Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
1997-10-03
2003-07-29
Webman, Edward J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C424S400000, C514S887000, C514S937000
Reexamination Certificate
active
06599512
ABSTRACT:
BACKGROUND OF THE INVENTION
1 . Technical Field of the Invention
The present invention relates to stable water-in-oil emulsions having a high electrolyte content, comprising at least 2% by weight, relative to the total weight of the composition, of a water-soluble metal salt, at least one hydrophobic gelling agent and an amount of a suitable emulsifying system effective to provide a stable composition, particularly a stable topically applicable composition.
This invention also relates to dermocosmetic compositions comprising the above stable w/o emulsions, for treating 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 and skin disorders and diseases in which pruritus, acne rosacea and/or discreet erythema exist.
2 . Description of the Prior Art
It is known to this art that certain skin types are more sensitive than others. The symptoms of sensitive skin were hitherto poorly characterized and the problem of these skin types was consequently poorly defined since it was unknown exactly what process was involved in skin sensitivity
onallergic hyperreactivity of the skin. Certain researchers considered that sensitive skin was a skin which reacted to cosmetic and/or dermatological products, while others considered that it was a skin which reacted to various external factors, not necessarily associated with cosmetic and/or dermatological products.
Certain tests have been conducted in an effort to characterize sensitive skin, for example tests using lactic acid and DMSO which are known irritants: see, for example, the article by K. Lammintausta et al.,
Dermatoses
, 36, pages 45-49 (1988); and the article by XT. Agner and J. Serup,
Clinical and Experimental Dermatology
, 14, pages 214-217 (1989). However, these tests did not permit the characterization of sensitive skin, which was likened to allergic skin.
The symptoms associated with sensitive skin were demonstrated and described in FR-95/04,268 filed Apr. 10, 1995 and assigned to the assignee hereof. These symptoms are, in particular, subjective signs, which are essentially dysaesthetic sensations. By the term “dysaesthetic sensations” are intended the more or less painful sensations experienced in a region of skin, such as stinging, tingling, itching or pruritus, burning, heating, discomfort, tautness, etc.
It has also been shown that a sensitive skin was not an allergic skin, since 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 occurs only when an allergen is present and which affects only sensitized individuals. In contrast, the essential characteristic of sensitive skin is a mechanism of response to external factors, which may affect any individual, although individuals with so-called sensitive skin react faster thereto than others. This mechanism is not immunological, but a specific.
Sensitive skin may be divided into two major clinical categories, irritable skin and intolerant skin. An irritable skin is a skin which reacts, via pruritus, namely, by itching or by stinging, to various factors such as the environment, emotions, foods, the wind, rubbing, shaving, hard water having a high calcium concentration, temperature variations or wool. In general, these signs are associated with a dry skin with or without dartres, or with a skin which displays an erythema. An intolerant skin is a skin which reacts, by sensations of heating, tautness, tingling 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 skin, or even a rosaceiform skin, with or without dartres.
In general, sensitive skin is defined by a specific reactivity of the skin. This hyperreactivity may, in particular, be induced by environmental, emotional and dietary factors or, alternatively, by the application of or contact with cosmetic or dermatological products. This hyperreactive state which defines sensitive skin distinguishes such skin from the ubiquitous reactivity occasioned by irritant agents which induce a skin irritation in almost all individuals.
This hyperreactive state is experienced and recognized by individuals suffering therefrom as a “sensitive skin.”
“Sensitive” scalps have a more univocal clinical semiology: the sensations of pruritus and/or of stinging and/or of heating are essentially triggered by local factors such as rubbing, soap, surfactants, hard water having a high calcium concentration, shampoos or lotions. These sensations are also in certain instances triggered by factors such as the environment, emotions and/or foods. Erythema and hyperseborrhoea of the scalp and the presence of dandruff are often associated with the above signs.
Moreover, in certain anatomical regions such as the major folds (groin, genital, axillary, popliteal, anal and submammary regions, and in the crook of the elbow) and the feet, sensitive skin is reflected in pruriginous sensations and/or dysaesthetic sensations (heating, stinging) associated, in particular, with sweat, rubbing, wool, surfactants, hard water having a high calcium concentration and/or temperature variations.
Pruritus is a common symptom of dermatitis, which often causes considerable inconvenience to the patient. When the pruritus is very severe, the inconvenience may be such that the patient cannot continue his or her usual activity. In addition, pruritus may be a source of complications: excoriations which may become overinfected, lichenification of the pruriginous regions, the consequence of which is to position the patient in a veritable vicious circle. Among the forms of dermatitis often associated with pruritus, exemplary are eczema, a topic dermatitis, contact dermatitis, flat lichens, prurigo, urticaria pruriginous toxidermias and certain clinical forms of psoriasis.
Pruritus is sometimes the predominant pathological skin sign, as in the case of aquagenic pruritus, pruritus of the scalp while dandruff is present (pityriasis capitis), pruritus of blood dialysis patients, renal insufficiency, AIDS sufferers and individuals suffering from biliary obstructions, or pruritus of the paraneoplastic manifestations of certain cancers.
Further, pruritus is a sign often encountered over the course of certain parasitic attacks on the skin, or generally. These may be, for example, scabies, filariasis, oxyuriasis or demodicidosis of the skin.
Since the characteristics of sensitive skin are poorly understood, it was hitherto very difficult to treat it, and it was treated indirectly, for example by limiting the use of products irritant in nature, such as surfactants, preservatives or fragrances, as well as certain active agents, in cosmetic or dermatological compositions.
To date, pruritus was treated using emollient preparations, local corticoids, PUVA therapy or antihistamines. Local corticoids are, admittedly, very effective for alleviating the symptoms, but their effect is, unfortunately, not immediate. Too, they often elicit very severe side effects such as atrophy, and expose the patient to risks of mycosal and/or bacterial infections. PUVA therapy is the local irradiation of the diseased skin with UVA radiation, after absorption of a photosensitizing species (psoralen). This technique presents the major drawback of photoaging which may result in skin cancers. Further, this treatment is not ambulatory, thus obliging patients to regularly visit a specialized center throughout the treatment period, which is very restrictive and limits their professional activity. Emollients elicit a very modest anti-pruriginous effect and are of poor efficacy when the pruritus is considerable. Moreover, antihistamines are not of constant efficacy and must be administered orally.
Thus, serious need continues to exist in this art for improved treatment of the above skin afflictions which does present the above drawbacks.
The use of at least one
Burns Doane Swecker & Mathis L.L.P.
La Roche Posay-Laboratoire Pharmaceutique
Webman Edward J.
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