NZ510657A - Knoxlice - a natural head lice remedy comprising a vegetable oil and a wax - Google Patents

Abstract

A composition containing an effective amount of agents with pediculicidal properties comprising at least one wax compound selected from the group consisting of beeswax, paraffin, carnauba and combinations thereof and at least one vegetable oil such as, canola or olive oil or a combination thereof, is disclosed. The composition is made from a mixture of the components in a ratio of approximately 100:1 w/v wax to oil. A method of applying a pediculicide composition to the hair or skin for the control of adults and nits of the species of the order Anoplura is also disclosed. The waxy/sticky composition is to be washed out after it has been applied to the affected site and left for 4 to 12 hours or more.

Description

New Zealand Paient Spedficaiion for Paient Number 510657 510657 PATENTS FORMl*©^ ;Patents Act 1953 q ;No5IOfcS,l(a! C0^Cr^J ;INTELLECTUAL PROPERTY ;OFFICE OF N.Z. ;1 8 MAR 2002 RECEIVED ;ntellectual Property Office of New Zealand ;It Pou Rilwi Hanga Hou ;Date: ;h) Pro\i^i(j°)c^ ;COMPLETE SPECIFICATION ;(b) te. .7....CK.. .c\ct^cA... \\Zod\\ct. ...rz<ro.e.chj ;r... U\ iC.C... .T ;I (or WE), (c)...yJo.hn... ...Vv)^£.t....ClT)C( C{<?iC<%.. sj&D&f Wfsf. ;.d^. .. . .n.... k?.Q.i^T) ;.. Ale^vO... .2L£.a.Ko*rsd .Q^.Tc .2J?A5 hereby declare the invention, for which I (or we) pray that a patent may be granted to me (or us), and the method by which it is to be performed, to be particularly described in and by the following statement (d) .T.. ... cnlfe.

POST-DATED UNDER SECT. 12(3) .TO. (a) Where priority as provided by subsection (2) or subsection (3) of section 11 of the Patents Act 1953 is desired in respect of one or more provisional specifications, quote number or numbers and date or dates (b) Insert title of invention (c) State (in full) name, address, and nationality of applicant or applicants as in application form (d) Here begin full description of invention. The continuation of the specification should be upon paper of the same size as this form, on one side only, with the lines well spaced and with a margin of 2.5 cm on the left hand part of the paper.

The completion of the description should be followed by the words "What I (or we) claim is" after which should be written the claim or claims numbered consecutively. (See note below.) The specification and the duplicate thereof must be signed at the end NOTE.-The claims must relate to a single invention, must be clear and succinct, and must be fairly based on the matter disclosed in the specification. They should form in brief a clear statement of that which constitutes the invention. Applicants should be careful that their claims include neither more nor less than they desire to protect by their patent. Any unnecessary multiplicity of claims or prolixity of language should be This invention is a natural headlice remedy.

The objective of the invention is to provide a safer and more effective remedy than is currently available for the eradication of headlice and which also minimises headlice resistance.

Many parents and caregivers like ourselves have felt great frustration with the cost and ultimate ineffectiveness of most commercial preparations. Also, the cumulative effect of applying pesticides to children's scalps is a major concern.

Other manufacturers have started producing natural remedies generally working on the basis of differing combinations of essential aromatic oils. The cost of these is similar to pesticide preparations and effectiveness unsubstantiated, as tested by Consumer in May We then set out to make a safe, effective and inexpensive remedy to combat the problem. We decided on using beeswax as our base when, with experimentation, we discovered that headlice became stuck to the scalp after we thinned the beeswax sufficiently with vegetable oil so that a tacky consistency was obtained. Our product works on two levels. Firstly through immobilising which, at the very least, severely impedes movement, thus interferring with feeding and reproduction. Also the headlice are easy to remove when they cannot move quickly. Secondly, our product coats the chitinous exoskeleton of the headlice blocking the "breathing pores".

We package the cream in a 100 gm size pot which is enough for one complete treatment of three applications.

The cream is applied to well brushed hair, parted to expose the scalp and the cream is worked in progressively over the head with subsequent partings. We then recommend combing hair to ensure all the scalp is covered, and the cream is left in overnight. The hair should be thoroughly shampooed the next day. To complete the treatment (and beat any cycle of hatching eggs and maturing females) the application should be repeated in 1 week and 2 weeks' time.

What we claim is that Stixlice is a tacky cream which is a simple, safe, cheap and effective treatment in the eradication of headlice. 2001.

INTELLECTUAL OFFICE Of 1 8 MAR 2002 RECEIVED 510 6 57 PATENTS FORM NO. 5 Fee No. 4: $250.00 PATENTS ACT 1953 COMPLETE SPECIFICATION After Provisional No: 510657 Dated: 14 September 2002 LICE REMEDY We, John West and Claire West, both New Zealand citizens of 197 Tainui Street, Greymouth, New Zealand, hereby declare the invention for which we pray that a patent may be granted to us, and the method by which it is to be performed to be particularly described in and by the following statement: Intellectual Property Office Of NZ 1 James & Wells Ref: 42481/29 12 DEC 2003 received LICE REMEDY TECHNICAL FIELD The invention relates to a composition and method for treating lice infection. More specifically the invention relates to a composition and method for treatment of hair 5 lice infection in the scalp.

BACKGROUND ART Lice are a problem, particularly for parents, where children, through natural contact with others, become infected with the insects.

There are numerous stories of purported treatments such as tedious hair washing 10 sessions, and products that do not work - sometimes after weeks of treatment -and the frustration of finding that a re-infestation has occurred and the problem has started again.

Lice are small, flat insects about 2 to 3 mm long that breed all year long. They live in hair, feed on the skin or scalp and lay eggs on the hair shaft in the case of head 15 lice.

There is much anecdotal evidence that lice have become or can become resistant to chemical insecticide treatments.

As a result there has been interest in developing alternative treatment methods, as chemical treatments are less successful and tend to be subject to consumer fears 20 that arise in relation to the possible side-effects of insecticides.

Current alternative products are largely based on herbal extracts such as herbal and essential oil treatments. By way of example, use of essential oils as active ingredients for the treatment of lice is described in W00064265 and US6342253. 2 James & Wells Ref: 42481/29 However, according to the New Zealand Consumer Magazine May 2001 issue, there is little evidence that treatments based on tea tree oil and other essential oils actually reduce head lice infection.

The Consumer article also describes that oils make lice easier to dislodge. Some 5 unusual treatment products include rubbing olive oil, hair gel and/or mayonnaise, conditioners, into infected hair. Like the Consumer magazine article, the website www.headlice.com also describes the use of olive oil in treating lice.

According to an internet site1, hair conditioner may be used and will stun the lice but this action only lasts for a period of 20 minutes before the lice again become 10 active, and may not be effective in removing all active lice at that time.

The use of oils in conjunction with lice treatments are also described in JP01038004 (a chemical treatment), and RU2134100 (a soap).

JP01038004 and RU2134100 refer only to the use of vegetable oil, and in the case of RU2134100, also palm oil, as carrier substances for other active ingredients 15 used in the composition. The effects that the oils themselves may have on treating lice infection is not described.

The use of wax in lice treatments is described in patents JP01038004, EP0392806, CN1078644, W09518598, and W00072814. The inclusion of wax in the formulations described in the documents above is as a suitable carrier substance, 20 usually in the form of paraffin. The use of wax itself to assist in treating lice is not described.

Two further documents describe the use of bees wax, (JP01038004 and W09830124), however, inclusion of bees wax appears to be only as a carrier 1 www.icu.edu.au/school/phtm/PHTM/hlice/hldetkit.htm 3 James & Wells Ref: 42481/29 substance for other active ingredients and not as the active ingredient in a treatment composition.

A further problem of both chemical and herbal remedies is the cost. The treatments are generally expensive, and seldom cure the problem after a single 5 use or after following the recommended treatment regime. Often lice infestations re-establish and as a result additional treatments are required.

It is therefore an object of the present invention to address the foregoing problems or at least to provide the public with a useful choice.

All references, including any patents or patent applications cited in this 10 specification are hereby incorporated by reference. No admission is made that any reference constitutes prior art. The discussion of the references states what their authors assert, and the applicants reserve the right to challenge the accuracy and pertinency of the cited documents. It will be clearly understood that, although a number of prior art publications are referred to herein, this reference does not 15 constitute an admission that any of these documents form part of the common general knowledge in the art, in New Zealand or in any other country.

It is acknowledged that the term 'comprise' may, under varying jurisdictions, be attributed with either an exclusive or an inclusive meaning. For the purpose of this specification, and unless otherwise noted, the term 'comprise' shall have an 20 inclusive meaning - i.e. that it will be taken to mean an inclusion of not only the listed components it directly references, but also other non-specified components or elements. This rationale will also be used when the term 'comprised' or 'comprising' is used in relation to one or more steps in a method or process.

Further aspects and advantages of the present invention will become apparent 25 from the ensuing description which is given by way of example only. 4 James & Wells Ref: 42481/29 DISCLOSURE OF INVENTION For the purposes of this specification, the term 'sticky' or 'stickiness' is used to mean that the compound or compounds are tacky to touch on their own or when mixed and can adhere at least in part to surfaces including lice, lice body parts and lice eggs.

Also, for the purposes of this specification, the term 'oily' is used to refer to a compound or compounds that are viscous and/or have surface tension which is substantially equivalent to vegetable oils at room temperature.

According to one aspect of the present invention there is provided a composition for treatment of hair lice that includes a combination of: at least one sticky compound; and at least one oily compound; characterised in that the composition when applied to lice infected hair and skin, controls and/or reduces lice infection.

Through frustration with existing remedies for hair lice, the applicants have found that by applying a composition that includes compounds which are sticky and oily at room temperature, a treatment has unexpectedly been found that appears to control or reduce head lice infection.

It is the applicants understanding that the combination: (i) immobilises lice or at least impedes movement therefore interfering with feeding and reproduction via the sticky compound or compounds, and; (ii) the oily compound or compounds smother the lice by coating the chitinous exoskeleton of the lice and blocking the lice 'breathing pores'.

James & Wells Ref: 42481/29 In the applicants experience the particular combination is remarkably successful in addressing hair lice infection and has numerous advantages over existing remedies such as its lower cost due to the natural raw material used which obviate the need for expensive chemical treatments.

In preferred embodiments the resulting composition is a viscous cream at room temperature.

Preferably treatment by the composition significantly controls and/or reduces the level of lice infection by controlling and/or reducing active lice in the hair and on the skin.

Preferably, the sticky compound or compounds used in the invention are selected from waxes that are substantially solid at room temperature. More preferably, waxes may be selected from: beeswax, paraffin, carnauba, and combinations thereof. However, this list should not be seen as limiting as other waxes having similar properties may also be utilised in the present invention. Most preferably, the 15 wax used is beeswax.

Preferably, the oily compound or compounds used in the invention are selected from oils that are substantially liquid at room temperature. More preferably, oils may be selected from the group of vegetable oils. More preferably still, the oil may be selected from either canola oil, olive oil, or a combination thereof. However this 20 list should not be seen as limiting as other oils having similar properties may also be utilised in the present invention.

Note that oils known to cause allergic reactions such as peanut oils are preferably not used although this should not be seen as limiting.

In preferred embodiments the composition includes a mixture of approximately 50 25 to 200 grams of wax and 0.5 to 2.0 litres of oil. More preferably, the composition 6 James & Wells Ref: 42481/29 includes a mixture of approximately 100g of wax and 1 litre of oil to make up approximately 21 pots containing 100 grams of composition. It will be appreciated by a person skilled in the art that larger or smaller portions may be manufactured by maintaining the approximate ratio of components described but increasing or 5 decreasing the amount of wax and oil mixed. A further reason to vary the range is increase or decrease the stickiness of the mixture e.g. to take into account the ambient temperature of the climate in which the composition is to be used.

In alternative embodiments, further physiologically and/or pharmaceutical^ acceptable compounds may also be added to the composition in order to obtain 10 additional properties of such compounds. For example only, the composition may in some embodiments also include aromatic oils, stabilisers and surfactants.

According to another aspect of the present invention there is provided a composition for treatment of lice including a combination of: at least one wax compound; and, at least one vegetable oil compound; characterised in that the composition when applied to lice infected hair and skin, reduces the degree of lice infection.

Preferably, the lice treated are hair lice.

Preferably, the infection is in head hair and the scalp but this should not be seen 20 as limiting as it will be appreciated by those skilled in the art that the method of the present invention can be used for any infection site.

According to another aspect of the present invention there is provided a method of reducing lice infection by: 7 James & Wells Ref: 42481/29 (a) applying a composition substantially as described above onto the infected site; (b) leaving the composition in the infected site for a period of time, and; (c) washing out the composition.

The preferred infection site is in hair and skin. Most preferably, the infection site is head hair and the scalp.

Preferably, before application of the composition, the hair is well brushed or combed and is free of knots.

In preferred embodiments, the composition is applied by: (i) parting the infected hair with a comb to reveal the infected skin; (ii) applying the composition onto the skin where the hair is parted; (iii) repeating steps (i) and (ii) on new partings until the entire infected area is covered.

Preferably, the method of application is by hand, usually with a fingertip.

Preferably, hair is further combed after step (iii) to ensure full coverage by the composition. In preferred embodiments a nit comb is used. Combing may also remove lice that have been stunned and/or are less mobile.

Preferably the composition is left on the infected hair and skin for a time period of 4 to 12 hours or more. Most preferably, the time period is from 8 to 10 hours. In 20 practice, the composition is left in the hair and skin overnight - although in some cases it may be necessary to leave the composition on the skin and hair for more than a day depending on the extent of the infestation. 8 James & Wells Ref: 42481/29 Preferably, the composition is then washed out of the hair using standard shampoo or in an alternative embodiment, dishwashing detergent may be used.

In preferred embodiments, steps (a) to (c) are repeated again. Most preferably, two further repeats are completed. A second repeat of steps (a) to (c) is 5 completed approximately 1 week after the first treatment and a third repeat approximately 2 weeks after the first treatment. It is the applicants' experience that by repeating the treatment, hatched lice eggs and maturing female lice are controlled and/or reduced and the life cycle of the lice stopped altogether.

Preferably during each cycle of steps (a) to (c), approximately 25 to 40 grams of 10 composition is used. More preferably, a total of approximately 100 grams is used for a three repeat course.

According to another aspect of the present invention there is provided the use of a composition containing at least one sticky compound and at least one oily compound substantially as described above in the manufacture of a composition 15 for the treatment of hair lice in a subject.

Preferably, the sticky compound may be beeswax and the oily compound may be vegetable oil.

It will be appreciated from the above discussion that there is provided a composition that provides a non-chemical and inexpensive method to treat lice 20 infection. Further, the composition is simple to produce and unexpectedly has a strong efficacy in controlling and/or reducing lice infection.

BEST MODES FOR CARRYING OUT THE INVENTION The composition of the invention will now be described in terms of its manufacture, method of use and results found. For ease of reading, the examples given relate 25 to use of beeswax and either canola oil or olive oil. This should not be seen as 9 James & Wells Ref: 42481/29 limiting as other waxes and/or oils may be used in the present invention without departing from the key functions of the compounds i.e. stickiness and oiliness.

Manufacture In a preferred embodiment, the composition is made into a viscous cream by: 1. Melting approximately 100 grams of beeswax; 2. Mixing into the molten wax approximately 1 litre of either canola oil or olive oil; 3. Stirring the resulting mixture well to ensure full mixing; 4. Allowing the resulting mixture to cool either by cooling at room temperature or 10 by other cooling methods for example, inserting the mixture into a cold environment such as a cooler room.

The mixture can either be added to storage containers before it solidifies or after step 4.

Use The cream produced above is applied by: 1. Parting the infected hair with a comb to reveal the infected skin, typically the scalp; 2. Applying the cream onto the scalp where the hair is parted; 3. Creating another parting and repeating steps 1 and 2 on the new parting; James & Wells Ref: 42481/29 4. Continuing the process by parting the hair around the scalp and rubbing in the cream until the entire scalp is covered; and, . Combing the hair using a nit comb to ensure that the hair and scalp are completely covered by the cream.

The cream is then left in the hair overnight and then thoroughly washed out using either shampoo or dishwashing liquid.

The process of application is then repeated two further times at approximately one week intervals.

Findings In trials completed by the applicant on lice infected scalps, the cream described above has unexpectedly been effective in controlling and/or reducing hair lice infection. This is even the case in subjects who have tried a variety of standard treatment methods that have not been successful.

The trials have shown that the initial application controls and/or reduces most active lice. However, with further treatments, the growth cycle is disrupted as newly developed lice from eggs are controlled in subsequent treatments before they can establish a new breeding cycle.

Aspects of the present invention have been described by way of example only and 20 it should be appreciated that modifications and additions may be made thereto without departing from the scope thereof as defined in the appended claims. 11 James & Wells Ref: 42481/29

Claims (37)

WHAT WE CLAIM IS:

1. A composition for treatment of hair lice including a combination of: at least one wax compound; and at least one vegetable oil compound; characterised in that the composition when applied to lice infected hair and skin, controls and/or reduces lice infection.

2. A composition as claimed in claim 1 wherein the wax compound or compounds are sticky.

3. A composition as claimed in claim 1 or claim 2 wherein the vegetable oil compound or compounds are liquid at room temperature.

4. A composition as claimed in any one of the above claims wherein the composition is a viscous cream at room temperature.

5. A composition as claimed in any one of the above claims wherein treatment by the composition reduces the level of hair lice infection by controlling and/or reducing active hair lice in the hair and on the skin.

6. A composition as claimed in any one of the above claims wherein the wax compound or compounds used in the invention are selected from waxes that are substantially solid at room temperature.

7. A composition as claimed in any one of the above claims wherein the wax compound or compounds may include: beeswax, paraffin, carnauba, and combinations thereof. 12 James & Wells Ref: 42481/29

8. A composition as claimed in any one of the above claims wherein the vegetable oil compound or compounds used in the invention may include oils that are substantially oily in consistency at room temperature.

9. A composition as claimed in any one of the above claims wherein the vegetable oils are selected from either canola oil, olive oil, or a combination thereof.

10. A composition as claimed in any one of the above claims wherein the composition includes a mixture of approximately 50 to 200 grams of wax and 0.5 to 2.0 litres of oil.

11. A composition as claimed in any one of the above claims wherein the composition includes a mixture of approximately 100 grams of wax and 1 litre of oil.

12. A composition as claimed in any one of the above claims wherein the approximate ratio of components is 100 :1 w/v wax to oil

13. A composition as claimed in any one of the above claims wherein further physiologically and/or pharmaceutical^ acceptable compounds are added.

14. A method of reducing hair lice infection by: (a) applying a composition as claimed in any one of claims 1 to 13 onto the infected site hair; (b) leaving the composition in the infected site for a period of time, and; (c) washing out the composition.

15. A method as claimed in claim 14 where the site is infected hair and skin. 13 James & Wells Ref: 42481/29

16. A method as claimed in claim 15 wherein, before application of the composition, the hair is well brushed or combed and is free of knots.

17. A method as claimed in claim 15 or claim 16 wherein the composition is applied in step (a) by: (i) parting the infected hair with a comb to reveal the infected skin; (ii) applying the composition onto the skin where the hair is parted; (iii) repeating steps (I) and (ii) on new partings until the entire infected area is covered.

18. A method as claimed in claim 17 wherein the composition is applied in step (ii) by hand.

19. A method as claimed in any one of claims 15 to 18 wherein hair is further combed after step (iii) to ensure full coverage by the composition.

20. A method as claimed in any one of claims 17 to 19 wherein the comb is a nit comb.

21. A method as claimed in any one of claims 14 to 20 wherein the composition is left on the infected site for a time period of 4 to 12 hours or more.

22. A method as claimed in any one of claims 14 to 21 wherein the composition is washed out of the site using shampoo.

23. A method as claimed in any one of claims 14 to 21 wherein the composition is washed out of the site using dishwashing detergent.

24. A method as claimed in any one of claims 14 to 23 wherein steps (a) to (c) are repeated. 14 James & Wells Ref: 42481/29

25. A method as claimed in claim 24 wherein two further repeats of treatment are completed.

26. A method as claimed in claim 24 or claim 25 wherein the second repeat is completed one week after the first treatment and a third repeat is completed two weeks after the first treatment.

27. A method as claimed in any one of claims 14 to 26 wherein during step (a) approximately 25 to 40 grams of composition is used.

28. A method as claimed in any one of claims 14 to 26 wherein a total of approximately 100 grams is used for an initial course of treatment plus two repeats duration.

29. The use of a composition containing at least one sticky compound and at least one oily compound as claimed in any one of claims 1 to 13 in the manufacture of a composition for the treatment of hair lice in a subject.

30. A composition for treatment of hair lice that includes a combination of: at least one sticky compound and, at least one oily compound; characterised in that the composition when applied to a lice infected area, controls and/or reduces lice infection.

31. A composition as claimed in claim 30 wherein the sticky compounds are sticky at room temperature.

32. A composition as claimed in claim 30 or claim 31 wherein the oily compounds are liquid at room temperature. InteHectual Property Office of NZ 2 4 FEB 2004 is James & Wells Ref: 42481 / 29

33. A composition as claimed in any one of claims 30 to 32 wherein the sticky compounds are waxes.

34. A composition as claimed in any one of claims 30 or claim 32 wherein the oily compounds are types of vegetable oil.

35. A composition substantially as hereinbefore described in the accompanying description and examples.

36. A method substantially as hereinbefore described in the accompanying description and examples.

37. The use of a composition substantially as hereinbefore described in the accompanying description and examples. John and Claire West by their authorised agents JAMES & WELLS \ 2 DEC 2003 16 James & Wells Ref: 42481/29