Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2000-01-25
2001-07-24
Fay, Zohreh (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S407000, C514S881000, C514S250000, C424S070210, C424S405000, C424S094610, C424S653000, C424S461000, C132S142000
Reexamination Certificate
active
06265384
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to methods and kits for the diagnosis, treatment, removal or prevention of pedicular parasite infestations. More particularly, the methods and kits relate to the use of nontoxic driable agents that rapidly immobilize head lice and keep them immobilized when dried, in order to facilitate their removal from the hair and scalp. The methods and kits further relate to the use of driable agents that inhibit hatching of nits, obviating nit-picking and combing in the treatment of lice infestation.
BACKGROUND OF THE INVENTION
Pediculosis is a scalp infestation produced by
Pediculus humanus capitis.
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, cause skin irritation and lesions from the resulting scratching, and can cause a serious infection with ganglionic inflammation. Lice are also vectors of certain diseases, such as exanthematic or epidemic typhus 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 an approach that eliminates all 3 stages of the louse life cycle.
Many currently utilized treatment methods are based on the application of pediculicides, which are toxic pharmaceutical agents that, when internalized, poison and kill lice. Typically, such pediculicidal agents enter via the respiratory spiracles, and once inside the louse, interfere with the function of a critical metabolic or physiological pathway, leading to death. Malathion, for example, inhibits acetylcholinesterase, disrupting signaling in the nervous system.
Examples of insecticidal agents used to treat lice are described in EP 0191236 and U.S. Pat. No. 5,288,483. 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. Additionally, clinicians and parents are reluctant to treat children with agents that can also prove toxic to human beings. There are reports in the medical literature, for example, that children treated with lindane have developed seizures.
Moreover, many of these compounds have unpleasant odors or other undesirable properties, causing noncompliance by the patient, leading to re-infestation of the individual, and spreading of the infestation to others. In addition, the harshness of these agents make them unsuitable for use as prophylactics.
Home remedies such as application of corn oil, olive oil, eucalyptus oil, neem oil, coconut oil, mayonnaise, or petroleum jelly for a period of time sufficient to kill the lice (e.g. overnight) are not practical or completely effective.
A further disadvantage of prior methods is the requirement of removing the nits from the hair in a separate treatment step. The removal of nits has typically been done by hand using special fine-tooth combs. U.S. Pat. No. 4,927,813 teaches compositions containing formic acid that facilitate removal of nits from the hair; however, formic acid is a known caustic agent.
Use of combing alone to treat head lice has the disadvantage that the lice can hold onto the hair shafts using their claws or escape by crawling away from the area being combed. This labor intensive method requires daily combing, is painful, and is unpleasant since the lice are active, visible and crawling.
Heat has also been suggested as a means of killing head lice. However, its use has not been effective, due in part to the fact that crawling lice will rapidly move away from the heat source. Moreover, the temperatures needed to kill the lice, typically 140° F. or higher, can burn or scald the scalp.
The use of heat in conjunction with pediculicidal compositions is discouraged. Not only are some of the solvents used in the pediculicidal compositions inflammable at the temperatures necessary to kill the lice, but the heat may additionally degrade the active pediculicidal agents as well.
Thus, there remains a need in the art for methods and kits useful for treating and removing lice infestations that are easy to use, inexpensive, cosmetically attractive and effective against lice resistant to other treatments. Moreover, there remains a need for methods and kits that eradicate nits as well as adults and instars, and that can be used prophylactically to prevent initial infection or re-infestation. Accordingly, these are some of the objects of the present invention.
SUMMARY OF THE INVENTION
These and other objects are furnished by the present invention, which in one aspect provides a method for the treatment or removal of lice and/or nits, particularly head lice and/or nits, in animal subjects, including humans. According to the method, an effective amount of a driable 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. The driable pediculostatic agent is then dried, and the lice and/or nits removed prior to or concomitantly with removal of the dried agent.
In one embodiment, the dried agent is removed, along with lice and nits, by combing the hair with a fine-toothed delousing comb, preferably prior to shampooing or wetting the hair. In another embodiment, the dried agent is removed, along with lice, by washing the hair with water, optionally with the aid of soaps, shampoos, conditioners, etc. If the dried agent is removed by washing, nits are optionally removed by combing the washed hair with a fine-toothed delousing comb.
The driable pediculostatic agent can be dried with the application of heat or air-dried, depending upon the formulation. To avoid dilution of the pediculostatic agent, 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.
Regardless of the method of removing the dried agent, the efficiency of nit and/or lice removal can be optionally increased by adding a combing step between applying and drying the driable pediculostatic agent. In this optional embodiment, the agent applied to the hair is allowed to remain on the hair for a period of time sufficient to trigger the immersion reflex in lice. While the wet agent is still in the hair, the hair can be combed with a fine-toothed delousing comb. The wet agent removed by combing can be conveniently collected on paper towels, which can be sealed in a plastic bag, conveniently a zipper-loc plastic bag. The agent remaining on the hair can then be dried onto the hair and scalp and removed as previously described. In this alternative embodiment, the wet agent collected on the paper towels can be inspected for the presence of lice and/or nits, thereby providing a convenient diagnostic means for monitoring the course of the treatment and/or the severity of the infestation.
A pediculostatic agent is one that elicits the “immersion reflex” in lice, whereby the lice become immobilized as a consequence of reflexes that have evolved to avoid suffocation. The lice remain immobilized while in contact with the driable pediculostatic agent in its wet form, and do not recover from the immersion reflex once the agent has been dried onto the lice. In a preferred embodiment of the method of the present invention, the driable pediculostatic agent induces the immersion reflex within about 2 hours, preferably within about 5 minutes and most preferably within about 6 seconds, and can be readily dried by air evaporation or by application of heat from, for example, a hair-drier or hair curlers.
In a preferred method, the dried agent is permitted to remain on the hair for a period of time sufficient to induce the immersion reflex in the substantial majority of lice,
Becker Daniel M.
Fay Zohreh
Fish & Neave
Kwon Brian-Yong
LandOfFree
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