Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
1999-12-23
2002-03-19
Jarvis, William R. A. (Department: 1614)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C424S195110, C514S844000
Reexamination Certificate
active
06358516
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a system for cleansing, conditioning, and treating the skin. In particular, the present invention relates to a one-step system that delivers a combination of surfactants, humectants, emollients, antimicrobial agents, and other beneficial ingredients in a no-rinse, self-drying formulation that promotes effective absorption into the surface layers of the skin.
2. Discussion of Background
Many different types of products are used in cleansing and conditioning the skin: solid and liquid soaps, surfactants, humectants, moisturizers, emollients, astringents, deodorants, and antimicrobial agents, and other compositions which provide the desired beneficial effects. The normal method of cleansing the skin with soap and water originated in about 2000 BC with a soap invented by the Mesopotamians. Unfortunately, most soaps are alkali based and rely on consuming the natural skin oils to free up dried or dead skin, dirt, and soil. This strips the skin of natural oils and causes dry skin, flaking and even skin tears, especially in older persons. Liquid cleansers are becoming increasing popular; however, many liquid cleansers do not lather sufficiently well for thorough cleansing. Various cleansing aids such as wash cloths and sponges may impede lathering or even absorb liquid cleansers and moisturizers.
The primary function of human skin is to provide a barrier that contains the other organs of the body. The effectiveness of skin as a barrier depends on its physical integrity, thus, preserving the integrity of healthy skin and restoring the integrity of injured skin are important aspects of maintaining good health. Injuries (burns, cuts, abrasions, incisions) can lead to localized or systemic infection if contaminated; dry skin can lead to pruritis and hasten the formation of skin ulcers (including decubitus ulcers), an especial concern for bedridden patients and the elderly. The normal techniques used in skin cleansing—washing with soap and water, rubbing with sponges and wash cloths—can exacerbate these problems.
The technique of cleansing skin using a basin of water and soap commonly used for bed ridden patients today was popularized by Florence Nightingale over 100 years ago. This technique usually starts with a basin filled with hot water, and involves the use of soap and rough wash cloths to loosen dead skin. Patients are bathed by scrubbing their skin with a well-soaped wash cloth, followed by vigorous towel drying. This technique can easily result in some areas of a patient's body becoming contaminated by bacteria carried from other parts via the washcloth or towel. Another concern is skin damage (abrasions, tears, etc.) due to friction from washcloths and towels, especially in elderly patients and others with fragile, easily-damaged skin.
Most skin cleansing formulations and techniques were developed primarily to remove dirt, soil, and germs carried on the surface of the skin or in the skin's oil, and do little or nothing to protect or enhance the skin or its natural functions. In fact, many sacrifice skin health to achieve the primary objective of skin cleansing.
More recently, substrates pre-moistened with various cleansers, moisturizers, and other additives have been used to provide greater convenience and disposable cleansing systems. For example, Elmore (U.S. Pat. No. 4,220,244) describes a soft cloth pad saturated with salt water and enclosed in a moisture proof envelope having a mirrored surface. The pad can be taken out when needed to refresh and clean the user's face. Toohey (U.S. Pat. No. 4,749,080) teaches a plurality of woven cloths pre-moistened with an aqueous moistening liquid such as pure water, contained in a resealable package. The package is sealed by application of heat and pressure, and sterilized by exposure to gamma radiation. Toohey states that the liquid can contain additives for skin freshening such as alcohol, iodine as an antiseptic, and a skin smoothing agent such as glycerin or lemon oil, altogether not exceeding 10% of the total weight of the aqueous solution.
Some products, such as the delivery system and treatment compositions described by Deckner (U.S. Pat. No. 4,563,346), are designed to air dry after application to the skin. Deckner uses a volatile silicone and a non-ionic lipophilic emulsifier that can be used to deposit a variety of active ingredients on the skin, including oils, humectants, emollients, sunscreens, antiperspirants, and topically active drugs. Other ingredients may include parabens, benzyl alcohol, and imidazolidinyl urea, emollients such as alcohol benzoate, and moisturizers such as panthenol, propylene glycol, or glycerol incorporated into the water phase of the delivery system. The system is said to produce a wash-resistant and sweat-resistant moisturizer film on the skin, which makes it unsuitable for use as a cleanser.
In addition to good cleaning action, cosmetic cleansers should be gentle, causing little or no irritation without drying the skin or leaving it taut. Wivell, et al. (U.S. Pat. No. 5,439,682) provides a personal cleansing and moisturizing composition that includes an anionic surfactant, a long chain C16-22 suspending agent, a dispersed, insoluble oil phase, an additional surfactant, an optional suspending agent, and water. Gordon, et al. (U.S. Pat. No. 5,650,384) combines a hydrophobic, diamond-mesh sponge with a liquid cleansing and moisturizing composition. The composition contains a moisturizing phase and an anionic surfactant in order to clean and moisturize the skin in a single step. Notably, most of the ingredients are rinsed away during use, leaving the relatively heavy, oily moisturizers behind.
Blieszner, et al. (U.S. Pat. No. 5,648,083) teach the addition of a cleansing composition to pre-moistened disposable wipes for personal cleansing of the perineal area. The composition includes water, a protective barrier agent that contains silicone oil, and an emulsifier; it may also include additional components such as pH-adjusting agents, antimicrobial agents, chelating agents, fragrances, skin soothing aids, moisteners, humectants, emollients, and powders. The composition is formulated for use in the normally moist perineal area; thus, repeated use in other, normally-drier areas would cause problems.
Additional compositions and methods are disclosed by Martin, et al. (U.S. Pat. No. 5,702,992), who add an anti-microbial agent to a patient care kit that includes a plurality of cleanser-impregnated cloths packaged in a sealed polyethylene bag. The cleanser is a nonionic, non-rinsing mixture of surfactants, emollients or humectants, vitamin E and deionized water. Williams, et al. (U.S. Pat. No. 4,761,402) describes a soluble, phophorylated glucan composition for treatment of viral and fungal infections; additional ingredients may include antimicrobial agents such as aminoglycoside and gentamicin. The composition is administered in vivo through injection, orally, topically, or by inhalation. Buchalter (U.S. Pat. No. 3,896,807) impregnates an article such as a glove with a therapeutic substance (a non-oily solid which is activated to form a cream upon addition of water or moisture). Murphy's cosmetic product (U.S. Pat. No. 5,653,967) also includes beta glucan as a suspension agent. The beta glucan is non-toxic and non-irritating, but was not noted to demonstrate any stimulation of macrophages or curative effects.
Many of the substrates used with cleansing compositions are unsuitable for long-term use. For example, paper substrates are biodegradable but abrasive to the skin, and, like dense woven or nonwoven substrates, are ineffective at trapping and carrying away dirt. Unfortunately, most nonwoven substrates that are available to consumers are selected for softness and reduced friction without regard for their ability to trap and carry away dirt or soil.
Most known skin cleansing systems contain ingredients that are aimed at producing specific outcomes, but that may also have detrimental side effects. For
Jarvis William R. A.
Kim Vickie
Reichmanis Maria
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