Background Pesticides and insects repellents have long been sought for use against harmful or annoying parasites. Pests such as lice and fleas are irritating and painful to their human and animal hosts, and can also be vectors for other agents of disease. The pesticides and repellents available in the prior art, however, suffer from various deficiencies. Often, compositions provided as insect repellents are not insecticidal. Furthermore, many compositions are either toxic or generally unpleasant to the host.

Still others require too many separate active ingredients for efficient production and regulation.

Many synthetic prior art compositions have been proposed as insect repellents, but have later been determined to be unsuitable for safe use by humans. One common active ingredient in prior commercial compositions is N, N-Diethyl-m- toluamide (DEET). However, DEET has recently been associated with causing various undesirable side-effects, such as

stinging, damage to mucous membranes, and possibly seizures.

In 1989, the Centers for Disease Control issued a cautionary statement regarding the use of DEET. Many other prior art compounds proposed for use as a repellent have proven unsuitable for topical application to humans or other animals due to their toxic or noxious effect on the infested individual.

Various crude oil extracts of certain plants, such as citronella oil obtained from Cymbopogon citrata, or eucalyptus oil obtained from Eucalyptus citriodora, have been provided in the prior art as pest repellents. However, the oil complex itself is greasy and may have an unpleasant odor, which makes its use undesirable. Furthermore, consistent production of a safe and effective product is difficult, due to varying amounts of constituent compounds within batches of these complex oils and the difficulty of monitoring a large number of components.

Therefore, insect repellents containing the whole oil of citronella, for example, are undesirable due to their limited repellency, unpleasant odor and consistency, and unreliable composition of potentially harmful and unnecessary agents.

Most prior art insect treatments are taught to be effective only with specific synergistic combinations of multiple pesticides. In the art, there has not been recognized a simple but effective pediculicidal and ovicidal composition that is effective at low concentrations and which does not require a combination of excess multiple pesticidal ingredients.

What is needed in the art is an especially effective pediculicidal and ovicidal composition with fewer active components and with a lower concentration of pediculicidal and ovicidal compositions. The composition should also be able to cleanse an individual being treated for infestation.

Summary Of The Invention The present invention provides a pediculicidal and ovicidal composition containing low concentrations of the active ingredient which demonstrates an extraordinarily lethal

effectiveness against parasites, such as lice. The pediculicidal and ovicidal composition of the present invention is effective in cleansing an individual, human or animal, of a pest infestation.

The composition of the present invention contains a purified derivative of an organic oil. An example of an organic oil from which these compounds can be derived is citronella oil.

These purified derivatives can be both pediculicidal and ovicidal.

Examples of purified derivatives of citronella oil include citronellal, citronellol and citronellyl compounds. Purified nerol and geraniol can also be derived from citronella oil. The pediculicidal and ovicidal composition preferably contains a active agent such as citronellal, citronellol or citronellyl compound. The citronellal, citronellol or citronellyl compound is present in a concentration of less than 8% w/w. The pediculicidal and ovicidal composition more preferably comprises a citronellyl salt and an alcohol. The composition also preferably contains an acid and an aqueous detergent. The compositions can be administered topically to humans, animals or to any infested areas.

Another example of an organic oil from which a compound can be derived is teatree oil. Compounds such as terpinen-4-ol can be derived from teatree oil.

The present invention also includes a method of using the pediculicidal and ovicidal compositions. The method includes applying the composition to the infested area, allowing the composition to remain in contact with the infested area for a period of time, rinsing the composition from the area and, in the case of an infestation of hair such as a lice infestation, combing the infested area with a suitable nit comb.

The method also includes varying the period of time the composition is allowed to remain in contact with the infested area, called the residence time, so that lower concentrations of active ingredient can be used while pediculicidal and ovicidal effectiveness is maintained. For example, the residence time can be increased when a composition containing a lower

concentration of the active ingredient is used in the treatment method.

Therefore, it is an object of the present invention to provide a composition that is mortally effective against parasites, such as lice and their ova.

It is also an object of the present invention to provide an effective pediculicidal and ovicidal composition with lower concentrations of the active ingredient or ingredients that still exhibits pediculicidal and ovicidal activity.

Yet another object of the present invention is to provide a pediculicidal and ovicidal composition capable of cleansing an individual of a pest infestation.

It is further an object to provide a composition that may be used as a cleansing shampoo, soap, cream, lotion, gel or spray.

Another object of the present invention is to provide a method of using a pediculicidal and ovicidal composition to cleanse an individual of a pest infestation.

These and other objects of the invention will be apparent to those skilled in the art.

Brief Description of the Drawings Fig. 1 shows a linear regression of percent mortality against concentration of active ingredient.

Fig. 2 shows exposure time against percent activity.

Detailed Description Of The Invention A"pest"is meant to include all parasites, such as but not limited to arthropods, arachnids, triatomes, insects, bugs, flies, lice, fleas, mites, gnats, nits, chiggers, mosquitoes, and ticks, for example. The composition of the present invention is, therefore, intended to be used against all parasites which succumb to the lethal properties thereof.

The present invention provides pediculicidal and ovicidal compositions comprising purified derivatives of organic oils as

active ingredients. For example, purified derivatives of citronella oil can be used as active ingredients in pediculicidal and ovicidal compositions. Examples of derivatives purified from citronella oil include citronellal, citronellol and citronellyl compounds.

Other examples include nerol and geraniol.

The present invention provides a pediculicidal and ovicidal composition comprising an alcohol, an acid, an aqueous detergent and an active agent comprising citronellal, citronellol or citronellyl in a concentration of less than 8% w/w. Citronellal, citronellol and citronellyl are currently available in the trade as food and cosmetic additives. A pharmaceutical grade of citronellyl acetate may be available from Delmar Chemicals (Montreal, Canada). In preferred embodiments, the pesticidal agent utilized is citronellyl. In more preferred embodiments, the citronellyl compound is selected from the group consisting of citronellyl acetate, citronellyl butyrate, citronellyl formate, citronellyl isobutyrate, citronellyl phenylacetate, citronellyl proprionate and citronellyl valerate. In a more preferred embodiment, the citronellyl salt is acetate.

The invention preferably provides a pediculicidal and ovicidal composition wherein the pesticidal agent, for example citronellyl, is in a concentration of between about 0.01% and 8% w/w, more preferably between about 1% and 8% w/w, and most preferably between about 2.5% and 8% w/w.

Compositions are also provided which contain nerol or geraniol as their active agent. Varying percentages of these compounds can be used in compositions. These percentages can vary from 0.1 % w/w to 25 % w/w.

Other purified derivatives of organic oils which have a similar structure to those described, which have similar modes of action and which have pediculicidal and ovicidal activity in the compositions of the present invention may also be used.

The composition of the present invention also includes an alcohol. Preferably, the alcohol is a short chain alcohol, such as ethanol, propanol or isopropanol. The amount of alcohol in the

present invention can range from 1 to 40 % w/w. Preferably, the concentration is between about 10 and 30 % w/w, more preferably between about 15 and 25 % w/w, and most preferably about 20 % w/w. The alcohol is preferably isopropanol. It is believed that the presence of an alcohol in the composition increases the composition's pediculicidal and ovicidal effectiveness by permeabilizing the outer membrane of the parasite ova thereby allowing the pesticidal agent to penetrate the outer membrane of the ova. Functional substitutes that achieve the same result can be substituted for the alcohol without departing from the scope and spirit of the claims.

In some embodiments of the present invention, the composition also contains an acid in a concentration of between about 0.01 and 10 % w/w. More preferably, the invention contains between about 1 and 8 % w/w, and most preferably contains about 5 to 6 % w/w. The acid is an ionic or organic acid. Preferably, the acid is hydrochloric acid or acetic acid.

More preferably, the acid is glacial acetic acid. It is believed that the acetic acid makes the membranes more permeable as the chitinous bards may be weakened at low pH.

Some embodiments of the present invention also include an aqueous detergent. The aqueous detergent is capable of chelating debris or disrupting hydrophobic suspensions, for example, in order to assist in the removal of pests and their ova.

The concentration of the aqueous detergent within the present invention is preferably between about 7 and 21 % w/w and more preferably between about 14 and 18 % w/w. Many well known cleansing agents can be used. Preferably, the aqueous detergent is a surfactant, such as sodium laureth sulfate. Sodium laureth sulfate is available in commercial preparations such as Steol CS-230, which is available from Stepan (North Field, Illinois). Steol@ CS-230 is an aqueous preparation of sodium lauryl ether sulfate derived from fatty alcohols, ethoxylated to an average of two moles, and sulfated via a continuous S03 process. Steol@ CS-230 is about 25.5 % sodium laureth sulfate.

The concentration of Steol@ CS-230 within the present invention is preferably between about 30 and 80 % w/w and more preferably between about 55 and 70 % w/w.

The composition of the present invention may be suitably preserved. Any suitable preservative may be used so long as it does not interfere with the pest removing ability of the composition. For example, in one embodiment of the present invention, methylparaben and propylparaben are included in the composition as preservatives. Methylparaben and propylparaben are preferred parabens, but others can be substituted.

The composition of the present invention can contain other ingredients so long as the beneficial, pediculicidal and ovicidal nature of the invention is not adversely affected and so long as the effectiveness of the invention is not altered. For example, embodiments of the present invention can contain methylparaben and propylparaben which are antimicrobial agents. Additionally, embodiments of the present invention can contain viscosity modifiers such as sodium chloride or antipruritic agents such as camphor.

The composition of the present invention can be used in different forms, such as a liquid body soap or a shampoo. In other embodiments, the present invention takes the form of a gel, an emulsion, a lotion, an aerosol spray, a mousse, or a cream. Preferably, the composition of the present invention is in the form of a shampoo.

The invention also provides a method of treating an individual having a parasite infestation comprising administering to the infestation an insecticide composition as described above.

In particular, the composition of the present invention is effective as an insecticide intended for killing and removing lice from humans. Varied treatment regimens are contemplated as being within the method of treatment provided by this invention.

Treatment regimens can vary from a single administration to repeated administrations over long time periods. The various possible treatment regimens would be apparent to one skilled in

the art based on the invention disclosed herein and are intended to be encompassed in the scope and spirit of the claims.

This method includes applying the composition to the infested area, such as the hair of an individual with a lice infestation. In the case of hair, the composition is applied to the hair. The composition is left on the hair for a period of time referred to as the residence time. The residence time can vary as needed to produce effective results. The residence time can be as long as 12 hours and as short as one minute. Preferably, the residence time is between 5 and 60 minutes. More preferably, the residence time is between approximately 10 and 30 minutes.

At the end of the residence time, the composition is rinsed from the area of infestation. These treatment steps of applying and rinsing can be repeated one or more times to complete the removal of the pest infestation. The time period between uses of the pest removing composition can vary as needed to remove the pest infestation from the individual. The composition of the present invention is advantageous because it allows for frequent use, whereas the use of compositions containing high doses of pesticides can be limited by their high toxicity. This ability to use the composition of the present invention increases the its effectiveness in cleansing individuals of pest infestations.

Before or after application of the composition the hair may be combed with a suitable nit comb, however combing is not necessarily required. Any suitable nit comb can be used in the described method of use of the composition of the present invention. A suitable nit comb may be made of various materials such as metal and plastic. Metal teeth are sturdier and stiffer than those composed of materials such as plastic. Nit combs with metal teeth therefore often last longer than nit combs without metal teeth. The number of teeth and the diameters of the teeth can also vary. The spacing between teeth can also vary; however, the teeth should be close enough to one another to remove nits. The distance between teeth should be 0.3mm or less, the generally accepted width of nits attached to

human hair. Preferably, a nit comb such as the ALB006 is used, which is available from Albyn Stonehaven Ltd. (Stonehaven, Scotland). This comb has 62 metal pins arranged side by side which act as the teeth of the comb. These pins extend approximately 12.5mm from a plastic piece which acts as the handle of the nit comb. The pins on either end have a diameter of 0.9mm and the 60 inner teeth have a diameter of 0.6mm.

The gap between the teeth is 0.3mm.

In a preferred embodiment, the pediculicidal and ovicidal composition comprises 1 to 8% w/w citronellyl acetate. This embodiment of the present invention further comprises about 1 to 40% w/w isopropyl alcohol, 0.01 to 5% w/w methylparaben, 0.01 to 5% w/w propylparaben, 0.01 to 10% w/w acetic acid, 30 to 60% w/w detergent and water q. s. p. 100 g. The pediculicidal and ovicidal composition of the present invention more preferably comprises about 7.5% citronellyl acetate, about 20% w/w isopropyl alcohol, 0.2% w/w methylparaben, 0.1% w/w propylparaben, 5.0% w/w acetic acid, 55.5% w/w detergent and water q. s. p 100 %.

Embodiments of the pediculicidal and ovicidal composition of the present invention can further include a viscosity modifier, or an antipruritic agent, for example. In one preferred embodiment, the pediculicidal and ovicidal composition further comprises camphor as an antipruritic agent, sodium chloride as a viscosity modifier, methylparaben and/or propylparaben as an antimicrobial agent, acetic acid as a pH modifier and cleansing agent, and water. In a preferred embodiment, the pediculicidal and ovicidal composition further comprises about 0.01 to 5% w/w camphor and 1 to 10% w/w sodium chloride. The pediculicidal and ovicidal composition can comprise about 0.75% w/w camphor, 4.87% w/w sodium chloride, 0.2% w/w methylparaben, 0.1% w/w propylparaben, 5.7% w/w acetic acid, 35.14% w/w detergent and water q. s. p 100 %.

The pediculicidal and ovicidal composition of the present invention can further be embodied in a two component system.

In the two component system, two components are prepared and stored separately, and then mixed together at the point of use. The"Active Ingredient Component"comprises an alcohol, a pediculicidal and ovicidal agent, an antimicrobial agent and a detergent. The"Diluent Component"comprises a pH modifier and an antimicrobial agent. In a preferred embodiment, the "Active Ingredient Component"further comprises isopropanol as an alcohol, citronellyl acetate as an active ingredient, methylparaben as an antimicrobial agent, propylparaben as an antimicrobial agent and Steol CS-230 as a detergent and water, and the"Diluent Component"further comprises glacial acetic acid as a pH modifier and as a cleansing agent, methylparaben as an antimicrobial agent, propylparaben as an antimicrobial agent and water as a diluent. In a preferred embodiment, the"Active Ingredient Component"further comprises 8.5% w/w citronellyl acetate, 22.64% w/w isopropanol, 0.2% w/w methylparaben, 0.1% w/w propylparaben, and 62.8% w/w Steol CS-230, and the "Diluent Component"further comprises 42.86% w/w glacial acetic acid, 0.2% w/w methylparaben, 0.1% w/w propylparaben, and water q. s. In this preferred embodiment, the"Diluent Component"comprises about 11 2/3% of the combined final product. The combined final product in this most preferred embodiment comprises 7.5% w/w citronellyl acetate, 20% w/w isopropanol, 0.2% w/w methylparaben, 0.1% w/w propylparaben, 55.5% w/w Steol CS-230,5% w/w acetic acid and water q. s. Therefore, the"Active Ingredient Component" and the"Diluent Component"are combined in a ratio of about 7.5 to 1. One skilled in the art can routinely modify the relative concentrations of these components, and accordingly the ratio of their combination, to yield a functional pesticide composition.

To the inventors'knowledge, there has not previously been a recognition of the pediculicidal and ovicidal effectiveness of citronellyl at low concentrations as demonstrated herein. The

invention provides that citronellal and citronellol also possess a surprising degree of pediculicidal and ovicidal effectiveness at low concentrations. Therefore, the invention contemplates that either citronellal and citronellol may be substituted for citronellyl, or added to the pesticidal agent of the composition.

Additionally, to the inventors'knowledge, there has not been a previous recognition or demonstration of the effectiveness of the present invention at cleansing individuals of pest infestations.

Without being limited by theory, it is believed that the composition of the present invention is surprisingly effective due to the purification of individual compounds. Citronella oil is a complex mixture containing components which may ordinarily mask the potential effectiveness of the individual pesticidal agents citronellyl, citronellol, and citronellal, as disclosed by the present invention. It also appears that a synergistically beneficial effect is achieved in the compositions of the present invention. The presence of an alcohol in the compositions appears to aid the surprising pediculicidal and ovicidal effectiveness of the low concentration pesticide compositions described herein.

Furthermore, the presence of an acid and an aqueous detergent with the active pesticidal ingredient is believed to contribute to the surprising effectiveness of the present invention at killing pests and cleansing individuals of pest infestations.

The present invention is intended to be administered topically to infested areas of an individual, such as the hair and scalp or pubic areas. The composition is preferably provided in the form of a liquid or solid, such as shampoo, soap, cream, or lotion. The invention contemplates that various other complimentary ingredients can be included, such as an antipruritic agent, a pH modifier, or as a general medium. For example, glycerins, glycols, alcohols, lanolins, aloe vera gel, may be provided in the composition. The preferred compositions are shampoos and soaps containing ingredients capable of assisting in cleansing individuals of the debris of dead parasites.

The composition may also be provided in sun screening, tanning or any other topically applicable products. Other uses of the composition are contemplated, such as a pediculicidal and ovicidal spray or fogger for application directly to pests or potentially infested areas. For example, the composition can be provided as a pesticide and cleaning agent for fruits and vegetables. The composition can additionally serve as a repellent for cats, dogs, birds, cattle, or sheep, for example. The composition may also be used as a carpet powder, or as a detergent additive, rinse or spray for clothing, bedding or other fabrics. The composition may also be used as an aerosol bomb or as a room spray. Other such uses would be apparent to one skilled in the art upon contemplating the invention disclosed herein and such uses are intended to be encompassed in the scope and spirit of the claims.

EXAMPLES Example I Method of Testing the Pediculicidal Activity of a Composition "The Standard Test Method for Effectiveness of Liquid, Gel, or Cream Insecticides Against Adult Human Lice"was used to determine pediculicidal activity for various compositions of the invention. The test protocol has been published by the American Society for Testing and Materials under the designation E938-83 (reapproved 1988) and is hereby incorporated by reference.

Briefly, the test were conducted as follows. Twenty-five (25) adult lice were placed into a vial having a screen bottom. The vial was placed in a container of the composition to be tested which was maintained at a temperature of 32°C. A screened plunger was inserted into the top of the vial containing the lice to ensure that the lice did not float to the surface. The lice were thus submerged in the test composition for a set

exposure time. The lice containing vial was then dipped in distilled water maintained at a temperature of 32°C and gently agitated for one minute. The lice were then gently washed by a stream of 32°C distilled water. Excess water was removed by blotting with paper toweling.

The lice were then placed on a dark patch and incubated at 31.7°C and 60 % RH. At one and twenty-four hours after treatment, the lice were tested to determine if they would move towards a 37°C patch. Lice not dead, morbid or moribund will move towards the 37°C patch."Morbid"refers to a louse which is unable to move towards heat one hour after treatment; the louse is sickly, but not necessarily dying. A"morbid"louse may recover by twenty-four hours after the treatment."Moribund" refers to a louse unable to move towards heat twenty-four hours after treatment; the louse is dead or dying. Those lice that were dead or moribund at twenty-four hours were counted as mortalities.

Mortality percentages were corrected by Abbott's Formula. The percent of mortality in a control was subtracted from the percent mortality in the test and then divided by the percent mortality in the test.

Example II Method of Testing the Ovicidal Activity of a Composition The"Standard Test Method for Determining the Effectiveness of Liquid, Gel, Cream, or Shampoo Insecticides Against Human Louse OVA"was used to determine the ovicidal activity of various compositions of the invention. This protocol was published by the American Society for Testing and Materials as designation: E5117-93 and is hereby incorporated by reference.

Briefly, each test was conducted as follows. Thirty human louse eggs attached to human hair cuttings were used for each test condition. The human hair cuttings were affixed to a wood applicator stick and then immersed in the composition to be

tested for various exposure times. The test composition was maintained at 32°C. The eggs were then washed by vigorously moving the stick up and down in 32°C tap water for one minute.

A wash bottle was then used to further wash the eggs with 32°C tap water for an additional minute.

The eggs were then incubated until all eggs exposed to control conditions hatched (approximately 12 days). All eggs were then observed for hatching. Eggs that failed to hatch were recorded as mortalities.

Mortality percentages were corrected by Abbott's Formula. The percent of mortality in a control was subtracted from the percent mortality in the test and then divided by the percent mortality in the test.

Example III Production of a Two Component Pediculicidal and Ovicidal Compositions Each component of the composition was produced and stored separately. The two components were mixed just prior to use. The first component was an"Active Ingredient Component"and the second component was an"Diluent Component."The two component composition was prepared in the following manner.

The following ingredients were combined in approximate relative amounts to make the"Active Ingredient Component." Citronellyl Acetate0-9. 05% w/w Isopropanol 22.64 % w/w Methylparaben 0.2 % w/w Propylparaben 0.1 % w/w Steol CS-230 62.8 % w/w Purified Water. s.

The isopropanol and the methyl and propylparabens were mixed in a vessel until the parabens were completely dissolved.

The Steol CS-230 was then added and mixed until completely uniform. Then, citronellyl acetate was added and mixed until uniform. This step was skipped in the 0% formulation. Purified water was then used to dilute the mixture to its final weight and mixed until completely uniform.

The following ingredients were combined in approximate relative amounts to produce the"Diluent Component." Acetic Acid 42.86 % w/w Meth 1 araben 0.2 % w/w Propylparaben 0. 1 % w/w Purified Water. s.

A portion of the total purified water was added to a mixing vessel. Glacial acetic acid was added to the vessel and mixed until completely uniform. The methyl and propylparabens were then added to the mixing vessel and mixed until completely dissolved. The resulting solution was then diluted to the final target weight with purified water.

The two components were mixed together at the point of use in relative amounts such that the"Diluent Component" comprised approximately 11 2/3 % of the final combined product. The final product contained the following ingredients in the approximate relative amounts listed below. Citronellyl Acetate 0-8% w/w Isopropanol 20.0 % w/w Methylparaben 0.2 % w/w Propylparaben 0. 1 % w/w Steol CS-230 55.5 % w/w Acetic Acid 5.0 % w/w PurifiedWater. s.

The amount of citronellyl acetate contained in the"Active Ingredient Component"and consequently the concentration of citronellyl acetate in the final product varied between formulations. The final concentrations of citronellyl acetate in each of the formulations is shown below.

Formulation % Citronellyl Acetate A 0. 0 B 1. 0 C 2. 5 D 5. 0 E 10.0 F 12. 5 Formulations A-F were each tested for in vitro pediculicidal activity with a 10 minute exposure time in the test described in Example I. Formulation A and B showed only 2.1 and 4.3% pediculicidal activity, respectively, while formulations C, D, E and F demonstrated 40.7,100,100 and 100% pediculicidal activity, respectively.

Example IV Production of Pediculicidal and Ovicidal Compositions Additional formulations were made and tested for in vitro efficacy using a slightly amended method from that previously described in Example 1. The method was amended in the following ways. Ten (10) adult lice were placed on nylon gauze square (approximately 2"x 2"). The gauze, with lice, was soaked in a petri dish containing test or control product for 5 seconds. The gauze, with lice, was then removed and allowed to sit for the 10 minute residence time. After ten minutes, the gauze and lice were rinsed thoroughly with purified water.

Three replicates of lo lice each were run for each test product.

The following components were combined in approximate relative amounts to product the test products for pediculicidal assessment using the amended method: Citronellyl Acetate A 0.10 % (w/w) B 0.50 % (w/w) C 1. 00 % (w/w) D 1.75 % (w/w) E 2.50 % (w/w) F 5. 00 % (w/w) H 8.00 % (w/w) Isopropanol 20.0 % (w/w) Methylparaben 0. 2 % (w/w) Propylparaben 0.1 % (w/w) Glacial Acetic Acid 5.0 % (w/w) Steol CS-230 55.5 % (w/w) Purified Waterq. s.

Results of amended pediculicidal assessment: # Lice Corrected Treat Total # # Lice Moribu Mortality Mortality LiceKillednd%%mentStrength A 0.0 6071028. 321.6 B 0.1 59 3 1 8.2 1. 5 C 0. 5 6 2 7 2 14. 5 7.8 D 0.75 62 11 16 43.6 36. 9 E 1.0 61 6 1 11.5 4. 8 FF1.75 11.700 G 2.5 59 17 9 44. 1 37.4 H 5.0 60 30 12 70 63. 3 II8.0 1796.79041 Contre 1 0 60 3 1 6.7 0

The linear regression in Fig. 1 shows excellent fit indicating statistically significant activity and a linear relationship of strength and efficacy at citronellyl acetate concentrations of 2.5% and above. While the results of the concentrations at 1.75% and lower appear to be random, the 0.75% strength also indicates significant activity.

Statistical analysis was performed on the data using simple ANOVA single factor testing with alpha = 0.025. Each concentration was statistically tested against the control using the ANOVA test (ie: null hypothesis was that the mean activity of the test sample was equal to the control.) Therefore, those concentrations with resulting p-values less than alpha = (0.025) allow for rejection of the null hypothesis indicating statistically significant pediculicidal activity. Based on the analysis, formulations with 0.75%, 2.5,5.0, and 8.0% citronellyl acetate show statistically significant activity, thus formulations with 0.75% or higher concentrations of citronellyl acetate exhibit lethal activity. The p-values from the ANOVA testing are summarized below. % Citronellyl P-value from Acetate ANOVA 0.0 0.034415859 0.1 0. 960136389 0. 5 0. 05647516 0.75 0.020617983 1. 0 0. 360600685 1.75 0.101191507 2.5 0. 00427084 5.0 0.001261799 8. 0 1. 48511E-05

Example V Treatment of Lice Infestations with a Pediculicidal and Ovicidal Composition A clinical study was designed and performed to evaluate the efficacy and safety of treating human patients with infestations of human head lice with a two component pediculicidal and ovicidal composition. Twenty patients diagnosed with a head lice infestation were treated on Day 1 with the pediculicidal and ovicidal composition described in Example m containing a 7.5% concentration of citronellyl acetate. After wetting the hair, the pediculicidal and ovicidal composition was applied and allowed to sit for a residence time of 10 minutes before it was rinsed out.

When rinsing the pediculicidal and ovicidal composition from the hair following the residence time, the rinse water was strained to collect lice that were removed from the hair after treatment. The lice were placed in a petri dish, examine for viability, and incubated for 24 +/-2 hours under appropriate conditions.

Patients returned on Day 8 for clinical assessment and received a second treatment of the pediculicidal and ovicidal composition under the same procedures except nits were not collected. A final clinical assessment was completed 14 days later (about Day 22). Based on the final clinical assessment, each patient was classified with a final outcome. Each outcome was classified as cured, substantial improvement, re-infestation, or failure based on the number of lice and nits found in the patient's hair. The results are presented in the following table.

SUMMARY OF CLINICAL OUTCOME Outcome Number (% of total) Cured 7 (17.5%) Subst. Improvement 12 (30.0%) Total Cured/19 Subst. Improved (95%) Failure 1 (2.5%)

Secondary efficacy criteria included viability assessment of lice collected before and after treatment. The results of the viability assessment of the collected lice is shown in the table below. Total Dead Moribund Live % Activity | Lice Visit 1 450 450 0 0 100% Visit 2 203 203 0 0 100 % In conclusion, the pediculicidal and ovicidal composition with 7.5% citronellyl acetate effectively reduced or eliminated head lice infestations. Additionally, the composition was 100% pediculicidal, and the composition was well tolerated.

Example VI Treatment of Lice Infestations with Pediculicidal and Ovicidal Compositions Containing Increasing Concentrations of Citronellyl Acetate A double blind dose escalation study was performed to evaluate the efficacy and safety of the pediculicidal and ovicidal compositions described in Example IV in the eradication of Pediculus humanus capitus (human head lice) when treated by health care professionals.

During the study, pediculicidal and ovicidal compositions with citronellyl acetate concentrations of 2.5%, 5.0%, and 7.5% were tested. The study employed the procedure described in Example VI with the following changes: 1) The pediculicidal and ovicidal composition was applied to dry hair.

2) Combing was limited to a maximum of 20 minutes.

3) Patients did not return until Day 15 for clinical assessment and possible retreatment.

4) Final clinical assessment was completed 14 days after the last application of the pediculicidal and ovicidal composition.

As in Example VI, the primary efficacy outcome criterion was clinical outcome evaluated 14 days after the final application.

Outcome was classified as cured, re-infestation, or failure based on the number of lice and nits found in the hair. 2.5% 5. 0% 7.5% Cured 6/10 5/9 7/10 (60%) (56%) (70%) Failure 4/10 4/9 3/10 (40%) (44%) (30%) Reinfestation 0 0 0 TotalPatients 10 9 10 Secondary efficacy criteria included a viability assessment of lice collected before and after treatment. The viability of the lice collected was assessed 1 hour after collection and 24 hours after collection. After 1 hour, 74.4,78.7 and 86.1 % of the lice collected after treatment with the 2.5 %, 5.0 % and 7.5 % pediculicidal and ovicidal compositions, respectively, were dead.

After 24 hours, 99.1,99.6 and 100 % of the lice collected after

treatment with the 2.5 %, 5.0 % and 7.5 % pediculicidal and ovicidal compositions, respectively, were dead.

Each pediculicidal and ovicidal composition tested (2.5, 5.0 and 7.5 % citronellyl acetate) was effective in treating lice infestations and was well tolerated. Additionally, each pediculicidal and ovicidal composition showed a very high degree of pediculicidal activity.

Example VII Assessment of the Ovicidal Activity of Pest Treatment Compositions A study was conducted to determine the ovicidal activity of pest trreatment compositions containing increasing amounts of citronellyl acetate. The ovicidal test procedure detailed in Example II was used to evaluate the ovicidal activity of compositions containing varying concentrations of citronellyl acetate against nits collected from human subjects.

Compositions with citronellyl acetate concentrations of 2.5% and 7.5%, as well as pediculicidal and ovicidal compositions with citronellyl acetate concentrations of 7.5% and 12.5 % that were diluted 50/50 with tap water were prepared according to the method described in Example IV. Each composition was tested on nits collected from lice infested humans.

The pediculicidal and ovicidal composition with a citronellyl acetate concentraion of 2.5 % showed 97.3% ovicidal activity, while the 7.5% composition showed 100% ovicidal activity. The 7.5% and 12.5 % compositions diluted 50/50 with tap water demonstrated 99.9% and 99.4% ovicidal activity, respectively.

Example VIII Production of a Two Component Compositions Each component of the composition is produced and stored separately. The two components are mixed just prior to use. The first component is an"Active Ingredient Component"

and the second component is an"Diluent Component."The two component composition are prepared in the following manner.

The following ingredients are combined in approximate relative amounts to make the"Active Ingredient Component." Citronellyl Acetate 0.113-4.73% w/w Iso anol 22.64 % w/w Meth 1 araben 0.2 % w/w Propylparaben 0.1 % w/w Steol CS-230 62.8 % w/w Purified Water. s.

The isopropanol and the methylparabens and propylparabens are mixed in a vessel until the parabens are completely dissolved. The Steol CS-230 is then added and mixed until completely uniform. Then, citronellyl acetate is added and mixed until uniform. Purified water is then used to dilute the mixture to its final weight and mixed until completely uniform.

The following ingredients are combined in approximate relative amounts to produce the"Diluent Component." Acetic Acid 42.86 % w/w Methylparaben 0.2 % w/w Propylparaben 0.1 % w/w Purified Water s.

A portion of the total purified water is added to a mixing vessel. Glacial acetic acid is added to the vessel and mixed until completely uniform. The methylparabns and propylparabens are then added to the mixing vessel and mixed until completely dissolved. The resulting solution is then diluted to the final target weight with purified water.

The two components are mixed together at the point of use in relative amounts such that the"Diluent Component" comprised approximately 11 2/3 % of the final combined product. The final product contains the following ingredients in the approximate relative amounts listed below. Citronellyl Acetate 0.1-4.2% w/w Isopropanol 20.0 % w/w Meth 1 araben 0.2 % w/w Propylparaben 0.1 % w/w Steol CS-230 55.5 % w/w Acetic Acid 5.0 % w/w Purified Water q. s.

Example IX Production of a Two Component Compositions Containing Geraniol Each component of the composition is produced and stored separately. The two components are mixed just prior to use. The first component is an"Active Ingredient Component" and the second component is an"Diluent Component."The two component composition are prepared in the following manner.

The following ingredients are combined in approximate relative amounts to make the"Active Ingredient Component." Geraniol 8.44 % w/w Isopropanol 22.64 % w/w Methy1paraben 0.2 % w/w Propylparaben 0. 1 % w/w Steol CS-230 62.8 % w/w PurifiedWater. s.

The isopropanol and the methylparabens and propylparabens are mixed in a vessel until the parabens are completely dissolved. The Steol CS-230 is then added and mixed until completely uniform. Then, geraniol is added and mixed until uniform. Purified water is then used to dilute the mixture to its final weight and mixed until completely uniform.

The following ingredients are combined in approximate relative amounts to produce the"Diluent Component." Acetic Acid 42.86 % w/w Methy1paraben 0.2 % w/w Propylparaben 0. 1 % w/w Purified Water q. s.

A portion of the total purified water is added to a mixing vessel. Glacial acetic acid is added to the vessel and mixed until completely uniform. The methylparabns and propylparabens are then added to the mixing vessel and mixed until completely dissolved. The resulting solution is then diluted to the final target weight with purified water.

The two components are mixed together at the point of use in relative amounts such that the"Diluent Component" comprised approximately 11 2/3 % of the final combined product. The final product contains the following ingredients in the approximate relative amounts listed below. Geraniol 7.5 % w/w Isopropanol 20.0 % w/w Meth 1 araben 0.2 % w/w Propylparaben 0. 1 % w/w Steol CS-230 55. 5 % w/w Acetic Acid 5.0 % w/w Purified Water. s.

The composition is then tested for in vitro pediculicidal activity with a 10 minute exposure time in the test described in Example I.

Example X Production of a Two Component Compositions Containing Nerol Each component of the composition is produced and stored separately. The two components are mixed just prior to use. The first component is an"Active Ingredient Component" and the second component is an"Diluent Component."The two component composition are prepared in the following manner.

The following ingredients are combined in approximate relative amounts to make the"Active Ingredient Component." Nerol 8.44 % w/w Isopropanol 22.64 % w/w Methylparaben 0.2 % w/w Propylparaben 0. 1 % w/w Steol CS-230 62.8 % w/w Purified Water. s.

The isopropanol and the methylparabens and propylparabens are mixed in a vessel until the parabens are completely dissolved. The Steol CS-230 is then added and mixed until completely uniform. Then, nerol is added and mixed

until uniform. Purified water is then used to dilute the mixture to its final weight and mixed until completely uniform.

The following ingredients are combined in approximate relative amounts to produce the"Diluent Component." Acetic Acid 42.86 % w/w Meth 1 araben 0.2 % w/w Pro 1 araben 0. 1 % w/w Purified Water. s.

A portion of the total purified water is added to a mixing vessel. Glacial acetic acid is added to the vessel and mixed until completely uniform. The methylparabns and propylparabens are then added to the mixing vessel and mixed until completely dissolved. The resulting solution is then diluted to the final target weight with purified water.

The two components are mixed together at the point of use in relative amounts such that the"Diluent Component" comprised approximately 11 2/3 % of the final combined product. The final product contains the following ingredients in the approximate relative amounts listed below. Nerol 7.5 % w/w Isopropanol 20.0 % w/w Meth 1 araben 0.2 % w/w Propylparaben 0. 1 % w/w Steol CS-230 55.5 % w/w Acetic Acid 5.0 % w/w Purified Water. s.

The composition is then tested for in vitro pediculicidal activity with a 10 minute exposure time in the test described in Example I.

Example XI Production of a Two Component Compositions Containing Terpinen-4-ol Each component of the composition is produced and stored separately. The two components are mixed just prior to use. The first component is an"Active Ingredient Component" and the second component is an"Diluent Component."The two component composition are prepared in the following manner.

The following ingredients are combined in approximate relative amounts to make the"Active Ingredient Component." Terpinen-4-ol 8.44 % w/w Isopropanol 22. 64 % w/w Methylparaben 0. 2 % w/w Propylparaben 0.1 % w/w Steol CS-230 62.8 % w/w Purified Water. s.

The isopropanol and the methylparabens and propylparabens are mixed in a vessel until the parabens are completely dissolved. The Steol CS-230 is then added and mixed until completely uniform. Then, terpinen-4-ol is added and mixed until uniform. Purified water is then used to dilute the mixture to its final weight and mixed until completely uniform.

The following ingredients are combined in approximate relative amounts to produce the"Diluent Component."

A portion of the total purified water is added to a mixing vessel. Glacial acetic acid is added to the vessel and mixed until completely uniform. The methylparabns and propylparabens are then added to the mixing vessel and mixed until completely dissolved. The resulting solution is then diluted to the final target weight with purified water.

The two components are mixed together at the point of use in relative amounts such that the"Diluent Component" comprised approximately 11 2/3 % of the final combined product. The final product contains the following ingredients in the approximate relative amounts listed below. Terpinen-4-ol 7. 5 % w/w Isopropanol 20. 0 % w/w Methylparaben 0. 2 % w/w Propylparaben 0.1 % w/w Steol CS-230 55. 5 % w/w Acetic Acid 5.0 % w/w Purified Water. s.

The composition is then tested for in vitro pediculicidal activity with a 10 minute exposure time in the test described in Example I.

Example XII Pediculicidal Activity with Increasing Residence Times Compositions containing 0.1,0.75,1.75 and 2.5 % w/w citronellyl acetate are prepared according to Example VIII.

These compositions are then tested for pediculicidal activity according to the method set forth in Example I, except that the amount of time the composition is left in contact with the test lice, the residence time, is varied. Each concentration is tested for pediculicidal activity with a residence time of 20 minutes and 30 minutes.

The results of the exposure time testing are summarized in Fig. 2. Graphical representation of the data clearly shows that increasing the exposure time from 10 minutes to 30 minutes has little significant effect on the in vitro pediculicidal activity of the compositions. However, it did increase the 1.75% effectiveness considerably (from 1.7% to 50.8% and 21.7%) which collaborates the findings of the dose escalation study which showed that citronellyl acetate concentrations above 0.75% possess statistically significant activity. Exposure Time Effect on Pediculicidal Activity Exposure Treatment Total # Lice Lice Mortality % Time Lice Killed Moribund 10 min. _ 0.1 % 59 3 1 8.2 1.75 % 60 0 1 1.7 2.5 % 59 17 9 44.1 0.75% 62 11 16 43.6 Control 60 3 1 6.7 20min. _ 0.1 % 60 6 18 40 1.75 61 13 18 50.8 2.5 % 61 4 10 20.3 0.75% 63 7 4 17.5 Control 60 1 0 1.7 30min. _ 0.1 % 67 6 9 22.4 1.75 60 3 10 21.7 2.5 % 66 7 10 18.2 0. 75% 62 5 6 17. 7 ontrol 60 1 0 1.7

The Examples above are intended to be demonstrative, but not exhaustive, of the embodiments contemplated by the present invention. It is intended that other deviations apparent to those skilled in the art from the invention described above are encompassed in the scope and spirit of the claims.