Claims for Patent: 10,098,910

Summary for Patent: 10,098,910

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. (Wayne, PA)
Application Number:	15/368,761
Patent Claims:	1. An applicator configured to store and dispense 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, the applicator comprising: a frangible ampoule having the topical composition disposed therein an applicator body having the frangible ampoule arranged therein; an applicator hub in fluid communication with the applicator body; a tip arranged at a proximal end of the applicator hub; and a filter arranged between the frangible ampoule and the tip. 2. The applicator of claim 1 wherein the applicator body further comprises an additional ingredient of the topical composition disposed therein, whereby the agent is released from the frangible ampoule responsive to the frangible ampoule being ruptured and is mixed with the additional ingredient in the applicator body prior to administration of the topical composition. 3. The applicator of claim 1, wherein the topical composition is released from the frangible ampoule responsive to the frangible ampoule being ruptured and flows through the applicator body, the filter, and out of the applicator through the tip. 4. The applicator of claim 1, further comprising a pressure area arranged on an outer surface of the applicator body to indicate a portion of the applicator body to apply pressure to rupture the frangible ampoule. 5. The applicator of claim 1, wherein the frangible ampoule is formed from at least one of glass, plastic, borosilicate glass, Type 1 borosilicate glass, and tinted glass. 6. The applicator of claim 1, wherein the applicator body is formed from polypropylene, high-density polyethylene, low-density polyethylene, polyvinyl chloride, polyethylene, or a combination thereof. 7. The applicator of claim 1, wherein the filter is configured to prevent shards of a ruptured frangible ampoule from passing through and to allow the topical composition to flow through. 8. The applicator of claim 1, wherein the filter is formed from at least one of polypropylene, high-density polyethylene, low-density polyethylene, polyethylene, polystyrene, a ceramic material, a foam material, sand, diatomaceous earth, and paper fibers. 9. A method of treating a skin condition, the method comprising administering a topical composition comprising up to 50% hydrogen peroxide and up to 5% 2-propanol using an applicator comprising: a frangible ampoule having the topical composition disposed therein, an applicator body having the frangible ampoule arranged therein; an applicator hub in fluid communication with the applicator body; a tip arranged at a proximal end of the applicator hub; and a filter arranged between the frangible ampoule and the tip. 10. The method of claim 9, 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. 11. The method of claim 9, 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. 12. The method of claim 9, wherein administering the topical composition comprises applying a squeezing force to the exterior surface of the applicator body to dispense the composition. 13. The method of claim 9, 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. 14. The method of claim 9, 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. 15. The method of claim 9, 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. 16. The applicator of claim 1, further comprising a debriding element arranged on an exterior portion of the applicator. 17. The method of claim 9, wherein the applicator further comprises a debriding element arranged on an exterior portion of the applicator. 18. The method of claim 17, further comprising mechanically or physically abrading, ablating, thinning, curetting, destroying, removing, excising, or otherwise debriding a targeted lesion of the skin condition prior to administering the topical composition.