Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
1999-12-09
2001-07-17
Jones, Dwayne C. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
active
06262050
ABSTRACT:
The present invention relates to a cosmetic, dermatological and/or pharmaceutical composition intended in particular for the treatment in man of certain cutaneous disorders and/or skin diseases, in particular painful and/or pruriginous diseases.
Some of these diseases are currently treated by means of local corticoids or of PUVA therapy. Corticoids are very effective in soothing the symptoms of these diseases but, unfortunately, they exhibit side effects which are often highly disadvantageous such as atrophies or infections, in particular mycotic or bacterial infections. PUVA therapy is, for its part, the local irradiation of the diseased skin with UVA radiation, after absorption of a photosensitizing substance. This technique exhibits the serious disadvantages of a photoageing, which can very often result in cancers of the skin. Moreover, this treatment is not ambulatory, obliging the patients commonly to go to a specialist centre throughout the duration of the treatment, which is highly restricting and limits their occupational employment and their leisure activities.
The precise subject of the present invention is a topical composition which makes it possible to effectively treat these cutaneous diseases, while overcoming these disadvantages.
Moreover, it is known that certain skins are more sensitive than others. Now, the symptoms of sensitive skins were, until now, poorly characterized and no one knew exactly the process implicated in the sensitivity of the skin. Some thought that a sensitive skin was a skin which reacted to cosmetic or pharmaceutical products, others that it was a matter of a skin which reacted to a number of external factors, not necessarily related to cosmetic products.
Some tests were tried in attempting to define 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 did not make it possible to characterize sensitive skins.
Moreover, sensitive skins were classified as allergic skins.
Due to this ignorance of the characteristics of sensitive skins, it was, until now, very difficult to treat them, and they were treated indirectly, for example by limiting the employment in cosmetic or dermatological compositions of products with an irritant nature, such as surfactants, preservatives or fragrances.
After many clinical tests, the Applicant has been able to determine the symptoms related to sensitive skins. These symptoms are in particular subjective signs which are essentially dysaesthetic sensations. Dysaesthetic sensations is understood to mean more or less painful sensations felt in a cutaneous region, such as smarting, pins and needles, itching or pruritus, burning sensations, warming sensations, discomfort, stabbing pains, and the like.
In addition, the Applicant has been able to show that a sensitive skin was not an allergic skin. In fact, an allergic skin is a skin which reacts to an external agent, known as an allergen, which triggers an allergic reaction. This relates to an immunological process which only takes place in the presence of an allergen and which only affects sensitized subjects. In contrast, the essential characteristic of sensitive skin is, according to the Applicant, a mechanism of response to external factors which can concern any individual, even if individuals said to have sensitive skins react thereto faster than other individuals. This mechanism is not immunological.
The Applicant has now found that sensitive skins could be divided into two major clinical forms: irritable and/or reactive skins and intolerant skins.
An irritable and/or reactive skin is a skin which reacts by a pruritus, that is to say by itching or by smarting, to different factors, such as the environment, the emotions, food, the wind, friction, shaving, soap, surfactants, hard water with a high calcium concentration, temperature variations or wool. In general, these signs are associated with a dry skin, with or without sores, or with a skin which exhibits an erythema.
An intolerant skin is a skin which reacts with sensations of warming, stabbing pains, pins and needles and/or redness to different factors, such as the environment, the emotions or food. In general, these signs are associated with a hyperseborrhoeic or acneic skin, with or without sores, and with an erythema.
“Sensitive” scalps have a less ambiguous clinical symptomatology: the sensations of pruritus and/or of smarting and/or of warming are essentially trigggered by local factors such as friction, soap, surfactants, hard water with a high calcium concentration, shampoos or lotions. These sensations are also sometimes triggered by factors such as the environment, the emotions and/or food. An erythema and a hyperseborrhoea of the scalp and a dandruff state are frequently associated with the above signs.
Moreover, in certain anatomical regions, such as the major folds (inguinal, genital, axillary, popliteal, anal, submammary or bend of the elbow regions) and the feet, sensitive skin is reflected by pruriginous sensations and/or dysaesthetic sensations (warming or smarting) related in particular to sweat, to friction, to wool, to surfactants, to hard water with a high calcium concentration and/or to temperature variations.
In order to determine if a skin is sensitive or not, the Applicant has also developed a test. In fact, he has found, surprisingly, that there existed a connection between people with sensitive skins and those who reacted to a topical application of capsaicin.
This test with capsaicin consists in applying, to approximately 4 cm
2
of skin, 0.05 ml of a cream containing 0.075% of capsaicin and in noting the appearance of subjective signs caused by this application, such a smarting, burning sensations and itching. In subjects with sensitive skins, these signs appear between 3 and 20 minutes after application and are followed by the appearance of an erythema which begins at the periphery of the application region.
Capsaicin causes release of neuropeptides and in particular of tachykinins which arise from nerve endings in the epidermis and in the dermis. The dysaesthetic manifestations which are caused by the release and/or the synthesis and/or the binding of its neuropeptides are known as “neurogenic”.
The Applicant has now discovered that, by acting on the cutaneous and ocular receptors sensitive to capsaicin, it was possible to obtain a preventive and/or curative effect with respect to cutaneous and/or mucosal and/or ophthalmological diseases related to the release and/or synthesis and/or binding of neuropeptides, such as shingles, eczema, sensitive skins and eyes, pruritus and pruriginous diseases, herpes, atopic or contact dermatitides, lichens, prurigos, erythemas, in particular sunburn, insect stings, rosacea, conjunctivitis, uveitides, cutaneous or ocular pain, or irritations.
The Applicant has envisaged the use of capsazepine in the treatment of the symptoms associated with these cutaneous diseases and with sensitive skins or eyes in man. In fact, it has been found, surprisingly, that the incorporation of capsazepine in a composition for topical application made it possible to prevent the irritation, the dysaesthetic sensations, the pruritus and the disorders of the skin mentioned above.
The subject of the present invention is therefore a topical composition containing, in a topically and physiologically acceptable medium, capsazepine and at least one active principle with an irritant side effect.
Another subject of the invention is the use of capsazepine in or for the manufacture of a topical composition containing a cosmetically and/or dermatologically acceptable medium for preventing and/or combating cutaneous pain, in particular of neurogenic origin, and more particularly the pain from shingles and in particular the pain which follows shingles, “phantom” pain after limb amputation, the pain due to burns
Burns Doane Swecker & Mathis L.L.P.
Jones Dwayne C.
Societe L'Oreal S.A.
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