Topical Avermectin Formulations and Methods For Elimination and Prophylaxis of Susceptible and Treatment Resistant Strains of Head Lice

Abstract

An avermectin-based topical formulation is disclosed which is useful for prevention and treatment of head lice (Pediculus humanus capitis). This topical formulation may be formulated as a shampoo-condition which comprises an effective amount of avermectin, solubilizers, suspending agents, preservatives, nonionic surfactants, humectants, a silicone compound, and water. Also disclosed are methods of using the topical formulations disclosed within this specification to treat either a susceptible or treatment-resistant strain of lice, as well as uses in the manufacture of a medicament for treating or preventing a lice infestation from a susceptible or treatment-resistant strain in a human patient.

1 .- 20 . (canceled) 
     
     
         21 . A method for treatment or prophylaxis of a lice infestation, the method comprising:
 (a) applying a unit dose of between about 1 mL and about 100 mL of a topical pediculicidal formulation to a human scalp infested with lice; wherein the formulation comprises:
 about 0.1% to about 2.0% by weight ivermectin; 
 at least one suspending agent; 
 a nonionic surfactant selected from the group consisting of sorbitan tristerate, erucyl alcohol, ricinolyl alcohol, arachidyl alcohol, capryl alcohol, capric alcohol, behenyl alcohol, lauryl alcohol, myristyl alcohol, palmitoleyl alcohol, linoleyl alcohol, elaidyl alcohol, elaidolinoleyl alcohol, glycerine, polydextrose,  quillaia , and combinations thereo 
 a solubilizing agent selected from the group consisting of cetyl acetate, acetylated lanolin alcohol and combinations thereof; 
 water, 
   (b) maintaining the topical pediculicidal formulation on the scalp for about 1 to about 60 minutes to provide treated lice; and   (c) removing the pediculicidal formulation from the scalp,   wherein the treated lice have a faster mortality response than lice treated with unformulated 0.5% ivermectin.   
     
     
         22 . The method of  claim 21 , wherein the unit dose is at least about 60 mL 
     
     
         23 . The method of  claim 21 , wherein the at least one suspending agent is selected from the group consisting of fats, fatty oils and combinations thereof. 
     
     
         24 . The method of  claim 21 , wherein the at least one suspending agent is selected from the group consisting of coconut oil, palm oil, cottonseed oil, vegetable oil, soybean oil, olive oil, peanut oil, corn oil, sunflower oil, safflower oil, jojoba oil, canola oil, shea butter, cocoa butter, milk fat, amaranth oil, apricot oil, argan oil, avocado oil, babassu oil, ben oil, algaroba oil, coriander seed oil, false flax oil, grape seed oil, hemp oil, kapok seed oil, meadowfoam seed oil, okra seed oil,  perilla  seed oil, poppyseed oil, prune kernel oil, pumpkin seed oil,  quinoa  oil ramtil oil, rice bran oil,  camellia  oil, thistle oil, wheat germ oil and combinations thereof. 
     
     
         25 . The method of  claim 21 , wherein the at least one suspending agent is olive oil, shea butter or a combination thereof. 
     
     
         26 . The method of  claim 21 , wherein the topical pediculicidal formulation further comprises a conditioner. 
     
     
         27 . The method of  claim 21 , wherein the topical pediculicidal formulation further comprises a preservative. 
     
     
         28 . The method of  claim 21 , wherein the topical pediculicidal formulation further comprises a pharmaceutically accepted glycol. 
     
     
         29 . The method of  claim 21 , wherein the topical pediculicidal formulation is maintained on the scalp for about 1 to about 60 minutes. 
     
     
         30 . The method of  claim 21 , wherein the topical pediculicidal formulation is maintained on the scalp for about 3 minutes, about 5 minutes, or about 10 minutes 
     
     
         31 . The method of  claim 21 , wherein the topical pediculicidal formulation is applied as a single dose. 
     
     
         32 . The method of  claim 21 , wherein the topical pediculicidal formulation is applied as an initial dosage with one or two additional dosages. 
     
     
         33 . The method of  claim 21 , wherein the topical pediculicidal formulation is formulated as a lotion. 
     
     
         34 . The method of  claim 21 , wherein the topical pediculicidal formulated as a shampoo-conditioner.