Claims for Patent: 9,895,388

Summary for Patent: 9,895,388

Title:	Methods and compositions useful for controlling cutaneous mites
Abstract:	The present invention relates to compositions and methods useful for the topical treatment of cutaneous mites comprising spinosyn or a physiologically acceptable derivative or salt thereof.
Inventor(s):	Mettert; Kerry W. (Westfield, IN), Culpepper; William H. (Carmel, IN)
Assignee:	ParaPRO (Carmel, IN)
Application Number:	13/951,835
Patent Claims:	1. A method for controlling Sarcoptes scabiei mites in the treatment of human scabies, comprising: topically applying to skin of a human a composition comprising water and: (a) a mixture of spinosyns including Spinosyn A, Spinosyn D, and at least three other spinosyns selected from the group consisting of Spinosyn B, Spinosyn C, Spinosyn E, Spinosyn F, Spinosyn G, Spinosyn H, Spinosyn J, and Spinosyn K; (b) one or more solubulizers for the mixture of spinosyns, said one or more solubilizers including benzyl alcohol; (c) one or more stabilizers; (d) one or more humectants; (e) one or more emulsifying agents; and (f) one or more surfactant agents; and allowing the composition to remain on the skin for at least one hour. 2. The method of claim 1 wherein the one or more stabilizers comprise hydroxyethyl cellulose. 3. The method of claim 1 wherein the one or more emulsifying agents comprise Ceteareth-20. 4. The method of claim 1 wherein the one or more surfactant agents comprise stearalkonium chloride. 5. The method of claim 1 wherein the composition also comprises cetearyl alcohol. 6. The method of claim 1 wherein said topically applying comprises topically applying the composition to about 90% or greater of the surface area of the skin of the human. 7. The method of claim 1 wherein said topically applying provides about 0.1 microgram to about 1 microgram of the spinosyns per cm.sup.2 of the skin to which the composition is applied. 8. The method of claim 1 wherein the skin is infested with the mites. 9. The method of claim 1 wherein the composition comprises: about 44% water; about 20% isopropyl alcohol; about 10% benzyl alcohol; about 6% hexylene glycol; about 4.2% stearalkonium chloride; about 3% cetearyl alcohol; about 3% propylene glycol; about 1.1% hydroxyethyl cellulose; about 1% of said mixture of spinosyns; about 0.9% ceteareth-20; and about 0.1% butylated hydroxytoluene. 10. The method of claim 1, wherein the composition exhibits a decrease in viscosity of at least about 1000 cP when warmed from 20.degree. C. to about 37.degree. C. and wherein the composition has a viscosity greater than 2000 cP at 20.degree. C. and a viscosity less than 1000 cP at 37.degree. C. 11. The method of claim 10, wherein said allowing comprises allowing the composition to remain on the skin for at least two hours. 12. The method of claim 10, wherein the composition exhibits a nonlinear decrease in viscosity over at least one temperature range between 30.degree. C. and 37.degree. C. 13. A method for controlling Sarcoptes scabiei mites that cause human scabies comprising topically applying to skin of a human in need of control of mites that that cause human scabies a composition comprising an effective amount of one or more spinosyns, wherein the composition exhibits a decrease in viscosity of at least about 1000 cP when warmed from 20.degree. C. to about 37.degree. C. 14. The method of claim 13, wherein the composition has a viscosity greater than 2000 cP at 20.degree. C. and a viscosity less than 1000 cP at 37.degree. C., and wherein the composition exhibits a nonlinear decrease in viscosity over at least one temperature range between 30.degree. C. and 37.degree. C. 15. The method of claim 13, also comprising allowing the composition to remain on the skin for at least two hours. 16. The method of claim 13, wherein said one or more spinosyns is a spinosyn mixture constituted of Spinosyn A, Spinosyn D, and other spinosyns, wherein the spinosyn mixture is constituted 12% to 20% by weight of Spinosyn D and 2 to 15% by weight of the other spinosysns, with the remainder of the spinosyn mixture being constituted by Spinosyn A, and wherein the other spinosyns include at least three spinosyns selected from the group consisting of Spinosyn B, Spinosyn C, Spinosyn E, Spinosyn F, Spinosyn G, Spinosyn H, Spinosyn J, and Spinosyn K. 17. The method of claim 16, wherein said composition also comprises, water, isopropyl alcohol, benzyl alcohol, hexylene glycol, stearalkonium chloride, cetearyl alcohol, propylene glycol, hydroxyethyl cellulose, ceteareth-20, and butylated hydroxytoluene. 18. The method of claim 17, wherein said composition comprises: about 44% water; about 20% isopropyl alcohol; about 10% benzyl alcohol; about 6% hexylene glycol; about 4.2% stearalkonium chloride; about 3% cetearyl alcohol; about 3% propylene glycol; about 1.1% hydroxyethyl cellulose; about 1% of said mixture of spinosyns; about 0.9% ceteareth-20; and about 0.1% butylated hydroxytoluene. 19. A method for controlling Sarcoptes scabiei mites that cause human scabies, comprising topically applying to skin of a human in need of control of Sarcoptes scabiei mites that cause human scabies, a composition comprising an effective amount of one or more spinosyns and allowing the composition to remain on the skin for at least one hour, wherein the composition is effective to cause penetration of the one or more spinosyns to the stratum corneum of skin of the human when applied externally to the skin. 20. The method of claim 19 wherein the composition also comprises: one or more solubulizers; one or more stabilizers; one or more humectants; one or more emulsifying agents; and one or more surfactant agents. 21. The method of claim 20 wherein the solubilizer comprises benzyl alcohol. 22. The method of claim 20 wherein the one or more humectants comprise propylene glycol. 23. The method of claim 20 wherein the one or more stabilizers comprise hydroxyethyl cellulose. 24. The method of claim 20 wherein the one or more emulsifying agents comprise Ceteareth-20. 25. The method of claim 20 wherein the one or more surfactant agents comprise stearalkonium chloride. 26. The method of claim 20 wherein the composition also comprises cetearyl alcohol. 27. The method of claim 20 wherein said topically applying provides about 0.1 microgram to about 1 microgram of the one or more spinosyns per cm.sup.2 of the skin to which to the composition is applied, and wherein said allowing comprises allowing the composition to remain on the skin for at least two hours. 28. A method according to claim 1, wherein the composition is effective to cause penetration of the one or more spinosyns to the stratum corneum of skin of the human when applied externally to the skin. 29. The method according to claim 28, wherein the composition, when applied externally to the skin of the human, does not result in the presence of the one or more spinosyns in the systemic bloodstream of the human. 30. A method for controlling mites that burrow into and lay eggs under the surface of human skin, comprising: (1) topically applying to skin of a human a composition comprising: (a) a mixture of spinosyns including Spinosyn A and Spinosyn D; (b) one or more solubulizers for the mixture of spinosyns, said one or more solubilizers including benzyl alcohol; (c) one or more stabilizers; (d) one or more humectants; (e) one or more emulsifying agents; and (f) one or more surfactant agents; wherein the composition further (i) exhibits a decrease in viscosity of at least about 1000 cP when warmed from 20.degree. C. to about 37.degree. C. and (ii) is effective when topically applied to human skin to cause penetration of the Spinosyn A and Spinosyn D to a stratum corneum layer of the human skin; and (2) allowing the composition to remain on the skin for at least one hour.