Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
1997-06-24
2001-03-20
Kishore, Gollamudi S. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C424S059000, C424S062000, C424S063000, C424S069000, C424S070100, C424S078020, C424S043000, C424SDIG001, C514S844000, C514S845000, C514S846000, C514S847000, C514S848000, C514S880000, C514S937000, C514S974000
Reexamination Certificate
active
06203803
ABSTRACT:
The present invention concerns the use of a substance P antagonist in a cosmetic composition used to treat sensitive skin, and the cosmetic composition obtained.
It is known that some skin is more sensitive than others. Until now, the symptoms of sensitive skin were poorly characterized, and, accordingly, the problem of sensitive skin was poorly defined. No one knew exactly what process was implicated in skin sensitivity. Some specialists thought that sensitive skin reacted to cosmetic products, while others felt sensitive skin reacted to a number of external factors not necessarily associated with cosmetics.
A number of tests were conducted to attempt to identify sensitive skin. For example, these tests made use of lactic acid and DMSO, which are known irritants. (See, for example, the article by K. Lammintausta et al.,
Dermatoses,
1988, 36, pages 45-49, and the article by T. Agner and J. Serup,
Clinical and Experimental Dermatology,
1989, 14, pages 214-217.) However, these tests did not make it possible to characterize sensitive skin.
In addition, sensitive skin was held to resemble allergic skin.
Because the characteristics features of sensitive skin were poorly known, treatment has proved very difficult until now. Skin was treated indirectly, for example, by restricting the use of irritating products such as surfactants, preservatives, and perfumes in cosmetic compounds.
The Applicant conducted numerous clinical tests and was able to determine the symptoms shown in sensitive skin. These symptoms are, in particular, subjective in nature, i.e., basically sensations of dysesthesia. These are more or less painful sensations in a skin area, e.g., tingling, prickling, itching or pruritus, burning, overheating, discomfort, tugging sensations, etc.
The Applicant was also able to show that sensitive skin was not allergic skin. Indeed, allergic skin reacts to an external agent, i.e., an allergen, which triggers an allergic reaction. This is an immunological process which occurs only when an allergen is present and which does not affect sensitized subjects. In the Applicant's view, the basic feature of sensitive skin is, on the contrary, a response mechanism to external factors which may affect any individual, even though individuals considered to have sensitive skin react faster than others. This mechanism is not immunological, but aspecific.
The Applicant has since discovered that sensitive skin could be divided into two major clinical groups, irritable and/or reactive skin, and intolerant skin.
An irritable and/or reactive skin reacts by means of pruritus, that is, by itching or tingling, to various factors such as the environment, emotion, food, wind, friction, shaving, soap, surfactants, hard water having a high limestone concentration, temperature variations, or wool. In general, these signs are associated with dry skin with or without desquamation, or with skin exhibiting erythema.
Intolerant skin reacts by producing sensations of overheating, tugging, prickling, and/or redness to various factors such as the environment, emotion, and food. In general, these signs are associated with skin exhibiting hyperseborrhea or acne, with or without desquamation, and with erythema.
“Sensitive” scalp has a more pathognomonic clinical semiology: the sensations of pruritus and/or tingling or overheating are triggered basically by localized factors, such as rubbing, soap, surfactants, hard water containing a high limestone concentration, shampoos or lotions. These sensations are sometimes triggered by factors such as the environment, emotion, and/or food. Erythema and hyperseborrhea of the scalp, as well as the presence and extent of dandruff, are frequently associated with the aforementioned signs.
Furthermore, in some anatomical regions such as the major bend areas (the inguinal, genital, axillary, popliteal, and submammary regions and the bend of the elbow) and the feet, sensitive skin leads to pruriginous and/or sensations of dysesthesia (overheating, tingling) linked, in particular, to sweat, rubbing, wool, surfactants, hard water containing high limestone concentrations, and/or to temperature variations.
To determine whether a particular skin is sensitive or not, the Applicant also perfected a test. In fact, after conducting a large number of tests for the purpose of defining sensitive skin, the Applicant found, surprisingly, that there was link between persons having sensitive skin and those who reacted to a topical application of capsaicin.
The capsaicin test is performed by applying, over approximately 4 cm
2
of skin, 0.05 ml of a cream containing capsaicin in a concentration of 0.075% and by noting the appearance of subjective signs caused by this application, such as tingling, burning, and itching. In subjects with sensitive skin, these signs appear at between 3 and 20 minutes following application, and are followed by the appearance of an erythema, which begins at the periphery of the area of application.
To date, capsaicin has been used as a drug, in particular to treat the pain arising from shingles. Capsaicin causes the release of neuropeptides, in particular tachykinins, which emanate from nerve ends in the epidermis and dermis. The Applicant found that the physiopathological process common to all states of sensitive skin was linked to a pronounced ability to release tachykinins, and, more specifically of substance P, in the skin. The manifestations of dysesthesia caused by their release are termed “neurogenic.”
Substance P is a chemical polypeptide produced and released by nerve endings. It belongs to the group of tachykinins. Substance P acts in particular in pain transmission and in diseases of the central nervous system, such as anxiety and schizophrenia, in respiratory, inflammatory, gastrointestinal, and rheumatic diseases, and in certain skin disorders, such as eczema.
The Applicant has now discovered that the basic characteristic of sensitive skin is linked to the release of substance P, and thus, that the use of substance P antagonists could produce a preventive and/or curative effect on sensitive skin.
To treat sensitive skin, the Applicant thus contemplated the use of substance P antagonists. Indeed, the Applicant found, surprisingly, that the incorporation of a substance P antagonist in a cosmetic compound made it possible to prevent irritation, sensations of dysesthesia, and pruritis in the skin.
Therefore, the present invention concerns the use of a substance P antagonist in a composition containing a cosmetically-acceptable medium in order to treat sensitive skin.
The present invention further relates to the use of a substance P antagonist to prevent and/or combat skin irritations, desquamation, erythemas, sensations of overheating or of dysesthesia, and/or pruritis in the skin.
A cosmetically-acceptable medium is a medium compatible with the skin, the nails, and the hair. The composition containing the substance P antagonist may be applied on the face, the neck, the hair, and the nails, or any other cutaneous region of the body.
To be acknowledged as a substance P antagonist, a substance must possess the following characteristics:
a selective affinity for the NK1 receptors on the tachykinins;
a pharmacological substance P-antagonist action; that is, it must induce a consistent pharmacological response in at least one of the following two tests:
the antagonist substance must reduce the extravasation of plasma through the vascular wall caused by the capsaicin or by antidromic nerve excitation, or else
the antagonist substance must cause inhibition of the contraction of the smooth muscles caused by administration of substance P.
To date, substance P antagonists have been used to treat the diseases indicated above. To this end, reference may be made to the following documents; U.S. Pat. No. 4,472,305, U.S. Pat. No. 4,839,465, EP-A-101929, EP-A-333174, EP-A-336230, EP-A-394989, EP-A-443132, EP-A-498069, EP-A-515681, EP-A-517589, WO-A-92/22569, GB-A-2216529, EP-A-360390, EP-A-429366, EP-A-430771, EP-A-499313, EP-A-514273, EP-A-514274, EP-A-514275, EP-A-514
Breton Lionel
De La Charriere Olivier
Burns Doane Swecker & Mathis L.L.P.
Kishore Gollamudi S.
Societe L'Oreal S.A.
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