestation, as indicated above.

Patent EP-B-2081428, for its part, relates to the use of butylene glycol dicaprate-dicaprylate in an amount greater than or equal to 20% by weight and, preferably, greater than or equal to 40% by weight, for the external treatment of infestations by ectoparasites. Example 6 of EP-B-2081428 highlights a mortality of adult (head) lice greater than 90% and a mortality of nits greater than 65% for an exposure time of 15 minutes, which represents a time of relatively long exposure (in particular compared to the exposure time of the latest generations of anti-lice products, which is rather of the order of 10 minutes, for reasons of practicality and good observance of the treatment).

The plaintiff, in the context of research aimed at developing an effective pediculicidal and ovicidal composition, while respecting the "naturalness" requirements which it imposes (in particular in order to minimize health and environmental risks), has discovered that this double objective could be achieved by a composition for external use comprising at least one external antiparasitic agent selected from vegetable oils and oils of vegetable origin, in a percentage by mass representing more than 50%, preferably more than 60 %, preferably at least 70%, advantageously at least 80% and, in a particularly preferred manner, at least 90% of the total mass of said composition.

Statement of the invention

Consequently, the subject of the invention is an antiparasitic composition for external use, which can be administered to a human or animal individual, preferably human, said composition being devoid of synthetic insecticide and comprising a percentage by mass of silicone of less than 1%, preferably less than or equal to 0.1% relative to the total mass of the composition, said composition advantageously being free of silicone; said composition comprising at least one external antiparasitic agent (namely for external use) selected from vegetable oils and oils of vegetable origin, advantageously from oils of vegetable origin, said at least one external antiparasitic agent being included in a percentage by mass representing more than 50%, preferably more than 60%, preferably at least 70%, advantageously at least 80% and in a particularly preferred manner, at least 90% of the total mass of said composition.

Advantageously, the composition according to the invention has not only a pediculice effect but above all a good - even very good - ovicidal effect, while:

respecting the naturalness requirements of the applicant, and in particular avoiding the many problems inherent in the use of synthetic insecticides and silicones.

The Applicant has also discovered that said external antiparasitic effect (in particular anti-phthiraptères and more particularly anti-lice) was optimal when said at least one external antiparasitic agent was present in the composition according to the invention in a percentage by mass of at least 80% and, preferably, at least 90% relative to the total mass of said composition.

Said at least one external antiparasitic agent acts by mechanical action, by suffocating the ectoparasites (for example lice, such as head lice) and their eggs (for example nits, such as head lice nits). Said at least one external pest control agent can therefore be described as a "suffocating agent".

The antiparasitic composition for external use according to the invention is suitable for preventing, treating and / or regulating infestations of ectoparasites such as arthropods ectoparasites and said at least one external antiparasitic agent can also be qualified as “antiectoparasitic agent” (to external use) or “anti ectoparasitic arthropod agent”.

Preferably, the antiparasitic composition for external use according to the invention is suitable for preventing, treating and / or regulating infestations of ectoparasitic arthropods in humans or animals, preferably in mammals, advantageously in humans.

According to a particularly preferred embodiment, the invention relates to an anti-phthiropteran composition for external use, which can be administered to a human or animal, preferably human, said composition being devoid of synthetic insecticide and comprising a percentage by mass of silicone. less than 1%, preferably less than or equal to 0.1% relative to the total mass of the composition, said composition advantageously being free of silicone; said composition comprising at least one external anti-phthirapières agent (namely for external use) selected from vegetable oils and oils of vegetable origin, advantageously from oils of vegetable origin, said at least one anti-phthirapières agent being included in a percentage by mass representing more than 50%, preferably more than 60%, preferably at least 70%, advantageously at least 80% and in a particularly preferred manner, at least 90% of the total mass of said composition.

The composition according to the invention is particularly suitable for the prevention, treatment and / or regulation of human pediculosis due to the following lice: Pediculus humanus corporis, Pediculus humanus capitis and Phtirius pubis, preferably due to Pediculus humanus corporis and Pediculus humanus capitis, advantageously due to Pediculus humanus capitis (head louse).

According to a preferred embodiment, the composition according to the invention comprises a percentage by mass of essential oil (s) of less than 5%, preferably less than 3%, advantageously less than 1% and preferably less or equal to 0.1%; particularly preferably said composition being devoid of essential oil (s).

The composition according to the invention is preferably devoid of essential oils (and in particular of terpenes). This allows the composition according to the invention to be administered to children under 6 months of age as well as to pregnant or lactating women, which is prohibited when a composition of this type contains one or more essential oils; the topical application of compositions containing one or more essential oils being, in general, prohibited in children under two or three years of age.

According to one embodiment of the invention, said at least one external antiparasitic agent is different from the following compounds:

caprylcaproyl macrogol-8 glyceride, diethylene glycol monoethyl ether (C6H14O3, CAS number: 111-90-0), caprylic / capric triglyceride (triple ester of glycerol and caprylic and capric acids; CAS no: 73398-61-5 / 65381-09-1), isopropyl myristate (isopropyl myristate; CAS number: 110-27-0), and butylene glycol dicaprate-dicaprylate (decanoic / octanoic acid ester with 1,3-butanediol; no. CAS: 211107-84-5).

According to one embodiment of the invention, said at least one external antiparasitic agent does not comprise an ethylene glycol or butylene glycol unit.

According to one embodiment of the invention, said at least one external antiparasitic agent does not comprise an alkylene glycol unit, for example an ethylene glycol unit ("ethylene glycol unit", in English), propylene glycol or butylene glycol.

According to one embodiment of the invention, said at least one external antiparasitic agent does not comprise decanoic acid and / or free octanoic acid (s).

Preferably, said at least one external antiparasitic agent is selected from:

- the following vegetable oils: coconut oil, calophyllum oil, sunflower oil, sweet almond oil, castor oil, hazelnut oil, olive oil , jojoba oil, argan oil and avocado oil, preferably from the following vegetable oils: castor oil, hazelnut oil, olive oil, jojoba oil, argan oil , avocado oil, advantageously from the following vegetable oils:

jojoba oil and hazelnut oil; and

- the following vegetable oils:

a) fatty acid esters, preferably fatty acid monoesters, advantageously fatty acid monoesters of general formula (I)

in which is a linear, saturated or unsaturated aliphatic alkyl group, comprising a number of carbons between 6 and 20, preferably between 7 and 18, and in which R2 is a saturated, linear or branched aliphatic alkyl group, comprising a number of carbons between 1 and 12, preferably between 2 and 10, and advantageously between and 3,

b) mono- and di-esters of fatty acids and dicarboxylic acids, preferably diesters of fatty acids and dicarboxylic acids, advantageously the diesters of fatty acids and dicarboxylic acids of general formula (II)

O O

RrO-UX-lLo-Rî _(||) in which and R ₂ each independently represent a linear or branched aliphatic alkyl group (advantageously branched), saturated or unsaturated (advantageously saturated), comprising a number of carbons between 4 and 12, preferably between 6 and 10, and X represents a saturated linear aliphatic alkyl group comprising a number of carbons between 1 and 4, preferably between 2 and 3, and

c) fatty acid ethers, advantageously of general formula (III) ^R i- ° -R _{2 (|||)} in which Rt and R ₂ each independently represent a saturated linear or branched (advantageously linear) aliphatic alkyl group or unsaturated (advantageously saturated), comprising a number of carbons between 4 and 18, preferably between 6 and 12, advantageously between 7 and 9; in a particularly preferred manner Rt and R ₂ each independently represent a linear or branched (advantageously linear), saturated or unsaturated (advantageously saturated) aliphatic alkyl group comprising 8 carbon atoms.

Preferably, said at least one external antiparasitic agent is selected from the abovementioned oils of plant origin.

According to a preferred embodiment, the fatty acid monoester of general formula (I) is selected from propylheptylcaprylate (CAS number: 617-930-3), ethyl oleate (CAS number: 111-62-6 ), ethyl stearate (CAS number: 111-61-5), ethyl palmitate, ethyl linoleate (CAS number: 544-35-4) or their mixtures. Advantageously, the composition according to the invention comprises the following mixture:

- ethyl oleate (CAS No: 111-62-6), preferably in a mass concentration of 45-60% relative to the total mass of the said mixture,

- ethyl stearate (CAS No: 111-61-5), preferably in a mass concentration of 23-30% relative to the total mass of the said mixture,

- ethyl linoleate (CAS No: 544-35-4), preferably in a mass concentration of 5-10% relative to the total mass of the said mixture,

- ethyl palmitate (CAS No: 628-97-7) preferably in a mass concentration of 2-8% relative to the total mass of the said mixture.

According to one embodiment, the above mixture also comprises 5 to 10% by mass of shea butter unsaponifiables (“shea butter unsaponifiables”, in English).

According to a preferred embodiment, the composition according to the invention comprises Lipex

SheaLight®, the composition of which is presented in Table A below:

Trade name INCI name (in descending order for mixes) Composition CASE LIPEX SHEA LIGHT® Shea butter ethyl esters (citric acid 0.001%) ethyl oleate 45-60%, (ethyl oleate 45-60%) 111-62-6 ethyl stearate 2330% (ethyl stearate 2330%) 111-61-5 ethyl linoleate 5-10% (ethyl linoleate) 510% 544-35-4 ethyl palmitate 2-8% (ethyl palmitate 2-8%) 628-97-7 Shea butter unsaponifiables 510%)

Table A

According to one embodiment of the invention, in the compound of general formula (I), when FT is a linear aliphatic saturated alkyl group containing 13 carbon atoms, R ₂ is different from an isopropyl group.

According to one embodiment of the invention, in the compound of general formula (I), Rt is a saturated linear aliphatic alkyl group comprising between 14 and 20 carbon atoms, preferably between 15 and 19 carbon atoms, preferably between 16 and 18 carbon atoms.

According to a preferred embodiment of the invention, in the compound of general formula (I), has 17 carbon atoms and a number of unsaturation (s) between 0 and 2 (whole number). In this preferred embodiment, R ₂ is advantageously an ethyl group.

According to a particularly preferred embodiment of the invention, the compound of general formula (II) is dicapryle succinate (CAS number: 28880-24-2).

According to a particularly preferred embodiment of the invention, the compound of general formula (III) is dicaprylic ether ("Dicaprylyl ether", in English, CAS number: 629-82-3).

According to a preferred embodiment, the composition according to the invention advantageously comprises in combination with Lipex SheaLight® - Cetiol® OE and / or Sustoleo® DCS, preferably Cetiol® OE or Sustoleo® DCS, preferably Cetiol ® OE.

According to one embodiment of the invention, said at least one external antiparasitic agent is selected from vegetable oils and oils of vegetable origin which have a molecular weight of between 100 to 400 g / mol, preferably between 200 to 400 g / mol (advantageously between 240 to 345 g / mol), a total number of carbon atoms between 16 and 20 and an average dynamic viscosity between 3 and 11cp (viscosity measured at brookfield model LVDV-II + at 20 ° C (cp); S00 V20).

According to a particularly preferred embodiment of the invention, said at least one external antiparasitic agent is selected from vegetable oils and oils of vegetable origin having a spreading value greater than 500 mm ² to 15 minutes (namely 500 mm ² after 15 minutes), preferably greater than 800 mm ² to 15 minutes, preferably greater than 1000 mm ² to 15 minutes, advantageously greater than or equal to approximately 1100 mm ² to 15 minutes and preferably, greater than or equal at around 1200 mm ² to 15 minutes. Advantageously, said at least one external pest control agent has a spreading value of between approximately 1150 mm ² and approximately 1450 mm ² to 15 minutes, and preferably between approximately 1250 mm ² and approximately 1430 mm ² to 15 minutes. This aspect of the invention is particularly important insofar as the Applicant has discovered that there is a correlation between the spreading value of vegetable oils and oils of plant origin and their effectiveness as a pediculicide and / or ovicide , preferably as a pediculicide and an ovicide (see example 5 below).

According to a particularly preferred embodiment, said at least one external antiparasitic agent comprises:

- at least one first oil of vegetable origin derived from shea butter, preferably at least one ester of shea butter, preferably at least one ethyl ester of shea butter (“Shea butter ethyl esters”, in English), advantageously ethyl oleate (CAS number: 111-62-6), ethyl stearate (CAS number: 11161-5), ethyl palmitate (CAS number: 628-97-7) and / or l ethyl linoleate (CAS No: 54435-4), and

- at least one second oil of plant origin, different from said at least one first oil of plant origin, selected from:

b) mono- and di-esters of fatty acids and dicarboxylic acids, preferably diesters of fatty acids and dicarboxylic acids, advantageously the diesters of fatty acids and dicarboxylic acids of general formula (II)

OO r ₁ -o- ^u -x- ^u -or _{2 (ll)} in which FL and R ₂ each independently represent a linear or branched aliphatic alkyl group (advantageously branched), saturated or unsaturated (advantageously saturated), comprising a number of carbons between 4 and 12, preferably between 6 and 10, and X represents a saturated linear aliphatic alkyl group comprising a number of carbons between 1 and 4, preferably between 2 and 3, and

c) fatty acid ethers, advantageously of general formula (III)

Ri- ° -R _{2 (|||)} in which FL and R ₂ each independently represent a linear or branched aliphatic alkyl group (advantageously linear), saturated or unsaturated (advantageously saturated), comprising a number of carbons between 4 and 18 , preferably between 6 and 12, advantageously between 7 and 9; in a particularly preferred manner Rt and R ₂ each independently represent a linear or branched (advantageously linear), saturated or unsaturated (advantageously saturated) aliphatic alkyl group comprising 8 carbon atoms.

In this particularly preferred embodiment, said at least one second oil of plant origin is preferably selected from:

c) fatty acid ethers, advantageously of general formula (III)

Rl- ° - ^R 2 _(|||) in which and R ₂ each independently represent a linear or branched aliphatic alkyl group (advantageously linear), saturated or unsaturated (advantageously saturated), comprising a number of carbons between 4 and 18, preferably between 6 and 12, advantageously between 7 and 9; in a particularly preferred manner Rt and R ₂ each independently represent a linear or branched (advantageously linear), saturated or unsaturated (advantageously saturated) aliphatic alkyl group comprising 8 carbon atoms.

Preferably, said at least one first oil of vegetable origin is comprises, consists essentially of, or consists of the following mixture:

- ethyl oleate (CAS No: 111-62-6), preferably in a mass concentration of 45-60% relative to the total mass of the said mixture,

- ethyl stearate (CAS No: 111-61-5), preferably in a mass concentration of 23-30% relative to the total mass of the said mixture,

- ethyl linoleate (CAS No: 544-35-4), preferably in a mass concentration of 5-10% relative to the total mass of the said mixture,

- ethyl palmitate (CAS No: 628-97-7) preferably in a mass concentration of 2-8% relative to the total mass of the said mixture.

According to one embodiment, the above mixture further comprises 5 to 10% by mass of shea butter unsaponifiables (“shea butter unsaponifiables”, in English).

According to a particularly preferred embodiment, said first vegetable oil comprises, consists essentially of, or consists of Lipex SheaLight®. Preferably, said first vegetable oil consists of Lipex SheaLight®.

According to a particularly preferred embodiment, said at least one second oil of vegetable origin comprises, consists essentially of, or consists of Cetiol® OE and / or Sustoleo® DCS, preferably Cetiol® OE or Sustoleo® DCS , preferably Cetiol® OE. Preferably, said second oil of vegetable origin consists of Cetiol® OE or Sustoleo® DCS and, in a particularly preferred manner, of Cetiol® OE.

Preferably, said at least one second oil of vegetable origin is dicaprylic ether ("Dicaprylyl ether", in English, CAS number: 629-82-3).

Preferably, the mass ratio between said at least one second oil of vegetable origin and said at least one first oil of vegetable origin is between approximately 6/1 and approximately 15/1, preferably between approximately 8/1 and about 12/1, preferably between about 8/1 and about 10/1; advantageously said mass ratio is approximately 9/1.

A subject of the invention is also i) one or more vegetable oil (s) and / or oil (s) of vegetable origin as defined above or ii) a mixture of at least a first and at least a second vegetable oil as defined above for its / their (s) use (s) as a pest control for external use, preferably in the prevention, treatment and / or regulation of ectoparasitic infestations such as ectoparasitic arthropods, preferably as anti-phthirapters for external use, advantageously as a pediculicide and / or ovicide (preferably as a pediculicide and ovicide) in humans or animals (advantageously in humans).

The invention also relates to the use of at least one vegetable oil and / or at least one oil of vegetable origin as defined above or of a mixture of oils of vegetable origin. as defined above, for the preparation of an antiparasitic composition for external use, preferably anti-phthirapters for external use, preferably pediculicide and / or ovicide, (preferably as pediculicide and ovicide) in humans or animals (advantageously in humans).

According to a particularly preferred embodiment, and in particular in order to avoid the numerous problems inherent in the use of synthetic insecticides and silicones and to satisfy the requirements of "naturalness" posed by the applicant, the composition according to the invention does not include other external pest control agents than said at least one external pest control agent.

According to one embodiment, the composition according to the invention has a spreading value greater than 1100 mm ² to 15 minutes, preferably greater than 1200 mm ² to 15 minutes, preferably greater than or equal to approximately 1300 mm ² to 15 minutes , advantageously greater than or equal to about 1400 mm ² to 15 minutes; in a particularly preferred manner, said composition having a spreading value of between approximately 1400 and approximately 1600 mm ² to 15 minutes.

The invention also relates to a lotion, a shampoo, a solution, a suspension, a foam, a spray, a cream, a paste or a gel, preferably a lotion, comprising the composition according to the invention.

A lotion (oily) is generally composed of emollient (s), perfume (s), antioxidant (s) and active ingredient (s).

By way of illustration, the above lotion can comprise one or more of the following antioxidants: tocopherol, BHA, oryzanol, BHT, ascorbyl plamitate.

By way of illustration, the above lotion may include one or more of the following perfumes: redcurrant, almond, gardenia, exotic mango, green flowers ... and - in certain particular embodiments - essential oils such as "citrus limon fruit oil "," Lavandula angustifolia oil "(advantageously in small quantities in view of the problems mentioned above).

By way of illustration, the above lotion can comprise one or more of the following active agents: anti-uv filters, vitamin A, wheat germ, oily extracts of Calendula, of Witch Hazel ...

The subject of the invention is also the composition according to the invention for its use as a medicament in human or veterinary medicine, preferably in human medicine.

Another subject of the invention relates to the composition according to the invention for its use as an antiparasitic agent for external use, preferably in the prevention, treatment and / or regulation of infestations of ectoparasites such as ectoparasite arthropods, preferably as anti-phthirapters for external use, advantageously as a pediculicide and / or ovicide, (preferably as a pediculicide and ovicide) in humans or animals (preferably in humans). Advantageously, said composition is administered topically to the area of the human or animal body to be treated for a period of approximately 10 minutes. The pediculicidal and, in particular, significant ovicidal power of the composition according to the invention makes it possible to obtain an effectiveness of prevention, treatment and / or optimal regulation while limiting the duration of treatment. This relatively short duration of treatment promotes compliance with the treatment and is practical for the human or animal patient. Optimally, the treatment is then repeated 8 to 10 days later in order to eliminate any slow residual maturity and to treat re-infestations by the environment and / or intermediaries.

According to a particularly preferred embodiment, the subject of the invention is the composition according to the invention for its use in the prevention, treatment and / or regulation of pediculosis in humans or animals, advantageously in humans . Advantageously, the composition according to the invention is used for the prevention, treatment and / or regulation of human pediculosis due to head lice (pediculosis of the scalp).

Definitions

Antiparasitic composition for external use: Composition intended to prevent, regulate and / or treat (preferably to treat) infestations of humans or animals (for example of a mammal, in particular of a pet such as than dogs or cats), preferably humans, by ectoparasites and, preferably, by ectoparasite arthropods.

Anti-phthirapters composition: Composition intended to prevent, regulate and / or treat (preferably to treat) infestations of man or animal (for example of a mammal, in particular of a pet such as the dog or the cat), preferably of the man, by phthiraptères.

Phthiroptera (phthiraptera) Single order grouping together all the insects classically designated as lice, among which is the human louse. Preferably, the antiparasitic composition according to the invention is an antiphthirapteric composition. Advantageously, said composition is an anti-anoploures composition (Anoplurà).

Anoploures (Anoplurà): Group of insects (sub-order of the order Phthiraptera) consisting of lice or blood-sucking mammals (230 species). Similar to mallophages, anoploures have sharp mouthparts that pierce the epidermis like tiny styli. Their claws allow them to firmly grip the hair of their host. These anoploures are sucking lice which include human lice (for example head, body and pubic lice) and parasitic lice of other mammals. They feed on blood. They can cause local skin irritations, and can cause epidemic blood-borne diseases that are dangerous to humans.

The Anoplura suborder contains families:

Echinophthiriidae Enderlein,

Enderleinellidae Ewing,

Haematopinidae Enderlein,

Hamophthiriidae Johnson,

Hoplopleuridae Ewing,

Ewing Hybophthiridae,

Linognathidae Webb,

Microthoraciidae Kim and Ludwig,

Neolinognathidae Fahrenholz,

Pecaroecidae Kéler,

Enderlein pedicinidae,

Pediculidae Leach,

Polyplacidae Fahrenholz,

Pthiridae Ewing, Ratemiidae Kim and Ludwig.

Human louse (or human louse): The human louse (Pediculus humanus) includes two parasitic subspecies of man: Pediculus humanus corporis and the head louse (Pediculus humanus capitis). Pubic louse (Phtirius pubis), on the other hand, belongs to a separate species.

Pubic louse (Phtirius pubis): Pubic louse, commonly known as crab lice, is a sucking louse belonging to the sub-order of Anoplura. In humans, it is the cause of phtiriase.

Pediculicidal agent (or, more simply, “pediculicidal”): By pediculicidal agent, one understands, within the meaning of the present invention, an agent allowing, after appropriate treatment (s), to destroy at least 60%, preferably at least 70%, preferably at least 80%, advantageously at least 90% (preferably at least 95%), and, in a particularly preferred manner, approximately 100% of lice, under the conditions of an effectiveness test ex-vivo pediculicide.

Preferably the pediculicidal effect is determined at 1 hour, advantageously after contact of the lice (s) with the pediculicidal agent for a period of approximately 10 minutes. This gives a precise and reliable indication of the pediculicidal power that can be expected in vivo.

Ovicidal agent (or, more simply, "ovicidal"; also called lenticidal or "lenticidal" agent): By ovicidal agent is meant, within the meaning of the present invention, an agent allowing, after appropriate treatment (s) ), destroy at least 70%, preferably at least 80%, preferably at least 90%, advantageously at least 95% and, in a particularly preferred manner, approximately 100% of the eggs / nits, under the conditions of a test d ex-vivo ovicide / lenticide efficacy.

Preferably, the ovicidal effect is determined at 10 days, preferably after contact of the egg (s) / nits with the ovicidal agent for a period of approximately 10 minutes. This gives a precise and reliable indication of the ovicidal power that can be expected in vivo.

If the "pediculicide" effect of the composition according to the invention is obviously important for achieving the desired goal, the "ovicide" effect, for its part, is essential in order to prevent any future re-infestation. This is why the Applicant has concentrated its research on pediculicidal agents, certainly, but above all on ovicides.

Pediculosis (commonly known as "lice infestation"): Infestation with human external parasites which are phthiropteran insects called lice and which may belong to three species: Pediculus humanus capitis or head louse, Pediculus humanus corporis or body louse , Phtirius inguinalis or pubis or pubic louse. According to a preferred embodiment, the present invention relates to the field of treatment, prevention and / or regulation of human pediculosis due to head lice.

Biocidal insecticides: Active substances or phytosanitary preparations having the property of killing insects (for example those belonging to the order Phthiraptera and in particular anoploures such as head louse, body louse and pubic louse) by an action chemical and / or biological. These biocidal insecticides include synthetic insecticides (also commonly known as "chemical insecticides").

Synthetic insecticides (chemical insecticides): Ingredients or preparations that kill insects and that are not of natural or vegetable origin.

In view of the sum of drawbacks and potential side effects mentioned in the preamble to this patent application, the applicant has sought to dispense with the use of these synthetic insecticides, and in particular of neurotoxic and / or flammable.

Silicones (also called polysiloxanes): Inorganic compounds formed by a silicon-oxygen chain (-Si-O-Si-O-Si-O-) on which groups are attached, on the silicon atoms. As indicated in the preamble to the present application, the silicones traditionally used as pediculicidal agent are in particular dimethicone, cyclometicone (mixture of D4, D5 and D6) and their mixtures (in particular a mixture of dimethicone and decamethylcyclopentasiloxane) .

Essential oil: An essential oil is a product obtained from a vegetable raw material, either by steam training, or by mechanical processes from the Citrus pericarp, or by dry distillation, and which is separated from the aqueous phase by physical processes (source: AFNOR standard NT 75-006 [Feb 2006]).

As indicated above, the composition according to the invention is preferably devoid of essential oils (and in particular of terpenes). This allows the composition according to the invention to be administered to children under 6 months of age as well as to pregnant or lactating women, which is prohibited when a composition of this type contains one or more essential oils; the topical application of compositions containing one or more essential oils being, in general, prohibited in children under two or three years of age.

Vegetable oil (also known as "pure vegetable oil"): Fatty extract from an oleaginous plant, namely from a plant whose seeds, nuts or fruits contain lipids, mainly consisting of free fatty acids and so-called compounds " unsaponifiables ”. There are several extraction methods. By way of illustration, the following extraction methods can in particular be mentioned: by hydraulic press with scourtins (in order to obtain a virgin vegetable oil by cold pressure), by mechanical press, by centrifugation, for oleaginous fruits.

Vegetable oils are also called oily “macerates”, butters and vegetable waxes. Indeed, fatty substances rich in unsaturated acids are liquid (oils) and those rich in saturated fatty acids are more or less solid (butter and vegetable waxes. ).

By way of example of vegetable oil used as an external antiparasitic agent (and in particular as anti-phthirapters), we can cite the following vegetable oils: coconut oil, calophyllum oil, sunflower oil, sweet almond oil, castor oil, hazelnut oil, olive oil, jojoba oil, argan oil and olive oil avocado, with a preference for jojoba and hazelnut oils, which have a less oily / heavy feel. These vegetable oils also have the advantage of nourishing the hair.

Unlike synthetic insecticides, these vegetable oils, used as external antiparasitic agents (and in particular as anti-phthirapteric agents), act mechanically, by obstructing the respiratory openings of lice, larvae and nits. These external pest control agents acting mechanically - not chemically or biologically - are called "suffocating agents".

In addition, certain vegetable oils have, in addition to the inherent advantage of the antiparasitic / anti-phthiropteran effect, that of nourishing the hair. This is the case, for example, for the following vegetable oils: coconut oil, castor oil, hazelnut oil, olive oil, jojoba oil, argan oil and avocado oil, with a preference for jojoba and hazelnut oils, which have a less oily / heavy feel.

According to a particular embodiment, vegetable oil is different from coconut oil.

The designation "vegetable oil" includes natural oils.

Natural oil: Oil obtained from plants from physical processes (such as grinding, drying, distillation ...) or other preparation procedures, including traditional methods, without the intention of chemically modifying the ingredient.

Oils of vegetable origin (also called “modified oils”): Oils which have undergone a transformation process, for example of trans-esterification or interesterification (the latter being the most widespread): modification of the triglyceride structure without modification of the fatty acid composition.

As previously indicated, the Applicant has surprisingly discovered that these oils of vegetable origin, and in particular esterified oils, have a very satisfactory external antiparasitic activity (and in particular anti-phthirapters). As with vegetable oils, and unlike synthetic insecticides, these vegetable oils act mechanically, by obstructing the respiratory ports of lice, larvae and nits. These external antiparasitic / anti-phthirapières agents acting mechanically - and not chemically or biologically - are qualified as "suffocating agents".

The designation oil of vegetable origin includes oils 100% of natural origin.

Oil 100% of natural origin: Oil derived from plants, obtained exclusively from ingredients of natural origin having undergone physical and chemical processes authorized according to the standards of standard ISO 16128 part 1 [14] (entitled "Guidelines on technical definitions and criteria for natural and organic cosmetic ingredients and products - Part 1: Definitions of ingredients ”).

Spreading value: In a preferred embodiment, this spreading value is determined by implementing the reference test defined below.

Reference test to determine the spreading value: The reference test to determine the spreading value is that presented in Example 5, the operating mode of which is detailed in point 5.4.1.1 below. It can be summarized / conceptualized as follows:

hydrate a Vitro skin® synthetic skin plate (obtained from the “IMS Inc.” Laboratory) using a solution of purified water and glycerin for 20 hours in an incubation chamber provided for this purpose, after 20 hours of incubation, remove the skin plate from the incubation chamber and place 10 μΙ of the test solution, then replace the plate in the incubation chamber, wait 15 minutes for the test solution to diffuse on the Vitro skin® plate, when the 15 minutes have elapsed, remove the plate from the incubation chamber and then determine, by any appropriate means, the spreading area in mm ² .

The result obtained therefore represents the spreading value in mm ² after 15 minutes.

Synthetic skin plate Vitro skin® (obtained from the Laboratory "IMS Inc."): Synthetic skin in the form of a sheet (or substrate) and which effectively imitates the surface properties of human skin. It was formulated to have topography, pH, critical surface tension and ionic strength similar to the skin on a man's back.

detailed description

A particularly preferred embodiment of the invention relates to a lotion comprising the composition according to the invention for the prevention, regulation and / or treatment of infestation by head lice in humans, and in particular in adults, children from 6 months and pregnant or breastfeeding women.

The lotion according to the invention acts locally on the hair and the scalp, by physical / mechanical means and this at three levels:

- Its spreading (diffusion) and capillary conditioning performances make it possible to cover the whole of the scalp and the hair, then to target all the lice, nymphs and lice eggs which may be difficult to access;

- It works by physically covering lice and nymphs and obstructing their spiracles or cuticles (located on the exoskeleton, at the thoracic and abdominal level), through which they breathe and exchange water (especially when the insect sucked human blood), causing death of the louse by asphyxiation, dehydration and rupture of the intestine by osmotic stress.

- It acts by physically coating the nits and by obstructing their aeropyles (respiratory openings), through which they breathe, causing the death of the nits by asphyxiation.

In other words, lice and nits are destroyed by a "suffocation" technique, implemented using "suffocating agents". This mechanical / physical suffocation technique is an alternative to treatments through the use of biocidal insecticides (chemical insecticides such as pyrethroids, malathion and lindane). In addition, it prevents the development of lice resistance phenomena observed with chemical treatments.

In addition, this effective lotion to treat pediculosis, is specially formulated with ingredients of natural origin, with at least 99.5% of the formula easily biodegradable in water, which represents a significant advantage compared to the compositions of prior art. In this regard, it is important to note that, unlike products comprising silicones (for example dimethicone and cyclometicone 5), the antiphthirapter agent (s) according to the invention is / are biodegradable Persian.

Also, this lotion is neither volatile nor flammable, unlike many products on the market which are highly flammable and therefore potentially dangerous for the user.

Preferably, the lotion according to the invention is used as follows: spray said lotion evenly on dry hair, about 5 to 10 cm from the hair and massage to cover all the hair. Leave on for 10 minutes. An anti-lice comb can, if necessary, be used because the texture of the lotion facilitates its passage. Wash hair with shampoo and rinse. Repeat the application under the same conditions 8 to 10 days after the first treatment, to eliminate:

- all mature nymphs from eggs in the time interval,

- any re-infestation, due to environmental exposure during this waiting period of 8 to 10 days (for example, by contaminated people or members of the household).

In view of the state of the art, it is undeniable that the above lotion according to the invention and, more generally the composition according to the invention, has an extremely positive benefit / risk ratio.

Examples

Example 1: Composition according to the invention (in the form of a lotion) and its preparation process

A composition is prepared in the form of a lotion, the formula of which is presented in Table 1 below.

ingredients CAS # Function Percentage (m / m) Cetiol® OE: Pediculicide and ovicide agent (mechanical action suffocating agent) 89587 - Dicaprylyl ether 629-82-3

Lipex SheaLight®: Pediculicide and ovicide agent (mechanical action suffocating agent) 10 Shea butter ethyl esters 1456887- 14-1 Perfume (white peach nectar) Perfume 0363 Vitamin E Coviox® T-70®: - Tocopherols - Helianthus annuus seed oil antioxidant 0.050 of which: 0,035 0,015

Table 1

To do this, we implement the process presented below:

in a stainless steel tank topped with a propeller stirrer, successively incorporate the following raw materials, with stirring and at room temperature:

- CETIOL® OE

LIPEX SHEA LIGHT® (avoiding the formation of an ethyl stearate precipitate or, if it forms, by removing it by heating the raw material to 20-25 ° C with gentle stirring)

- VITAMIN E COVIOX T70, and

- NECTAR PECHE BLANCHE PERFUME APF126473; then keep stirring for about 30 minutes.

At the end of this process, a slightly opalescent, clear colorless to very pale yellow oily liquid is obtained, slightly perfumed (white peach nectar perfume). Cetiol® OE has little odor in itself.

The tests for skin use and use on hair of the lotion of Example 1 are satisfactory. The lotion of example 1 makes it possible to obtain a velvety, non-greasy finish on the hair.

Regarding the stability of this lotion, the one-year stability monitoring is good and the accelerated aging tests (3 months, 4 ° C / 40 ° C and 1 month 50 ° C) are positive.

Example 2: Composition according to the invention (in the form of a lotion) different from that of Example 1

The process described in Example 1 is implemented and adapted in order to obtain a composition also in the form of a lotion, the formula of which is presented in Table 2 below.

A clear, very slightly opalescent, pale yellow liquid is obtained, the dominant odor of which is the characteristic odor of neem oil, accompanied by a slight scent of white peach nectar.

As in Example 1, the skin use tests and the hair use tests are both positive, the lotion of Example 2 making it possible to obtain a velvety, non-oily finish on the hair.

The stability tests also prove to be positive since the lotion of Example 2 is found to be stable for 6 months at room temperature. Regarding the accelerated aging tests, these show stability for 3 months at 4 ° C / 40 ° C and 1 month at 50 ° C.

ingredients CAS # Function Percentage (m / m) SUSTOLEO DCS: Dicapryl succinate 28880-24-2 Pediculicide and ovicide agent (mechanical action - suffocating agent) 88587 Lipex SheaLight®: Shea butter ethyl esters 1456887-14-1 Pediculicide and ovicide agent (mechanical action - suffocating agent) 10,000 Perfume (white peach nectar) Perfume 0363

Virgin neem oil (Melia azadirachta seed oil) 68956-68-3 / 8002-65-1 1 Vitamin E Covi-ox® T-70®: - Tocopherols - Seed oil Helianthus annuus antioxidant 0.050 of which 0,035 0,015

Table 2

Example 3: Ex Vivo Test Using the Compositions of Examples 1 and 2

The pediculicidal and ovicidal efficacy of the compositions of Examples 1 and 2 was evaluated by an internationally renowned hospital parasitology laboratory.

3.1 Material and method

3.1.1 Products tested

The products tested are the lotions of Examples 1 and 2. As negative control, tap water is used (product T).

3.1.2 Insects used

Head lice (Pediculus humanus capitis) collected from patients presenting for pediculosis are used as insects of the order Phthiroptera. The samples are taken using a fine comb, styling the parasitized subject over a smooth white surface. Lice and nits are then collected in a petri dish and examined with a binocular microscope. For the tests, only live lice are used, without any injury, and viable nits (full).

3.1.3 10-minute immersion pediculicide tests

Three batches of 30 lice are identified for each series of tests. Each batch is placed at the bottom of a 85 mm diameter petri dish, one of which is labeled "example 1 lotion", one is labeled "example 2 lotion" and one is labeled "T" (for witness). The lice are drowned in 5 ml of product poured into the corresponding boxes: the lotion of example 1 in the box labeled "lotion of example 1", the lotion of example 2 in the box labeled "lotion of l 'example 1' and the product T in the box labeled 'T'. The insects are kept submerged for 10 minutes, then the products are aspirated using a pipette. The lice are then washed with a neutral shampoo and rinsed with tap water. They are immediately examined under a binocular microscope, then observed at room temperature for 24 hours. They are examined with a binocular microscope according to the following hourly calendar: 15 min, 30 min, 60 min, 120 min and 24 hours. The tests are carried out at an ambient temperature varying from 22 to 24 ° C. To verify the reproducibility of the results, three series of tests are thus carried out.

3.1.4 Pediculicide tests by 30-minute immersion

The same tests are carried out under the same conditions but with a lice immersion time of 30 minutes in the product to be tested.

3.1.5 Lenticidal tests (ovicides) by 10-minute immersion

Three batches of 20 nits are identified in Petri dishes each bearing the reference of one of the products to be tested. A box labeled "Example 1 Lotion", a box labeled "Example 2 Lotion" and a box labeled "T". The nits are immersed for 10 minutes in 5 mL of the product corresponding to the reference of the box. They are then washed in a mild shampoo, rinsed with tap water and put into aging conditions in a humid room (75% humidity), in an oven at 24 ° C. They are examined every day for 10 days under a binocular magnifier and the outbreaks are noted in a table. To verify the reproducibility of the results, three series of tests are thus carried out.

3.2 Results - Discussion

3.2.1 Pediculicide tests

A total of 540 lice were used to assess pediculicidal efficacy, including 270 for the 10-minute immersion tests and 270 for the 30-minute immersion tests. Each product is thus evaluated using 90 lice immersed for 10 minutes and 90 lice immersed for 30 minutes.

Under the conditions of these tests, the mortality from lice one hour after immersion in the lotion of Example 1 is 100%. This result is obtained with an immersion of 10 minutes or 30 minutes. This product therefore proves to be an excellent pediculicide (with a pediculicidal effect which can even be described as "optimal") regardless of the duration of the immersion.

Under the same conditions, the lice mortality reaches 62.2% one hour after a 10-minute immersion in the lotion of Example 2 and 72.2% after a 30-minute immersion. In the light of these results, the lotion of Example 2 therefore appears to be moderately pediculicidal.

Finally, note that no mortality was observed among lice immersed 10 or 30 minutes in the control product, tap water.

3.2.2 Lenticidal tests

A total of 180 nits of Pediculus humanus capitis were used to evaluate the lenticidal efficacy of the product, including 60 for the lotion of Example 1, 60 for the lotion of Example 2 and 60 for the product T ( tap water).

Under the conditions of these tests, the lotion of Example 1 proved to be an excellent lenticide with only one hatching out of 60 nits tested. This outbreak occurred in the first 24 hours (D1) in the second series of tests.

The lotion in Example 2 also proved to be a good lenticide with 4 out of 60 nits tested. These outbreaks also occurred on D1 and D2. With the control product, tap water, 50 outbreaks are observed on 60 nits.

Importantly, the fact that we observe the hatching of some mature nymphs (close to hatching) on D1 (for the lotion of example 1) and on D1 and D2 (for the lotion of example 2) demonstrates that the product works effectively by blocking (putting out of use) the respiratory orifices of the slow and not via a biocidal insecticidal activity, namely by chemically killing the nymph inside the egg. This demonstrates, once again, that, unlike the prior art products containing synthetic insecticides (with biocidal action), the composition according to the invention acts mechanically, by suffocating the phthirapters and their eggs (here head lice and their nits).

3.2.3 Conclusion

Under the conditions of these tests, the lotion of Example 1 was found to be an excellent pediculicide and an excellent lenticide. The lotion of Example 2, on the other hand, is moderately pediculicidal and a good lenticidal.

3.3 General conclusion

As indicated previously, the lotion of Example 1 obtained the best results in terms of pediculicidal and lenticidal (ovicidal) action. However, even if the lotion of Example 2 appears to be moderately pediculicidal, the results in terms of lenticidal effect make it possible to retain this product. Indeed, the lenticidal action is essential to prevent / avoid any re-infestation with head lice and the lotion of example 2 proves to be a good lenticidal, as indicated previously (and, in any state of cause, a better lenticide than many products of the state of the art, and in particular those comprising synthetic insecticides).

Example 4 - Results obtained ex vivo from a reference composition comprising silicone (in the form of a lotion) and comparison of these results with those obtained in Example 3

The present example aims to compare the results obtained in terms of pediculicidal and lenticidal (ovicidal) efficacy of the lotion of example 1 (cf. example 3 above) with a reference composition comprising silicone (and more precisely a mixture dimethicone and decamethylcyclopentasiloxane (cyclopentasiloxane)). This reference composition in the form of a lotion is hereinafter called “reference lotion”.

The procedure and the results obtained are presented below.

4.1 Material and method

4.1.1 Products tested, preparation processes and “safety” aspects

4.1.1.1 Products tested

A reference lotion comprising silicone (and more precisely a mixture of dimethicone and decamethylcyclopentasiloxane (cyclopentasiloxane)) is tested, which is in the form of a white viscous solution.

The composition of the above reference lotion is presented in Table 3 below:

ingredients INCI Name CAS # Function Percentage (m / m) Silicone 200/50 C.S. Dimethicone 63148-6-9 Pediculicide and ovicide agent (mechanical action suffocating agent) 10,000 Mirasil CM5 Cyclopentasiloxane 541-02-06 texture agent pediculicide and ovicide agent secondary 83.800 DUB VCI 10 ISODECYL neopentanoate 60209-82-7 Emollient 5,000 THETIS PERFUME 30260 PERFUME Perfume 0,200 DERMOFEEL VISCOLID HYDROGENATED VEGETABLE OIL 68334-28-1 Lipophilic gelling agent 1,000

Table 3

It should be noted that, the prior art pediculicidal compositions comprising dimethicone include, as a general rule, this compound in a mass concentration of 5% relative to the total mass of the composition. However, and in order to demonstrate - without possible dispute - the superiority of the compositions according to the invention in terms of pediculicidal and especially ovicidal efficacy, the concentration of dimethicone in the reference lotion was deliberately increased, from 5 to 10% en masse.

As negative control, tap water (product T) is used.

4.1.1.2 Method for preparing the reference lotion

Premix # 1:

- In a stainless steel tank introduce the DUB VCI 10 and heat to 55 ° C.

- At 55 ° C, add DERMOFEEL VISCOLID with propeller stirring (Rayneri type).

- Shake until completely dissolved: the premix must be clear.

- Check the solubilization, the homogeneity of the premix: clear, slightly yellow liquid, absence of particles.

In the closed vacuum tank (Dumek type):

- Introduce CYCLOPENTASILOXANE and SILICONE 200/50 C.S.

- Shake for 5 min with turbine + planetary shaking.

- Add the hot premix # 1 with stirring. Be careful if the premix freezes on the walls of its container, put it back to heat and incorporate it hot.

- Stir under vacuum and with turbine + planetary stirring, the mixture will thicken slightly with stirring.

- Check the formation of the fluid gel: white opalescent gel without lumps.

- If necessary, cool under vacuum and with planetary stirring to 20 ° C.

Add PERTIS THETIS 30260 and shake until completely homogeneous.

We obtain a fluid gel, smooth after shaking, opalescent white with a characteristic odor of the thetis perfume.

4.1.1.3 Security aspect

The nature of certain raw materials implies the wearing by operators of protective glasses, gloves and masks (filter type AB).

Note also that operators must be informed of the risk of slipping if 200/50 CS silicone is sprayed onto a smooth surface.

4.1.2 Insects used

Head lice (Pediculus humanus capitis) collected from patients presenting for pediculosis are used as insects of the order Phthiroptera. The samples are taken using a fine comb, styling the parasitized subject over a smooth white surface. Lice and nits are then collected in a petri dish and examined with a binocular microscope. For the tests, only live lice are used, without any injury, and viable nits (full).

4.1.3 10-minute immersion pediculicide tests

Two batches of 30 lice are identified for each series of tests. Each batch is placed at the bottom of an 85 mm diameter petri dish, including a box labeled "reference lotion comprising silicones", and a box labeled "T" (for control). Lice are drowned in 5 mL of product poured into the corresponding boxes: I a reference lotion comprising silicones in the box labeled "I a reference lotion comprising silicones", and product T in the box labeled "T". (NB: the reference lotion comprising silicones is well shaken before use). The insects are kept submerged for 10 minutes, then the products are aspirated using a pipette. The lice are then washed with a neutral shampoo and rinsed with tap water. They are immediately examined under a binocular microscope, then observed at room temperature for 24 hours. They are examined with a binocular microscope according to the following hourly calendar: 15 min, 30 min, 60 min, 120 min and 24 hours. To verify the reproducibility of the results, three series of tests are thus carried out.

The pediculicidal efficacy for the purposes of this example is determined at the observation time of 60 min.

4.1.4 Pediculicide tests by 30-minute immersion

The same tests are carried out under the same conditions but with a lice immersion time of 30 minutes in the product to be tested.

4.1.5 Lenticidal tests (ovicides) by 10-minute immersion

Two batches of 20 nits are identified in Petri dishes, each bearing the reference of one of the products to be tested. A box labeled "reference lotion including silicones" and a box labeled "T". (NB: the reference lotion comprising silicones is well shaken before use). The nits are immersed for 10 minutes in 5 mL of the product corresponding to the reference of the box. They are then washed in a mild shampoo, rinsed with tap water and put into aging condition in a humid room (75% humidity), in an oven at 28 ° C. They are examined every day for 10 days under a binocular magnifier and the outbreaks are noted in a table. To verify the reproducibility of the results, three series of tests are thus carried out.

4.2 Results - Discussion

4.2.1 Pediculicide tests

In total, 3 series (12 tests) were carried out: 360 lice were used to assess the pediculicidal efficacy, including 180 for the reference lotion comprising silicones and 180 for the product T.

Under the conditions of these tests, the reference lotion comprising silicones appears to be a very good pediculicide. Almost 100% of treated lice are immediately immobilized and killed. The rare lice observed dying can be considered dead since they also do not wake up, even after 24 hours of observation. The reference lotion comprising silicones is fully effective from 10 minutes of immersion and the immersion time of 30 minutes does not improve the results.

4.2.2 Lenticidal tests

A total of 180 nits of Pediculus humanus capitis were used to assess the product's lenticidal efficacy. 180 were used to carry out 9 tests. Each product is tested 3 times.

Under the conditions of this test, the reference lotion (comprising silicones) proves to be disappointing, insofar as only 50% of the nits are killed within the framework of the test “by immersion of 10 minutes” presented in point 3.1.5. supra.

4.2.3 Comparison of the results obtained with those of Example 3

The results obtained ex vivo from the reference lotion comprising silicone are compared with those obtained in Example 3, from the lotion of Example 1. Table 4 below allows these results to be easily compared. .

Ex-vivo efficiency test Anti-lice efficacy for 10 min contact Anti-slow effectiveness for 10 min contact lotion of example 1 (ex vivo tests of example 3) 100% lice mortality 90 dead lice out of 90 lice tested (observation to 1 hour) => excellent pediculicide 98.3% mortality from nits => 59 dead nits out of 60 nits tested (observed on D1, 1 slow hatch at maturity) b excellent lenticide Reference composition comprising silicone (dimethicone 10%) (ex vivo tests of the present example) 96.7% lice mortality 87 dead lice and 3 moribund lice out of 90 lice tested (observation at 1 h) => excellent pediculicide 50% mortality from nits 30 dead nits out of 60 nits tested (30 slow hatched, observed from D1 to D6) => moderately lenticidal

Table 4

In conclusion, the (natural) lotion of Example 1 is 100% effective on lice and acts faster than the reference composition comprising silicone (dimethicone 10%). In addition, the lotion of Example 1 is, very significantly, more effective on nits than the reference composition comprising silicone (dimethicone 10%); said lotion of Example 1 being an excellent ovicide, unlike the reference lotion which turns out to be moderately lenticidal (ovicide). As previously indicated, this lenticidal action is essential to prevent / avoid any re-infestation with head lice, which is why it is advisable to favor the use of the composition according to the invention over the reference lotion.

EXAMPLE 5 Spreading Tests, Pediculicidal Tests and Cross Results

5.1 Introduction / Objectives

The objective of this example is to carry out spreading tests from the lotions of Examples 1 and 2, in order to evaluate certain characteristics which contribute to the effectiveness of the product, in particular with regard to spreading properties ( and in particular of spreading value).

The formulas of Examples 1 and 2 - 100% of natural origin - are compared with a reference formula containing silicone and with certain raw materials, the latter 5 being presented in Table 5 below.

Trade name INCI Name CAS # Chemistry Origin Naturalness according to ISO 16128 Cegesoft GPO Elaeis Guineensis (Palm) Oil 8002-75-3 Vegetable oil Palm oil -> use of the fruit 100% natural SustOleo DCS Dicapryl succinate 28880-24-2 ester vegetable: castor oil and wheat 100% natural lipex shealight® Shea butter ethyl esters 1456887-14-1 -ethyl ester Vegetable, ester derived from shea butter 100% natural Cetiol® OE Dicapryl ether 629-82-3 ether Vegetable from palm oil and / or coconut oil 100% natural Cyclopentasilox donkey cyclopentas iloxane 541-02-6 Volatile silicone = cyclic siloxane / Decamet hylcyclop entasilox ane summary Unnatural Silicone 200/50 CS dimethicone 63148-62-9 Fluid silicone = linear siloxane summary Unnatural

Myritol 318 Caprylic / capric triglyceride 73398-61-5 / 65381-09-1 Triglyceris of Vegetable (coconut oil -> use of palm fruit -> use of fruit 100% natural Cetiol® sensoft Propylhepty I caprylate 617-930-3 ester From natural raw materials renewed and synthetics ‘Would be of natural origin Cetiol® ultimate Undecane (and) tridecane 1120-21-4 629-50-5 Hydrocar good From 100% natural and renewed raw materials ‘Is 100% natural

* based on data provided by the supplier.

Table 5

The composition of the reference formula comprising silicone (dimethicone 5%) is presented in Table 6 below.

ingredients INCI Name CAS # Function Percentage (m / m) Silicone 200/50 C.S. Dimethicone 63148-6-9 Pediculicide and ovicide agent (mechanical action suffocating agent) 5,000

Mirasil CM5 Cyclopentasiloxane 541-02-06 texture agent pediculicide and ovicide agent secondary 89,800 DUB VCI 10 ISODECYL neopentanoate 60209-82-7 Emollient 5,000 THETIS PERFUME 30260 PERFUME Perfume 0,200

Table 6

5.2 Measurements carried out

Diffusion tests (spreading) were carried out on synthetic skin (Vitro Skin®) obtained from the Laboratory "IMS Inc.", on the raw materials of table 5 above, on the lotions of Examples 1 and 2 and on the composition standards comprising silicone, the formula of which is presented in Table 6 above.

In parallel, ex vivo pediculicidal efficacy tests were carried out at an internationally renowned hospital parasitology laboratory, following the procedure set up for pediculicidal tests; operating mode presented in example 3 (cf. in particular points 3.1.3 and 3.1.4 above).

5.3 Presentation of equipment used for the tests

5.3.1 Vitro Skin® plates and its hydration chamber

We use a Vitro skin® kit with its hydration chamber and the "synthetic skin" substrate plates obtained from the IMS Laboratory. Inc.

The Vitro skin® kit plates mimic the surface properties of human skin. The polymer used to develop the above-mentioned "synthetic skin" was formulated to have a topography, a pH, a critical surface tension and an ionic strength similar to human skin.

5.4 Diffusion tests

5.4.1 Hydration of a Vitro Skin® synthetic skin plate

5.4.1.1 Procedure (source: IMS Laboratory. Inc)

Note: Before starting the handling, the Vitro skin® plate must be hydrated between 16 and 24 hours. For all the tests carried out for the purposes of Example 5, this incubation time was standardized at 20 hours.

Note that the plates have a sense of use. There is a shiny side and a dull side. It’s on the mat side that you have to work.

The procedure for the hydration phase of the Vitro skin® plate includes the following steps:

Prepare a solution of purified water and glycerin (298g / 52g) m / m;

- Pour all the solution into the incubation chamber;

Place the grids inside the chamber and close the cover;

Cut a plate of Vitro skin® in half. Then on each of the shiny faces draw marks with a pen:

- Every 6.5 cm vertically,

In the horizontal direction, separate the sheet in half by drawing a straight line in the middle of each half-sheet;

Turn the half-leaves over on the shiny side (matt side above), then place them on the racks in the incubation chamber;

Close the enclosure tightly without projecting and without moving it too much. The glycerine solution must not come into direct contact with synthetic skin; hydration takes place by absorption of vapors.

After 20 hours of incubation, remove the plate from the chamber and deposit 3 times 10 μΙ of the solutions to be tested. Then replace the plate in the incubation chamber. Wait 15 minutes for the products to spread on the Vitro skin® plate.

Note: It is necessary that the waiting time for the diffusion takes place in the chamber so that the plate does not dry out during the test. When the 15 minutes have passed, remove the plate from the chamber then trace the outline of the stains obtained with a pen. Take a photo of these tracks. Then transcribe these plots on a sheet of millimeter tracing paper and take a photo according to the same settings as above.

From the plot on graph paper, count the number of tiles to express a spreading area in mm ² .

The result obtained therefore represents the spreading value in mm ² after 15 minutes (or "15 minutes").

It should be noted that although in the literature, the results in terms of spread value can be expressed in mm ² / 10minutes after some laboratory tests, it appeared that 15 minutes had adequate time to test all products on 6.5 cm ² work surfaces. Even those who broadcast the most do not exceed these "work surfaces" in terms of measurement time.

Furthermore, with regard to comparing the spreading value of the compositions of Examples 1 and 2, the Applicant started from the premise that the time of "laying" on the patient's head is closer to 15 minutes than to 10 minutes.

5.4.1.2 Result table for spread value

The results obtained by implementing the procedure described in point 5.4.1.1 are presented in Table 7 below.

Trade name spread N ° 1 (mm ² ) spread N ° 2 (mm ² ) spread N ° 3 (mm ² ) average spread (mm ² ) standard deviation CVs CEGESOFT GPO 410 438 525 458 60 13 MYRITOL318 860 1426 888 1058 319 30 CETIOLOOE 1487 1347 1422 1419 70 5 CETIOL® SENSOFT 1261 1237 1266 1255 16 1 CETIOL® ULTIMATE 1358 1175 1434 1322 133 10 LIPEXSHEA LIGHT® 1387 1276 1583 1415 155 11

Cyclopentasiloxane 1726 1872 1294 1631 301 18 SILICONE 200/50 C.S 1299 1744 1262 1435 268 19 SUSTOLEO DCS 1192 1205 1069 1155 75 6 Reference composition comprising silicone (dimethicone 5%) 1935 2124 1965 2008 102 5 Example 1 lotion 1563 1533 1439 1512 65 4 Example 2 Lotion 1210 1635 1242 1362 237 17

Table 7

5.5 Pediculicide tests

5.5.1 Introduction

On the model of the ex vivo tests detailed in Example 3 above, the Applicant has carried out, with an internationally renowned hospital parasitology laboratory, ex vivo efficacy studies on Pediculus humanus capitis, the head louse.

5.5.2 Products tested

The ex vivo pediculicide tests were carried out on three raw materials, on the lotion of Example 1, as well as on the reference composition comprising silicone (dimethicone 5%), the composition of which is presented in Table 6 above.

The three raw materials tested are presented in Table 8 below:

Trade name INCI Name CAS # Chemistry Origin Naturalness according to ISO 16128 cyclopentasiloxane cyclopentasil oxane 541-02-6 Volatile silicone = cyclic siloxane / Decameth ylcyclopen tasiloxane summary Unnatural Cetiol® sensoft Propylheptyl caprylate 617-930-3 Ester From natural raw materials renewed and synthetics * would be of natural origin Cetiol® ultimate Undecane (and) tridecane 1120-21-4 629-50-5 Hydrocarb on From 100% natural and renewed raw materials * Is 100% natural

* based on data provided by the supplier.

Table 8

Tap water is used as a negative control.

5.5.3 Insects used

Lice are removed from patients presenting for pediculosis. The samples are taken using a fine comb, styling the parasitized subject over a smooth white surface. Lice and nits are then collected in a petri dish and examined with a binocular microscope. Only live, uninjured lice are used for testing.

5.5.4 Procedure for pediculicide tests

Four batches of 30 lice are identified for each series of tests. Each batch is placed at the bottom of an 85 mm diameter petri dish labeled with the name of the product to be tested. Lice are drowned in 5 mL of product spilled in the box corresponding to its labeling. The insects are kept submerged for 10 minutes, then the product is aspirated using a pipette. The lice are then washed with a neutral shampoo, rinsed with tap water and lightly dried with Joseph paper. They are immediately examined under a binocular microscope, then observed at room temperature for 24 hours. They are examined with a binocular microscope according to the following hourly calendar: 15mn, 30mn, 60mn, 120mn and 24 hours. The tests are carried out at an ambient temperature varying from 24 +/- 2 ° C. To verify the reproducibility of the results, three series of tests are thus carried out.

Pediculicidal efficacy for the purposes of this example is determined at the observation time of 60 minutes.

5.5.5 Results

A total of 360 lice were used, i.e. 90 lice for the pediculicidal evaluation of each of the products tested. The results are reproducible in the three series of tests.

Under the conditions of these tests, one hour after contact of the lice with the products to be tested, the products prove to be all pediculicides:

- the Cetiol® ultimate product with a mortality rate of 95.6% proves to be a very good pediculicide,

- the Cetiol® sensoft product with a mortality rate of 90% is highly pediculicidal,

- the cyclopentasiloxane product with a mortality rate of 76.7% proves to be a good pediculicide,

- finally, lice placed in water survive 100%.

5.6 Putting the pediculicide effect into perspective with the spreading value

With regard to the three raw materials tested, there is a certain correlation between spreading values ("spreading value" in English) and pediculicidal efficiency. Indeed :

Hydrocarbons (Cetiol® ultimate) and Cetiol® sensoft fatty acid esters which give spreading values of between approximately 1250 mm ² (after 15 minutes) and approximately 1330 mm ² (after 15 minutes), are correlated with a mortality of around 89 and 96%.

The silicones (cyclopentasiloxane) which have a higher spreading value, namely approximately 1630 mm ² (after 15 minutes) 'have a lower lice mortality rate, of the order of 77%.

According to the tests carried out, at a certain range of spreading value values, the anti-lice and optimal efficacy, considered excellent from 90% of mortality and optimal from 95% of mortality.

Although the chemical structure of the pediculicide also has an influence, this parameter "spreading value" appears important for the selection of the most effective pediculicides (and lenticides).

In the light of the above, we will therefore move, for optimal efficiency, towards the choice of pediculicidal agents having a spreading value between 1200 and 1430 mm ² after 15 minutes, and preferably between 1250 and 1430 mm ² after 15 minutes.

Preferably, the pediculicidal agent used is the ether of Cetiol® OE fatty acids, preferentially to the Cetiol® ultimate hydrocarbon or to esters such as Cetiol® sensoft, insofar as this fatty acid ether is (with certainty) of plant origin, non-flammable, easily biodegradable, non-CMR (i.e. carcinogenic, mutagenic and reprotoxic; unlike the Cetiol® ultimate hydrocarbon) and of lower cost.

Bibliography [1] DUTRA, JMF et al. "Prehistorical Pediculus humanus capitis infestation: quantitative data and low vacuum scanning microscopy". Rev Inst Med Trop Sao Paulo (2014). 56: 115119. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4085847/ [2] COMBESCOT-LANG, C et al. "Ex vivo effectiveness of French over-the-counter products against head lice (Pediculus humanus capitis De Geer, 1778)". Parasitol Res, Springer-Verlag Berlin Heidelberg (2015). DOI 10.1007 / s00436-015-4363-9 [3] SANGARE, A.K et al. "Management and Treatment of Human Lice". Hindawi Publishing Corporation, BioMed Research International (2016). Volume 2016, Article ID 8962685, 12 pages, http://dx.doi.Org/10.1155/2016/8962685.

[4] FRANKOWSKIi BL, Weiner LB. ”Head lice”. Pediatrics. (2002) .110 (3): 638-43.

[5] Higher Council of Public Health. "What to do in front of a subject with scalp pediculosis". Superior Council of Public Hygiene of France, Section of Communicable Diseases. Sitting held on January 17, 2003.

[6] BARKER, S etal. “International guidelines for clinical trials with pediculicides”. Int J Dermatol (2012). 51: 853-858.

http://phthiraptera.info/sites/phthiraptera.info/files/219.%20GuidelinesClinicalTrials.pdf [7] CONNOR, CJ et al. “Severe pediculosis capitus: a case of“ crusted lice ”with autoeczematisation”. Dermatology Online Journal, 22 (3). (2016). Permalink: http://escholarship.org/uc/item/7c91z913 [8] IZRI, A et al. “Clinical efficacy and safety in head lice infection by Pediculus humanis capitis De Geer (Anoplura: Pediculidae) of a capillary spray containing a silicon-oil complex”. Parasite. (2010). 17 (4): 329-35. https: //www.parasite- journal.org/articles/parasite/abs/2010/04/parasite2010174p329/parasite2010174p329.html [9] CUMMINGS, C et al. “Head lice infestations: A clinical update”. Canadian Pediatric Society (2016).

[10] BURGESS, I.F. "The mode of action of dimeticone 4% lotion against head lice, Pediculus capitis". BMC Pharmacology, BioMed Central (2009). doi: 10.1186 / 1471-2210-93, http: //www.biomedcentral.eom/1471-2210/9/3 [11] KOCH, E et al. "Management of Head Louse Infestations in the United States - A

Literature Review ”. Pediatrics Dermatology (2016). Flight. 33 No. 5 466-472.

[12] TANG, QO et al. “Burns due to dimeticone with cyclometicone 5 excipient anti-lice lotion”. Burns. (2013). Volume 39, Issue 4,828 - 829 [13] Dorge DD et al. “Flammability testing of 22 conventional European pediculicides”. Parasitol Res. (2017). 116: 1189.

[14] “INTERNATIONAL STANDARD ISO 16128-1”. AFNOR - Norm’lnfo, © ISO (2016).

15 First edition 2016-02-15, ISO 16128-1: 2016 (F).

Claims (15)

claims 1. Antiparasitic composition for external use, which can be administered to a human or animal, preferably human, said composition being devoid of synthetic insecticide and comprising a percentage by mass of silicone of less than 1%, preferably less than or equal to 0, 1%, relative to the total mass of the composition, said composition advantageously being free of silicone; said composition comprising at least one external antiparasitic agent selected from vegetable oils and oils of vegetable origin, advantageously from oils of vegetable origin, said at least one external antiparasitic agent being included in a percentage by mass representing more than 50% , preferably more than 60%, preferably at least 70%, advantageously at least 80% and, in a particularly preferred manner, at least 90% of the total mass of said composition. 2. Composition according to claim 1, said composition comprising a percentage by mass of essential oil (s) of less than 5%, preferably less than 3%, advantageously less than 1% and, preferably, less than or equal to 0.1%; particularly preferably, said composition being devoid of essential oil (s). 3. Composition according to claim 1 or 2, wherein said at least one external antiparasitic agent is selected from: - the following vegetable oils: coconut oil, calophyllum oil, sunflower oil, sweet almond oil, castor oil, hazelnut oil, olive oil , jojoba oil, argan oil and avocado oil, preferably from the following vegetable oils: castor oil, hazelnut oil, olive oil, jojoba oil, argan oil , avocado oil, advantageously from the following vegetable oils: jojoba oil and hazelnut oil; and - the following vegetable oils: a) fatty acid esters, preferably fatty acid monoesters, advantageously fatty acid monoesters of general formula (I) in which FL is a linear, saturated or unsaturated aliphatic alkyl group comprising a number of carbons included between 6 and 20, preferably between 7 and 18, and in which R ₂ is a saturated, linear or branched aliphatic alkyl group, comprising a number of carbons between 1 and 12, preferably between 2 and 10, and advantageously between 1 and 3, b) mono- and di-esters of fatty acids and dicarboxylic acids, preferably diesters of fatty acids and dicarboxylic acids, advantageously the diesters of fatty acids and dicarboxylic acids of general formula (II) O O R ^ -O-ll — x — U_Q_R _{2 ((|)} in which R 1 and R ₂ each independently represent a linear or branched, saturated or unsaturated aliphatic alkyl group comprising a number of carbons between 4 and 12, preferably between 6 and 10, and X represents a linear saturated aliphatic alkyl group comprising a number of carbons between 1 and 4, preferably between 2 and 3, and c) fatty acid ethers, advantageously of general formula (III) R _r OR _{2 (m)} in which Ri and R ₂ each independently represent a linear or branched, saturated or unsaturated aliphatic alkyl group, comprising a number of carbons between 4 and 18, preferably between 6 and 12, advantageously between 7 and 9; in a particularly preferred manner, R 1 and R ₂ each independently represent a linear or branched, saturated or unsaturated aliphatic alkyl group comprising 8 carbon atoms. 4. Composition according to one of the preceding claims, in which said at least one external antiparasitic agent is selected from vegetable oils and oils of vegetable origin having a spreading value greater than 500 mm ² to 15 minutes, preferably greater than 800 mm ² to 15 minutes, preferably greater than 1000 mm ² to 15 minutes, advantageously greater than or equal to approximately 1100 mm ² to 15 minutes, and, preferably, greater than or equal to approximately 1200 mm ² to 15 minutes. 5. Composition according to the preceding claim, wherein said at least one external antiparasitic agent has a spreading value of between approximately 1150 mm ² and approximately 1450 mm ² to 15 minutes, and preferably between approximately 1250 mm ² and approximately 1430 mm ² to 15 minutes. 6. Composition according to one of claims 1 to 5, wherein said at least one external antiparasitic agent comprises: at least one first oil of vegetable origin derived from shea butter, preferably at least one ester of shea butter, preferably at least one ethyl ester of shea butter, advantageously ethyl oleate, ethyl stearate, l 'ethyl palmitate and / or ethyl linoleate, and - at least one second oil of plant origin, different from said at least one first oil of plant origin, selected from: b) mono- and di-esters of fatty acids and dicarboxylic acids, preferably diesters of fatty acids and dicarboxylic acids, advantageously the diesters of fatty acids and dicarboxylic acids of general formula (II) O O ROUXUO-Rî _(||) in which Ri and R ₂ each independently represent a linear or branched, saturated or unsaturated aliphatic alkyl group, comprising a number of carbons between 4 and 12, preferably between 6 and 10, and X represents a saturated linear aliphatic alkyl group comprising a number of carbons between 1 and 4, preferably between 2 and 3, and c) fatty acid ethers, advantageously of general formula (III) R _r OR _{2 (m)} in which Ri and R ₂ each independently represent a linear or branched, saturated or unsaturated aliphatic alkyl group, comprising a number of carbons between 4 and 18, preferably between 6 and 12, advantageously between 7 and 9; in a particularly preferred manner Ri and R ₂ each independently represent a linear or branched, saturated or unsaturated aliphatic alkyl group, comprising 8 carbon atoms. 7. Composition according to the preceding claim, in which the mass ratio between said at least one second oil of vegetable origin and said at least one first oil of vegetable origin is between approximately 6/1 and approximately 15/1, of preferably between about 8/1 and about 12/1, preferably between about 8/1 and about 10/1; advantageously said mass ratio is approximately 9/1. 8. Composition according to one of the preceding claims, said composition not comprising other external antiparasitic agents than said at least one external antiparasitic agent. 9. Composition according to one of the preceding claims, said composition having a spreading value greater than 1100 mm ² to 15 minutes, preferably greater than 1200 mm ² to 15 minutes, preferably greater than or equal to approximately 1300 mm ² to 15 minutes, advantageously greater than or equal to about 1400 mm ² to 15 minutes; particularly preferably, said composition having a spreading value of between approximately 1400 mm ² and approximately 1600 mm ² to 15 minutes. 10. Lotion, shampoo, solution, suspension, foam, spray, cream, paste or gel, preferably lotion, comprising the composition according to one of the preceding claims. 11. Composition according to one of claims 1 to 9, for its use as a medicament in human or veterinary medicine, preferably in human medicine. 12. Composition according to one of claims 1 to 9, for its use as an antiparasitic agent for external use, preferably in the prevention, treatment and / or regulation of infestations of ectoparasites such as ectoparasitic arthropods, preferably as anti-phthirapters for external use, advantageously as a pediculicide and / or ovicide, preferably as a pediculicide and ovicide, in humans or animals. 13. Composition according to the preceding claim, said composition being in a form suitable for being administered topically to the area of the human or animal body to be treated for a period of approximately 10 minutes. 14. Vegetable oil (s) and / or oil (s) of vegetable origin as defined in one of claims 3 to 5 or mixture of oils of vegetable origin such as defined in claim 6 or 7 for its / their use (s) as an antiparasitic for external use, preferably in the prevention, treatment and / or regulation of infestations of ectoparasites such as arthropods ectoparasites, preferably as anti-phthirapters for external use, advantageously as a pediculicide and / or ovicide, preferably as a pediculicide and ovicide, in humans or animals, preferably in humans. 10 15. Use of at least one vegetable oil and / or at least one oil of vegetable origin as defined in one of claims 3 to 5 or of a mixture of oils d of plant origin as defined in claim 6 or 7 for the preparation of an antiparasitic composition for external use, preferably antiphthirapteres for external use, preferably pediculicide and / or ovicide, advantageously pediculicide and ovicide, in humans or animals 'animal.