USOO6593371 B1 (12) United States Patent (10) Patent No.: US 6,593,371 B1 Staggs (45) Date of Patent: Jul. 15, 2003

(54) TREATMENT FORWARTAND RELATED (56) References Cited DSORDERS U.S. PATENT DOCUMENTS (76) Inventor: Jeff J. Staggs, 1285 E. Goldsmith Dr., 4,180,058 A 12/1979 Brem ...... 128/1 R Highlands Ranch, CO (US) 80126 6,063,381 A * 5/2000 Staggs ...... 424/195.1 (*) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 * cited by examiner U.S.C. 154(b) by 0 days. Primary Examiner Kevin E. Weddington (21) Appl. No.: 09/571,644 (57) ABSTRACT (22) Filed: May 15, 2000 A novel treatment for wart and related disorderS Such as papillomas derived from extracts of pepper, , and Related U.S. Application Data related plant species containing Vanillyl (FIG. 3), and pip eridine (FIG. 7) ring structures typical of the pungent (63) Continuation-in-part of application No. PCT/US93/04763, principals found in pepper, and ginger. The pepper extracts, filed on May 19, 1993. which also possess antifungal properties are demonstrated in (51) Int. Cl." ...... A61K 31/16; A61K 31/70 the topical treatment of warts. (52) U.S. Cl...... 514/627; 514/31 (58) Field of Search ...... 514/627, 31 38 Claims, 7 Drawing Sheets U.S. Patent Jul. 15, 2003 Sheet 1 of 7 US 6,593,371 B1

OH PHENOL CH5OH FIGURE 1

OCH3 OH ORTHO-METHOXYPHENOL CHOCH4OH FIGURE 2

CH2

OCH OH VANILLYL (CHO)(OH) Chi -CH2 FIGURE3 U.S. Patent Jul. 15, 2003 Sheet 2 of 7 US 6,593,371 B1 CH2 -NH2

OCH3 OH

3-METHOXY-4-HYDROXYBENZYLAMINE (CH3O)(OH) C6H3-CH-NH2

FIGURE 4

CH-NH - R where R is an organic hydrocarbon group OCH OH VANILLYLAMIDE (CHO)(OH)CH-NH-R

FIGURES U.S. Patent Jul. 15, 2003 Sheet 3 of 7 US 6,593,371 B1

CH-NH - R 21 N OCH3 OH

R - CO-(CH2)4-CH=CH-CH-(CH3)2 CAPSAICN R - CO-(CH2)6- CH-(CH3)2 DIHYDRO R - CO-(CH2)5- CH-(CH3) NORDIHYDRO " R - CO-(CH2)9 - CH-(CH3)2 HOMODIHYDRO " R - CO-(CH2)5- CH=CH-CH (CH3)2 HOMO R - CO-(CH2)7 - CH NONANOIC ACID VANILLYLAMIDE R - CO-(CH2)3-CH DECANOIC ACID VANILLYLAMIDE CAPSACINOIDS

FIGURE 6 O H PIPERIDINE (CH2)NH F RE 7 U.S. Patent Jul. 15, 2003 Sheet 4 of 7 US 6,593,371 B1

"N--- O) PPERINE R N---O PIPERYLINE "N-- O) PIPERETTINE *N----O PIPEROLEIN A 's--~~~ O) PPEROLEIN B () PIPERINNE * N-n-a-So O

WHERE R= ( O IO)

PUNGENT ALKALODS PRINCIPALS OF PEPPER

FIGURE 8 U.S. Patent Jul. 15, 2003 Sheet 5 of 7 US 6,593,371 B1

OCH3 OH

EUGENOL C10H12O2

IGURE

CURCUMIN C2H20O6

E 1 U.S. Patent Jul. 15, 2003 Sheet 6 of 7 US 6,593,371 B1

5.O OH (CH2)CH3 O (CH2)CH3 OCH d +H2O OH OH

GINGEROL C17H24O3 (where n = 4, 6, or 8)

(CH2)CH3

O O +C2H5OH +CH3(CH2)CHO OCH3 OCH3 OH OH

PARADOL ZINGERONE C11H14O3

GNGEROLS

FIGURE 11 U.S. Patent Jul. 15, 2003 Sheet 7 of 7 US 6,593,371 B1

OCH RF OH R = -( )- OH

RESINIFERATOXIN TINYATOXIN

FIGURE 12 FIGURE 13 US 6,593,371 B1 1 2 TREATMENT FORWART AND RELATED Physician administered nitrogen free Zing, DISORDERS electrodesiccation, curettage, laser, and Stronger acid treat ments are effective to destroy the wart, but often leave a Scar PRIORITY INFORMATION in place of the wart. Treatment is expensive, requiring This is a continuation-in-part of continuation-in-part 5 administration by a physician, and often requires follow-up. application PCT/US93/04763 International Filing date May In spite of these measures, the wart returns about one-third 19, 1993, which is also U.S. PCT National Stage Application of the time, or new ones crop up around the edges of the old Ser. No. 08/338 489 filed Mar. 18, 1997 which became U.S. one. These poor results are obtained at a cost of Several Pat. No. 6,063,381 all of which claim priority from U.S. hundred dollars. National application Ser. No. 07/886,640 filed May 21, 1992 The failure of prior art medications to produce an now abandoned effective, reasonably priced wart treatment has Several nega tive consequences. Patients cannot get adequate relief The TECHNICAL FIELD high cost of treatment adds further to the already exorbitant The invention relates to a novel treatment for wart and cost of healthcare borne by employers, government, and related disorderS Such as papillomas derived from extracts of 15 ultimately the patient through added medical bills, increased pepper and ginger and chemically related Species. insurance premiums and higher taxes. Repeated physician Visits reduce worker productivity, and leisure time. BACKGROUND ART Unresolved wart cases with cancer causing HPV may Warts, or verrucae infect man and animal alike. More than result in Severe illness, or loss of life for many, in addition 80 related strains of papillomavirus (HPV) have been iden to the much greater medical costs associated with cancer tified as the cause. It is estimated than 40 million Americans treatment. These misfortunes are multiplied as cancer caus have some form of HPV infection. ing HPV Strains are spread to others. At particular disad Vantage are low-income individuals without healthcare Most warts are harmless, but may also harbor bacterial insurance who cannot afford cancer treatment, and are most infections. Still other may cause cancer of the cervix, Vagina, 25 Vulva, anus, penis, mouth, throat, or esophagus. likely to perish as a result. Warts affect all age groups, but are most common in Prior art wart treatments lack the effectiveness necessary children. Almost everyone has had common warts. These to treat the problem Sufficient to attract consumer appeal and infect the fingers, around nails, knees, face, Scalp, and may Secure product profitability, and Success for drug companies. Spread to other areas including the mouth. They lack economic feasibility for development of low cost treatments for the poor of industrialized countries, develop Plantar warts develop on the Sole of the foot, causing pain, ing countries, and Similar products for livestock, companion particularly while walking and thickening of the Surrounding animal, and other veterinary uses to the detriment of patient skin. Plantar warts are difficult to cure. and Supplier alike. Filiform warts form long, narrow, Small growths on eyelids, face, neck, or lips. 35 Today, more than every before, the importance of having medications that are not only Safe, and effective, but cost Flat warts (more common in children and young adults) effective as well, is becoming critical to the preservation of form Smooth yellow-brown spots usually on the face. our way of life. Escalating health care costs in the United Seborrheic warts, though not caused by a virus are found States are causing real hardship on the middle and lower most commonly on the face of the aged. 40 income Americans as 1 in 6 cannot afford health care Genital warts are transmitted Sexually, infecting the Vulva, insurance. A greater share of the household budget otherwise vaginal wall, cervix, and areas around the Vagina In men, the Spent on housing, college education, retirement, penis and Surrounding areas may be infected. Also a Site of entertainment, and consumer goods must instead go to cover infection is the area around the anus and in the rectum more health care costs. The Standard of living is lowered as capital common in homosexual men, and in Women who engage in 45 is taken from industries that provide employment, and create anal Sex. Some types of genital warts emit foul Smelling tax revenues. The national debt continues to Soar as increas Secretions. The mouth and throat are also an area of infection ing numbers of citizens are excluded from adequate medical and transmission as a result of oral SeX with infected care. Is health care at the risk of economic rum a real benefit genitalia. Genital warts return frequently and require to Society? repeated treatment. They are highly contagious, with an 50 estimated 1 million new cases occurring each year in the DISCLOSURE OF INVENTION U.S. Sites of infection including vagina, cervix, uterus, Several objects and advantages of my invention include penis, rectum, mouth, throat ect, are at increased risk for an improved treatment for wart infections of unparalleled developing cancer. Immunocompromised patients with effectiveness. A treatment that Saves the misery of millions AIDS, cancer, diabetes, and recipients of organ transplant 55 of Sufferers, is low in toxicity, low in cost, Safe, leaves no medication are most susceptible to HPV, as well as other Scarring, is affordable to the poor, and hence of broader infections. commercial feasibility. A treatment that quickly resolves Warts are unsightly, causing revulsion, embarrassment in wart varieties with cancer causing potential prior to the addition to itch, foul odor, pain discomfort, and increased cancerous Stage to avert Serious illness, loss of life, and cancer risk. Prior art treatments are expensive, prolonged, 60 spread of the infection to other parts of the body, and to other and often ineffective. Even wealthy sufferers, with the best perSons, and eliminates the need for costly cancer treatment. health care available are hardly much better off than the A treatment that Saves billions of dollars annually in patient poorest of the world with regard to wart afflictions. productivity, healthcare costs, and capable of becoming a The prior art acid peel method requires Several weeks or model for demonstrated Savings in commercial healthcare, months of repeated daily applications hoping to Soften the 65 and government Sponsored programs Such as Medicare, and wart enough to allow it to be peeled off This method often Medicaid. An economically feasible veterinary wart treat burns the Surrounding healthy Skin and frequently fails. ment for livestock, pets, companion, and other animals of US 6,593,371 B1 3 4 broadened commercial appeal. An important reseach tool It appears that the high nutrient concentration found in applicable toward other related tumors, neoplasms, growths, pepper including Vitamins, minerals, carotenoids, lipids, and papillomas, cancers, and viral disorders. others assist the above therapeutic effects in addition to the I have discovered that pepper, and chemically related pungent compounds. Pepper compounds are Safe, and have compounds, and Species of plants contain active agents of been in widespread use as food for thousands of years and unparalleled effectiveness in the treatment of wart infec do not induce illness, or injury as do Some prior art treat tions. These agents administered in a wide range of concen mentS. trations within commonly used drug vehicles and carriers As a generally recognized as Safe (GRAS) listed nutrient Such as a lotion, drops, tincture, and other vehicles with a food compound, pepper medications are ideal for livestock, level of effectiveness truly generations ahead of currently pet, and companion animal use in addition to human. available prior art wart treatments. 1O Sytemic, as well as topical medications to control a variety Various types of warts including common warts, plantar of other viral disorders can be developed including feed warts, filiform warts, flat warts, genital warts, Seborrheic additives to prevent disease. warts and otherS may be completely healed in as few as a The veterinary market for treatment of warts can be Single topical treatment with this medication. This treatment greatly broadened given the high effectiveness, low toxicity, requires no follow up, no attending physician, and leaves no 15 and very low cost of my medication. Wart infections need no Scarring. Lower dose treatments produce cure in as few as longer afflict livestock, pets, companion or other animals as half a dozen applications of my medicine rather than many before. Scores of applications over a period of many weeks usually Prior art topical wart treatments have prevented the for required by prior art wart medications that often do not cure. mation of a market for the treatment of livestock Such as Currently available prior art over the counter topical wart cattle. The cost of medicine, its very slow action, coupled treatments containing Salicylic acid usually require twelve with the very considerable amount of labor required to weeks of daily multiple treatments. The time, and inconve repeatedly administer the medicine, can not be justified nience involved in making repeated applications with mea economically. For this reason, no significant market exists ger results add further to the misery and discomfort of the 25 within the industry for such products. disease. The weak therapeutic action of prior art over-the The current invention, however, enlarges the Scope of counter treatments is often insufficient to produce adequate product possibilities by making treatment of these disorders results. Often, the disorder must be treated Surgically by a economically feasible. physician with Scarring and failure to cure a common The many therapeutic properties, and beneficial compo OutCOme. nents found in pepper provide ideal prospects for treatment Physician administered wart treatments are the most of other related disorders including tumors, cancers, expensive, costing Several hundred dollars with usually neoplasms, and other papillomas Such as polyps, and Villous disappointing results. Nitrogen freezing, electrodesiccation, papillomas. These agents also provide application toward curretage, laser, and Stronger acid treatments do little more. treatment of herpes simplex disorders including genital than mutilate the Site of the wart, leaving a Scar in place of 35 herpes, and cold Sores. A Systemic treatment for the more the wart, and often damage Surrounding healthy Skin. In Serious, and often life threatening viral disorders combining Spite of these measures, the wart returns in about a third of high effectiveness with a reduction in toxic side effects that the cases, or new warts emerge around the Site of the old too often further endanger the health of the patient is also ones. In addition to being ineffective, these treatments are feasible with these agents. With the steadily rising number burdensome to healthcare costs and Services, and result in 40 of cancer, AIDS, and immunosuppressant drug treatment loSS of patient productivity and free time. cases reported now, and anticipated for the future, pepper With the current invention, physician administered treat compounds provide an important research tool in treatments ments for warts with the excessive cost, inconvenience, and directed toward these more Serious, life threatening condi poor result are in most cases a thing of the past. tions. Speedy resolution of warts with cancer causing poten Pepper extracts appear to possess multiple therapeutic 45 tial is itself an important cancer preventative through elimi actions in addition to direct antiviral/antimicrobial action. nation of the precancerous Stage, and spread of the wart Case observations Suggest general healing (Vulnerary), causing virus to other parts of the body, and to other keratolytic, immunostimulation and modulation, adjuvant, individuals. drug delivery, and prophylactic properties beyond direct Commercial implementation of this topical wart treatment antimicrobial. Though not tested to date for antiviral activity 50 alone can have major impact by making affordable a certain in vitro, antiviral, and other antimicrobial properties are cure to even the poorest people of both industrialized, and believed to exist. In vitro antifungal Screens prove propor developing countries now excluded from care because of the tionally increased potency against terminal drug resistant high cost, and low effectiveness of prior art treatments. A fungi Strains in addition to unparralled effectiveness in complete cure that does not require an attending physician, treatment of actual disease in afflicted patients. Reference is 55 and for less than one penny on the dollar for what is required made to U.S. Pat. No. 6,063,381 with regard to antifungal of prior art treatments will bring relief to many millions of uses, and related therapeutic properties and actions that are Sufferers, rich and poor alike while expanding the consumer believed to be applicable in treating papillomas, and these demand base for the product accordingly. HPV related disorders. Antifungal medications in general, Full-scale implementation of these medications will Save whether prior art or future art may also possess properties 60 billions of dollars in Gross National Product in the treatment useful in treating wart-like disorders as disclosed here. More of wart disorders in the U.S. alone, not to mention the world. Specifically: nyStatin, amphotericin B, griseofulvin, This enhanced level of Safety, effectiveness, and dramatic tolnaftate, and all the "azole' derivative antifungals cost Savings of this medication should Serve as a model to including, but not limited to clotimazole, miconazole, both private managed care programs including government econazole, ketoconazole, along with the “triazole' class 65 healthcare programs Such as Medicaid, and Medicare including, but not limited to Such derivatives as fluconazole, wherein billions of dollars in medical expenditures are Saved terconazole, and itraconazole ect. while providing the best care for recipients. US 6,593,371 B1 S 6 In conclusion, this novel wart treatment can Save our Among the Piperaceae family; Species of the Peperoma, nation and many nations of the World millions of dollars and Piper genus which include the retrofractum, nigrum, and each day in medical costs, and lost productivity. It provides longum Species. Other species of plants having similar highly lucrative new products for commercial exploitation in chemistry may also be used in place of the above. the areas of human and animal health. It provides an Variations in performance of each preparation will vary important research tool in the prevention, and treatment of with type, concentration of extract, carrier, and Solvent used cancers, and other viral disorders including life-threatening in relation to organism, host, and Site of infection. The varieties that could perhaps even Save lives of man and Scientific literature may be consulted for more detailed animal alike. It makes now available Speedy relief to hun investigations as to chemical properties, Solubility, dreds of millions of Suffers. Separation, and quantitation of constituent compounds. With reference to red pepperS for example, See procedures BRIEF DESCRIPTION OF THE DRAWINGS described in the article “Separation and Quantitation of Red FIG. 1 is a molecular diagram of phenol. Pepper Major Heat Principals by Reverse Phase High Pressure Liquid Chromatography” by Patrick Hoffman et. FIGS. 2-13 show molecular diagrams of compounds of 15 al., in the Journal of Agricultural Food Chemistry 1983, Vol. the current invention. 31, pages 1326-1330. The major capsaicinoids (FIG. 6) FIG. 2 is a molecular diagram of ortho-methoxyphenol. include: . C.H.,NO N-(4-hydroxy-3- FIG. 3 is a molecular diagram of vanillyl. methoxyphenyl)methyl8-methy-6-nonenamide). Dihydro FIG. 4 is a molecular diagram of 3-methoxy-4- capsaicin. CHNO (N-(4-hydroxy-3-methoxyphenyl) hydroxybenzylamine. methyl-8methylnonanamide). Norcapsaicin. C7H5NO FIG. 5 is a molecular diagram of vanillylamide. (N-(4-hydroxy-3-methoxyphenyl)methyl)7-methyl 5octenamide). . C7H7NO. (N-(4- FIG. 6 is a molecular diagram of the capsaicinoids. hydroxy-3-methoxyphenyl)methyl-7-methyloctanamide. FIG. 7 is a molecular diagram of piperidine. Homo capsaicin. CHNO (N-(4-hydroxy-3- FIG. 8 is a molecular diagram of the pungent alkaloid 25 methoxyphenyl)methyl-9-methyl-7decenamide). Homodi principals of pepper. hydro capsaicin. CoH NO N-(4-hydroxy-3- FIG. 9 is a molecular diagram of . methoxyphenyl)methyl)-9methyldecanamide). N-vanillyl n-nonamide. C7H7N (N-(4-hydroxy-3-methoxyphenyl) FIG. 10 is a molecular diagram of . methyl-n-nonamide). Nonanoic acid Vanillylamide. FIG. 11 is a molecular diagram of . C7H9NO Decanoic acid Vanillylamide. CHNO FIG. 12 is a molecular diagram of . Other capsaicinoids, identified in research literature as FIG. 13 is a molecular diagram of tinyatoxin. trace elements may be used in medicinal preparations along with other analogous compounds. BEST MODES FOR CARRYING OUT THE Capsaicinoids are acid amide derivatives of Phenol (FIG. INVENTION 35 1). The characteristic pungent, irritating Sensory effects of A medicinal preparation of pepper, and its active con these compounds are typical of acid amides, whether Stituents may be administered in a wide range of derived from phenol, or piperidine (FIG. 7). concentrations, and conventional drug vehicles and carriers. Phenol (FIG. 1), though lacking pungent flavor, is highly The preparations described below are made from an corrosive, caustic, and toxic, deriving many of its properties ordinary commercial grade of ground cayenne pepper 40 from its basic benzene structure. While this gives phenol (Capsicum frutescens), or (Piper nigrum) to certain antimicrobial properties, it is generally considered Serve as an indicator of approximate concentration within unsuitable for therapeutic use in man, and animals, due to each carrier. Their equivalents may also be prepared from it's and irritating effects on tissue. pepper oleoresin, which is available. commercially in a wide 45 With the addition of a methoxy group (OCH3) to phenol, range of concentrations, and pungencies. Components parts methoxyphenol is formed. In the ortho position, we have Such as the pungent principals are inclusive of pure natural, ortho-methoxyphenol (FIG. 2), also known as guaiacum, an Synthetics, and artificial form. extract obtainable from trees of the Guaiacum genus. The The term "pepper', or "pepper compounds are used effect of this methoxy group in part is an increase in Somewhat generically, and is inclusive of related botanicals 50 aromacy, and a decrease in toxicity, and caustic properties having Similar constituents. For example, the Zingiberaceae otherwise existing in phenol, yet without apparent decrease family including ginger (Zingiber officinale), in antimicrobial properties. The attachment of hydrocarbon (Curcuma longa), cardamon (Elettaria cardamomum), groups to the ring structure, to form higher analogues Melegueta pepper (Alframonum melegueta), members of the apparently increases the antimicrobial properties of Euphorbia genus including , poinSettia 55 methoxyphenol, and phenol. It is presumed that the meta, or (Euphorbia pulcherrima), (Eugenia aromatica), all para isomers of methoxyphenol have Similar properties to spice (Pimenta officinalis) and others such as . These the ortho, in like manner to the similarities between the also may be prepared in the same way as pepper by phenol isomers. following the general procedures outlined in the illustration The addition of the methylene group (CH2) in the para below. Higher concentrations may also be used, as many of 60 position to ortho-methoxyphenol produces vanillyl (FIG.3). these lack the pungency of actual pepper, and Sensory Like phenol, and methoxyphenol, it is presumed that chang irritation is less of a concern. ing the position of the methylene group to form other Included among this list of botanicals are the other Vanillyl isomers will produce compounds of Similar, members of the Solanaceae pepper family including mem although not exact properties to that of Vanillyl. bers of the Capsicum genus with the annuum, baccatum, and 65 The Vanillyl Structure on which the capsaicinoids are longum Species. These include hot pepperS and Sweet pep constructed is also typical of the pungent principals found in pers including paprika. ginger (Zingiberaceae) species of plants. US 6,593,371 B1 7 8 Collectively known as gingerol (FIG. 11): Shogaol, Hydrolysis of the piperidine Series, like the capsaicinoids, paradol, Zingerone, gingerol and other analogs, have a yield active, pungent compounds. Chavicine, for example is different Side chain than the capsaicinoids, and lacking an hydrolysed to piperidine, which receives an additional ammonia (NH) group, are neither amines, or amides like hydrogen (H) atom to form a primary amine, and chavicic the capsaicinoids or piperidine Series. Hydrolysis of gin acid, which receives the hydroxy (OH) group to form the gerols yield Vanillyl, and a fatty acid Side chain, both of fatty acid. which demonstrate like therapeutic properties to the capsai cinoid hydrolytes. Hydrolysis of these capsaicinoid, and piperidine acid Also members of the ginger, or Zingiberaceae family, amides, as well as the other listed compounds may be turmeric (Curcuma longa L.) contains the compound cur accomplished with chemical catalysts, or by boiling a liquid (FIG. 10), actually a vanillalderivative differing from preparation in water. Hydrolysis does not appear to diminish vanillyl by one hydrogen (H) atom having an (CH) pungency, and in Some applications appears to enhance both substituent, rather than a methylene (CH2) in the para pungency, and therapeutic action. position. This analog differs further with a side chain unique The carbonyl group (C=O) side chain substituent, com from the others. Cardamon, allspice, clove, black pepper, mon to all the above compounds (except eugenol) is also and many others contain eugenol, another Vanillyl analog 15 believed to be a contributor to therapeutic action. with yet another hydrocarbon Side chain. Other active agents found within capsicum include citric Other botanical Sources of Vanilly analogs include gum acid, Vitamins A, B1, B2, C, and E, iron, potassium and euphorbium, and extract of certain Species of the Euphorbia niacin in Significant quantities, along with other lipids, and genus, which contain the capsaicin analog resiniferatoxin (FIG. 12), along with its analog tinyatoxin (FIG. 13) and carotenoids including capSanthin, capSorubin, and others. others. Vitamin C concentrations of 100 milligrams per ounce, are Replacement of one of the hydrogen (H) atoms of ammo the highest of any natural food compound. Vitamin A nia (NH3), with vanillyl, and replacement of the other content is also high, with 6170 I.U. per ounce. hydrogen (H) atom with an organic hydrocarbon group An infusion of pepper is prepared by Soaking approxi produces vanillylamide (FIG. 5). In the case of the capsai 25 mately 4 cm (4 teaspoon) of commercially available cinoids (FIG. 6), or capsaicin analogs for example, this ground red, or black pepper, to one liter (1 quart) of water organic hydrocarbon group is a chain acid (R), varying from of Sensibly comfortable temperature. Set at least ten minutes about 8, to 14 carbon atoms, depending upon the particular before use for best results. Strain plant residue before use if capsaicinoid. These side chains, both Saturated, and unsat desired. urated add to the pungency of capsicums, and themselves A more potent tea uses about 16 cm (1 teaspoon) of possess antimicrobial properties of their own, without appar ground pepper for each liter (quart) of Sensibly comfortable ently contributing corrosiveness, or toxicity to Vanillyla water. Tea may also be prepared from boiling water, or itself mide. be boiled in water before use. Boiling pepper in water Hydrolysis of capsaicinoids yield active agents as well. assures complete hydrolysis of the pungent principals, The Splitting off of the Side acid chain, and its replacement 35 which are also active agents. A Stronger tea would use the with a hydrogen (H) atom yields the primary amine Same amount of Spice with less water, perhaps /4 the amount vanillylamine, or 3-methoxy-4-hydroxybenzylamine (FIG. above. 4) from vanillylamide (FIG. 5), in the case of all capsaici A tincture is prepared by Soaking ground red, or black noids. Conversely, the Side acid chain, receiving a hydroxy pepper in a Solution containing approximately 60% ethanol, (OH) group, is converted to a fatty acid, and yields a 40 and 40% water. Pure ethanol, acetone, chloroform, Vinegar different hydrolyte for each individual capsaicinoid. In the (acetic acid), and others may also be used. The fluid volume case of capsaicin (FIG. 6), hydrolysis of the Side acid chain of the solution may be about three, or four times that of the R" (FIG. 6) CO-(CH-)-CH=CH-(CH) yields iso dry Volume of the ground pepper. The mixture should be decylenic acid COOH-(CH) -CH=CH-CH-(CH). agitated, at least occasionally, over a period of at least two The piperidine series (FIGS. 7 & 8)), represent a group of 45 hours, with maximum extraction being obtained after about analogous alkaloid compounds from which most of the Six hours. Allowing the mixture to Sit over night produces pungent principals found within plants of the Piperaceae excellent results. Strain off the residual ground pepper. family, of which black pepper (Piper nigrum) is a member, A preparation of pepper drops is obtained by reducing are found. Also classified as acid amides, the piperidine tincture through heat, or passive evaporation. Drops made Series, like the capsaicinoids found in capsicum Species, are 50 by this method are similar in purity to Some grades of primarily responsible for the characteristic sharp, pungent commercially available oleoresin. DropS appear to concen of black pepper. trate by a factor of about 10 fold. The piperidine ring (FIG. 7) structure is diverse from that Aplaster, or poultice is prepared by mixing ground pepper of phenol (FIG. 1). Though also a six membered, carbocy with water, until it has a paste-like consistency that will clic compound, the piperidine Series instead contain one 55 assure good adherence to the Skin, or cloth to which it is nitrogen (N) hetero atom within the ring. Piperidine is applied. heteroparaffinic, and contains no double bonds. The hetero A lotion, a cream, or a shampoo may be obtained by nitrogen atom within the ring is a contributor to the pun adding to any commercially available, Shampoo, cream, or gency of these compounds. The attachment of a hydrogen lotion, a portion of drops, or tincture equal to approximately (H) atom to the hetero nitrogen atom within the ring forms 60 the amine Structure. Attachment of a hydrocarbon group, in 25% of the Volume of lotion, cream, or Shampoo carrier. the form of a side acid chain (R" FIG. 8) attached to a A douche is prepared from infusion, or tea that is Strained benzene Structure establishes the acid amide Structure. These of the plant residue material before use. compounds include; C7H9NO (FIG. 8), chavi A Suppository is made in cocoa butter, or gelatin in the cine C7H9NO, piperettine C 1903N, piperidine 65 Same Strength as douche, or lotion. (CH2)5H, piperyline, piperolein A, piperolein B, piperanine, An injection is prepared from a purified version of and others. infusion, tea, drops, etc., administered into tissue via US 6,593,371 B1 10 hypodermic, or in a fluid Stream into body cavities Such as The boy has a large, brownish colored plantar wart on the the vagina, on the cervix, uterus, rectum, mouth, and throat upper inside portion of the heel of his right foot. For more directly on infected areas. than two years, the wart has caused the boy mild, to extreme A powder is pepper in ground form, or extracts mixed, discomfort, particularly when walking. On numerous occa and/or bound within a binding powder carrier Such as talc. Sions over the course of this period, the wart has been treated A pepper impregnated fabric include clothing, and Shoe with Several over the counter, and physician prescribed liners made from capsicum wool, or any other pepper topical medications that yield no noticeable improvement in compound. For plantar warts, Socks, or shoes with liners the condition. The boy is accustomed to shaving the wart off impregnated with pepper may be worn. Also undergarments, at the Skin Surface at regular intervals to reduce the size, and and athletic wear, or anything that has contact with infected 1O hence the degree of discomfort associated with its rapid areas of the skin including bandages. growth. When the upper layers of the wart are removed in Treatment recommendations given below are general this manner, the remainder of the tumor appears as a cluster guidelines and may be altered to Suit Specific conditions. If of milky-white stones buried below the translucent layers of one recommended concentration appears unsuitable, the skin on the heel. Regardless of these continued treatments, next graduation should be used. the wart continues to grow back causing the usual discom Consideration as to area of infection, patient Sensitivity to 15 fort. the medication and certainly how anxious the patient is to be Prior to treatment with pepper drops, the wart is rid of the warts. Higher concentrations seem most effective. examined, and appears to occupy a brownish, rough area of In the lower concentrations, an infusion may be used the heal approximately 25 mm. (1") in diameter at the base. where Skin Sensitivity is high. Infusion works well as a Scalp The central portion is raised, forming a nodule approxi rinse, mouth rinse, a bath for the feet and skin, genital area, mately 6 mm. (4") above the skin surface. and as a douche, or injection. The wart is treated topically with one (1) drop of pepper In higher concentrations, administrations equivalent to a drops that were prepared from a Standard 4:1 red pepper tincture, a powder, a poultice, and a preparation of drops are acetone tincture that was reduced 40 times by room tem recommended where skin Sensitivity will permit. perature evaporation. Upon application, the boy reports no Still higher concentration drops for areas of low skin 25 notable Sensation from the treatment. Sensitivity appear most effective having produced cure of Eight weeks after this Single treatment, the boy's heel is plantar warts in less than one day after one Single treatment. again examined, and to the astonishment of the boy and his DropS appear also to have a prophylactic action of greatest mother the wart is completely disappeared Close examina duration lasting days after application. This appears also to tion of the entire foot shows no evidence of warts. The prevent new wart growths around the old, a common prob previously infected area of skin looks perfectly normal and lem with prior art treatments. Drops made from cayenne healed, with no trace of disease, or abnormality. pepper are extremely irritating to eyes, mucosa, and more When asked about details of the course of healing of the Sensitive skin Such as in the crotch area, So care should be wart, the boy replied that after treatment with the pepper taken. Drops made from leSS pungent botanicals should be drops, he had experienced no further discomfort in the area considered. Drops made from paprika for example, are much 35 of the wart. This lack of discomfort caused him to forget better tolerated, and can even be administered full Strength about the wart, and he had not looked at it since treatment. to these Sensitive areas without undue discomfort. It has been many months at this writing Since the boy's A tea represents a moderate concentration of pepper treatment. The wart has not returned, nor have new ones compounds. It may be used in the same manner as infusion. arisen. Tea may also be used in place of the higher concentration 40 In a Second illustration, a ten-year old girl afflicted with carriers, Such as drops or tincture. two plantar warts on the great toe is completely healed after An injection directly into the wart to maximize treatment less than ten treatments with a pepper extract. and minimize exposure to more Sensitive Surrounding tissue The girl has two Spotted, dark, brownish-colored plantar Such as in the genital area is recommended where possible. warts, approximately 5 mm (/s") in diameter on the upper, Alotion or Shampoo may be prepared with any commonly 45 and lower inside edge of the great toe of the right foot. Each available lotion, or shampoo, and applied to infected areas in waft is Surrounded with a raised callus. For the preceding its intended manner. Other therapeutic agents, in addition to few weeks, the wart has caused the girl increasing pepper extracts, may be added to shampoo and lotion. If discomfort, particularly when walking. The girl was irritation is a concern, a topical anesthetic, Such as lidocaine, received no prior treatment for the wart. or benzocaine may be added to lotion to reduce Severity. If Each wart is then brushed lightly with a cotton Swab skin is very dry, emollients may also be added to lotion. 50 dipped in pepper drops prepared from a Standard 4:1 red A pepper aerosol may be used in the treatment of the pepper acetone tincture that was reduced 40 times by room mouth, or throat. In this administration, care should be taken temperature evaporation. This procedure is repeated every as aeroSol is extremely irritating to the nose, throat, lungs, day or two over the course of Several, days. The girl reports and eyes, especially when airborne. This is especially true of no notable Sensation from treatment. capsicum aeroSol. 55 On the Second day just prior to a Second treatment, the Pepper powder is also very irritating when airborne, and warts are again examined. Each wart appears to have like aeroSol, has a more limited medical application than the reduced in Size, and taken on a darker, more distinctive other carriers. If used as a foot powder for example, it is best appearance. When asked about walking discomfort due to to fix the pepper compounds within a powder binder Such as the wart, the girl replied that she had not noticed any talc, to prevent, or lessen escape of airborn particulate. 60 discomfort Since the first treatment on the previous day. The unprecedented effectiveness of the current invention Prior to each Subsequent treatment, the girl is again asked is demonstrated in the treatment of three patients, all if she has noticed any discomfort due to the wart. On each infected with warts. occasion, she states she has felt no discomfort at all since In the first illustration, a 12 year old boy, afflicted with a before the first treatment. large plantar wart on the heel of his foot, in which the boy 65 On the morning of the eighteenth day from the first is completely healed after a single treatment with a pepper treatment, the girls toe is again examined. The wart on the eXtract. upper part of the toe has disappeared, leaving a cup shaped US 6,593,371 B1 11 12 indentation in its place. The remaining wart on the lower 4. The method of claim 1, wherein the papillomas include portion of the toe is then treated. Late in the afternoon, the polyps. toe is again examined only to reveal that the wart on the 5. The method of claim 1, wherein the papillomas include lower portion of the toe has likewise disappeared, leaving a WartS. Similar cup shaped indentation in its place as with the other 6. The method of claim 1, wherein the papillomas include wart. The girl's Sock is then inverted and Shaken, only to COmmon WartS. have the wart fall out on a table Surface. 7. The method of claim 1, wherein the papillomas include Subsequent examinations of the girl's toe over a period of plantar warts. days reveal a gradual reduction and eventual disappearance 8. The method of claim 1, wherein the papillomas include of the indentations, and calluses to where the Skin appears genital warts. perfectly healthy, with no evidence whatsoever of the prior 9. The method of claim 1, wherein said administration is wart or callus remaining. The girl is completely healed. After by injection. more than 30 months of observation, the girl has yet to have 10. The method of claim 1, wherein said agent is a the warts return, or new ones emerge anywhere on the body. capsaicinoid analog. In a third illustration, a seven-year old boy afflicted with 11. The method of claim 1, wherein Said agent has a a plantar wart on the great toe is completely healed in one 15 piperidine constituent. day, after one Single treatment with a pepper extract. 12. The method of claim 1, wherein said pepper is The boy has a spotted, dark brownish-colored plantar cayenne pepper. wart, approximately 5 mm (/s") in diameter on the lower 13. The method of claim 1, wherein said pepper is inside edge of the great toe of the left foot. The wart is paprika. Surrounded with a raised callus. For the preceding weeks, 14. The method of claim 1, wherein said pepper is the wart has caused the boy increasing discomfort, particu piperaceous. larly when walking. The boy was received no prior treatment 15. The method of claim 1, wherein said pepper is black for the wart. pepper. 16. The method of claim 1, wherein said equivalent is a A Single drop of pepper drops prepared from a Standard 25 Synthetic. 4:1 red pepper acetone tincture that was reduced 40 times by 17. The method of claim 1, wherein said concentration is room temperature evaporation was placed directly on the equivalent to oleoresin or greater. wart using an eyedropper. A Section of clear adhesive tape is 18. The method of claim 1, wherein said concentration is placed over the treated wart to avoid contact with the Socks, equivalent to a tincture or greater. and fingers. The boy reports no notable Sensation from 19. The method of claim 1, wherein said concentration is treatment. The boy puts his Socks and Shoes on, and leaves equivalent to a lotion or greater. for School that morning. 20. The method of claim 1, wherein said concentration is That afternoon after returning home from School, the equivalent is a lotion or less. boy's shoe and Sock are removed for inspection, only to find 21. The method of claim 2, further comprising villous a cup shaped indentation in place of where the wart had papillomas. been. The tape was also missing. When asked, the boy 35 22. The method of claim 2, wherein the papillomas explained that during afternoon recess, he had removed his include polyps. shoe, Sock, the tape, and lifted the wart out of the skin 23. The method of claim wherein the papillomas himself. When asked if the wart was hurting, the boy said no, include warts. that he removed the wart “because it was wiggley”. When 24. The method of claim wherein the papillomas asked if it hurt, or bled to remove the wart, the boy said “no, 40 include common warts. it didn't hurt or bleed; it came out real easy”. 25. The method of claim wherein the papillomas Subsequent examinations of the boy's toe over a period of include plantar warts. days reveal a gradual reduction and eventual disappearance 26. The method of claim wherein the papillomas of the indentation, and callus. The skin returns to a perfectly include genital warts. healthy condition, with no evidence whatsoever of the prior 45 27. The method of claim 2, wherein said administration is wart or callus remaining. The boy is completely healed. by injection. After more than 20 months of observation, the boy has yet 28. The method of claim 2, wherein said medication is to have the wart return, or new ones emerge anywhere on the amphotericin B. body. 29. The method of claim 2, wherein said medication has While my above description includes many be regarded as 50 an azole constituent. limitations as an exemplification of Specificities, these 30. The method of claim 2, wherein said medication has should not on the invention, but rather certain preferred a triazole constituent. embodiments. Accordingly, the Scope of the invention 31. The method of claim 1, further comprising animal should not be determined by these illustrated embodiments, papillomas. but by the appended claims, and their legal equivalents. 55 32. The method of claim 31, wherein said animal is I claim: livestock. 1. A method of treating papillomas comprising: 33. The method of claim 31, wherein said animal is a pet. 34. The method of claim 31, wherein said animal is a Administration to the papilloma a Suitable carrier con companion animal. taining a primary therapeutic agent obtainable from 35. The method of claim 2, further comprising animal pepper, or an equivalent in a therapeutically effective 60 papillomas. concentration. 36. The method of claim 35, wherein said animal is 2. A method of treating papillomas comprising: livestock. Administration to the papilloma a Suitable carrier con 37. The method of claim 35, wherein said animal is a pet. taining as a primary therapeutic agent an antifungal 38. The method of claim 35, wherein said animal is a medication in a therapeutically effective concentration. 65 companion animal. 3. The method of claim 1, further comprising villous papillomas.