Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Ester doai
Reexamination Certificate
2000-01-28
2002-05-28
Dees, Jose′ G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Ester doai
C424S401000, C514S866000
Reexamination Certificate
active
06395779
ABSTRACT:
BACKGROUND
1. Field of the Invention
The present invention is related generally to the therapeutic application of a peroxidized lipid or a composition containing a peroxidized lipid to promote wound healing and to treat circulatory insufficiencies and skin disorders, particularly in diabetics.
2. Related Art
It is known that many people suffer from circulatory insufficiency of arterial or venous origin, which is often chronic. Circulatory insufficiencies may be local and benign, manifested by, for example, a feeling of painful numbness at the finger ends caused by cold (tingling), or heaviness in the lower limbs. Circulatory insufficiencies may be manifested in much more serious forms associated with an arrest of the blood circulation (ischemia), which is capable of causing localized necrosis. Arterial or venous leg ulcers, for example, are the result of such a circulatory insufficiency and are a clinical manifestation of insufficient irrigation of the superficial and deep tissues by blood flow. Certain peroxidized lipids are known to have a high level of efficacy in tissue revascularization when applied topically. One use of such peroxidized lipids is known to promote increased blood flow in subjects patients suffering from male sexual asthenia, as disclosed in U.S. Pat. No. 5,254,585, issued on Oct. 19, 1993, which is hereby incorporated by reference in its entirety.
Chronic circulatory insufficiency is common in diabetic patients, who are particularly susceptible to problems and disorders associated with poor blood flow, particularly in the extremities. Diabetes affects nearly every part of the body, causing capillary blood vessels to narrow and harden. It has been estimated that up to about one third of diabetics will experience a skin disorder caused or aggravated by the disease. A skin disorder is often the first sign that a person has diabetes. Some skin disorders are common to many people but occur more often and more easily with diabetics. Chronic dry skin, bacterial infections, fungal infections, and itching, occur with many people, especially diabetics. Diabetic dermopathy, necrobiosis, lipodica diabeticorum, diabetic blisters, and eruptive xanthomatosis occur only among diabetics. Many treatments have been proposed for overcoming these insufficiencies. Thus, it has already been recommended to use numerous vasodilative or vasoprotective products by oral or percutaneous administration, often by perfusion. However, these products have many undesirable side-effects, so their use is restricted to the most serious cases of circulatory insufficiency.
Patients with chronic circulatory insufficiency, including diabetics, are particularly susceptible to problems with the wound healing process. The wound healing process involves a complex cascade of biochemical and cellular events to restore tissue integrity following an injury. The wound healing process is typically characterized by four stages: 1) hemostasis; 2) inflammation; 3) proliferation; and 4) remodeling. The synthesis of collagen, which accounts for about 90% of the proteins found in the human dermis, is known to play a role in the necessary biological cascade of wound healing. Collagen has diverse biological roles including morphogenesis (shaping and contouring), tissue repair, remodeling, cellular adhesion, cellular migration, chemotaxis and platelet aggregation. An important factor in the rate of production of collagen is adequate blood flow. Reduced blood flow is a primary causative factor in elongated wound healing time and is also related to the general health aspects of skin.
SUMMARY
In one embodiment, the present invention is directed to a method for treating a wound in a subject with a diabetic condition. The method involves administering a peroxidized lipid to a subject in need of such treatment in an amount effective to promote wound healing in the subject.
In another embodiment, the method is directed to treating a wound in a subject with a diabetic condition otherwise free of symptoms of male sexual asthenia. The method involves administering a peroxidized lipid to a subject in need of such treatment in an amount effective to promote wound healing in the subject.
In another embodiment, the method involves treating a subject with a diabetic condition who has sustained a wound. The method involves administering a peroxidized lipid to a subject in need of such treatment in an amount effective to promote wound healing in the subject.
In another embodiment, the method involves treating a subject with a diabetic condition who has sustained a wound. The subject is otherwise free of symptoms of male sexual asthenia. The method involves administering a peroxidized lipid to a subject in need of such treatment in an amount effective to promote wound healing in the subject.
In another embodiment, the method involves treating a circulatory insufficiency in a subject with a diabetic condition, by administering a peroxidized lipid to a subject in need of such treatment in an amount effective to promote circulation in the subject.
In another embodiment, the method is directed to treating a diabetic skin disorder in a subject. The method involves administering a peroxidized lipid to a subject in need of such treatment in an amount effective to promote healing of the diabetic skin disorder.
According to each of the above-described embodiments, the peroxidized lipid includes at least one peroxide.
DEFINITIONS
“Subject,” as used herein, shall mean a human or vertebrate animal including, but not limited to, a dog, cat, horse, cow, pig, sheep, goat, chicken, primate, e.g., monkey, rat, and mouse.
“Diabetic subject: as used herein, shall mean a human or vertebrate animal including, but not limited to, a dog, cat, horse, cow, pig, sheep, goat, chicken, primate, e.g., monkey, rat, and mouse with a diabetic condition.
“Skin disorder,” as used herein, means a disturbance of function, structure, or both, resulting from exogenous factors such as poison, trauma or disease.
“Diabetic skin disorder,” as used herein, means a skin disorders that may occur in any population, but occurs more frequently in subjects having circulatory insufficiencies and/or diabetes.
“Wound,” as used herein, means a trauma to any of the tissues of the body, especially that caused by physical means and with interruption of continuity.
“Peroxidized lipid,” as used herein, means any peroxidized lipid compound useful in the present invention including all natural and/or synthetic analogues of peroxidized lipids or lipid-like compounds which possess the biological activity of peroxidized lipids in the skin, such as the promotion of collagen synthesis in the dermis, and increased blood flow, among other effects. Also encompassed within the term “peroxidized lipid” are geometric and stereoisomers of the peroxidized lipids. Biologically active “peroxidized lipids” useful in the methods of the invention include at least one peroxide obtained by the peroxidation of lipids of vegetable origin.
“Composition including peroxidized lipids,” as used herein, means a composition including substantial amounts of the previously defined peroxidized lipids. Other materials, or other lipids that do not have the biological activity of the previously described peroxidized lipids may be included in the composition.
“Substantial amount,” as used herein, means at least about 2%.
“Emollient,” as used herein, refers to the non-irritating character of the composition as a whole. That is, the nature of the vehicle and amount of peroxidized lipid therein should be selected so as to provide a sub-irritating dose for topical application.
An “effective amount” as used herein, is a dosage of the peroxidized lipid sufficient to provide a medically desirable result.
“Carrier,” as used herein, denotes an organic or inorganic ingredient, natural or synthetic, with which the active ingredient is combined to facilitate the application.
“Pharmaceutically-acceptable carrier,” as used herein, means one or more compatible solid or liquid filler, diluents or encapsulating substances which are suitable f
Desjonqueres Stephan
Koop Eileen P.
Schwarz Mary Jo
Dees Jose′ G.
Lamm Marina
Neoteric Cosmetics, Inc.
Wolf Greenfield & Sacks P.C.
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