Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
1997-01-10
2003-10-07
Zeman, Mary K. (Department: 1631)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S110000, C514S547000, C514S844000, C514S886000, C424S401000, C424S059000, C424S063000, C424S520000
Reexamination Certificate
active
06630442
ABSTRACT:
TECHNICAL FIELD OF THE INVENTION
The present invention deals with the combination of several anti-oxidants, including enzymatic co-factors and thiol compounds, and various tissue and cell growth stimulating factors in appropriate delivery vehicles employed in topical carriers as a means of ameliorating complications and also concomitantly enhancing repair from free radical damage to the skin undergoing treatment with exfoliants or chemosurgery (chemical peels) and laser (thermal injury) therapy and also stimulating the growth, differentiation and maturation of epidermal cells resulting both from these aesthetic therapeutic procedures or interventions, burns and the existing complicating environmental and cellular metabolic factors, which also engender abundant free radicals in cutaneous tissues.
BACKGROUND OF THE INVENTION
When cutaneous tissues are exposed to radiation, such as solar ultraviolet rays (UVA and UVB radiation), burns from chemical and thermal injuries, damage to the skin ensues, particularly exposure to UVB which results in sunburn and tanning., Many common pathologic factors exist as the various layers of skin are injured from local release of free radical species, emanating from cellular metabolism and enhanced by the putative inflammatory injury.
Skin peeling programs (chemical or thermal peels) are designed to remove “dead” skin with the aim of being replaced by new, clearer and younger cells yielding smooth and firmer skin. These treatments are recommended for solar (ultraviolet radiation) damaged skin, scarring resulting from skin conditions such as acne or for embarrassing cutaneous large pores, fine lines or the so-called “razor bumps.” Home treatments (exfoliation with enzymes or alpha hydroxy acids) have been designed to bring about the separation and removal of dead skin, particularly from the face and neck without causing bleeding or scabbing or breakage of deeper dermal tissues. To avoid uneven skin results, these exfoliating chemical treatments need be applied evenly, unlike the uneven solar damage to the skin. These home peel treatments need be repeated periodically; however, for severe skin conditions or problems, stronger chemical treatments or more prolonged applications or laser therapy need be performed by aesthetic professionals or medical practitioners of the art, such as plastic surgeons or dermatologists.
Cosmetic skin care technology has evolved the use of various chemicals and enzymes to induce desquamation (exfoliation) of cutaneous cells in the superficial layer, the stratum corneum. This purportedly results in the gradual reduction of the skin's fine lines and an improvement in skin texture through the process of desquamation. Most of these preparations utilize one or more alpha hydroxy acids (AHA) for use as so-called chemical peels. These are generally administered by cosmetic or plastic surgeons, dermatologists or aestheticians, particularly when AHA concentrations are high, such as 30% or greater, with consequent low pH values and accelerated desquamation of corpus stratum with side effects of inducing production of free radicals in epidermis and dermis. In addition, many cosmetic products with less than 10% active AHA have been formulated in stable forms for home use. These may be purchased over the counter and are also sold by salons, cosmetologists, aestheticians, and drug stores as AHA-containing chemical peels. At these lower AHA concentrations they are more effective when used chronically, to achieve the desired goals.
The most effective AHAs are glycolic acid and lactic acid, but personal care products may also contain malic, citric, tartaric and gluconic acids. Glycolic acid is obtained from sugar cane, lactic from milk, malic from apples, tartaric from grapes, and citric acid from citrus fruits. A beta hydroxy, salicylic acid, is gaining some popularity too as it also exfoliates and has been helpful in acne-prone skin. AHAs absorb moisture from the atmosphere increasing also stratum corneum moisture and plasticity.
Some enzymes function as exfoliants that help break up or “dissolve” superficial skin cells. Exfoliation then allows skin to regenerate and thereby protect itself. These enzyme preparations are usually not irritating to the skin since they do not penetrate deeply. “Double dose” exfoliation may be accomplished by using these enzymes in masks or “scrub” preparations. Some of these enzyme cosmeceuticals are sold also with AHAs or antioxidants. The major enzymes used as topical exfoliants are obtained from papaya (papain), pineapple (ananase) or digestive enzymes from hog pancreas. Other preparations use various enzymes or proteins whose function is to block the body's natural enzymes (collagenase and elastase), which usually impair the skin by digesting connective tissue collagen and elastin fibers.
Chemosurgery, vernacularly known as “chemical peels,” is a non-invasive technique which aims to restore wrinkled, blemished, unevenly pigmented (“brown age spots”) or sun damaged facial skin. The professional or self administered procedures use chemicals in varying concentrations and at an acid pH values to “peel away” the skin's most superficial layers, the stratum corneum and the epidermis. The aim is for the “new” cells that form during the healing (repair) process to produce a smoother, tighter and “younger looking” skin surface. Chemical peels are not substitutes for surgical face lifts which eliminate sagging or excessive skin. Chemosurgery may be used for large surfaces, such as face and/or neck region or on specific areas such as forehead, under the eyes, or around the mouth.
Professionals employ three types of chemosurgery, namely chemical solutions containing phenol, trichloroacetic acid (TCA) and alpha hydroxy acids (AHA), the latter in higher concentrations than those available for home, chronic self use cosmetic type preparations.
Phenol full face peels are used to treat mainly coarse facial wrinkles, prominent brown age spots and chronic sun damaged skin, including some precancerous cutaneous growths. On the other hand, TCA peels are used primarily for fine surface wrinkles and superficial pigmentations. Results with TCA are less dramatic and shorter lasting, but may be repeated regularly and also used on the neck, in contrast to the more drastic phenol chemosurgery, which may cause scarring in the neck area.
Other techniques to reduce scarring for dermatologic conditions like acne and to eliminate the aged-skin appearance secondary to chronic photo-damage besides chemical (acid) peels have been employed. Dermabrasion uses physical means to accomplish desquamation, but purportedly despite its success rate has a number of complications, such as pigmentary changes and either atrophic or hypertrophic scarring. These may be ameliorated or reduced both in frequency after dermabrasion, which is so highly user dependent or intensity, by the post dermabrasion use of antioxidants, growth stimulating factors and melanocyte controlling compounds to render more normal post therapy dermatologic results.
Another technique which has been used by aesthetic surgeons and dermatologists is the thermal therapy applied via a continuous wave carbon dioxide laser. These lasers vaporize tissue ensuing in areas of variable but important degrees of thermal damage, also resulting in scarring. Although antioxidant preparations could ameliorate this dermal damage, this technique fortunately is being quickly replaced by so-called pulsed carbon dioxide lasers, a revolutionary approach in aesthetic surgery, but as all surgical techniques not fully devoid of bothersome and untoward cutaneous side effects and risks. True that pulsed CO
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lasers selectively vaporize thinner layers of tissue and leave behind narrower zones of thermal damage, albeit free radicals are still elicited and cause their deleterious function on skin healing and scar promotion. Although these lasers improve substantially the wrinkling caused by photoaging, postoperatively, oozing and crusting develop for seven to fourteen days depending on the seve
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