Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
1999-09-08
2001-08-21
Harrison, Robert H. (Department: 1619)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C424S070100, C514S844000, C514S859000, C514S937000, C514S944000
Reexamination Certificate
active
06277387
ABSTRACT:
The present invention relates to the use of a histamine antagonist, an interleukin-1 antagonist and/or a TNF alpha antagonist in a cosmetic, pharmaceutical or dermatological composition for topical application, intended, in particular, for the treatment of sensitive skins, as well as to a composition containing a histamine antagonist, an interleukin-1 antagonist and/or a TNF alpha antagonist for the purpose of decreasing or even abolishing the irritant effects of certain products, and in particular of certain active agents used in the cosmetics, pharmaceutical or dermatological field.
It is known that some skins are more sensitive than others. The symptoms of sensitive skin were hitherto poorly characterized and the problem of these skins was, as a result, poorly defined; nobody understood precisely the process involved in sensitivity—non-allergic cutaneous hyperreactivity—of the skin. Some workers believed that a sensitive skin was a skin which reacted to cosmetic products, others that such a skin was one which reacted to several external factors, not necessarily associated with cosmetic products.
Some tests have been tried in an effort to pinpoint sensitive skins, for example tests involving lactic acid and DMSO, which are known to be irritant substances: see, for example, the paper by K. Lammintausta et al., Dermatoses, 1988, 36, pages 45-49; and the paper by T. Agner and J. Scrup, Clinical and Experimental Dermatology, 1989, 14, pages 214-217. However, these tests did not enable sensitive skins to be characterized completely.
Moreover, sensitive skins were likened to allergic skins.
Since the characteristics of sensitive skins were poorly understood, it was very difficult to treat them hitherto, and they were treated indirectly, for example by limiting the use of products having an irritant character, such as surfactants, preservatives or perfumes as well as certain active agents, in cosmetic or dermatological compositions.
The Applicant has carried out numerous clinical tests and has been able to determine the symptoms associated with sensitive skins. These symptoms are, in particular, subjective signs which are essentially dysaesthetic sensations. Dysaesthetic sensations are understood to mean more or less painful sensations experienced in an area of the skin, such as prickling, tingling, itching or pruritus, burning, inflammation, discomfort, tightness, and the like.
The Applicant was able to show, in addition, that a sensitive skin was not an allergic skin. In effect, an allergic skin is a skin which reacts to an external agent, an allergen, which triggers an allergic reaction. This is an immunological process which takes place only when an allergen is present and which affects only sensitized subjects. The essential characteristic of sensitive skin is, according to the Applicant, on the contrary, a mechanism of response to external factors, which can affect any individual, even if individuals with so-called sensitive skin react to them more quickly than do others. This mechanism is not immunological.
The Applicant has now found that sensitive skins could be divided into two major clinical forms, irritable skins and intolerant skins.
An Irritable skin is a skin which reacts by pruritus, that is to say by itching or by prickling, to different factors such as the environment, emotions, foods, windy conditions, rubbing, shaving soap, surfactants, hard water with a high chalk concentration, temperature changes or wool. In general, these signs are associated with a dry skin with or without sores, or with a skin which displays erythema.
An intolerant skin is a skin which reacts by sensations of inflammation or of tightness, by pruritus, that is to say by itching or prickling, by tingling and/or red blotches, to different factors such as the environment, emotions and foods. In general, these signs are associated with erythema and with a skin with or without sores.
“Sensitive” scalps have a more unequivocal symptomatology: the sensations of pruritus and/or of prickling and/or of inflammation are essentially triggered by local factors such as rubbing, soap, surfactants, hard water with a high chalk concentration, shampoos of lotions. These sensations are also sometimes triggered by factors such as the environment, emotions and/or foods. Erythema and hyperseborrhoca of the scalp as well as a dandruff state are frequently associated with the above signs.
Moreover, in some anatomical regions, such as the major folds (inguinal, genital, axillary, popliteal, anal and inframammary regions, bend of the elbow) and the feet, sensitive skin manifests itself in pruriginous sensations and/or dysaesthetic sensations (inflammation, prickling) associated especially with sweating, with rubbing, with wool, with surfactants, with hard water with a high chalk concentration and/or with temperature changes.
To determine whether a skin is sensitive or otherwise, the Applicant has also developed a test. In effect, after performing a large number of tests with the object of defining a sensitive skin, it found, surprisingly, that there was a link between persons having sensitive skin and those who reacted to a topical application of capsaicin.
The capsaicin test consists in applying 0.05 ml of a cream containing 0.075% of capsaicin to approximately 4 cm
2
of skin, and noting the appearance of subjective signs caused by this application, such as prickling, burning and itching. In subjects having sensitive skins, these signs appear between 3 and 20 minutes after the application, and are followed by the appearance of an erythema which begins at the periphery of the area of application.
Hitherto, capsaicin was used as a medicinal product, especially for treating the pains of shingles. Capsaicin causes a release of nouropeptides, and especially of tachykinins which originate from nerve endings of the epidemiis and the dermis. The Applicant found that the physiopathological mechanism common to all the states of sensitive skins was associated with a groat capacity to release tachykinins and more especially substance P in the skin. It is known, in addition, that substance P released by epidermal sensory endings induces a cascade of biochemical events in which the first steps affect the mast calls. The binding of substance P to mast cell receptors induces a release of numerous pro-inflammatory mediators, among them histamine, serotonin, initerleukin-1 (IL-1), interleukin-6 (IL-6), interleukin-8 (IL8) and tumour necrosis factor alpha (TNF alpha).
Moreover, the Applicant found that sensitive skins as are defined above are, in addition, characterized by high levels of interleukin-1 and/or of histamine in the superficial layers of the epidermis. These levels rise proportionately as the state of reactivity of the skin increases.
The Applicant has now discovered that the essential characteristics of sensitive skins (irritation reactions and cutaneous intolerance reactions) are associated with the release of substance P and consequently with the release of histamine, of interleukin-1 and particularly of TNF alpha, and that interleukin-1 antagonists and/or TNF alpha antagonists and/or histamine antagonists may be used in the preventive and/or curative treatment of sensitive skins.
Histaminc, interleukin-1 and/or TNF alpha “antagonists” are understood to mean all substances capable of inhibiting the release and/or synthesis and/or receptor binding of histamine, of interleukin-1 and/or of TNF alpha, respectively. The antagonists inhibiting the receptor binding of histamine are agents specific for the type 1 histamine (H
1
) receptor.
In addition, the Applicant found that the addition of interleukin-1 antagonists and/or of TNF alpha antagonists to cosmetic, pharmaceutical or dermatological compositions for topical application containing irritant products (alpha-hydroxy acids, retinoids, benzoyl peroxide, etc.) also enabled the irritation reactions usually caused by these products to be decreased or even eliminated. These irritation reactions manifest themselves within moments following application, in dysaesthetic sensa
Breton Lionel
Cohen Catherine
De Lacharriere Olivier
Burns Doane Swecker & Mathis L.L.P.
Harrison Robert H.
L'Oreal
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