Claims for Patent: 10,729,720

Summary for Patent: 10,729,720

Title:	Peroxide formulations and methods and applicators for using the same
Abstract:	Embodiments are directed to a stable composition comprising stabilized hydrogen peroxide and 2-propanol and applicators configured to store, dispense, and apply such stable compositions. Such compositions may be used to treat skin conditions such as warts, condyloma accuminatum, molluscum contagiosum, acrochordons, seborrheic keratosis, or a combination thereof. Some embodiments also describe take home compositions, in office compositions, over-the-counter compositions, and kits for the use of such compositions.
Inventor(s):	Shanler; Stuart D. (Malvern, PA), Powala; Christopher (Radnor, PA), Phillips; Christopher (Doylestown, PA), Beger; Brian (Newtown, PA), Greenaway Evans; Charles Rodney (Surrey, GB), Lim; Sian Tiong (Surrey, GB), Brown; Marc Barry (Watford Hertfordshire, GB), Botta; Michael A. (Ridge, NY), Nagler; Thomas (Greenlawn, NY)
Assignee:	ACLARIS THERAPEUTICS, INC. (Wayne, PA)
Application Number:	15/961,236
Patent Claims:	1. A topical composition for treating a skin condition comprising about 25% w/w to about 70% w/w hydrogen peroxide, an alcohol in an amount of about 0.1% w/w to about 10% w/w, and at least four stabilizers selected from stannate, sodium pyrophosphate, organophosphonate, nitrate, phosphoric acid, and colloidal silicate. 2. The topical composition of claim 1, wherein the alcohol is a primary alcohol, a secondary alcohol, a tertiary alcohol, or a combination thereof. 3. The topical composition of claim 1, wherein the alcohol is selected from methanol, ethanol, butanol, 1-propanol, pentanol, hexanol, octanol, nonanol, decanol, 2-butanol, 2-propanol, 2-pentanol, benzyl alcohol, an isomer thereof, or a combination thereof. 4. The topical composition of claim 1, wherein the composition comprises hydrogen peroxide in an amount of about 40% w/w of the composition. 5. The topical composition of claim 1, wherein the composition comprises hydrogen peroxide in an amount of about 45% w/w of the composition. 6. The topical composition of claim 1, further comprising a gelling agent. 7. The topical composition of claim 6, wherein the gelling agent is selected from polycarbophil, polyvinyl pyrrolidone, poloxamer, bentonite, high molecular weight cross linked copolymers of acrylic acid and a hydrophobic comonomer or a copolymer, silicates, hyaluronic acids, cross-linked hyaluronic acids, a combination thereof, or a compositional or chemical equivalent thereof. 8. The topical composition of claim 1, wherein the composition has a surface tension of about 42 mNm-1 to about 55 mNm-1 at 37.degree. C. 9. The topical composition of claim 1, wherein the alcohol is in an amount sufficient to decrease a surface tension of the composition to a level that effectively increases the penetration of the composition into crevices, invaginations and/or surface irregularities of a skin lesion. 10. The topical composition of claim 1, wherein the alcohol is in an amount sufficient to decrease surface tension while minimizing spread of the composition onto non-targeted skin when applied to a targeted lesion. 11. The topical composition of claim 1, wherein the composition is stable for at least two years at 5.degree. C., at least one year at 30.degree. C., at least 6 months at 40.degree. C., or a combination thereof. 12. The topical composition of claim 1, wherein the topical composition comprises about 45% w/w cosmetic-grade hydrogen peroxide and about 5% w/w alcohol, and wherein the topical composition has a surface tension of about 42 mNm-1 to about 55 mNm-1 at 37.degree. C. 13. The topical composition of claim 1, wherein the topical composition comprises about 40% w/w cosmetic-grade hydrogen peroxide and about 5% w/w alcohol, and wherein the topical composition has a surface tension of about 42 mNm-1 to about 55 mNm-1 at 37.degree. C. 14. The topical composition of claim 1, wherein the topical composition comprises about 40% w/w hydrogen peroxide and about 5% w/w alcohol. 15. The topical composition of claim 1, wherein the topical composition comprises about 45% w/w hydrogen peroxide and about 5% w/w alcohol. 16. The topical composition of claim 1, wherein the topical composition has a mean steady state release of hydrogen peroxide between 0.5 hours and 4 hours of between about 1000 .mu.g/cm.sup.2/hour and about 1750 .mu.g/cm.sup.2/hour. 17. The topical composition of claim 1, wherein the topical composition has a mean redox potential of about 415 mV to about 430 mV. 18. The topical composition of claim 1, wherein the topical composition has a pH of about 1.7 to about 3.7. 19. The topical composition of claim 1, wherein the stabilizers of the topical composition comprise stannate, sodium pyrophosphate, organophosphonate, and nitrate. 20. A topical composition comprising about 25% w/w to about 70% w/w hydrogen peroxide, a surface tension modifying agent, and at least four stabilizers selected from stannate, sodium pyrophosphate, organophosphonate, nitrate, phosphoric acid, and colloidal silicate. 21. The topical composition of claim 20, wherein the composition comprises hydrogen peroxide in an amount of about 32.5% w/w to about 50% w/w. 22. The topical composition of claim 20, wherein the surface tension modifying agent is selected from an alcohol, ethanol, butanol, PEG (polyethylene glycol) stearate, polysorbate, or a combination thereof. 23. The topical composition of claim 20, wherein the alcohol is a primary alcohol, a secondary alcohol, a tertiary alcohol, or a combination thereof. 24. The topical composition of claim 22, wherein the alcohol is selected from methanol, ethanol, butanol, 1-propanol, pentanol, hexanol, octanol, nonanol, decanol, 2-butanol, 2-propanol, 2-pentanol, benzyl alcohol, an isomer thereof, or a combination thereof. 25. The topical composition of claim 22, wherein the alcohol is 2-propanol. 26. The topical composition of claim 20, wherein the surface tension modifying agent is in an amount sufficient to decrease a surface tension of the composition to a level that effectively increases the penetration of the composition into crevices, invaginations and/or surface irregularities of a skin lesion. 27. The topical composition of claim 20, wherein the surface tension modifying agent is in an amount sufficient to decrease surface tension while minimizing spread of the composition onto non-targeted skin when applied to a targeted lesion. 28. The topical composition of claim 20, wherein the surface tension modifying agent is in an amount of about 0.5% w/w to about 25% w/w. 29. The topical composition of claim 20, wherein the topical composition comprises about 40% w/w hydrogen peroxide and about 0.5% w/w to about 25% w/w surface tension modifying agent. 30. The topical composition of claim 20, wherein the topical composition comprises about 45% w/w hydrogen peroxide and about 0.5% w/w to about 25% w/w surface tension modifying agent. 31. The topical composition of claim 20, wherein the composition has a surface tension of about 42 mNm-1 to about 55 mNm-1 at 37.degree. C. 32. The topical composition of claim 20, wherein the composition is stable for at least two years at 5.degree. C., at least one year at 30.degree. C., at least 6 months at 40.degree. C., or a combination thereof. 33. The topical composition of claim 20, wherein the topical composition has a mean steady state release of hydrogen peroxide between 0.5 hours and 4 hours of between about 1000 .mu.g/cm.sup.2/hour and about 1750 .mu.g/cm.sup.2/hour. 34. The topical composition of claim 20, wherein the topical composition has a mean redox potential of about 415 mV to about 430 mV. 35. The topical composition of claim 20, wherein the topical composition has a pH of about 1.7 to about 3.7. 36. The topical composition of claim 20, wherein the stabilizers of the topical composition comprise stannate, sodium pyrophosphate, organophosphonate, and nitrate.