Claims for Patent: 9,675,639

Summary for Patent: 9,675,639

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, GB), Botta; Michael A. (Ridge, NY), Nagler; Thomas (Greenlawn, NY)
Assignee:	ACLARIS THERAPEUTICS, INC. (Malvern, PA)
Application Number:	14/692,665
Patent Claims:	1. A topical composition for treating a skin condition comprising about 25% w/w to about 70% w/w hydrogen peroxide and 2-propanol in an amount of about 1% w/w to about 5% w/w. 2. The topical composition of claim 1, wherein the composition comprises hydrogen peroxide in an amount of about 70% w/w, about 50% w/w, about 45% w/w, about 40% w/w, about 32.5% w/w, about 25% w/w, or in a range between any two of these amounts. 3. The topical composition of claim 1, wherein the 2-propanol comprises about 1% w/w of the composition. 4. The topical composition of claim 1 further comprising a stabilizer. 5. The topical composition of claim 4, wherein the stabilizer comprises stannate, sodium pyrophosphate, organophosphonate, nitrate, phosphoric acid, colloidal silicate, or a combination thereof. 6. The topical composition of claim 1, wherein the hydrogen peroxide is a stabilized hydrogen peroxide. 7. The topical composition of claim 1 further comprising a gelling agent. 8. The topical composition of claim 7, 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. 9. 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. 10. The topical composition of claim 1, wherein the 2-propanol 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. 11. The topical composition of claim 1, wherein the 2-propanol 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. 12. 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. 13. The topical composition of claim 1, wherein the topical composition comprises about 45% w/w stabilized cosmetic-grade hydrogen peroxide and about 5% w/w 2-propanol, 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 stabilized cosmetic-grade hydrogen peroxide and about 5% w/w 2-propanol, and wherein the topical composition has a surface tension of about 42 mNm-1 to about 55 mNm-1 at 37.degree. C. 15. The topical composition of claim 1, wherein the topical composition comprises about 32.5% w/w stabilized cosmetic-grade hydrogen peroxide and about 5% w/w 2-propanol, and wherein the topical composition has a surface tension of about 42 mNm-1 to about 55 mNm-1 at 37.degree. C. 16. The topical composition of claim 1, wherein the topical composition comprises about 25% w/w stabilized cosmetic-grade hydrogen peroxide and about 5% w/w 2-propanol, and wherein the topical composition has a surface tension of about 42 mNm-1 to about 55 mNm-1 at 37.degree. C. 17. 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. 18. The topical composition of claim 1, wherein the topical composition has a mean redox potential of about 415 mV to about 430 mV. 19. The topical composition of claim 1, wherein the topical composition has a pH of about 3.5 to about 4. 20. The topical composition of claim 1, wherein the composition comprises hydrogen peroxide in an amount of about 30% w/w to about 50% w/w of the composition. 21. The topical composition of claim 1, wherein the composition comprises hydrogen peroxide in an amount of about 35% w/w to about 50% w/w of the composition. 22. The topical composition of claim 1, wherein the composition comprises hydrogen peroxide in an amount of about 40% w/w to about 50% w/w of the composition. 23. The topical composition of claim 1, wherein the composition comprises hydrogen peroxide in an amount of about 35% w/w to about 45% w/w of the composition. 24. The topical composition of claim 1, wherein the composition comprises hydrogen peroxide in an amount of about 40% w/w to about 45% w/w of the composition. 25. The topical composition of claim 1, wherein the composition comprises hydrogen peroxide in an amount of about 40% w/w of the composition. 26. The topical composition of claim 1, wherein the composition comprises hydrogen peroxide in an amount of about 45% w/w of the composition. 27. The topical composition of claim 1, wherein the 2-propanol comprises about 2% w/w to about 5% w/w of the composition. 28. The topical composition of claim 1, wherein the 2-propanol comprises about 3% w/w to about 5% w/w of the composition. 29. The topical composition of claim 1, wherein the 2-propanol comprises about 4% w/w to about 5% w/w of the composition. 30. The topical composition of claim 1, wherein the 2-propanol comprises about 4.5% w/w to about 5% w/w of the composition. 31. The topical composition of claim 1, wherein the 2-propanol comprises about 1.5% w/w of the composition. 32. The topical composition of claim 1, wherein the 2-propanol comprises about 2% w/w of the composition. 33. The topical composition of claim 1, wherein the 2-propanol comprises about 2.5% w/w of the composition. 34. The topical composition of claim 1, wherein the 2-propanol comprises about 3% w/w of the composition. 35. The topical composition of claim 1, wherein the 2-propanol comprises about 3.5% w/w of the composition. 36. The topical composition of claim 1, wherein the 2-propanol comprises about 4.0% w/w of the composition. 37. The topical composition of claim 1, wherein the 2-propanol comprises about 4.5% w/w of the composition. 38. The topical composition of claim 1, wherein the topical composition comprises about 40% w/w hydrogen peroxide and about 5% w/w 2-propanol. 39. The topical composition of claim 1, wherein the topical composition comprises about 45% w/w hydrogen peroxide and about 5% w/w 2-propanol. 40. The topical composition of claim 1, wherein the topical composition comprises about 40% w/w hydrogen peroxide, about 5% w/w 2-propanol and water. 41. The topical composition of claim 1, wherein the topical composition comprises about 45% w/w hydrogen peroxide, about 5% w/w 2-propanol and water. 42. The topical composition of claim 1, wherein the topical composition comprises 40% w/w hydrogen peroxide, 5% w/w 2-propanol and water. 43. The topical composition of claim 1, wherein the topical composition comprises 45% w/w hydrogen peroxide, 5% w/w 2-propanol and water. 44. A topical composition consisting of about 25% w/w to about 70% w/w stabilized hydrogen peroxide and 2-propanol in an amount of up to about 1% w/w to about 5% w/w and an excipient. 45. The topical composition of claim 44, wherein the topical composition consists of about 40% w/w stabilized hydrogen peroxide and about 5% w/w 2-propanol. 46. The topical composition of claim 44, wherein the topical composition consists of about 45% w/w stabilized hydrogen peroxide and about 5% w/w 2-propanol. 47. The topical composition of claim 44, wherein the topical composition consists of about 40% w/w stabilized hydrogen peroxide, about 5% w/w 2-propanol and the excipient is water. 48. The topical composition of claim 44, wherein the topical composition consists of about 45% w/w stabilized hydrogen peroxide, about 5% w/w 2-propanol and the excipient is water. 49. The topical composition of claim 44, wherein the topical composition consists of 40% w/w stabilized hydrogen peroxide, 5% w/w 2-propanol and the excipient is water. 50. The topical composition of claim 44, wherein the topical composition consists of 45% w/w stabilized hydrogen peroxide, 5% w/w 2-propanol and the excipient is water. 51. A method of treating a skin condition in a subject in need thereof comprising topically administering a topical composition comprising about 25% w/w to about 70% w/w hydrogen peroxide and 2-propanol in an amount of about 1% w/w to about 5% w/w to the subject. 52. The method of claim 51, wherein the composition comprises hydrogen peroxide in an amount of about 50% w/w, about 45% w/w, about 40% w/w, about 32.5% w/w, about 25% w/w, or in a range between any two of these amounts. 53. The method of claim 51, wherein the skin condition is selected from the group consisting of warts, seborrheic keratosis, acrochordons, recalcitrant warts, recurrent warts, treatment naive warts, common warts, palmoplantar warts, flat warts, epidermodysplasia verruciformis related warts, anogenital warts, condyloma accuminatum, cervical intraepithelial neoplasia (CIN), chicken pox, Herpes zoster, shingles, molluscum contagiosum, orf, callus, cutaneous horns, corns, fibroepithelial polyps, prurigo nodularis, actinic keratoses, squamous cell carcinoma, squamous cell carcinoma in situ, keratoacanthoma, basal cell carcinoma, cutaneous lymphomas, benign lymphocytic infiltrates, hyperplasias of the skin, clear cell acanthoma, large cell acanthoma, epidermolytic acanthoma, porokeratosis, hyperkeratosis, keratosis pilaris, lichenoid keratosis, acanthosis, acanthosis nigricans, confluent papillomatosis, reticulated papillomatosis, nevi, acne, cysts, trichofolliculoma, fibrofolliculoma, perifollicular fibroma, trichodiscoma, nevus sebaceous, chondroid syringoma, trichoepithelioma, trichoblastoma, desmoplastic trichoepithelioma, pilomatricoma, pilomatrical carcinoma, tricholemmoma, trichelemmal carcinoma, tumor of the follicular infundibulum, tricoadenoma, proliferating pilar tumor, sebaceous hyperplasia, sebaceous adenoma, sebaceous epithelioma, sebaceous carcinoma, syringoma, poroma, hidradenoma, apocrine hidradenoma, spiradenoma, cylindroma, eccrine nevus, papillary adenoma, papillary adenocarcinoma, ephilides, cafe-au-lait macules, Becker's melanosis, lentigines, solar lentigines, lentigo simplex, mucosal melanocytic lesions, Mongolian spots, Nevus of Ota, blue nevus, common acquired melanocytic nevi, moles, congenital nevi, nevus spilus, recurrent nevi; vascular and perivascular neoplasms, hemangiomas, cherry angiomas, hobnail hemangiomas, tufted angiomas, hemangioendotheliomas, angiolymphoid hyperplasia with eosinophilia (ALHE), glomangiomas, hemangiopericytomas; neuromas, Schwannomas, neurofibromas, nerve sheath tumor, nerve sheath myxoma, neurothekeoma, granular cell tumor; fibroepithelial polyps, fibromas, fibrous papules, angiofibromas, pearly penile papules, periungual fibromas, dermatofibromas, fibrokeratomas, sclerotic or pleomorphic fibromas, connective tissue nevi, cutaneous scars, hyperplasias, keloids, rosacea, cutaneous fungal, dermatophyte infections, mold infections, onychomycosis, hyperpigmentation, rhytides, psoriasis, malignant melanoma, dermatosis papulosis nigra, inverted follicular keratosis, acrokeratosis verruciformis, stucco keratosis, and a combination thereof. 54. The method of claim 51, wherein the skin condition is selected from the group consisting of warts, common warts, recalcitrant warts, treatment naive warts, molluscum contagiosum, acrochordons, seborrheic keratosis, condyloma acuminata, or a combination thereof. 55. The method of claim 51 further including debriding a treatment site of the subject. 56. The method of claim 55, wherein debriding the treatment site may occur before, after or concurrent with administration of the composition. 57. The method of claim 51, wherein the composition is administered once daily, twice daily, weekly, bi-weekly, every other day, monthly, every two months, every three months or as directed by a packaging or a physician to achieve the desired clinical result. 58. The method of claim 51, further comprising administering a second composition comprising from about 25% w/w to about 50% w/w hydrogen peroxide and 2-propanol in an amount of about 1% w/w to about 5% w/w to the subject. 59. The method of claim 58, wherein the second composition is administered at least about 1 day, at least about 2 days, at least about 3 days, at least about 1 week, at least about 2 weeks, at least about 3 weeks, at least about 4 weeks, at least 1 month, at least two months, at least three months, at least 4 months, at least 5 months, or at least 6 months after an initial administration. 60. The method of claim 51, wherein the composition is a solution or a gel. 61. The method of claim 51, wherein administering the composition comprises contacting a treatment site 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. 62. The method of claim 51, wherein administering the composition comprises contacting a treatment site 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. 63. The method of claim 62, wherein administering the topical 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. 64. The method of claim 62, wherein administering the topical composition comprises contacting the tip with a targeted lesion of the skin condition whereby the topical composition dispenses through the tip onto the targeted lesion. 65. The method of claim 62, wherein administering the topical composition further comprises applying pressure to a pressure area arranged on an outer surface of the applicator body causing the frangible ampoule to rupture. 66. The method of claim 62, wherein administering the topical composition comprises causing the frangible ampoule to rupture and release the topical composition through the tip; and contacting the tip to a targeted lesion of the skin condition. 67. The method of claim 51, wherein the skin condition is seborrheic keratosis. 68. The method of claim 67, wherein the topical composition comprises about 40% w/w hydrogen peroxide and 2-propanol in an amount of about 5% w/w. 69. The method of claim 51, wherein the skin condition is selected from the group consisting of warts, common warts, recalcitrant warts, treatment naive warts and combinations thereof. 70. The method of claim 69, wherein the topical composition comprises about 45% w/w hydrogen peroxide and 2-propanol in an amount of about 5% w/w.