Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
2000-08-31
2002-11-12
Dees, Jose′ C. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C424S078050, C514S862000, C514S871000
Reexamination Certificate
active
06479058
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a composition for the treatment of rashes, dermatoses or skin eruptions, which are known to be treated topically to improve or favorably alter the disease condition. Such rashes, dermatoses or skin eruptions include acute, inflammatory reactions of the skin caused by an allergic or irritant reaction (such as that caused by poison ivy, poison oak or poison sumac, or other forms of allergic or irritant contact dermatitis), other forms of eczema, lichen simplex chronicus, rashes, dermatoses or skin eruptions of a chronic nature (e.g. seborrheic dermatitis, psoriasis, atopic dermatitis) or caused by infection, irritation or aggravation of another condition such as occurs with acne, and other rashes, dermatoses or skin eruptions.
Contact dermatitis may be produced by primary irritants or allergic sensitizes. Irritant contact dermatitis is a nonallergic reaction of the skin caused by exposure to irritating substances. Any person would react to an irritant if the concentration and duration of contact were sufficient. Most primary irritants are chemical substances, although physical and biologic (infectious) agents may produce the same reaction. Irritants account for 80% of occupational contact dermatitis and also cause the most frequent type of nonindustrial contact reaction. Allergic contact dermatitis is a manifestation of delayed hypersensitivity and results from the exposure of sensitized individuals to contact allergens. Poison ivy and poison oak induce sensitization in more than 70% of the population, thereby causing allergic contact dermatitis (Arndt, Kenneth A.,
Manual of Dermatologic Therapeutics
, 5
th
edition, 1995, Little, Brown and Co., page 49).
Irritants will cause an inelastic and stiff-feeling skin, discomfort due to dryness, pruritus secondary to inflammation, and pain due to fissures, blisters, and ulcers. Mild irritants produce erythema, microvesiculation, and oozing that may be indistinguishable from allergic contact dermatitis. Chronic exposure to mild irritants or allergens results in dry, thickened, and fissured skin. Strong irritants cause blistering, erosion, and ulcers of the skin. Allergic contact dermatitis, in its mild form, is similar in appearance to the irritant eruption. A more typical allergic contact reaction will consist of grouped or linear tense vesicles and blisters. If involvement is severe there may be marked edema, particularly of the face and in the periorbital and genital areas.
A variety of methods exist for treating contact dermatitis, including topical corticosteroids, aluminum acetate (Burow's solution), soothing shake lotions (e.g. calamine lotion), oral antihistamines, and systemic corticosteroids. Individually these therapies do not bring rapid relief of all the symptoms of pruritus (itch), the inflammation of the dermatitis, as well as vesiculation and oozing. Usually combination therapy is preferred.
Systemic corticosteroids will cure most cases of contact dermatitis, no matter how severe. But initial dosage should be 60 mg of prednisone daily (or an equivalent strength of another form of corticosteroid), and the course should be no shorter then 2-3 weeks. There are many contraindications to corticosteroid treatment. Absolute contraindications include ocular herpes simplex and untreated tuberculosis. Relative contraindications include acute or chronic infections, pregnancy, diabetes mellitus, hypertension, peptic ulcer, osteoporosis, psychotic tendencies, renal insufficiency, congestive heart failure, and recent intestinal anastomoses (Arndt, Kenneth A.,
Manual of Dermatologic Therapeutics
, 5
th
edition, 1995, Little, Brown and Co., page 309). There are many common corticosteroid complications, including psychiatric disorders, pseudotumor cerebri, osteoporosis with spontaneous fractures, aseptic necrosis of bone, myopathy, glaucoma, cataracts, fatty infiltration of the liver, intestinal perforation, pancreatitis, peptic ulceration, hypertension, sodium and fluid retention, hypokalemic alkalosis, atherosclerosis, immunosuppression, increased incidence of infections, suppression of the hypothalamic-pituitary-adrenal axis, growth failure, and inhibition of wound healing. So, while the clinical results from systemic corticosteroid use are encouraging, a more rapid and complete clinical response with less risk of side effects is desired.
Topical corticosteroids will eradicate a case of contact dermatitis, but will not rapidly stop new vesicles from forming or dry up oozing, weeping patches and vesicles rapidly. While these results are encouraging, a more rapid and complete clinical response is desired.
Soothing lotions (e.g. calamine lotion) and other drying agents such and aluminum acetate (Burow's solution) will dry oozing, weeping patches, vesicles and erosions. But when used alone they typically do not provide relief from the inflammation caused by the dermatitis. Again, while these results are encouraging, a more rapid and complete clinical response is desired.
None of the above agents provide rapid drying of a moist, oozing rash while helping to absorb further moisture and keep the skin dry, and at the same time treat the contact dermatitis.
There are several other papulosquamous skin diseases that can present and behave in a similar fashion to contact dermatitis. These include all other forms of eczema, lichen simplex chronicus, rashes, dermatoses or skin eruptions of a chronic nature (e.g. seborrheic dermatitis, psoriasis, atopic dermatitis), and others. All of these conditions can present with a rash that can become moist, weeping, and quite irritated. The rashes can also become secondarily infected. Current therapeutic options do not always clear these conditions as rapidly as desired.
SUMMARY OF THE INVENTION
Among the objects of the present invention, therefore, is the provision of a composition for topical treatment of rashes, dermatoses and skin eruptions, the provision of such a composition which is easily applied to the skin, the provision of such a composition which contains a corticosteroid of the appropriate potency for the condition being treated, the provision of such a composition which promotes rapid drying of moist areas and coats the skin with the drying agent for protection and healing, especially moist exudative rashes and/or rashes in moist areas.
Briefly, therefore, the present invention is directed to a composition for topical administration comprising (a) a corticosteroid, and (b) a drying agent.
These and other objects of the present invention will be more fully understood in the light of the description set forth below.
REFERENCES:
patent: 5110809 (1992-05-01), Wang
patent: 5219877 (1993-06-01), Shah et al.
patent: 5478814 (1995-12-01), Packman
patent: 5883085 (1999-03-01), Blank et al.
patent: 5972920 (1999-10-01), Seidel
patent: 6391282 (2002-05-01), Dugger, III
patent: 1095615 (1994-11-01), None
patent: 1111984 (1995-11-01), None
patent: WO 92/14472 (1992-09-01), None
patent: WO 97/27862 (1997-08-01), None
Facts and Comparisons, on Aveeno® anti-itch, by Rydelle, revised May 1992, pp. 564a.*
Physician's Desk Refernce, on Caldryl®, by Pfizer, obtained from PDR on-line.*
Kenneth A. Arndt et al. “Manual of Dermatologic Therapeutics” 5th Ed., Little, Brown & Co., pp. 49, 290, 309.
A. R. W. Bowring et al. “The Treatment of Napkin Dermatitis: a Double-Blind Comparison of Two Steroid-Antibiotic Combinations” Pharmatherapeutica, vol. 3, No. 9 (1984) pp. 613-617.
Roger C. Cornell et al. “Correlation of the Vasoconstriction Assay and Clinical Activity in Psoriasis” Arch Dermatol, vol. 121 (Jan. 1985) pp. 63-67.
E.G.V. Evans et al. “Does Naftifine Have Anti-Inflammatory Properties? A Double-blind Comparative Study with 1% Clotrimazole/1% Hydrocortisone in Clinically Diagnosed Fungal Infection of the Skin” British Journal of Dermatology, vol. 129 (1993) pp. 437-442.
Thomas B. Fitzpatrick et al. Dermatology in General Medicine, vol. II, 4th Ed., McGraw-Hill, Inc., (1993) pp. 2444-2447 and 2847.
Cynthia A. Guzzo et al. “Chapte
Dees Jose′ C.
Haghighatian M.
Senniger Powers Leavitt & Roedel
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