Compositions and methods for the treatment of skin disorders

Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Boron

Reexamination Certificate

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C424S657000, C424S658000, C424S660000, C424S402000, C424S443000, C424S445000, C424S446000, C424S447000, C514S825000, C514S826000, C514S827000, C514S828000, C514S846000, C514S847000, C514S848000, C514S858000, C514S859000, C514S860000, C514S861000, C514S862000, C514S863000, C514S864000, C514S865000, C514S871000, C514S886000, C514S887000, C514S928000

Reexamination Certificate

active

06399108

ABSTRACT:

TECHNICAL FIELD
The present invention is directed to treatments for skin disorders. In particular, the invention is directed to compositions and methods for treatment of skin disorders by administering borate compositions.
BACKGROUND OF THE INVENTION
Skin disorders are debilitating to persons or animals who suffer with such a disorder. The disorders can range from the mildly irritating levels of discomfort to medically threatening conditions. The presence of skin lesions or associated inflammation may limit the lifestyle choices of the patient and limit the ability to work or maintain a particular lifestyle. Skin disorders are usually difficult to treat and often require long term efforts at controlling the lesions.
There is a long felt need for treatment of skin disorders. There are many treatments available, but they are expensive, hard to administer or have unwanted side effects. Additionally, these treatments are not successful, or only provide temporary relief for patients.
One example of such ineffective treatments for skin disorders is the treatment of psoriasis. Currently used topical treatments include topical steroids, coal tar compositions, anthralin, Vitamin D compositions, retinoid therapy, exposure to sunshine and other lotions and creams. Occlusion therapy, wrapping the lesions with coverings and medications, is also commonly tried. Common side effects from such treatments include skin thinning, stretch marks and resistance to medications. Coal tar treatments may make the skin more sensitive to UV rays and anthralin can irritate or burn skin surrounding the psoriatic lesions. Other topical treatments may cause allergic reactions or skin irritation, an unwanted effect in treating already irritated skin. Sun therapy may cause skin cancers that lead to more serious medical conditions and treatments. Patients may also try a variety of herbal or dietary remedies.
Phototherapy with UV B radiation is another treatment for skin disorders. It may be used alone or in conjunction with topical treatments. The side effects include skin cancer and skin aging. PUVA, a combined psoralen and UV A radiation treatment, has also been used to treat skin disorders. The patient usually takes psoralen by mouth and administers UV A radiation to the skin surface. The short term side effects include nausea, itching and redness of the skin. The long term effects include changes in the skin's pigmentation, premature aging of the skin and cataracts.
Some patients have severe skin disorders covering large areas of the skin and require spa-type treatments. For example, in treating widespread psoriasis, day treatment programs have been used. The patients spend six to eight hours every day for two to four weeks in the day treatment program. They are treated with tar, anthralin and UVB radiation. These special treatment centers are located in certain metropolitan areas and are not available to persons unable to travel and disrupt their lives to this extent. Additionally, there is no such treatment for animals that suffer from skin disorders.
Internal medications have also been used in treatment of skin disorders. Steroids have long been used, but have many side effects that limit the persons who can take the steroids and limit the amount of time steroids can be administered. Additionally, there are side effects from taking the steroids and from cessation of steroid medications once treatment ends. Other common medications include methotrexate and oral retinoids. Short term side effects from methotrexate treatment include nausea, fatigue, loss of appetite, and mouth sores. Long term use can lead to liver damage and patients taking methotrexate must be closely monitored for this damage. Oral retinoids pose particular problems for women who may become pregnant because retinoids cause birth defects in developing fetuses. Such teratogenic effects are serious risks for patients seeking skin disorder treatments. Additionally, women who may become pregnant cannot drink alcohol while taking retinoids because the metabolic products of the combination cause birth defects. Cyclosporine can also treat skin disorders, but it has the side effect of immune suppression, and is routinely given to prevent organ rejection in transplant patients.
What is needed are compositions and methods of treating skin disorders in humans and animals that do not have the serious side effects of current therapies. Additionally, what is needed are methods and compositions for treatment of skin diseases that are safe, easily administered and provide flexible enough treatment regimens for humans and animals. Furthermore, what is needed are compositions and methods of treating skin disorders that are safe for patients, easily handled, and safely stored, and that provide relief of symptoms and that can be used in long term maintenance care without creating additional medical problems for the user.
SUMMARY OF THE INVENTION
The present invention is directed to compositions and methods for treatment of skin disorders. In particular, the present invention is directed to skin treatments that comprise borate compounds. Such compositions and methods are safe and effective for humans and animals, and can provide short-term and long-term relief from such conditions.
A preferred embodiment of the present invention comprises administration, preferably topical administration, of compositions comprising borate compounds, in a sequential manner until the skin disorder is resolved or under control. Preferred compositions comprise borate compounds, preferably borate salts and most preferably, mixtures or admixtures of borate compounds and boric acid.
Accordingly, it is an object of the present invention to provide methods and compositions for the treatment of skin disorders.
It is another object of the present invention to provide methods and compositions comprising borate compounds or borate compounds admixed or mixed with boric acid.
Further objects of the present invention comprise methods and compositions that are easily administered for short term relief of skin disorders.
Another object of the present invention comprises methods of topical administration of compositions for the treatment of skin disorders.
Yet another object of present invention comprises compositions of borate compounds that are administered for treatment of skin disorders.
An additional object of the present invention comprises methods and compositions for treatment of skin disorders that can be used for long-term treatment of skin disorders.
A further object of the present invention comprises methods and compositions that can be used for short term treatment of skin disorders.
DETAILED DESCRIPTION
The present invention is directed to methods and compositions for treatment of skin diseases. Such skin diseases include, but are not limited to, dermatological conditions linked to disorders of keratinization involving differentiation and proliferation, in particular, acne vulgaris, comedonic or polymorphic acne, nodulocystic acne, acne conglobata, senile acne and secondary acnes such as solar, drug or occupational acne; for other types of keratinization disorders especially ichthyoses, ichthyosiform conditions, Darier's disease, palmoplantar keratoderma, leukoplakia and luecoplakiform conditions or lichen and lichen planus; dermatological disorders having an inflammatory or immunoallergic component, in particular, all forms of psoriases, either cutaneous, mucosal or ungual, and psoriatic rheumatism, and cutaneous atopy such as eczema or respiratory atopy, dry skin, inflammation of the skin, solar erythema, skin allergies or other skin disorders of the epidermis and dermis. The present invention contemplates the treatment of skin disorders of humans and animals.
The present invention comprises compositions of borate compounds. In particular, preferred embodiments of the compositions comprise mixtures or admixtures of borate compounds and boric acid. The compositions may also comprise borate compounds. Preferably, the borate compound is a borate salt. The borate salt in a

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