Drug – bio-affecting and body treating compositions – Live hair or scalp treating compositions – Amphoteric or zwitterionic surfactant containing
Reexamination Certificate
2001-05-15
2003-04-08
Killos, Paul J. (Department: 1625)
Drug, bio-affecting and body treating compositions
Live hair or scalp treating compositions
Amphoteric or zwitterionic surfactant containing
C424S078050, C424S078070, C424S176100, C514S859000, C514S861000, C514S863000, C514S864000, C514S887000
Reexamination Certificate
active
06544502
ABSTRACT:
BACKGROUND
1. Field of the Invention
This invention relates to the treatment of certain skin conditions, and, more particularly, to the novel discovery that the topical application of a freshly prepared aqueous solution of a water soluble antibiotic in an electrolyzed water and in a carefully prescribed fashion contributes significantly to the healing process of these certain skin conditions, several of which historically have not been considered amendable to any treatment protocol involving antibiotics. The treatment methodology has also proven efficacious in preventing the flare up of acne in susceptible patients.
2. The Prior Art
The skin is the largest organ of the human body. It is composed of tissue that grows, differentiates, and renews itself constantly. Since the skin is a generally impermeable membrane, it acts as a barrier between the internal organs and the external environment, and it is, therefore, uniquely subjected to noxious external agents and is also a sensitive reflection of internal disease.
Various diseases affect the skin. These include, for example, acne, eczema, and psoriasis, to name a few. Numerous theories have been postulated for the cause or causes of, say, acne with professionals in the medical community disputing almost everything about it except its existence. The disputes about acne include its causation, histopathology, pathophysiology, treatment, and even the role of diet in acne flare-ups.
Numerous patents have issued for various acne treatments and generally involve the application of selected substances or combinations of substances to the skin. All known acne treatments using topically applied products have met with only limited success in the treatment of acne conditions. None of these topically applied products are known for the treatment of cystic acne conditions. Further, none are considered as a preventative treatment for acne.
Many topically applied products include an antibiotic in a lotion base along with numerous other ingredients including preservatives and the like. It is my contention that the lotions, preservatives, etc., interfere with the antibacterial activity of the antibiotic both directly by masking its presence with the topical creme as well as by chemically interacting with the antibiotic molecule. Oils are especially detrimental for a water-based antibiotic because it is through the aqueous medium that the antibiotic is optimally effective. In other words, the empirical evidence demonstrates that the delivery vehicle, ie., the lotion base with all its various ingredients, compromises the integrity or potency of the topical antibiotic.
Further, historically, the treatment of, say, acne is significantly different from the treatment of other skin diseases such as eczema, psoriasis, dermatitis, and the like. Each skin condition is subjected to a different treatment protocol, none of which involve the topical application of an aqueous solution of an antibiotic.
Young (U.S. Pat. No. 3,883,661) teaches the treatment of acne by topically applying a member of a certain class of fatty acid amides to the affected skin area. Oleic acid diethanolamide is illustrated as a representative of the useful class.
Kligman (U.S. Pat. No. 3,729,568) teaches the topical application of vitamin A acid to the affected area as a treatment for acne vulgaris. The vitamin A acid is preferably applied in a liquid solvent. A composition found to be particularly effective is vitamin A acid dispersed in small amounts in a water-miscible liquid carrier made up of hydrophilic liquids having a high solvating action.
Nelson (U.S. Pat. No. 4,323,558) teaches the use of pharmaceutical compositions containing triethylenetetramine (trien) for the treatment of skin disorders such as acne, seborrhea, and dermatitis. The trien appears to have a certain degree of anti-inflammatory activity.
Other references teach the use of antibiotics for the treatment of acne conditions. These antibiotics are either taken orally or mixed in some form of emollient base and applied topically to the skin. For those applied topically, a certain proportion of the antibiotic has been known to become absorbed through the skin due to the ability of the lipid-based emollient to penetrate the skin to a certain degree. Further, it is postulated that certain emollient-like carrier creams may exacerbate an acne condition by contributing to the blockage of the normal sebum flow as will be discussed more fully hereinafter.
In view of the foregoing, it would be an advancement in the art to provide a skin treatment that is beneficial for a variety of skin conditions including such conditions as acne, eczema, and psoriasis, to name a few. It would be a particularly significant advancement in the art to dissolve a water soluble antibiotic in an electrolyzed water, the electrolyzed water having a higher affinity for the keratin layer of the skin thereby more intimately carrying the antibiotic into intimate dispersion across the surface of the skin. It would be an even further advancement in the art to provide a skin treatment that is particularly characterized by the absence of harsh chemicals, noxious substances, ointments, and the like. It would also be an advancement in the art to provide a skin treatment protocol whereby antibiotic is delivered downwardly into the upper end of the follicular canal to thereby directly attack the bacterial component of an acne flare up. An even further advancement in the art would be to provide a skin treatment that has minimal side effects so that it can be used even by pregnant women. It is a significant advancement when the therapy in question is preventative in nature, and in a major percentage of patients treated (hundreds) a cure has been demonstrated and documented. Such a novel invention is disclosed and claimed herein.
BRIEF SUMMARY AND OBJECTS OF THE INVENTION
This invention relates to a novel skin treatment methodology for treating various skin conditions such as acne, eczema, psoriasis, and the like, with a freshly prepared solution of a water soluble antibiotic. Importantly, the water soluble antibiotic is dissolved in electrolyzed water, more specifically, the alkaline fraction of the electrolyzed water. The ability of the keratin layer of the epidermis to absorb a vast amount of water coupled with the fact that the water is primarily constituted of the alkaline fraction of the electrolyzed water causes the antibiotic to become intimately dispersed throughout the keratin layer on the surface of the skin. The underlying epidermis prevents the water and any significant quantity of antibiotic from being absorbed into the epidermis and underlying dermis. The treatment includes cleansing the hands followed by cleansing the affected area of the skin using a mild, water-based cleansing agent. For acne conditions, the cleansing step includes the application of an alcohol to the treatment area to help rid the treatment area of both excess oils and any residual bacteria, whether aerobic or anaerobic bacteria, that may be present. A freshly prepared, aqueous solution of a water soluble, broad spectrum antibiotic such as a soluble salt of doxycycline is then applied to the area and allowed to air dry. The water in the solution is obtained as the alkaline fraction of an electrolyzed water so that it is readily absorbed by the keratin layer thereby dispersing the antibiotic intimately over the surface of the skin. Importantly, particularly in the treatment of acne, the high affinity of the keratin layer for this type of water causes the antibiotic to be directed downwardly into the follicular canal through the keratin lining of the follicular canal where it more effectively suppresses the bacteria found there. An important following step in the treatment protocol is maintaining the treated area, to the extent practicable, free from contact with objects that could possibly recontaminate the treated area. The treated area can be covered with a suitable skin creme to help seal the antibiotic to the skin. The treatment process is repeated at least twice a day.
It
Foster Lynn G.
Killos Paul J.
Wasatch Pharmaceutical Inc.
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