Drug – bio-affecting and body treating compositions – Live hair or scalp treating compositions – Astringent or sebum inhibiting
Reexamination Certificate
2002-03-26
2003-05-06
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Live hair or scalp treating compositions
Astringent or sebum inhibiting
C424S401000, C424S439000, C424S464000, C424S489000, C424S070100, C424S078020, C424S078030, C424S078050, C424S078070, C514S859000, C514S860000, C514S861000, C514S863000
Reexamination Certificate
active
06558656
ABSTRACT:
FIELD OF THE INVENTION
The present invention generally relates to oral and topical compositions and methods for the treatment of acne. More specifically, the present invention generally relates to compositions and methods for the treatment of acne by oral treatment with a composition comprising containing thymosin fraction 5 preparation plus other beneficial ingredients, such as vitamins and the like, and concomitant use of novel topical compositions.
BACKGROUND OF THE INVENTION
Acne is considered by those afflicted to be a serious problem. At some point 80% of all individuals, both male and female, experience acne. Although the vast majority of individuals afflicted with acne have spontaneous resolution of the problem over time, the effects of this skin disorder can be emotionally scarring. Some people, however, have active acne, until their mid-fifties. Likewise, in the last 20 years, for reason that are currently unknown, there has been a dramatic increase in acne affecting women over the age of 30.
Many causes have been proposed for acne. However, for a cause to have true validity, the treatment resolving the hypothesized cause must prove to be effective in the vast majority of cases. Causes that have been proposed include, but are not limited to: diet, hormonal disregulation, stress, bacterial overgrowth, heredity and environmental exposure; all of which may cause a deficiency of Coenzyme A. In no case has a treatment designed for any of the aforementioned causes proven to be uniformly effective. The only treatment that is proven effective in the vast majority of cases is the oral administration of isotretinoin (Accutane™). This medication, however, has numerous side effects; the most disturbing of which being its potential to induce sever birth defects.
Many topical approaches to the treatment of acne have been utilized. Topical medicaments currently available have proven to be effective in less severe cases, but none have been proven to be uniformly effective. These treatments have included antibiotics, benzoyl peroxide, vitamin A derivatives, such as retinoic acid, and many different epidermolytic agents; i.e. salicylic acid, glycolic acid ant the like. A unique anhydrous preparation was developed that effectively induced epidermolysis, while at the same time delivering a substantial amount of pantothenic acid to the affected area. It should be noted that normally pantothenic acid is unstable. However, due to the anhydrous nature of the formula, pantothenic acid is stabilized. These topical treatments typically require consistent use at least twice daily and recurrence after discontinuing therapy is quite high.
Although acne is not a systemic disease and is not in and of itself life threatening, it causes substantial emotional discomfort. Virtually all acne sufferers are willing to try any therapy that they think will be effective. Therefore, there exists a clear need in the art for a safe non-toxic method that will treat acne in the vast majority of cases without potentially dangerous side effects.
Many different therapeutic modalities have been proposed for the treatment of acne. With the exception of the vitamin A analog, isotretinoin, which is administered orally, none of these modalities have been proven to be uniformly effective. Isotretinoin exerts its effect against acne by decreasing sebum production.
For the vast majority of intrinsic acne, the cause is at least in part related to a deficiency in acetyl coenzyme A. This deficiency may be caused by a variety of different problems, i.e.: stress, diet, genetics, hormonal disregulation, environmental exposure, and the like.
Other treatment modalities that have been shown to be effective include zinc and pantothenic acid. Zinc was shown to be moderately effective at dosage levels of 100-300 mg per day. Pantothenic acid was shown to be effective at a dosage level of 10 grams per day. Very high doses of micellized Vitamin A have also been moderately effective. However, vitamin A has known toxicity when administered at high dosage levels.
SUMMARY OF THE INVENTION
An object of the present invention is to provide a composition that will increase the formation of Acetyl Coenzyme A. Surprisingly this composition is an orally administered combination of ingredients, in substantially lowered dosage requirements that otherwise described in extant literature.
It is another object of the present invention to provide a composition that will increase the formation of Acetyl Coenzyme A and include certain thymic peptides to substantially enhance the vitamin and mineral composition of the present invention. These peptides not only decrease the ability of bacteria to attach themselves, but also enhance the ability of the immune system to neutralize said bacteria. This is particularly important for cystic acne sufferers.
It is well known that pantothenic acid deficiencies result in a condition known as seborrheic dermatitis. In other words, due to a deficiency of pantohenic acid, there is a resultant increase in the production of sebum and a subsequent inflammation of the affected skin. Acne is nothing more than an exaggerated form of seborrheic dermatitis. Pantothenic acid deficiency invariably leads to a decrease in synthesis of acetyl coenzyme A, both systemically and in the skin proper.
A topical preparation was developed that significantly increased the delivery of pantothenic acid to the skin surface in an anhydrous vehicle, when used in conjunction with the oral preparation it was found to be surprisingly more effective than either the oral preparation or the topical preparation alone.
The novel features that are considered characteristic of the invention are set forth with particularity in the appended claims. The invention itself, however, both as to its structure and its operation together with the additional object and advantages thereof will best be understood from the following description of the preferred embodiment of the present invention when read in conjunction with the accompanying drawings. Unless specifically noted, it is intended that the words and phrases in the specification and claims be given the ordinary and accustomed meaning to those of ordinary skill in the applicable art or arts. If any other meaning is intended, the specification will specifically state that a special meaning is being applied to a word or phrase. Likewise, the use of the words “function” or “means” in the Description of Preferred Embodiments is not intended to indicate a desire to invoke the special provision of 35 U.S.C. §112, paragraph 6 to define the invention. To the contrary, if the provisions of 35 U.S.C. §112, paragraph 6, are sought to be invoked to define the invention(s), the claims will specifically state the phrases “means for” or “step for” and a function, without also reciting in such phrases any structure, material, or act in support of the function. Even when the claims recite a “means for” or “step for” performing a function, if they also recite any structure, material or acts in support of that means of step, then the intention is not to invoke the provisions of 35 U.S.C. §112, paragraph 6. Moreover, even if the provisions of 35 U.S.C. §112, paragraph 6, are invoked to define the inventions, it is intended that the inventions not be limited only to the specific structure, material or acts that are described in the preferred embodiments, but in addition, include any and all structures, materials or acts that perform the claimed function, along with any and all known or later-developed equivalent structures, materials or acts for performing the claimed function.
REFERENCES:
patent: 5952314 (1999-09-01), DeMichele et al.
patent: 6030948 (2000-02-01), Mann
Evans Charesse
Page Thurman K.
The Halvorson Law Firm
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