Method for caring for skin or coat of animals

Abstract

To provide a method for caring for skin or coat of animals, and a method useful for caring for skin or coat of animals, such as helping reduce itching in the animals.SOLUTION: A method for caring for skin or coat of animals, comprising application of a rinse-off shampoo to the skin, followed by at least four consecutive applications of a composition in a form of a non-rinse-off foam to the skin or the coat. Also provided is a kit, in particular intended to implement a method for caring for the skin or coat of animals, and more specifically, to help reduce itching in the animals.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to a method for caring for the skin or coat of a pet, comprising the application of a rinse-off shampoo type composition followed by at least four successive applications of a composition in non-rinse-off foam form. The present invention also relates in particular to a kit intended to carry out the method for caring for the skin and / or coat of a pet, in particular to help relieve itching in pets, which contains the aforementioned composition in a compartment.

[0002] Presentation of prior art Pets such as dogs and cats frequently have skin or cutaneous problems, such as dry skin, peeling skin, pruritus, itching, dermatitis, excessive hair loss, and dull coat, etc. Itchy skin problems vary from very slight or occasional itching to very severe or nearly continuous itching.

[0003] In animals, atopic dermatitis is a chronic, inflammatory, and itchy skin disease with multiple origins. The disorder results from a complex interaction between genetic predisposition and environmental factors. The first signs of the disorder in dogs or cats generally appear between six months and three years of age. Lesions primarily affect the face, extremities, deep creases, and abdomen. Atopic dermatitis or the pruritic form of allergic dermatitis is typically treated with antipruritics, antihistamines, anti-inflammatory agents, or immunomodulators, such as cyclosporine, corticoids, or oclacitinib. These treatments are generally accompanied by supportive or care measures, such as shampoo treatments, to achieve better and more rapid results or to prevent or delay recurrence.

[0004] However, it has been found that in general practice, animal owners rarely use shampoo for their treatment.Because it is impractical for owners to use shampoo, which requires rinsing, which can be particularly difficult when the animal is a long-haired or nervous breed.Repeated application of rinse-off shampoo can also reduce the effectiveness of topical treatment against mites and fleas, especially if the time lag between application of antiparasitic agent and skin care is not observed.

[0005] Therefore, there is a need to develop protocols for caring for the skin or coat of pets that are easier to follow while being more effective or, in fact, more effective than previously known protocols.

[0006] The applicant has developed a specific protocol for applying the composition to the skin or integument of a pet, which is easy to implement because it consists of only a single application of rinse-off shampoo during the protocol, followed by a single application of the composition that does not require rinsing. This protocol makes it possible to obtain very satisfactory results, especially in terms of reducing itching, while making the treatment easier and more attractive for owners to use, thus improving treatment compliance. Summary of the Invention

[0007] The present invention relates to a method for caring for the skin or coat of an animal, which comprises applying a rinse-off shampoo to the skin, followed by at least four successive applications of a composition in a no-rinse-off foam form to the skin or coat. In particular, the method comprises applying a rinse-off shampoo followed by 5, 6, 7, or 8 consecutive applications of a composition in non-rinse-off foam form. In some embodiments, the shampoo and composition in non-rinse-off foam form are compositions comprising at least one compound intended to relieve itching in animals, particularly pets such as dogs or cats.

[0008] The present invention also relates to a kit comprising in one or more compartments at least one rinse-off shampoo and at least one composition in no-rinse-off foam form, and optionally instructions describing how to use said shampoo and composition in no-rinse-off foam form as defined in the present invention. [Brief explanation of the drawings]

[0009] [Figure 1] 1 shows the "control" protocol carried out in Example 1 (A) and the protocol according to the invention (B). [Figure 2] The results of the example studies (A) and (B) are shown (mean CADESI scores). A) Mean CADESI scores from the two studies. -CADESI-04 % change relative to day 0 - mean confidence interval (CI) at 95%. The horizontal lines represented by dashed lines (---) correspond to the severity delimiters (remission / average / moderate). The curve represented by dotted lines (...) is the curve for group (A). The curve represented by solid lines (_) is the curve for group (B). B) The CADESI scores of the two groups (A) and (B) of the example study are shown in the form of percentage change ((day x - day 0 / day 0) x 100). The horizontal lines represented by dashed lines (---) correspond to the threshold score of 40%. The curve represented by dotted lines (...) is the curve for group (A). The curve represented by solid lines (_) is the curve for group (B). DETAILED DESCRIPTION OF THE INVENTION

[0010] The present invention therefore relates to a method for caring for the skin or coat of an animal, in particular a pet, comprising the application of a rinse-off shampoo to the skin or coat of the animal, followed by at least four successive applications of a composition in non-rinse-off foam form to the skin or coat of said animal.

[0011] According to the present invention, the method applied to the skin or integument of an animal can be carried out before, during, or after the treatment of an animal with a skin or integument problem, particularly atopic dermatitis or pruritus or seborrheic disorders. Thus, the method of the present invention can be an adjunct or supportive treatment for a therapeutic treatment, particularly a treatment using an antipruritic, antihistamine, anti-inflammatory, or immunomodulator, such as corticoids, cyclosporine, or oclacitinib. Thus, animals treated by the method of the present invention may have previously been diagnosed with atopy. They may have a period of remission of clinical evidence of atopic dermatitis. They may have been treated for an atopic condition, particularly with an antipruritic, antihistamine, anti-inflammatory, or immunomodulator.

[0012] The method according to the invention can be carried out on animals that are or have been suffering from itching, optionally independently of therapeutic treatment, particularly systemically or especially by injection or orally, particularly using antipruritics, antihistamines, anti-inflammatory agents, or immunomodulators. The itching in an animal can be very slight or sporadic, slight or moderately frequent, moderate or at regular intervals, severe or present for a long period of time, or very severe or almost continuous.

[0013] According to a particular embodiment, the method of the present invention makes it possible to relieve itching in animals (also referred to as non-human mammals), in particular in pets such as dogs or cats.

[0014] According to a particular embodiment, the method according to the invention is characterized in that each application (following the first application) is carried out at an interval of at least 24 hours, or preferably at least 48 hours, from the previous application. The method is preferably carried out such that each successive foam application following the first application of rinse-off shampoo is carried out 24 to 72 hours after the previous application. Even more preferably, each successive foam application following the first application of rinse-off shampoo is carried out 36 to 72 hours, in particular 48 to 72 hours, after the previous application. Thus, the time interval between each application of non-rinse-off foam may vary from 24 to 72 hours, in particular 36 to 72 hours, more particularly 48 hours (2 days) to 72 hours (3 days). In particular, the protocol described in Figure 1 may be used.

[0015] Thus, more specifically, the method according to the invention comprises the following steps: application of shampoo (day 1), application of the composition in no-rinse-off foam form carried out 48 hours after shampooing (day 1) (day 3), followed by application of the composition in no-rinse-off foam form carried out 72 hours after the 3rd day (day 6), followed by application of the composition in no-rinse-off foam form carried out 48 hours after the 6th day (day 8), followed by application of the composition in no-rinse-off foam form carried out 48 hours after the 8th day (day 10), followed by application of the composition in no-rinse-off foam form carried out 72 hours after the 10th day (day 13), followed by application of the composition in no-rinse-off foam form carried out 48 hours after the 13th day (day 15), followed by application of the composition in no-rinse-off foam form carried out 48 hours after the 15th day (day 17), followed by application of the composition in no-rinse-off foam form carried out 72 hours after the 17th day (day 20).

[0016] According to a preferred embodiment, the method comprises the application of a rinse-off shampoo followed by 4, 5, 6, 7 or preferably 8 successive applications of the composition in no-rinse-off foam form. Thus, more particularly, the 4, 5, 6, 7 or preferably 8 successive applications of the no-rinse-off foam according to the invention are not interrupted by the application of shampoo.

[0017] The method according to the invention may extend over a period of about 18 to 21 days and may be repeated one, two, or three times, or indeed more, as necessary.

[0018] Thus, according to a particular embodiment, the method further comprises at least one step consisting of applying a rinse-off shampoo, as described above, after at least 4, 5, 6, 7 or 8 successive applications of the composition in non-rinse-off foam form, wherein the application of the shampoo may be followed by successive applications of the composition in non-rinse-off foam form, and in particular the application of the shampoo may be followed by at least 4 successive applications of the composition in non-rinse-off foam form according to the invention. According to more particular embodiments, the aforementioned additional step may be repeated several times, in particular 1, 2 or 3 times.

[0019] As used herein, the term "shampoo" includes any composition intended to cleanse the hair and skin of non-human mammals and requires rinsing with water after application to the animal. Generally, shampoos have certain essential characteristics. Of course, the shampoos used in the present invention must be well-tolerated and intended for topical application to non-human mammals. The shampoos possess moisturizing, foaming, and detergent properties to ensure adequate cleansing of the coat or skin. In general, the shampoo compositions of the present invention contain a surfactant, preferably at least one anionic, cationic, amphoteric, or polar nonionic surfactant, or indeed a mixture thereof.

[0020] Anionic surfactants include, inter alia, alkyl sulfates (such as magnesium or sodium lauryl sulfate), alkyl ether sulfates (such as lauryl ether sulfate), alkyl polyether sulfates, alkyl sulfonates (alkyl groups having 8 to 18 carbon atoms), fatty acid soaps, monosulfosuccinates of fatty alcohols, condensation products of fatty acids with methyl taurine, condensation products of fatty acids with sarcosine, and condensation products of fatty acids with protein hydrolysates.

[0021] Cationic surfactants include, among others, long-chain quaternary ammonium compounds, fatty acid and amino acid esters, and polyether amines.

[0022] Polar nonionic surfactants include, in particular, polyol esters and esters of sugars, condensation products of ethylene oxide with fatty acids, with fatty alcohols, with long-chain alkylphenols, with long-chain mercaptans, and with long-chain amides, and polyethers of polyhydroxyl fatty acids.

[0023] Amphoteric surfactants include in particular derivatives of amino acids such as asparagine derivatives, imidazolines and condensation products of monochloroacetic acid with alkylamine propionates, more particularly derivatives of betaine or imidazolines.

[0024] In the shampoo composition, the surfactant composition preferably represents 5 to 50% by weight relative to the total weight of the composition. Shampoos according to the invention may also contain other ingredients conventionally used in such compositions, such as viscosity-increasing agents, in particular acrylate / methacrylate copolymers, oils, waxes, plant extracts, emollients, carbomers, gums, in particular xanthan gum, polyethylene glycol, cyclomethicone, conditioners, preservatives, for example methyl or propyl parahydroxybenzoate, colorants, fragrances, or mixtures thereof.

[0025] No-rinse-off foams are therefore suitable for no-rinse application, i.e. the composition is not removed by rinsing, especially with water, after application. No-rinse-off foams generally contain a low amount of surfactant composition, generally 1 to 10% by weight, preferably 2 to 4% by weight, based on the total weight of the composition.

[0026] The no-rinse-off foams used in the present invention must, of course, be well tolerated and be compositions intended for topical application in the case of non-human mammals.

[0027] The no-rinse-off foams that can be used in the present invention can be of different types, in particular: aerosols, the foam of which is generated by a propellant gas, a foam called an aerosol or a spray; - overrun creams in which air bubbles are introduced into the product through a specific manufacturing process; -Foaming formulations with low foaming surfactant content but packed in packages equipped with a mechanical foam generator system (Pulvorex-type pump with grate).

[0028] The non-rinse-off foam is preferably a foam referred to as an aerosol or spray.

[0029] As used herein, "non-human mammal" or "animal" includes all mammals except humans. Non-human mammals are preferably pets, including, but not limited to, domestic animals such as dogs, cats, rabbits, ferrets, and hamsters, among others. In a more preferred embodiment of the invention, the non-human mammal is a cat, preferably a dog.

[0030] The shampoo compositions and / or non-rinse-off foam compositions used according to the present invention are intended to cleanse or wash the skin and / or coat. These compositions can be used to maintain the health of an animal's skin or coat, in particular by maintaining skin balance, maintaining or improving skin hydration, soothing the skin, or actually reducing or soothing the sensation of itching or irritation. Thus, in particular, the method for caring for an animal's skin or coat according to the present invention is a method for cleansing or washing the skin and / or coat, maintaining the health of an animal's skin or coat, maintaining skin balance, maintaining or improving skin hydration, soothing the skin, or actually reducing or soothing the sensation of itching or irritation.

[0031] According to a preferred embodiment of the present invention, the shampoo and / or non-rinse-off foam compositions used according to the present invention further comprise at least one compound intended for treating or caring for the skin or coat of an animal. The compound may in particular be at least one compound with hydrating or restructuring properties, a compound intended for improving or restoring the skin's barrier effect, or a compound intended for removing or reducing dandruff or excess sebum, or indeed for helping to relieve itching or dermatitis in pets. The shampoo and / or non-rinse-off foam compositions used according to the present invention may comprise, as an active compound, an antibacterial agent (a compound that limits the spread of bacteria, yeasts, or fungi), or a disinfectant, such as chlorhexidine.

[0032] The compound intended to aid in the treatment or care of the skin or coat of animals may be, for example, a compound of the type having a sphingoid base, or indeed a plant extract compound.

[0033] In particular, the active compounds present in the compositions of the method according to the invention, ie the shampoo and the non-rinse-off foam composition, may be the same or different, preferably they are the same.

[0034] In the shampoo compositions and / or non-rinse-off foam compositions of the present invention, the active compound intended to aid in the treatment or care of the skin or integuments is preferably present in an amount of from 0.001 to 30% by weight relative to the total weight of the composition, with the most preferred concentrations varying from 0.005 to 20%, 0.01 to 10%, 0.02 to 5%, or 0.05 to 3% by weight.

[0035] Compounds obtained from plants that can act on different factors of animal atopic dermatitis are particularly suitable for helping to relieve itching in animals. In particular, compounds obtained from Ophiopogon japonicus, as specifically described in Patent Application No. WO2017 / 121965, are suitable for topical application to the skin or integument of animals in the treatment of atopic animal care. They can be used in atopic skin, particularly to help reduce or delay the recurrence rate, reduce the severity score of atopic dermatitis in animals (CADESI score), reduce the intensity and / or frequency of itching or scratching, and more generally improve the quality of life of animals and / or their owners.

[0036] In the sense of the present invention, "active compounds obtained from Ophiopogon japonicus" means any molecule or mixture of molecules obtained from Ophiopogon japonicus. They may be natural molecules of the plant or molecules obtained by any type of transformation of natural molecules of the plant, for example by hydrolysis. The active compounds according to the present invention are preferably hydrolysates.

[0037] "Hydrolysate" refers to any extract derived from Ophiopogon japonicus obtained by a process comprising at least one step of enzymatic or chemical hydrolysis of Ophiopogon japonicus, preferably at least one step of enzymatic hydrolysis. "Ophiopogon japonicus" refers to all or part of the plant. It can be the whole plant or a part of the plant. Preferably, it is the tuber of Ophiopogon japonicus.

[0038] Ophiopogon japonicus is a rhizome-bearing, perennial, shrubby and abundant herbaceous species of the Liliaceae family.

[0039] The sphingoid base is preferably selected from the group consisting of sphingosine, sphinganine and phytosphingosine, with phytosphingosine being most particularly preferred.

[0040] Suitable examples of derivatives of sphingoid bases include N-lactyloyl-phytosphingosine, N-salicyloyl-phytosphingosine or N-retinoylphytosphingosine, ie, N-substituted compounds.

[0041] Other suitable examples of sphingoid base derivatives include salts of sphingoid bases.The anion of the salt can be derived from any suitable acid, i.e., an acid that produces a salt with improved water solubility after mixing with the sphingoid base in a suitable solid.Preferably, the acid is effective when applied to the integumentary skin or skin.Preferred salts of sphingoid bases used in the compositions of the present invention are those that can be obtained using acids that produce salts with increased water solubility relative to the water solubility of the sphingoid base itself when mixed with the above-mentioned sphingoid base in a suitable solvent.Salts of phytosphingosine are preferred for their improved solubility and bioavailability.

[0042] In a preferred embodiment, the acid is a hydrophilic acid capable of delivering the sphingoid base salt to the aqueous phase of the veterinary composition. Suitable hydrophilic acids include α-hydroxyalkanoic acids, 3-hydroxyalkanoic acids, α,p-dihydroxyalkanoic acids, alkanedioic acids, or mineral acids. Preferred examples of hydrophilic organic acids are lactic acid, glycolic acid, malic acid, pyruvic acid, succinic acid, fumaric acid, ascorbic acid, gluconic acid, and / or pyroglutamic acid, and preferred examples of mineral acids are hydrochloric acid, nitric acid, and / or phosphoric acid.

[0043] In another preferred embodiment, the acid is a lipophilic organic acid to allow for increasing the effectiveness of the lipophilic acid and sphingoid base in the sphingoid base salt.

[0044] It goes without saying that the method according to the present invention may include one or more steps, such as preceding or following steps, in addition to the steps cited above. Repetition of successive steps of the method according to the present invention is also conceivable. Thus, the protocol shown in Figure 1(B) can be repeated as many times as necessary, without requiring a break, if deemed appropriate.

[0045] The present invention further relates to a kit comprising, in one or more compartments, at least one rinse-off shampoo and at least one composition in non-rinse-off foam form, and optionally instructions describing how to use the shampoo and composition defined in the present invention.The rinse-off foam form composition may be present in only one compartment or in multiple compartments.In the latter case, each compartment preferably contains a non-rinse-off foam form composition corresponding to each of at least four consecutive applications.Therefore, the kit comprises at least four compartments, each compartment containing a non-rinse-off foam form composition and another compartment containing a rinse-off shampoo.

[0046] The present invention will be better understood from the following examples, which are illustrative and non-limiting.

[0047] Example 1: Treatment of dogs according to the present invention compared to conventional protocols The aim of this study was to evaluate the effectiveness of a combination of shampoos and foams containing phytosphingosine from a product series (Douxo Calm®, marketed by Ceva Sante Animale) during atopic dermatitis flare-ups in dogs. To conduct these tests, 6 to 9 dogs from each study previously diagnosed with atopic dermatitis, receiving concomitant treatment (oclacitinib or cyclosporine), and showing clinical flare-ups of atopic dermatitis were treated for 3 weeks.

[0048] For Test (A) (control), treatment consisted of shampoo applications on days 1, 8, and 15, and twice-weekly applications of no-rinse-off foam between shampoo applications on days 1, 8, and 15 (Figure 1(A)).

[0049] For study (B) (according to the invention), treatment consisted of a single application of shampoo on day 1, followed by foam applications every 2-3 days (48-72 hours) for 21 days.

[0050] To evaluate the effectiveness of these studies, CADESI-04 severity scores (Vet Dermatol. 2014, Apr;25(2):77-85, e25.doi:10.1111 / vde.12107. Epub 2014 Jan.25) and visual analogue scales of pruritus were analyzed and recorded weekly. Values obtained at a given time point were compared with the starting situation on day 0 (1 day before the first shampoo application (day 1)).

[0051] After 21 days of treatment, 3 / 5 (60%) of the treated dogs in study (A) showed a 40% reduction in CADESI scores, while 6 / 7 (85%) of the dogs in study (B) showed the same reduction.

[0052] These studies also demonstrate the effectiveness of Douxo Calm® shampoo and foam used in both studies, alongside long-term immunomodulator treatment, which did not change during the study. For the two groups (A) and (B), CADESI scores showed a significant decrease after 21 days of treatment, with group (B) showing a more significant improvement than group (A).

[0053] Figure 2A shows the mean change in CADESI score for each of studies (A) and (B). In both studies, a decrease in CADESI score was observed during treatment (Figure 2A). After 21 days of treatment, the mean percentage decrease was close to the provided threshold of -40% in group (A) and below the threshold of -40% in group (B), which generally means that CADESI decreased by less than 40% on average after 21 days of treatment (Figure 2B). At day 21, the mean percentage of CADESI change was -39.8 ± 23.1% in group (A) and -75.6 ± 19.0% in group (B).

[0054] The primary criterion was based on the percentage CADESI reduction between days 0 and 21. Therefore, the highest percentage obtained can be used as the primary criterion for distinguishing the tested groups. Different percentages were tested (see Table 1). Table 1 provides information on the number of dogs that reached a specific CADESI reduction percentage. The 50% threshold corresponds to the level of difference observed between the two protocols; in fact, only one dog in group (A) reached this threshold, while six out of seven dogs in group (B) reached the threshold. [Table 1]

Claims

1. 1. A method for caring for the skin or coat of an animal, comprising applying a rinse-off shampoo to said skin, followed by at least four successive applications of a composition in non-rinse-off foam form to said skin or coat.

2. 2. The method according to claim 1, characterized in that each application of the composition in non-rinse-off foam form is carried out at an interval of at least 24 hours, or preferably at least 48 hours, from the previous application.

3. 3. A method according to claim 1 or claim 2, characterized in that each successive application of foam following a first application of the rinse-off shampoo is carried out 24 to 72 hours, preferably 48 to 72 hours, after the previous application.

4. 10. A method according to any one of the preceding claims, characterized in that the method comprises the application of the rinse-off shampoo followed by 4, 5, 6, 7 or 8 successive applications of the composition in non-rinse-off foam form.

5. 5. The method according to any one of claims 1 to 4, characterized in that the method comprises the application of the rinse-off shampoo followed by eight successive applications of the composition in non-rinse-off foam form.

6. 6. The method according to any one of claims 1 to 5, characterized in that the method further comprises at least one step consisting of applying a rinse-off shampoo after said at least four successive applications of the composition in no-rinse-off foam form, wherein said shampoo application can be followed by successive applications of the composition in no-rinse-off foam form, in particular said shampoo application can be followed by at least four successive applications of the composition in no-rinse-off foam form.

7. 7. The method according to any one of claims 1 to 6, characterized in that the shampoo and the composition in non-rinse-off foam form are compositions comprising at least one compound intended to aid in the treatment or care of the skin or coat of animals, in particular pets, so as to relieve itching.

8. 10. A method according to any one of the preceding claims, characterized in that the method is a method for cleansing or washing the skin and / or coat, for maintaining the health of the skin or coat of the animal, for maintaining skin balance, for maintaining or improving the hydration of the skin, for soothing the skin, or indeed for reducing or soothing the sensation of itching or irritation.

9. 1. A kit comprising in one or more compartments at least one rinse-off shampoo, at least one composition in non-rinse-off foam form, and instructions describing the method as defined by any one of the preceding claims.

Images