Rhus dermatitis treatment composition and method

A poison ivy (and related dermatitis) treatment composition and method in which a novel composition containing a combination of active ingredients gives new and unexpected results over compositions of the prior art. The inventive composition includes three essential ingredients: extract (fresh sap) of jewelweed (Impatiens species); fresh sap of plantain leaf; and an aqueous colloidal dispersion of subdivided whole oat grains. It is believed that the amphiphilic nature of the aqueous colloidal oat dispersion both preserves the activity of the plantain and jewelweed enzymes, as a result of its oat oil fraction, and also enhances topical delivery to the epidermis due to its aqueous fraction and the stabilizing effect of the oat bran as bulking agent. At the same time the aqueous oat colloid dispersion provides an essential excipient and delivery agent for the jewelweed and plantain enzymes, it itself provides essential anti-inflammatory and antipruritic effect to minimize dermatitis exacerbation due to itching and scratching. In addition, the joint presence of the plantain and jewelweed saps is believed to give an enhanced anti-inflammatory effect as compared to the use of either plant sap alone.

FIELD OF THE INVENTION 
The present invention relates to a novel composition for treating poison 
ivy (Rhus dermatitis) and topical treatment methods using the novel 
composition. 
BACKGROUND OF THE INVENTION 
The present invention relates to a novel composition for the treatment of 
Rhus dermatitis associated with exposure to the irritant urushiol oil and 
other irritating constituents of the sap of the stems, leaves and roots of 
poison ivy, poison oak, poison sumac and related plants and plant parts. 
Urushiol oil itself can contain for example 3-alkylcatechols and 
3-alkenylcatechols in which the alkyl or alkenyl moieties are generally 
15-17 carbons in length, and compounds such as these can be extremely 
irritating to the skin. 
Exposure to urushiol oils can occur in various ways, and the oils are 
generally exuded to a greater degree by the stems, leaves and roots to the 
extent that these plant parts are crushed, cut or otherwise disintegrated 
such as by fire. Downstream smoke from a fire involving urushiol 
oil-containing plants is a well known cause of severe poison-ivy type 
dermatitis, and the oils can be carried by boots, shoes, clothes, tools 
and equipment in ways that can transmit skin irritants even to those who 
did not come in contact with the originating plant parts. Even though 
oxidation neutralizes urushiol oils over time, and despite the variability 
in potency of plants such as these depending on their season of origin, in 
some cases urushiol oils carried on shoes or other transmission vectors 
can remain active for years. It is believed that at least fifty percent of 
the population of the United States is sensitive to the active agents in 
urushiol oils, and the inflammatory response they stimulate, when brought 
in contact with the skin, is notorious--and in many cases severe. 
Various prior art patents and publications have addressed poison-ivy type 
dermatitis (Rhus dermatitis) and its treatment. U.S. Pat. No. 3,922,342 
discloses the use of a hydrophilic ion exchange material to absorb, upon 
contact with exposed skin, the phenolic compounds in the urushiol oils to 
minimize subsequent dermatitis. U.S. Pat. No. 3,875,301 describes a 
process for treating poison ivy dermatitis with tetraalkyl diamines. U.S. 
Pat. No. 3,862,331 discloses treating poison oak or ivy with 2-butanone. 
U.S. Pat. No. 3,749,772 describes a skin coating composition made of 
film-forming acrylic polymer which forms a barrier against topical 
exposure to urushiol oils. U.S. Pat. No. 4,259,318 discloses a "poison ivy 
relief" composition containing p-diphenol oxidase. U.S. Pat. No. 4,389,418 
discloses an emollient topical composition which commercially incorporates 
calamine for the treatment of poison ivy, insect bites, chicken pox rash 
and etc. U.S. Pat. No. 4,663,151 discloses an aluminum chlorhydrate 
composition for preventing and/or treating urushiol oil-associated 
dermatitis. U.S. Pat. No. 5,443,847, discussed further below, discloses 
detoxification of urushiol with manganese salts. 
Naturally-occurring chemicals are also known for treating poison-ivy type 
dermatitis, see Gibson, M. R. et al., "Activity of Jewelweed and its 
Enzymes in the Treatment of Rhus Dermatitis," Journal of the American 
Pharmaceutical Association, pp. 294-296, Gisvold, "The Effect of Some 
Adsorbents, Precipitants and Oxidants upon the Resin of Rhus 
Toxicondendron," Journal of the American Pharmaceutical Association, pp. 
17-18, and Scarborough, J., ed., Folklore and Folk Medicines, American 
Institute of the History of Pharmacy, Madison, Wis., 1987. These three 
articles all address the general applicability of jewelweed extract as an 
ameliorating agent for Rhus dermatitis, and the latter identifies the 
utility of plantain extract in this regard also. It should be noted that 
the Gibson et al. article calls into question the efficacy of jewelweed 
alone to ameliorate Rhus dermatitis, see page 295, column 2, last full 
paragraph, as does Scarborough, at the bottom of page 102. U.S. Pat. No. 
5,011,689 discloses the use of crushed plants of the genus Plantago, 
preferably broadleaf Plantain, to form a salve for treating poison ivy. 
European Patent Application 88116810 discusses an Impatiens capensis 
(jewelweed) extract for use in treating poison ivy dermatitis. 
In general, prior art methods and compositions have not provided a 
combination therapy in which urushiol oils are neutralized, skin layers 
are soothed, skin healing is promoted, and dermatitis pain and itching are 
minimized or eliminated, all from the application of a single specialized 
topical composition designed to accomplish all these goals. Specifically, 
poison ivy treatment methods and compositions heretofore have not 
adequately addressed the need to control inflammation and itching 
themselves as well as to neutralize the contact dermatitis active agent. 
As with all contact dermatitis, when the patient scratches the affected 
skin both the inflammation per se and the active agent exposure itself are 
exacerbated. A need thus remains for a composition which effectively 
neutralizes urushiol oils while simultaneously reducing the pain and itch 
adequately to prevent scratching or rubbing of the affected skin area. 
SUMMARY OF THE INVENTION 
In order to meet this need, the present invention is a Rhus dermatitis 
treatment composition and method in which a novel composition containing a 
combination of active ingredients gives new and unexpected results over 
compositions of the prior art. The inventive composition includes three 
essential ingredients: extract of jewelweed (Impatiens species such as 
Impatiens capensis, Impatiens biflora, Impatiens balsamea, and Impatiens 
pallida); extract of plantain leaf; and an aqueous colloidal dispersion of 
subdivided whole oat grains. In theory, without intending to be bound by 
this theory, the amphiphilic (i.e., simultaneously hydrophilic and 
lipophilic) nature of the aqueous colloidal oat dispersion both preserves 
the activity of the plantain and jewelweed enzymes, as a result of its oat 
oil fraction, and also enhances topical delivery to the epidermis due to 
its aqueous fraction and the stabilizing effect of cellulose and 
hemicellulose as bulking agents. At the same time that the aqueous oat 
colloid dispersion provides an essential excipient and delivery agent for 
the jewelweed and plantain enzymes, it itself provides essential 
anti-inflammatory and antipruritic effect to minimize dermatitis 
exacerbation by action of scratching. In addition, the joint presence of 
the plantain and jewelweed saps is believed to give an enhanced 
anti-inflammatory effect as compared to the use of either plant sap alone. 
Treatment of Rhus dermatitis with this composition may be prophylactic or 
ameliorative. In either case, the composition is applied topically, after 
which the treated area may be loosely covered or, preferably, is left 
exposed. 
DETAILED DESCRIPTION OF THE INVENTION 
The present invention is a composition intended for topical administration 
which neutralizes urushiol oils and promotes healing of Rhus dermatitis in 
an improved manner compared to prior art compositions. The inventive 
composition includes three essential ingredients: extract of jewelweed 
(Impatiens species such as Impatiens capensis, Impatiens biflora, 
Impatiens balsamea, and impatiens pallida); extract of plantain leaf; and 
an aqueous colloidal dispersion of subdivided whole oat grains. It is 
believed that the amphiphilic nature of the aqueous colloidal oat 
dispersion both preserves the activity of the plantain and jewelweed 
enzymes, as a result of its oat oil fraction, and also enhances topical 
delivery to the epidermis due to its aqueous fraction and the stabilizing 
effect of its cellulose and hemicellulose constituents as bulking agents. 
At the same time that the aqueous oat colloid dispersion provides an 
essential excipient and delivery agent for the jewelweed and plantain 
enzymes, it itself provides essential anti-inflammatory and antipruritic 
effect to minimize dermatitis exacerbation by action of scratching. In 
addition, the joint presence of the plantain and jewelweed saps is 
believed to give an enhanced anti-inflammatory effect as compared to the 
use of either plant sap alone. 
In the context of the present invention, "extract" should be understood to 
constitute the fresh juice of the stems and/or leaves of the jewelweed or 
plantain plants, or the extract may in turn be derived from a solvent 
extraction method such as with propylene glycol or other aqueous solvent. 
The usual extraction method for fresh juice production is crushing and 
filtering, although any method for separating pure sap from the plants may 
be employed. Solvent extractions, with subsequent removal of the solvent 
from the plant extract if desired, may be performed by means known in the 
art. When the solvent extraction process is complete, the dilution factor 
for the plant extract should be noted and any compensations made. Amounts 
and ratios described below are for fresh jewelweed and plantain juice, or 
sap. 
Treatment of Rhus dermatitis with the inventive composition may be 
prophylactic or ameliorative. In either case, the composition is applied 
topically, after which the treated area may be loosely covered or, 
preferably, is left uncovered. 
Additional ingredients form part of the preferred embodiments of the 
inventive composition, because they enhance the combined characteristics 
attributable to the three key ingredients described above. These 
ingredients include: (1) chamomile extract, a known soothing topical herb 
extract; (2) submicronized zinc oxide as an anti-inflammatory agent; (3) 
manganese gluconate; (4) xanthan gum; (5) methyl paraben; (6) menthol; (7) 
benzalkonium chloride; (8) oil of geranium; and (9) topical anesthetic. 
The most preferred embodiment of the present invention thus includes 
twelve ingredients--the three key ingredients and all nine optional ones. 
Further explanation of certain of the optional ingredients appears below. 
First, as to all twelve ingredients, it should be noted than none provides 
any substantial opacity to the inventive composition--not even the oat 
colloid. This is important as a cosmetic consideration because 
translucency in a topical composition provides consumer appeal. Even 
sufferers of Rhus dermatitis are reluctant to use old fashioned, opaque 
calamine lotions that can make lesions appear even worse than they are. 
The submicronized zinc oxide of the present invention is transparent 
within the present composition due to its extremely small particle size, 
and in the context of the present invention functions primarily as an 
anti-inflammatory agent, not a sunscreen. The oat colloid particles impart 
minimal opacity, but the composition as a whole is still translucent and 
really almost transparent. 
Topical anesthetics as constituents of the present composition are optional 
due to the effective soothing action of the oat colloid. However, standard 
amounts of various topical anesthetics may be included in the present 
composition without departing from its essential nature, and these 
anesthetics may constitute novocaine, carbocaine, benzocaine, benzyl 
alcohol, lidocaine, pramoxine hydrochloride, or other known anesthetics 
suitable for topical application. Typical concentrations of anesthetic 
compounds, in the inventive composition, are generally on the order of 
about 0.1-5 percent by weight. The addition of menthol with or without 
anesthetic provides an anti-inflammatory and soothing effect similar to a 
pharmacologic anesthetic, primarily due to the cooling sensation it 
creates. 
Manganese gluconate is a beneficial ingredient in certain embodiments of 
the present composition. Manganese is known to complex with the catechol 
constituents of urushiol oils, see U.S. Pat. No. 5,443,847 referenced 
above, but in its gluconate form it is especially compatible with the 
aqueous colloidal dispersion of oats because the gluconate fraction also 
tends to complex with the active moieties in urushiol oils. When xanthan 
gum is present it thickens the dispersion and increases the viscosity of 
the overall composition. Neither the gluconate nor the xanthan gum changes 
the amphiphilic character of the oat colloid itself. 
It should be noted that, when present, oil of geranium is included as an 
anti-inflammatory agent and, only incidentally, serves as a fragrance to 
the composition. Methyl paraben and benzalkonium chloride, although 
well-known stabilizers and preservatives of topical dermatological and 
cosmetic compositions considered individually, are especially compatible 
with the inventive compositions when used together because they do not 
alter the amphiphilic character of the oat colloid excipient which is 
essential to the present invention. 
Substitutions for methyl paraben may be made by means known in the art. For 
example, the commercial products Germaben II (0.5-1.0 percent) or Glydant 
Plus (0.1-0.3 percent) may either be used to replace the methyl paraben. 
Alternatively, 0.2 percent methyl paraben and 0.03 percent Kathon CG may 
be used in conjunction. In any case, the use of a small amount of a 
preservative in a composition such as that of the present invention is 
well within the skill of the art and in any case does not form a central 
feature of the disclosure herein. 
The colloidal dispersion of whole oat grains which forms an important part 
of the inventive composition may be obtained by various methods known in 
the art. Oat grains may be subdivided or pulverized by any known means 
including grinding, milling, ultrasonic pulverization, etc., either before 
or after soaking in water. Preferably, oat grains are soaked in pure water 
prior to division and are kept in the same water during the dividing or 
milling process. The oil fraction of the colloidal dispersion of whole oat 
grains is therefore the same percentage as found in the oat grains 
themselves, subject to the diluting factor of the water in which the 
divided grains are dispersed. Preferably, the ratio of oat grains to water 
is about 30 percent in the aqueous colloidal dispersion of whole oat 
grains. In turn, the dispersion itself contains on a "dry" basis 
approximately 8.0 percent by weight oat oil, approximately 18.5 percent 
hydrolyzed proteins; and balance phytic acid, ferulic acid, and beta 
glucan(s), polysaccharides, celluloses including hemicellulose, minerals, 
vitamins, arabans, polyphenols, ash, fiber and ambient moisture (about 10 
percent). 
The ratios of incorporation of the various constituents discussed above are 
not as critical as the nature of the ingredients themselves, but the 
following provides general guidelines. Between 25-70 parts by weight 
jewelweed extract, between 15-45 parts by weight aqueous colloidal 
dispersion of oats and between 5-15 parts by weight plantain extract may 
be included in compositions according to the present invention. 
Preferably, the present composition includes about 50 parts by weight 
jewelweed sap, about 30 parts by weight aqueous colloidal oat dispersion, 
and about 10 parts by weight plantain sap, remainder optional ingredients 
(if any). Remaining ingredient amounts include, as general guidelines: 
about 2-4 parts by weight chamomile extract, preferably 3.45; 2-4 parts by 
weight submicronized zinc oxide, preferably 3.00; 1-3 parts by weight 
manganese gluconate, preferably 2.00; 0.5-1.5 parts by weight xanthan gum, 
preferably 1.00; 0.10-0.30 parts by weight methyl paraben, preferably 
0.20; 0.1-5.0 parts by weight topical anesthetic, 0.1-0.2 parts by weight 
menthol, preferably 0.15; 0.01-0.10 parts by weight benzalkonium chloride, 
preferably 0.05; and 0.01-0.10 parts by weight oil of geranium, preferably 
0.05. 
The compositions according to the present invention are simple admixtures 
requiring no special techniques, temperatures, pressures or equipment to 
manufacture. As a general matter, the jewelweed and plantain saps and 
aqueous colloidal dispersion of oats are admixed first, after which any of 
the remaining optional ingredients are blended thoroughly into the initial 
admixture. Any mixing equipment known in the cosmetic formulation industry 
is suitable for preparation of the topical compositions of the present 
invention, and standard sterility techniques and laboratory practices 
should be followed. When feasible, the final admixture should be 
homogenized, although this is optional, prior to packaging of the product 
in tubes, jars, vials and applicator packaging known in the art. 
It should be noted in particular that the fresh saps of both jewelweed and 
plantain leaf are known to have little if any storage stability. In this 
context, therefore, not only does the formulation of the present invention 
provide these active agents in effective combination but also provides a 
storage stable composition of pharmaceutical and commercial value. 
Treatment of the skin with the present invention is straightforward and 
requires only application of an aliquot of the inventive composition to 
the skin, either manually or by means of an applicator.

The following example is illustrative. 
EXAMPLE 1 
One Hundred (100) g. of whole oat grains were soaked for forty-eight hours 
in 200 ml cold, pure water at room temperature. The soaked grains and 
water were pulverized in an ordinary kitchen blender to create an aqueous 
colloidal dispersion of whole oat grains; no fractions were removed. 
Thirty (30.00) parts by weight of the aqueous colloidal dispersion of oat 
grains were admixed with 50.00 parts by weight of fresh jewelweed sap and 
10.00 parts by weight sap of fresh plantain leaf. After thorough 
admixture, the following items were blended in the order given: 3.45 parts 
by weight chamomile extract; 3.00 parts by weight submicronized zinc 
oxide; 2.00 parts by weight manganese gluconate; 1.00 part by weight 
xanthan gum; 0.20 parts by weight methyl paraben; 0.10 parts by weight 
pramoxine hydrochloride; 0.15 parts by weight menthol; 0.05 parts by 
weight benzalkonium chloride; and 0.05 parts by weight oil of geranium. 
Mixing was continued until a homogenous, thickened admixture formed, and 
the composition was manually loaded into small cosmetic dispenser tubes 
with narrow applicator tips. 
Although the invention has been described with particularity above, with 
reference to particular methods, constituents and materials, the invention 
is only to be considered limited insofar as is set forth in the 
accompanying claims.