LYCD compositions and therapy

Drug – bio-affecting and body treating compositions – Extract – body fluid – or cellular material of undetermined...

Reexamination Certificate

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C424S401000, C424S060000, C424S061000, C424S063000, C424S064000, C424S078020

Reexamination Certificate

active

06177105

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to compositions for promoting growth of collagen in human skin, and more particularly, to topical preparations containing live yeast cell derivative (LYCD).
2. Discussion
At least since the time of Cleopatra, people have applied substances to their skin in an attempt to appear younger. While many of these substances did little to improve the appearance of skin, most of the clinically proven treatments for rejuvenating skin—&agr;- and &bgr;-hydroxy acids, retinoic acid, chemical peels, dermabrasions, laser resurfacings—have involved substantial irritation of the skin. For example, people who use hydroxy acids or retinoic acid often complain of erythema (redness), burning, stinging, and peeling.
Moreover, it appears that skin irritation is not simply a side effect of these treatments, but is necessary for their efficacy. For example, physicians' attempts to create products and procedures that reduce the side effects of chemical treatments were accompanied by a diminution of efficacy. Similarly, though many physicians have switched from harsh CO
2
laser resurfacing to “gentle” erbium lasers, they report that skin rejuvenation occurs only with comparable skin destruction
Current “irritant-based” treatments suffer other drawbacks. For example, the effectiveness of these treatments appears to diminish with long-term exposure or increased use. Research suggests that prolonged exposure to retinoic acid, &agr;- and &bgr;-hydroxy acids, and phenolic peels does not result in a continual improvement in skin appearance. A similar drawback occurs with CO
2
laser resurfacing, where physicians have noted that skin rejuvenation results only from moderate skin destruction. If aggressive laser destruction is performed in an attempt to correct severe skin damage, scarring can develop.
In recent years, physicians have begun exploring ways to improve skin appearance without irritation, but their efforts have met with limited success. For example, U.S. Pat. No. 4,942,031 discloses topical preparations containing live yeast cell derivative (LYCD) for reducing skin wrinkles. However, the disclosed anti-wrinkling compositions also contain retinoic acid, which, as discussed above, can irritate the skin. Another therapy, which is described in U.S. Pat. No. 5,709,868, discloses treating skin with lipoic acid but not in combination with LYCD. Moreover, the formulations disclosed in the latter patent focus on free radical scavenging and therefore do not target the result of the present invention—stimulation of collagen growth to rejuvenate skin. Thus, although the '868 patent may arguably improve skin appearance, it does so in a substantially different way than the present invention.
The present invention is directed to overcoming, or at least minimizing, one or more problems described above by using a synergistic combination of components, including LYCD.
SUMMARY OF THE INVENTION
The present invention provides topical preparations and therapies for rejuvenating skin by stimulating collagen growth. Compared to traditional skin therapies involving treatment with harsh chemicals or lasers, the present invention provides improved skin appearance and texture with less skin irritation.
In accordance with one aspect of the present invention, there is provided a topically applied serum comprising an aqueous solution of live yeast cell derivative (LYCD) and &agr;-lipoic acid, or a pharmaceutically acceptable salt or ester of &agr;-lipoic acid. The components of the serum are present in amounts effective to stimulate growth of new collagen fiber, which improves the appearance and texture of human skin.
In accordance with a second aspect of the present invention, there is provided a skin peel composition comprising an aqueous solution of LYCD and zinc acetate. The components of the skin peel composition are present in amounts effective to stimulate growth of new collagen fiber, which improves the appearance and texture of human skin.
In accordance with a third aspect of the present invention, there is provided a topically applied moisturizing cream comprising an aqueous mixture of LYCD and a hydrating agent. The hydrating agent is composed of tocopherol, tocopherol acetate or tocotrienol, either alone or in combination. The LYCD and the hydrating agent are present in amounts effective to stimulate growth of new collagen fiber, which improves the appearance and texture of human skin.
In accordance with a fourth aspect of the present invention, there is provided a method of rejuvenating human skin by stimulating growth of new collagen fiber. The method comprises the step of removing the outermost layers of skin using a skin peel composition comprising an aqueous solution of LYCD and zinc acetate. The method also includes the steps of hydrating the skin using a moisturizing cream comprising an aqueous mixture of LYCD and a hydrating agent, and oxygenating the skin using a serum comprising an aqueous mixture of LYCD and &agr;-lipoic acid, or a pharmaceutically acceptable salt or ester of &agr;-lipoic acid. The components of the peel solution, the moisturizing cream, and the serum are present in amounts effective to stimulate the growth of collagen in the skin. The hydrating agent is composed of tocopherol (vitamin E) or tocotrienol, either alone or in combination.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The compositions disclosed herein for rejuvenating human skin by stimulating collagen growth in human skin, all contain effective amounts of live yeast cell derivative (LYCD) in combination with &agr;-lipoic acid (6,8-dithiooctanoic acid), or pharmaceutically acceptable salts or esters of &agr;-lipoic acid, a hydrating agent, or zinc acetate. Suitable hydrating agents include tocopherol—vitamin E in its various forms, including the acetate—and tocotrienol, either alone or in combination.
LYCD and &agr;-lipoic acid stimulate new collagen fiber growth, which improves the appearance and texture of skin. While not wishing to be bound by any particular theory, it appears that LYCD stimulates collagen growth by providing a necessary precursor—oxygen —while &agr;-lipoic acid is added specifically to increase cellular activity, including the rate of collagen growth, by stimulating mitochondrial activity in the skin. Tocopherol and/or tocotrienol hydrate the skin and, along with zinc acetate, help transport LYCD through the outer skin layers to the basal cells where collagen fiber growth occurs.
LYCD is a skin respiratory factor derived from
Saccharomyces cerevisiae
, and is known to stimulate collagen growth. It is purified and produced by a complex fermentation process and is available from many producers including Langer Laboratories, a subsidiary of Sperti Drug Co., MDH Laboratories, Inc., and Universal Foods Corporation. LYCD is typically quantified in terms of Skin Respiratory Factor (SRF) units. One SRF unit is the amount needed to increase the oxygen uptake of 1 mg of dry weight rat abdominal skin by 1 percent at the end of a 1 hour testing period in a Warburg apparatus.
A first embodiment—a topically applied serum—is disclosed in Table 1. The serum contains 4 wt. % LYCD and 4 wt. % &agr;-lipoic acid, although both components can be used at levels as low as about 1 wt. %. LYCD and &agr;-lipoic acid can each be used at levels up to about 10 wt. % without adverse effects, but when LYCD and &agr;-lipoic acid are used in amounts substantially greater than about 4 wt. %, there is believed to be little increase in the effectiveness of the serum. Although the weight ratio of LYCD to &agr;-lipoic acid can vary from about 10:1 to about 1:10, LYCD and &agr;-lipoic acid are typically employed at about a one-to-one weight ratio. In addition to the free acid, one may use pharmaceutically acceptable salts and esters of &agr;-lipoic acid. The balance of the ingredients listed in Table 1 improve transport of the active ingredients through the outer skin layers to the basal cells (propylene glycol and zinc acetate), increase the viscosity and

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