Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from leguminosae
Reexamination Certificate
2001-04-22
2002-07-16
Lankford, Jr., Leon B. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from leguminosae
C424S725000, C424S539000, C514S026000
Reexamination Certificate
active
06419963
ABSTRACT:
BACKGROUND OF INVENTION
Diaper rash is a common form of irritation and inflammation of those parts of an infant's or adult's body normally covered by a diaper. It frequently occurs also in areas immediately adjacent to the diapered area. This condition is also referred to as diaper dermatitis, napkin dermatitis, napkin rash, and nappy rash.
The precise number of infants who suffer from diaper rash or diaper dermatitis is unknown. However, the United States Department of Health, Education and Welfare, has indicated that diaper dermatitis itself accounted for 97 visits to a doctor for every 1,000 infants in the United States between the ages of 0 to 2 years of age. [See Ambulatory Care Utilization Patterns of Children and Young Adults, Vital and Health Statistics Series 13, Number 39, U.S. Department of Health, Education and Welfare, Public Health Service (1978)]. Further, while certainly more common in infants, this condition is not, in fact, limited to infants. Any individual who suffers from incontinence may develop this condition. This ranges from newborns, to the elderly, to critically ill or non-ambulatory individuals. Approximately 10% of all infants can have their diaper rash classified as being moderate, with another 5% of the infants having diaper rash, which could be classified as severe.
The primary contributors to the development of diaper rash have long been thought to be infant urine and feces. For example, infants under two months of age can urinate up to 20 times per day. Thereafter, infants can urinate up to 8 times a day. In addition, infant defecation typically occurs several times a day.
The principal cause of the irritation that characterizes diaper dermatitis or diaper rash is the mixture of urine and stools. In effect, the urea contained in the urine is broken down into ammonium hydroxide by the ureases, which leads to an increase in pH. When the pH becomes basic, the enzymes produced at time of digestion such as the proteases and the lipases of pancreatic or intestinal origin, see their activity and thus their irritating power increase. The lipases in particular attack the triglycerides of the sebum and provoke the release of fatty acids.
The corium made permeable by a hyper-hydration, a significant rubbing and digestion by enzymes loses its function as a barrier and allows other irritating molecules such as biliary salts to pass through. In certain cases, an actual digestion of the epidermis of the infant's bottom could be observed due to the action of ureases, lipases and proteases.
It had been theorized that the breakdown of the urine to yield ammonia primarily contributed to the formation of diaper rash by increasing the alkalinity of the skin. However, more recent studies have concluded that the primary contributor to the development of diaper rash is the feces. As opposed to the alkaline pH associated with urine, feces typically exhibit an acidic pH due to bile. In fact, studies have shown that diaper rash is more prominent in the presence of feces than in the presence of urine, thereby providing a plausible explanation for the problems with diaper rash associated with infants who have diarrhea or frequent stools.
Diaper rash may predispose an infant to irritation and infection. It is generally accepted that true “diaper rash” or “diaper dermatitis” is a condition, which is, in its most simple stages, a contact irritant dermatitis [See Jacobs, “Eruptions in the Diaper Area”, Ped. Clin North Am 25:209 (1978)]. The irritation of simple diaper rash results from extended contact of the skin with urine, or feces, or both. Diapers are worn to catch and hold the body waste, but generally hold the waste in direct contact with the skin until changed, i.e., in occluded fashion for long periods of time. The same is true for an incontinence pad, or incontinence brief. However, while it is known that body waste “causes” diaper rash, the precise component or components of the urine or feces which are responsible for the resulting irritation of the skin remain the subject of much controversy. The most commonly accepted list of factors linked to diaper rash includes ammonia, bacteria, and the products of bacteria action, urine pH, and moisture. These are generally cited in the art as being the most likely candidates. The two most common types of infection are those associated with yeast, and bacteria. The most common yeast infection is caused by Candida albicans. Meanwhile, the most common bacterial infection is caused by Staphylococcus aureus.
There are a host of conditions, which are labeled (or more precisely mislabeled) “diaper rash” which may exhibit similar indications. In determining whether the condition that is being observed is actually diaper rash/dermatitis or some other condition no conclusive rule exists. If the dermatitis is limited to the diapered area and related to the use of the diaper or the contact of skin to body waste it can be safely concluded that the condition that exists is diaper dermatitis. There are a number of other conditions, however, which can begin in the area that is diapered on the infant, or which are simply more pronounced or aggravated in this area, but which are not truly “diaper rash” or “diaper dermatitis” in that they are not related to body waste contact. If the abnormal skin condition under scrutiny is present in locations other than in, or proximate to, the diapered area, e.g., the head, neck, extremities other than the genitalia, shoulders, etc., then one must consider other conditions, such as atopic dermatitis, seborrheic dermatitis, allergic contact dermatitis, psoriasis, scabies, bullous impetigo, papular urticaria, herpes simplex, and chemical or thermal burns. However, such observations are not conclusive because some diaper rash or diaper dermatitis conditions may have their genesis in the diapered area and then spread well beyond the diapered area.
Weston, et al., “Diaper Dermatitis: Current Concepts”, Pediatrics 66:4 (1980) has described and summarized the overall clinical features which can generally be associated with true diaper dermatitis. He has identified the forms of diaper rash or diaper dermatitis as follows: Four clinical forms of diaper dermatitis related to diaper wear have been recognized. The most frequently observed is chafing dermatitis. This form demonstrates mild redness and scaliness seen over the buttocks, waist, and convex surface of the thighs where the diaper contacts the skin, or limited to the perianal area. Dermatitis limited to the perianal area is seen in the neonatal period, and the more widespread form is seen after 3 months of age. The second, and also frequently seen, form of dermatitis is a sharply demarcated confluent erythema with involvement of the skin folds with or without an accompanying whitish exudate. The third form of dermatitis is characterized by discrete shallow ulcerations scattered throughout the diaper area including the genitalia. In the fourth form, beefy red confluent erythema of the entire perineum with prominent elevated margins, satellite oval lesions around the periphery of the confluent area, and vesiculopustular lesions are described. This form is seen when the dermatitis becomes secondarily invaded with Candida albicans. Diffuse involvement of the genitalia in the inguinal folds is a regular feature of this form. If left untreated, diaper rash and diaper dermatitis can result in masceration of the skin, thus leading to much more serious conditions and pathologies, e.g., infection, trauma, and systemic disease. [See Burgoon, “Diaper Dermatitis”, Pediatric Clinics of North America 18:835 (1961)].
Since a diverse range of factors have been suspected of being associated with diaper rash and diaper dermatitis requiring diverse therapies, conventional methods of treatment for diaper dermatitis have been directed toward a straightforward attempt to minimize the contact of the skin with the feces or urine present in a soiled diaper. An artificial barrier is usually provided between the skin and the body waste to
Coe Susan D.
Lankford , Jr. Leon B.
Welsh & Katz Ltd.
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