Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
2000-07-14
2001-12-18
Raymond, Richard L. (Department: 1624)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C424S063000
Reexamination Certificate
active
06331307
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a stable oil-in-water emulsion with a high electrolyte content, comprising at least 2% by weight, relative to the total weight of the composition, of a water-soluble metal salt, and a suitable emulsifying system in an amount which is sufficient to obtain a stable composition which is useful in particular for topical application. More particularly, the invention relates to the use of the composition of the invention in dermocosmetics, in particular for pathological and/or physiological disorders associated with the release of substance P and/or of TNF-alpha (Tumor Necrosis Factor-alpha) and in particular for treating sensitive skin, skin disorders and diseases on which pruritus, rosacea and/or discreet erythema is present.
2. Description of the Background
It is known that certain skins are more sensitive than others. The symptoms of sensitive skins have hitherto been poorly characterized and the problems of such skins has, consequently, been poorly defined, since no-one has known the exact nature of the process involved in skin sensitivity-non-allergic hyperreactivity of the skin. Some have thought that a sensitive skin is a skin which reacts to cosmetic and/or dermatological products, while others have thought that sensitivity involved skin which reacts to several external factors, which are not necessarily associated with cosmetic and/or dermatological products.
Certain tests have been tried in an attempt to delimit sensitive skins, for example tests with lactic acid and with DMSO which are known to be irritant substances, 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 have not made it possible to characterize sensitive skins, which have been likened to allergic skins.
The symptoms associated with sensitive skins have been revealed and described in patent application FR 95/04268 filed Apr. 10, 1995 in the name of L'Oreal. These symptoms are, in particular, subjective signs which are essentially dysaesthesic sensations. The term dysaesthesic sensations is understood to refer to the more or less painful sensations experienced in a region of skin, such as stinging, tingling, itching or pruritus, burning, heating, discomfort, tightness, etc.
It has also been shown that a sensitive skin is not an allergic skin, since an allergic skin is a skin which reacts to an external agent, an allergen, thereby triggering an allergic reaction. This is an immunological process which takes place only when an allergen is present, and which only affects the sensitized individuals. The essential characteristic of sensitive skin is, in contrast, a mechanism of response to external factors, which may concern any individual, even though individuals with so-called sensitive skin react faster thereto than other people. This mechanism is a specific rather than immunological.
Sensitive skins may 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 stinging to various factors such as the environment, the emotions, foods, the wind, friction, shaving, hard water with a high calcium concentration, temperature variations or wool. In general, these signs are associated with a dry skin with or without dry patches, or with a skin which exhibits erythema. An intolerant skin is a skin which reacts by heating, tightness or tingling sensations and/or redness, to various factors such as the application of cosmetic or dermatological products or soap. In general, these signs are associated with an erythema and with a hyperseborrhoeic or acneic, or even rosaceiform, skin, with or without dartres.
In general, sensitive skins are defined by a particular skin reactivity. This hyperreactivity may especially be brought into play by environmental, emotional or food factors or alternatively by the application of or contact with cosmetic or dermatological products. This hyperreactive state which defines sensitive skins differs from that of the ubiquitous reactivity brought about by irritants which induce irritation of the skin in almost all people.
This hyperreactive state is experienced and recognized by people suffering from it as “sensitive skin”.
“Sensitive” scalps have a more univocal clinical semeiology, that is, the sensations of pruritus and/or of stinging and/or of heating are essentially triggered by local factors such as friction, soap, surfactants, hard water with a high calcium concentration, shampoos or lotions. These sensations are also occasionally triggered by factors such as the environment, the emotions and/or foods. An erythema and hyperseborrhoea of the scalp, along with a state in which dandruff is present, are often associated with the above signs.
Moreover, in certain anatomical regions such as the major folds (inguinal, genital, axillary, popliteal, anal and submammary regions and in the crook of the elbow) and the feet, sensitive skin is reflected by pruriginous sensations and/or dyeaesthesic sensations (heating, stinging) associated in particular with sweat, friction, wool, surfactants, hard water with a high calcium concentration and/or temperature variations.
Pruritus is a common symptom of dermatitis, which often causes appreciable inconvenience for the patient when the pruritus is very severe, and the inconvenience may be such that the patient cannot continue his or her usual activity. In addition, the pruritus may be a source of excoriation complications which may become overinfected, lichenification of the pruriginous zones, the consequence of which is to place the patient in a veritable vicious circle. Among the dermatitides commonly associated with pruritus, mention may be made of eczema, atopical dermatitis, contact dermatitis, flat lichens, prurigo, urticaria, pruriginous toxidermia and certain clinical forms of psoriasis.
Pruritus is occasionally the predominant pathological sign on the skin, as in the cases of aquagenic pruritus, pruritus of the scalp during bouts of dandruff (pityriasis capitis), the pruritus of blood dialysis patients, renal insufficiency patients, AIDS patients and people suffering from biliary obstructions, or alternatively of pruritus in the paraneoplastic manifestations of certain cancers.
Furthermore, pruritus is a sign often encountered during certain skin or general parasitic attacks. These may be, for example, scabies, filariasis, oxyuriasis or cutaneous demodecidosis.
Since the characteristics of sensitive skins have been poorly understood, it has hitherto been very difficult to treat them. They have been treated indirectly, for example by limiting, in cosmetic or dermatological compositions, the use of products with an irritant nature such as surfactants, preserving agents or fragrances, as well as certain active agents.
Hitherto, pruritus have been treated using emollient preparations, local corticoids, PUVA-therapy or antihistamines. Local corticoids are, admittedly, very effective at soothing the symptoms but, unfortunately, their effect is not immediate. Furthermore, they have side effects that are often very penalizing, such as atrophy, and they expose the user to risks of mycosal and/or bacterial infections. PUVA-therapy is local irradiation of diseased skin with UVA rays, after absorption of a photosensitizing substance (psoralene). This technique has the serious drawbacks of photo-ageing which may lead to skin cancer. Furthermore, this treatment is not ambulatory, thus obliging sufferers to go regularly to a specialized center throughout the duration of the treatment, which is very restricting and limits their professional activity. Emollients have a very modest antipruriginous effect and are of poor efficacy when there is considerable pruritus. Moreover, antihistamines are not of constant efficacy and need to be taken orally.
There is thus a need for a treatment of these skin complai
Gagnebien Didier
Sebillotte-Arnaud Laurence
L'Oreal
Oblon & Spivak, McClelland, Maier & Neustadt P.C.
Raymond Richard L.
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