Claims for Patent: 9,980,983

Summary for Patent: 9,980,983

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. (Malvern, PA)
Application Number:	15/591,894
Patent Claims:	1. A method of treating seborrheic keratosis in a human in need thereof, comprising topically administering to the human a composition comprising about 40% w/w of stabilized hydrogen peroxide, wherein the compound used to stabilize the hydrogen peroxide comprises stannate, sodium pyrophosphate, organophosphonate, nitrate, phosphoric acid, colloidal silicate, or a combination thereof. 2. The method of claim 1, wherein the composition is administered once to the human. 3. The method of claim 1, wherein the composition is administered twice to the human. 4. The method of claim 3, wherein the second administration of the composition to the human occurs about 3 weeks after the first administration of the composition to the human. 5. The method of claim 1, wherein the composition has a surface tension of about 42 mNm-1 to about 55 mNm-1 at 37.degree. C. 6. The method 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. 7. The method of claim 1, wherein the 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. 8. The method of claim 1, wherein the composition has a mean redox potential of about 415 mV to about 430 mV. 9. The method of claim 1, wherein the composition has a pH of about 3.5 to about 4. 10. The method of claim 1, wherein the composition is a solution. 11. The method of claim 1, wherein the composition is a gel. 12. The method of claim 1, wherein administering the composition comprises contacting the seborrheic keratosis with an applicator selected from the group consisting of a sponge, a swab, a foam tipped stick, a cotton ball, a brush, a woven or non-woven fabric, roller, gauze, a glove, a pen-type applicator, a flocked, doe-foot applicator or a combination thereof. 13. The method of claim 1, wherein administering the composition comprises contacting the seborrheic keratosis with a tip of an applicator, wherein the applicator comprises: a frangible ampoule having the composition disposed therein, an applicator body having the frangible ampoule arranged therein; an applicator hub in fluid communication with the applicator body; the tip arranged at a proximal end of the applicator hub; and a filter arranged between the frangible ampoule and the tip. 14. The method of claim 13, wherein administering the composition comprises controlling a flow rate of the topical composition out of the tip by varying a squeezing force applied to the exterior surface of the applicator body. 15. The method of claim 13, wherein administering the composition comprises contacting the tip with the seborrheic keratosis whereby the topical composition dispenses through the tip onto the targeted lesion. 16. The method of claim 13, wherein administering the composition further comprises applying pressure to a pressure area arranged on an outer surface of the applicator body causing the frangible ampoule to rupture. 17. The method of claim 13, wherein administering the composition comprises causing the frangible ampoule to rupture and release the topical composition through the tip; and contacting the tip to the seborrheic keratosis. 18. The method of claim 1, wherein the composition further comprises a surface tension modifying agent. 19. The method of claim 1, wherein the composition further comprises an alcohol. 20. The method of claim 1, wherein the composition further comprises a stabilizer. 21. The method of claim 1, wherein the composition further comprises a gelling agent. 22. The method of claim 1, wherein the composition further comprises an excipient. 23. The method of claim 1 further including debriding the seborrheic keratosis. 24. The method of claim 1, wherein no additional active agent is needed to treat the seborrheic keratosis. 25. The method of claim 1, wherein no additional therapeutic intervention is needed to treat the seborrheic keratosis.