WO1999018800A1 - Procedes et kits pour l'elimination, le traitement ou la prevention de l'infestation par les poux de tete - Google Patents

Procedes et kits pour l'elimination, le traitement ou la prevention de l'infestation par les poux de tete Download PDF

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Publication number
WO1999018800A1
WO1999018800A1 PCT/US1998/021305 US9821305W WO9918800A1 WO 1999018800 A1 WO1999018800 A1 WO 1999018800A1 US 9821305 W US9821305 W US 9821305W WO 9918800 A1 WO9918800 A1 WO 9918800A1
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WO
WIPO (PCT)
Prior art keywords
lice
agent
pediculostatic
nits
area
Prior art date
Application number
PCT/US1998/021305
Other languages
English (en)
Inventor
Dale L. Pearlman
Dara B. Pearlman
Original Assignee
Pearlman Dale L
Pearlman Dara B
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Pearlman Dale L, Pearlman Dara B filed Critical Pearlman Dale L
Priority to EP98953343A priority Critical patent/EP1032270A1/fr
Priority to AU10742/99A priority patent/AU1074299A/en
Publication of WO1999018800A1 publication Critical patent/WO1999018800A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N61/00—Biocides, pest repellants or attractants, or plant growth regulators containing substances of unknown or undetermined composition, e.g. substances characterised only by the mode of action
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N25/00—Biocides, pest repellants or attractants, or plant growth regulators, characterised by their forms, or by their non-active ingredients or by their methods of application, e.g. seed treatment or sequential application; Substances for reducing the noxious effect of the active ingredients to organisms other than pests
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A61K8/342—Alcohols having more than seven atoms in an unbroken chain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/46—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing sulfur
    • A61K8/463—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing sulfur containing sulfuric acid derivatives, e.g. sodium lauryl sulfate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q17/00—Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings
    • A61Q17/02—Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings containing insect repellants

Definitions

  • the present invention relates to methods and kits for the treatment, removal or prevention of pedicular parasite infestations. More particularly, the methods and kits relate to the use of agents which rapidly immobilize _ n head lice to facilitate their removal from the hair and scalp.
  • Pediculosis is a scalp infection which is produced by Pediculus humanus capi tis . Cases of pediculosis are quite frequent both in their endemic and epidemic forms. As the lice feed on human skin and blood, they inject their digestive juices and fecal material into the skin. These materials, as well as the puncture wound itself, _ n cause skin irritation and lesions from the resulting scratching, and can cause a serious infection with ganglionic inflammation. Lice are also vectors of certain disease states such as exanthematic or epidemic thyphus and recurrent fever. The adult female louse has a life span of about one month and lays up to ten nits a day which are firmly attached to hair through an excreted cement . The nits hatch to release instars in about seven to nine days, and the instars become mature adults in another week. To cure someone of head lice requires a solution which eliminates all 3 stages of the louse life cycle.
  • pediculicides are pharmaceutical agents that kill lice.
  • a significant disadvantage of using these agents is that lice can become resistant .
  • the need for further treatment increases the exposure to these harsh agents and increases the cost.
  • many of these compounds have unpleasant odors or other undesirable properties, causing noncompliance with the treatment by the patient, leading to re-infestation of the individual, and spreading of the infestation to others.
  • the harshness of these agents make them unsuitable for use as prophylactics.
  • Patent No. 4,927,813 teaches compositions containing formic acid which facilitate removal of nits from the hair; however, formic acid is a known caustic agent .
  • one object of the present invention is to provide methods and kits for the treatment or removal of lice infestations using agents which are effective even against lice resistant to other treatments.
  • Another object of the invention is to provide methods and kits for the treatment or removal of lice infestations which are rapid, convenient, inexpensive, and cosmetically attractive.
  • Still another object is to provide methods and kits which can eradicate nits as well as adults and instars. Yet another object is to provide methods which can be repeated as needed as a prophylactic for persons at risk of initial lice infection or re-infection.
  • an effective amount of a pediculostatic agent is applied to a lice-infested area of an animal subject, preferably a human subject, for a time sufficient to trigger an immersion reflex in the lice, and removing the lice and/or nits, preferably while the pediculostatic agent remains on the infested area.
  • the agent is preferably applied to the dry hair of the lice-infested area, typically in an amount sufficient to completely soak or saturate the hair and skin.
  • a pediculostatic agent is one that elicits the "immersion reflex" in lice whereby they become immobilized due to strategics to avoid suffocation.
  • the lice remain immobilized while in contact with the pediculostatic agent.
  • the pediculostatic agent induces the immersion reflex within about 2 hours, preferably within about 5 minutes and most preferably within about 6 seconds.
  • the lice are removed using a fine-toothed delousing comb.
  • both the lice and nits are removed using the delousing comb.
  • the lice-infested area is pre-treated with the pediculostatic agent prior to treatment and removal.
  • a pediculostatic agent is applied to the dry hair of a lice-infested area of an animal subject, preferably a human subject, for a period approximately 4-12 hours, or even longer. During this time, a substantial number of the lice may suffocate and die.
  • the pediculostatic agent can be applied overnight, being kept on the hair with the aid of a shower cap or other non- absorbent covering.
  • an additional amount of the pediculostatic agent is applied to the lice-infested area for a period of time sufficient to trigger the immersion reflex in the lice, and the lice and/or nits are removed, preferably by combing with a fine-toothed delousing comb while the pediculostatic agent remains on the infected area.
  • Pediculostatic agents useful in the kits and methods of the present invention are water-soluble compounds or compositions, or aqueous-based compositions, that are capable of triggering an immersion reflex in lice.
  • the compositions can be any of a variety of forms common in the pharmaceutical arts for topical application to animals, including solutions, lotions, sprays, creams, ointments, salves, gels, etc.
  • Preferred pediculostatic agents are those that are viscous enough to remain on the - treated area, those that do not readily evaporate and/or those that are easily removed by rinsing with water, optionally with the aid of soaps, Cleansers and/or shampoos .
  • the pediculostatic agent is a surfactant or an aqueous-based composition comprising a surfactant.
  • suitable surfactants include anionic agents, cationic agents, amphoteric agents, zwitterionic agents, nonionic agents and mixtures thereof.
  • Non-limiting examples of such agents include sodium lauryl sulfate, sorbitan tristearate, sorbitan monostearate, sorbitan monopalmitate, and butylene glycol distearate.
  • a preferred aqueous-based surfactant pediculostatic agent is l-30wt% sodium lauryl sulfate.
  • the pediculostatic agent is a polar organic compound or an aqueous-based composition comprising a polar organic compound.
  • suitable polar organic compounds which are typically liquids infused heat, include (Ci-C 3o ) alkanols (e.g., ethanol, propanol, isopropanol, etc.), (C ⁇ Cz . ) alkylene glycols (e.g., ethylene glycol, propylene glycol, etc.), polyalkylene glycols, polyalkylene oxides other polyols (e.g., glycerol) and mixture thereof.
  • Preferred aqueous-based pediculostatic agents according to this aspect of the invention are l-50wt% ethanol, 1- 80wt% propylene glycol and l-70wt% isopropyl alcohol.
  • the pediculostatic agent is a commonly available substances such as honey, vinegar, mustard, gelatin, yogurt, skin Cleansers, skin conditioners, hair conditioners, shampoos, personal lubricating jelly, sunscreen, mouthwash or toothpaste, or an aqueous-based composition comprising one or more of these substances.
  • the pediculostatic agent is an aqueous-based composition comprising a surfactant and an alkanol .
  • a particularly preferred alkanol-surfactant pediculostatic agent according to this aspect of the invention is the alkanol- surfactant formulation sold under the tradename CETAPHIL ® Cleanser (Gallderma Laboratories, Inc., Fortworth, TX) .
  • CETAPHIL ® Cleanser Gallderma Laboratories, Inc., Fortworth, TX
  • a conventional pediculocidal active ingredient can be incorporated into the pediculostatic formulations described herein.
  • the pediculocidal active ingredients can be used at levels effective to achieve their intended result, typically from about 0.25% to about 2.5%.
  • pediculocidal agents include natural or other pyrethrins (with or without piperonyl butoxide) , permethrin, lindane, malathion, carbaryl, ivermectin and combinations thereof.
  • a pediculostatic agent can be applied first, followed by application of a pediculicidal composition to the infested area, or vice versa. If the pediculocidal agent is applied first, the hair of the infested area is preferably dried prior to application of the pediculostatic agent.
  • the pediculostatic agent is optionally combined with a dye for temporarily marking the treated area in order to verify that the agent has been applied.
  • the dye is preferably a fluorescent dye or other detectable agent capable of binding to the chitoness nits.
  • the invention provides diagnostic methods for monitoring the severity of a lice infestation or determining whether the infestation is due to an original infection or re-infection.
  • a pediculostatic agent is applied to the dry hair and skin of an area of the body having or suspected of having a lice infestation, as previously described. While the pediculostatic agent remains in the - hair, the hair is combed with a fine-tooth comb, preferably a delousing comb, and the pediculostatic agent
  • the methods can also be used to diagnose lice infestations prior to development of symptoms, and/or to determine whether a lice infestation is the result of an initial infestation, where only adult lice
  • the invention provides a kit for the treatment or removal of lice and/or nits.
  • the kit comprises an amount of a pediculostatic agent sufficient
  • the kit can contain individual components that when mixed together, with or without the addition of water, provide an amount of a pediculostatic agent sufficient for at 5 least one application.
  • the kit can optionally contain additional components, such as shower caps or other non- absorbent coverings, pediculostatic agents, dyes that can be mixed with the pediculostatic agents, etc.
  • the prior art teaches that the only effective topical agents to treat and cure head lice are pediculocides. If lice are temporarily inactivated and later recover from exposure, the agent is considered 35 ineffective by those skilled in the art. There is no mention of either the concept or examples of treatments using water-soluble agents which merely stun or immobilize the lice; in fact, the prior art teaches away from using such agents.
  • a pediculostatic agent that is one that triggers the immersion reflex, can be used in novel methods for the treatment or removal of lice and/or nits which overcome the disadvantages of the prior art methods.
  • the immersion reflex is a self preservation behavior which lice have developed to protect themselves against drowning when they are immersed in water.
  • Lice are obligate air breathers and cannot derive oxygen when underwater. This reflex allows them to greatly increase the amount of time they can survive without access to air. During submersion, breathing air through the spiracles and tracheoles is blocked by water. As the lice become anoxic, they rapidly switch into a state of profound suspended animation in order to decrease their need for oxygen, thus prolonging their survival. They become completely immobile, unresponsive to stimuli, and even cease gut motility. If the reflex continues too long, however, then eventually the lice run completely out of oxygen and die from anoxia.
  • the methods and kits of the invention take advantage of the immersion reflex to provide regimens for lice removal and treatment that are safe, effective, and non- toxic. Since the methods and kits do not require application of a pediculocidal agent for success, they are highly unlikely to engender resistance in the lice.
  • the methods and kits are non-toxic, they provide safe prophylactic treatment for the entire at- risk group, thereby providing effective means of eradicating lice outbreaks and re-infestations.
  • the method of treating or removing lice and/or nits according to the present invention comprises applying a pediculostatic agent to a lice-infested area of the body, typically the scalp, for a time sufficient to trigger the immersion reflex in the lice by oxygen deprivation. Before the pediculostatic agent is removed, the hair and scalp are combed using a fine-toothed comb, for example a delousing comb as described in U.S. Patent No. 5,131,418, to remove the lice and/or nits from the host.
  • a fine-toothed comb for example a delousing comb as described in U.S. Patent No. 5,131,418, to remove the lice and/or nits from the host.
  • the frequency of treatment or application is once every 2 days to once every 30 days.
  • a preferred schedule is 3 times in 2 weeks.
  • the treatment can be repeated at intervals as necessary to completely remove the lice and/or nits.
  • the treatment can also be used as needed as a prophylactic measure to prevent initial infestation or repeated as needed for persons at risk of re-infection. Because the pediculostatic agents of the invention are non-toxic and do not engender resistance, the treatment methods described herein can be repeated indefinitely, if necessary.
  • the pediculostatic agent be applied full strength, i.e., in substantially undiluted form. This can be accomplished by applying the agent to the dry hair of the infested area, preferably in an amount sufficient to completely soak or saturate the area and/or hair, and massaging the agent in. As those of skill will appreciate, hair can experience varying degrees of wetness, from dripping wet to completely dry. As used herein, the expression "dry hair” is intended to encompass not only hair that is completely dry, but also hair that is moist or damp, and hair that is substantially dry such as is obtained by towel-drying the hair following shampooing.
  • the critical aspect of the invention is that the hair be sufficiently dry such that the pediculostatic agent is not substantially diluted when applied to the hair.
  • Hair of the appropriate level of dryness can be obtained by squeezing, toweling or otherwise drying wet hair until water ceases dripping from the hair.
  • the pediculostatic agent is applied to towel dry hair, more preferably to completely dry hair.
  • the hair should be wrung out or towel dried, preferably completely dried, prior to application.
  • the time interval between application of the pediculostatic agent and combing to remove the lice and/or nits will depend upon the Immersion Reflex Index of the particular pediculostatic agent, which is defined as the time, in minutes, within which the immersion reflex is triggered in a louse upon being contacted with the agent.
  • combing can be commenced after a period of time equal to the Immersion Reflex Index of the particular pediculostatic agent used.
  • longer intervals between application and combing can be used, and in some cases are even preferred.
  • the pediculostatic agent remains in the hair for a period of time equal to about 5 to 30 times the Immersion Reflex Index of the particular pediculostatic agent being used prior to combing.
  • a louse remains immobilized by a pediculostatic agent, the longer it takes the louse to revive after the pediculostatic agent has been rinsed away or otherwise removed.
  • the pediculostatic agent is applied for a sufficiently long duration, i.e., on the order of 10 to 5000 times the Immersion Reflex Index of the agent, the agent can be removed prior to removal of the lice and/or nits by combing, provided the removal can be effected while the lice are still substantially stunned or immobilized. If lice are covered by a pediculostatic agent according to the invention for a sufficiently long duration, they suffocate and die.
  • Lice may be killed by prior, concurrent or post application of one or more commercially available pediculocidal agents, as will be discussed more thoroughly below, or by pre-treatment with a pediculostatic agent according to the invention for a time period sufficient to suffocate and kill some or all of the lice.
  • the pediculostatic agents of the invention are first used as pre-treatments, preferably for durations sufficient to kill some of the lice, followed by re-application for lice and/or nit removal.
  • a pediculostatic agent according to the invention is applied to a lice-infested area of the body, typically by applying to the dry hair of the infected area an amount of the agent sufficient to completely soak or saturate the infested area and/or hair. The agent is then allowed to remain on the area for a period sufficient to kill some of the lice.
  • the actual amount of time the pediculostatic agent must remain on the infested area will depend in part on the Immersion Reflex Index of the particular agent used; however, typically times on the order of 2000 to 10,000 times the Immersion Reflex Index are sufficient.
  • the pediculostatic agent of the invention it has been found that a duration of at least about 4 hours, preferably 9 to 12 hours, is sufficient.
  • the pediculostatic agent can be applied at bedtime, and the application site covered with, for example a shower cap, or other non-absorbant covering during sleep. Following this pre-treatment, a small amount of pediculostatic agent is re-applied to the infested area and massaged in. The agent is left on the area for a duration sufficient to trigger the immersion reflex in lice, and the lice and/or nits are then removed by combing as previously described.
  • the same or different pediculostatic agent may be used for the pre-treatment and treatment .
  • the pediculostatic agent may be removed, for example by rinsing and/or shampooing, with or without combing prior to removal. If the pediculostatic agent from the pre- treatment step is removed according to this alternative embodiment, the hair surrounding the infested area should be dried prior to re-application, and an amount sufficient to soak or saturate the area should be re- applied. However, re-application without first removing the pre-treatment is preferred.
  • Pediculostatic agents useful in the methods and kits of the present invention are characterized by their ability to induce an immersion reflex in lice, as determined by the following in vi tro Immersion Reflex
  • the pediculostatic agents of the present invention typically have an Immersion Reflex Index of no more than
  • the pediculostatic agents of the present invention comprise all water-soluble pharmaceutically acceptable compositions suitable for topical application to the hair, body and scalp of animals and humans and which induce an immersion reflex effect in lice.
  • the pediculostatic agent is a liquid or is incorporated into a liquid or semisolid composition which is flowable or spreadable over the scalp. These compositions are convenient in use, and are an effective medium for coating the lice and scalp.
  • water-soluble and/or aqueous-based formulations suitable for use in the present invention, including but not limited to, solutions, lotions, sprays, creams, ointments, emollients, salves, and gels.
  • Descriptions of non- 5 limiting examples of suitable formulations may be found in the PHYSICIAN'S DESK REFERENCE, Medical Economics Co., Pub., Oradell, N.J. and in THE NATIONAL FORMULARY, American Pharmaceutical Association, Pub., Washington, DC, each of which is incorporated herein by reference in its entirety.
  • the pediculostatic agent is preferably transparent or translucent in order to facilitate observation of the area being treated, and is preferably easily removed, such as by rinsing with water, or is readily washed out using a shampoo.
  • the pediculostatic agent used in the present invention is a liquid or semisolid that presents a barrier that prevents the transfer of oxygen to the lice.
  • pediculostatic agents of the invention are water-soluble or aqueous-based, water by itself is not a preferred pediculostatic agent. Bathing or swimming in water may cause a few lice to be dislodged, but others will likely remain attached. In either case, lice are unlikely to succumb to suffocation or drowning because of the immersion reflex, unless their host also perishes. Lice breathe air, but not in the same manner as do vertebrates. Water may not enter through the spiracles or fill the tracheoles of lice due to its high surface tension.
  • the pediculostatic agent of the present invention is a surfactant or an aqueous- based composition containing one or more surfactants.
  • suitable classes of surfactants include wetting agents, surface tension depressants, detergents, dispersing agents, emulsifiers, and quaternary ammonium antiseptics.
  • Non-limiting examples of suitable surfactants include anionic agents, cationic agents, amphoteric agents, zwitterionic agents, and nonionic agents.
  • the literature contains numerous examples of compositions containing surfactant systems which are suitable for use in the present invention. Examples are found in U.S. Patent Nos. 5,288,483; 4,495,079; 5,034,218; 5,656,280; 5,284,833; 5,562,912; and 5,480,633, each of which is incorporated herein in its entirety by reference.
  • a preferred anionic surfactant for use in the present invention is sodium lauryl sulfate, which can conveniently be used in an aqueous solution at a concentration from 1 to 30% by weight.
  • Non-limiting examples of nonionic surfactants include fatty alcohols such a lauryl alcohol, cetyl alcohol and stearyl alcohol, glyceryl esters such as mono, di and tri glycerides, fatty acid esters of fatty alcohols and other alcohols such as propylene glycol, polyethylene glycol, sorbitan, and sucrose.
  • Propylene glycol can be conveniently used in an aqueous solution at a concentration from 1 to 80% by weight. A preferred concentration is 10 to 50% propylene glycol.
  • suitable surfactants are Span 65
  • Span 40 (sorbitan monopalmitate) , sodium bis- (2- ethylhexyl) sulfosuccinate, butylene glycol distearate, and Tween 80 (polysorbate 80) .
  • An antifoaming agent can be optionally included in the composition, an example of which is silicone fluid.
  • All polar, water-soluble solvents which are pharmaceutically acceptable for topical application are included as pediculostatic agents of the present invention.
  • These solvents can be used neat or in the form of aqueous-based compositions containing the solvent.
  • Non-limiting examples of these solvents include (C 1 -C 20 ) alcohols such as ethanol which can be used in aqueous dilutions of from 1 % to 50% by weight, or isopropyl alcohol, which can be used in aqueous dilutions of from 1 % to 70% by weight.
  • Examples of polyhydroxylated solvents suitable as pediculostatic agents include propylene glycol, ethylene glycol, and glycerin.
  • the pediculostatic agents of the present invention can be used singly or in combination, and can optionally include other components such as thickeners, penetration enhancers, conditioners, osmotic adjusters, acids, bases, buffering agents, skin protectants, stabilizers, antioxidants, coloring agents, preservatives, and fragrances .
  • Thickeners can be included in the pediculostatic agents of the invention for decreasing the tendency of the composition to flow away from the treated area.
  • Non-limiting examples of thickeners include cetyl alcohol, stearyl alcohol, petrolatum, glyceryl monooleate, myristyl alcohol and isopropyl palmitate.
  • Other hydrophillic thickeners include polysaccharide gums, an example of which is xanthan gum.
  • Non-limiting examples of preservatives include methyl paraben, propylparaben, and butylparaben .
  • a non-limiting example of an acid is citric acid.
  • Non-limiting examples of coloring agents include FD&C Green No. 8, FD&C Green No.
  • D&C Violet No. 2 D&C Red No. 3.
  • Commercially available products such as soaps, Cleansers, lotions, moisturizers, conditioners and shampoos that are non-toxic and pharmaceutically acceptable for topical application may also be used as pediculostatic agents. These are preferably applied in their undiluted state and without agitation in order to minimize the ' formation of foam. The presence of air in the foam or suds can provide oxygen to the lice and therefore lessen the ability of the agent to stun the lice.
  • the pediculostatic agent includes commercially available skin Cleansers, skin conditioners, shampoos, personal lubricating jelly, sunscreen, mouthwash, toothpaste, and other products. Also included are commonly available products including honey, vinegar, mustard, gelatin, yogurt, or other foodstuffs which may be applied for a period of time sufficient to stun the lice, followed by physically removing the lice from the hair by combing.
  • the preferred agent is one which can be easily removed after the treatment by rinsing with water.
  • the pediculostatic agent is an aqueous-based composition containing one or more surfactants and one or more alkanols.
  • a suitable alkanol-surfactant pediculostatic agent is BABY MAGIC baby shampoo (Mennen Co., Morristown, N.J.) which contains water, polysorbate 20, sodium lauryl sulfate, lauroamphoglycinate, polysorbate 80, PEG-150 distearate, fragrance, citric acid, and quaternium 15.
  • the shampoo is applied in the absence of water in order to avoid foaming, for a period sufficient to stun the lice, followed by combing.
  • an alkanol-surfactant pediculostatic agent suitable for use in the present invention is SUAVE 81 Baby Care bath soap tear-free formula (Helene Curtis, Inc., Chicago, IL) which contains water, PEG-80, sorbitan laurate, sodium tridecyl sulfate, cocamidopropyl hydroxysultaine, disodium lauroamphodiacetate, PEG-150 distearate, sodium lauryl-13 carboxylate, aloe vera gel, quaternium-15 , DMDM hydantoin, methylchloro isothiazolinone, methylisothiazolinone, fragrance, citric acid, D&C Violet No. 2, D&C Red No. 3.
  • composition for use as a pediculostatic agent in the invention is a mixture of water, cetyl alcohol, propylene glycol, sodium lauryl sulfate, stearyl alcohol, methyl paraben, propylparaben, and butylparaben sold commercially as a nonirritating, non-greasy skin Cleanser under the trademark CETAPHIL * Cleanser (Galderma Laboratories, Inc., Fort Worth, TX) .
  • CETAPHIL Cleanser is additionally advantageous since it aids in the removal of the nits .
  • CETAPHIL ® Cleanser may dissolve or loosen the cement which holds the nits to the hair shaft, and may also make the shaft slippery, thus facilitating the removal of the nits during combing.
  • CETAPHIL ® Cleanser has the ability to rapidly trigger the "immersion reflex" in head lice. Both in vivo and in vi tro, lice coated in CETAPHIL 31 Cleanser became immobilized within 6 seconds. On the patients' scalp, the lice became totally immobilized, floating on the scalp in the Cleanser. They were easily removed by forceps without any effort to escape or to grasp the hair shaft to stay m place. Under the microscope, they were immobile, did not respond to being touched, and lost their normally visible gut motility. They remained immobilized as long as they were in the Cleanser. This phenomenon was observed for periods ranging from 6 seconds to 4 hours .
  • the invention can also incorporate a system for verifying whether the pediculostatic agent has been applied. This is an important feature for certain populations where cross-contamination is known to occur such as in a grade school setting.
  • the pediculostatic agent is optionally combined with a dye which will temporarily remain on and mark the hair and/or scalp ° after a treatment in order to verify that the agent has been applied.
  • the dye is present at a concentration which will leave an observable mark (e.g. 0.1-1% by weight in the pediculostatic formulation) and preferably will remain on the treated area for at least 12 hours .
  • the dye 5 is preferably fluorescent and is visible only under an ultraviolet light. Non-limiting examples of suitable dyes include those described in U.S. Patent Nos. 4,610,806 and 5,302,371.
  • a pediculostatic agent and a 0 conventional pediculicide can be coadministered.
  • a conventional pediculicidal active ingredient can be incorporated into the pediculostatic formulation described herein.
  • the active ingredients can be used at levels of from about 5 0.25% to about 2.5%.
  • Exemplary useful pediculocidal agents include natural pyrethrins (with or without piperonyl butoxide) , permethrin, lindane, malathion, carbaryl, and ivermectin and combinations thereof.
  • a pediculostatic agent can be applied first, followed by application of a pediculocidal composition, or vice versa.
  • compositions are well known in the art and include RID" (Pfizer Inc., New York, NY), NIX ® (Warner-Lambert, Harristown, NJ) , KWELL * (Reed and 5 Carnick, Jersey City, NJ) , A-200° (Hogil, Purchase, NY) , PRONTO 06 (Del Pharmaceuticals, Uniondale, NY), LINDAINE ® (Alpharma, Baltimore, MD) , CLEAR ® (Care Technologies, Inc., Greenwich, CT) , and those described in U.S. Patent No. 5,292,504, which is incorporated herein by reference in its entirety.
  • the pediculostatic agent and conventional pediculocide act synergistically to increase the rate of rendering the louse totally immobile. Therefore, within a short period of time, preferably less than about 5 minutes, the lice can be removed using, for example, a fine-toothed delousing comb.
  • combing is optional and not required.
  • the lice will be rendered inactive due to being immobilized by the pediculostatic agent or being killed by the pediculostatic agent.
  • the inactive lice can be removed, for example, by rinsing the hair.
  • the invention provides a kit having at least an amount of a pediculostatic agent for one treatment (about 8 ounces) and at least one delousing comb suitable for removing adult lice and nits.
  • the kit can contain ingredients in quantities suitable that when they are mixed together, either with or without the addition of water, provide an amount of pediculostatic agent sufficient for at least one application or treatment.
  • the teeth of the comb have spacings such that hair can pass therethrough while nits and lice will be caught in the teeth of the comb.
  • Suitable combs are known in the art and include Acu-Med Lice Comb (Health Enterprises, North Attleboro, MA) , LiceMeister Lice Comb (National Pediculosis Association), Medi-Sweep Lice Comb (U.S. Patent No. 4,612,944), and dog and/or cat Flea Comb (Classic Products, Oxnard, CA) , each of which is incorporated herein by reference in its entirety.
  • the comb is preferably constructed of rigid material such as metal or plastic.
  • the comb is inexpensive and designed to be disposable after a single use, in order to prevent contamination.
  • the comb has a removable, and preferably disposable, piece having a plurality of teeth which attaches to a handle portion such as described in U.S. Patent No. 5,636,646, incorporated herein by reference in its entirety.
  • kits of the invention can also be included in the Kits of the invention.
  • the kit will contain a quantity of pediculostatic agent and enough combs to completely eradicate a lice infestation, thereby providing an effective treatment for lice.
  • the methods and kits of the invention can be used as described for the treatment, removal or prevention of other types of lice infestations, including body and pubic lice. Moreover, the methods and kits can e used to treat, remove or prevent infestations of other bugs which undergo an immersion reflect when immersed in water, such, as for example, ticks.
  • CETAPHIL ® Cleanser Ten crawling lice were obtained from patients with head lice and each one placed on a separate microscope slide for observation under a microscope at lOx or 40x power. Each louse was placed in a drop of CETAPHIL ® Cleanser for up to 4 hours. All of them exhibited the same response. Within 6 seconds of application, they stopped all spontaneous movement. Usually within 30 seconds, and always within 60 seconds, they would not respond to contact by a probe and ceased previously visible gastrointestinal motility. They remained in this state of suspended animation as long as they were kept in wet CETAPHIL ® Cleanser. If the louse was pulled to the side of the drop, it could be seen that the CETAPHIL ® Cleanser formed an adherent layer surrounding and conforming to the body and limbs.
  • louse obtained from a patient with head lice was placed on a microscope slide and treated as described in EXAMPLE 1, except that water was used instead of CETAPHIL ® Cleanser. When the louse had water applied to it, it took 25 seconds for limb and head movement to stop. During a 3 minute observation period, the louse continued to show visible gut motility and remained reactive to the probe.
  • louse was then removed from the water, allowed to dry off, and treated with CETAPHIL ® Cleanser as described in EXAMPLE 1. The same pediculostatic events and timing of them were observed as with the lice of EXAMPLE 1.
  • CETAPHIL ® Cleanser acts quicker and more effectively as a pediculostatic agent than water. While not intending to be bound by any particular theory of operation, it is believed that the superiority of CETAPHIL ® Cleanser is due to its "stickiness.” Whereas the water readily comes off the louse, the CETAPHIL ® Cleanser adheres to the louse .
  • a group of 31 patients with active head lice infestations were treated with CETAPHIL ® Cleanser combined with combing with a variety of different types of combs. All patients gave a history of symptoms of lice and/or recent exposure to a close family member or friend with lice. Some of the patients had previously tried commercially available lice treatments; one patient had tried multiple treatments with these commercially available remedies. All patients or their parents signed informed consent forms prior to entry into the study. The patients ranged in age from 2 years to 43 years, with most of the patients being 6-9 years old. All treatments were done at the patients' homes, usually by the parent. Treatment was done once weekly until no lice were present. Several different comb designs were used.
  • Each bag received from patients was opened and all lice and nits present counted and recorded on a computerized data form. The total number of nits present, the number of instars present and the number of adult lice present were recorded.
  • the number of applications to achieve complete lice removal, or cure is defined as the number of applications that produced lice before the zero lice collection result was achieved. For example, if on the third application there were no lice in the towel data, then it took 2 applications to remove all the lice.
  • CETAPHIL ® Cleanser was applied at bedtime to the dry hair and scalp to completely soak the hair and scalp and left on overnight under a shower cap .
  • Cleanser was applied to the scalp and massaged in. After waiting for 2 minutes, thorough combing was done with a delousing comb as described in EXAMPLE 4. The data collection and evaluation processes were essentially as described in EXAMPLE 4.
  • EXAMPLE 7 Prophylactic Use of Pediculostatic Agents CETAPHIL ® Cleanser is applied as in the previous examples, but on a weekly basis in order to prevent re- infestation or to prevent infestation for persons who are uninfected but at risk for catching head lice.
  • CETAPHIL ® Cleanser is applied to the scalp at school and left in place until the child returns home at the end of the day. The lice can then be removed by the child's parents.

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pest Control & Pesticides (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Plant Pathology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
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  • Epidemiology (AREA)
  • Dentistry (AREA)
  • Wood Science & Technology (AREA)
  • Agronomy & Crop Science (AREA)
  • Emergency Medicine (AREA)
  • Toxicology (AREA)
  • Dermatology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Cosmetics (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne des procédés et des kits permettant d'éliminer, de traiter ou de prévenir l'infestation par les poux de tête chez les patients qui nécessitent une intervention. On procède à une application locale, sur la zone d'infestation, d'une quantité efficace d'agent pédiculostatique, pendant une durée suffisante pour immobiliser les poux, de sorte qu'ils présentent le réflexe d'immersion, puis on passe un peigne de manière à éliminer les poux et les lentes. Eventuellement, on applique un agent antipédiculaire avec l'agent susmentionné.
PCT/US1998/021305 1997-10-10 1998-10-08 Procedes et kits pour l'elimination, le traitement ou la prevention de l'infestation par les poux de tete WO1999018800A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP98953343A EP1032270A1 (fr) 1997-10-10 1998-10-08 Procedes et kits pour l'elimination, le traitement ou la prevention de l'infestation par les poux de tete
AU10742/99A AU1074299A (en) 1997-10-10 1998-10-08 Methods and kits for removing, treating or preventing lice

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US6202497P 1997-10-10 1997-10-10
US60/062,024 1997-10-10
US7468198P 1998-02-13 1998-02-13
US60/074,681 1998-02-13
US7957698P 1998-03-26 1998-03-26
US60/079,576 1998-03-26

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WO1999018800A1 true WO1999018800A1 (fr) 1999-04-22

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Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000042982A1 (fr) * 1999-01-26 2000-07-27 Pearlman Dale L Procedes et kits pour l'elimination, le traitement ou la prevention, en cas d'infestation par les poux, au moyen d'agents pediculostatiques sechables
WO2000062613A1 (fr) * 1999-04-20 2000-10-26 Effcon Laboratories, Inc. Composition destinee a l'elimination des parasites
US6685969B2 (en) 2001-06-11 2004-02-03 Schering-Plough Healthcare Products, Inc. Treatment for ectoparasites
US6689394B2 (en) 2001-06-11 2004-02-10 Schering-Plough Healthcare Products, Inc. Removal of ectoparasites
FR2896417A1 (fr) * 2006-01-20 2007-07-27 Abdelkrim Kherroubi Produit anti poux et lentes
US7282211B2 (en) 2001-05-21 2007-10-16 Btg International Inc. Pest treatment composition
US7897559B2 (en) * 2000-06-29 2011-03-01 Parks L Dean Dermatological composition and kit containing avermectin compound for treating dermatological conditions
US8178116B2 (en) 2002-04-29 2012-05-15 Piedmont Pharmaceuticals, Llc Methods and compositions for treating ectoparasite infestation
FR2996453A1 (fr) * 2012-10-08 2014-04-11 Horizzon Innovations Technologies Composition moussante anti-poux
WO2021247702A1 (fr) * 2020-06-03 2021-12-09 William V. MacGill & Co. Peigne anti-poux amélioré et procédés de fabrication et d'utilisation

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4927813A (en) * 1988-03-08 1990-05-22 Bernstein Joel E Method and composition for treating pediculosis capitis
US5131418A (en) * 1991-09-23 1992-07-21 John Vaccaro Comb for use with hair cutting
US5783202A (en) * 1995-03-14 1998-07-21 Soltec Research Pty. Ltd. Pediculicidal mousse composition for killing head lice

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4927813A (en) * 1988-03-08 1990-05-22 Bernstein Joel E Method and composition for treating pediculosis capitis
US5131418A (en) * 1991-09-23 1992-07-21 John Vaccaro Comb for use with hair cutting
US5783202A (en) * 1995-03-14 1998-07-21 Soltec Research Pty. Ltd. Pediculicidal mousse composition for killing head lice

Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000042982A1 (fr) * 1999-01-26 2000-07-27 Pearlman Dale L Procedes et kits pour l'elimination, le traitement ou la prevention, en cas d'infestation par les poux, au moyen d'agents pediculostatiques sechables
US6265384B1 (en) 1999-01-26 2001-07-24 Dale L. Pearlman Methods and kits for removing, treating, or preventing lice with driable pediculostatic agents
US6303581B2 (en) 1999-01-26 2001-10-16 Dale L. Pearlman Methods and kits for removing, treating, or preventing lice with driable pedicul ostatic agents
US6350734B1 (en) 1999-01-26 2002-02-26 Dale L. Pearlman Methods and kits for removing, treating, or preventing lice with driable pediculostatic agents
US6541455B2 (en) 1999-01-26 2003-04-01 Dale L. Pearlman Methods and kits for removing, treating, or preventing lice with driable pediculostatic agents
WO2000062613A1 (fr) * 1999-04-20 2000-10-26 Effcon Laboratories, Inc. Composition destinee a l'elimination des parasites
US6350724B1 (en) 1999-04-20 2002-02-26 Effcon Laboratories, Inc. Lice removing composition
US7902256B2 (en) 2000-05-19 2011-03-08 Effcon Laboratories, Inc. Pest treatment composition
US7897559B2 (en) * 2000-06-29 2011-03-01 Parks L Dean Dermatological composition and kit containing avermectin compound for treating dermatological conditions
US7282211B2 (en) 2001-05-21 2007-10-16 Btg International Inc. Pest treatment composition
US6689394B2 (en) 2001-06-11 2004-02-10 Schering-Plough Healthcare Products, Inc. Removal of ectoparasites
US6685969B2 (en) 2001-06-11 2004-02-03 Schering-Plough Healthcare Products, Inc. Treatment for ectoparasites
US8178116B2 (en) 2002-04-29 2012-05-15 Piedmont Pharmaceuticals, Llc Methods and compositions for treating ectoparasite infestation
US8815270B2 (en) 2002-04-29 2014-08-26 Piedmont Pharmaceuticals, Llc Methods and compositions for treating ectoparasite infestation
FR2896417A1 (fr) * 2006-01-20 2007-07-27 Abdelkrim Kherroubi Produit anti poux et lentes
FR2996453A1 (fr) * 2012-10-08 2014-04-11 Horizzon Innovations Technologies Composition moussante anti-poux
WO2021247702A1 (fr) * 2020-06-03 2021-12-09 William V. MacGill & Co. Peigne anti-poux amélioré et procédés de fabrication et d'utilisation
US11653738B2 (en) 2020-06-03 2023-05-23 William V. MacGill & Co. Lice comb and methods of manufacture and use

Also Published As

Publication number Publication date
AU1074299A (en) 1999-05-03
EP1032270A1 (fr) 2000-09-06

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