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WO 2015/164427 Al 29 October 2015 (29.10.2015) P O P C T (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2015/164427 Al 29 October 2015 (29.10.2015) P O P C T (51) International Patent Classification: 11961 (US). NAGLER, Thomas; 1 Harborview Avenue, A61K 8/00 (2006.01) Greenlawn, New York 11740 (US). (21) International Application Number: (74) Agents: STAKLEFF, N. Nicole et al; Pepper Hamilton PCT/US20 15/026948 LLP, Suite 5000, 500 Grant Street, Pittsburgh, Pennsylvania 152 19-2507 (US). (22) International Filing Date: 2 1 April 2015 (21 .04.2015) (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, English (25) Filing Language: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, (26) Publication Language: English BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (30) Priority Data: HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, 61/982,217 2 1 April 2014 (21.04.2014) US KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, 62/085,466 28 November 2014 (28. 11.2014) US MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, (71) Applicant: ACLARIS THERAPEUTICS, INC. (heir of PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, the deceased inventor) [US/US]; 101 Lindenwood Drive, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, Malvern, Pennsylvania 19355 (US). TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (72) Inventors: SHANLER, Stuart D.; 24 Quail Drive South, (84) Designated States (unless otherwise indicated, for every Malvern, Pennsylvania 19460 (US). POWALA, Chris¬ kind of regional protection available): ARIPO (BW, GH, topher; 714 Woodcrest Road, Radnor, Pennsylvania 19087 GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, (US). PHILLIPS, Christopher; 1 John Dyer Way, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, Doylestown, Pennsylvania 18902 (US). BEGER, Brian; TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, 69 Spring Garden Mill Drive, Newtown, Pennsylvania DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, 18940 (US). GREENAWAY EVANS, Charles Rodney; 38 Church Path, Mitcham, Surrey CR4 3BN (GB). SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). (72) Inventor: LEVI, Sian Tiong (deceased). Published: (72) Inventors: BROWN, Marc Barry; 30 Oxhey Road, Wat — with international search report (Art. 21(3)) ford, Hertfordshire WD 19 4QQ (GB). BOTTA, Michael A.; 651 Wading River Hollow Rd., Ridge, New York ¾ (54) Title: PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME ¾ (57) Abstract: Embodiments are directed to a stable composition comprising stabilized hydrogen peroxide and 2-propanol and ap - plicators 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. PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME BRIEF SUMMARY [0001] Embodiments in this disclosure are directed to a composition comprising hydrogen peroxide and an alcohol. In some embodiments, the hydrogen peroxide is stabilized hydrogen peroxide. In some embodiments, the hydrogen peroxide may be a standard grade, food grade, chemical synthesis grade, semiconductor grade, high-test hydrogen peroxide grade, antimicrobial grade, drinking water grade, pharmaceutical grade or cosmetic grade hydrogen peroxide. In some embodiments, the alcohol may be selected from a primary alcohol, a secondary alcohol, a tertiary alcohol, or a combination thereof. In some embodiments, the alcohol may be selected from 2-propanol, methanol, butanol, 1-propanol, pentanol, hexanol, octanol, nonanol, decanol, 2-pentanol, 2-butanol, benzyl alcohol, ethanol, an isomer thereof, or a combination thereof. In some embodiments, the hydrogen peroxide is in an amount up to about 50% of the composition. In some embodiments the alcohol is in a quantity sufficient to decrease the surface tension of the composition. In some embodiments, the alcohol is in an amount up to about 5% of the composition. In some embodiments, the composition is a solution. In some embodiments, the composition is a gel formulation. In some embodiments, the composition comprises two or more separate components that may be admixed before, at, or near the time of use. [0002] Some embodiments are directed to a topical composition comprising up to about 50% hydrogen peroxide and up to 5% 2-propanol. In some embodiments, the hydrogen peroxide is a stabilized hydrogen peroxide. In some embodiments, the topical composition further includes a stabilizer. The stabilizer may be selected from stannate, sodium pyrophosphate, organophosphonate, nitrate, phosphoric acid, colloidal silicate, any stabilizer known in the art, or a combination thereof. In some embodiments, the 2-propanol is in an amount sufficient to decrease the surface tension while minimizing spread of the composition onto non-targeted skin when applied to a targeted lesion. The composition may be stable for at least two years at 5°C, at least one year at 30°C, at least 6 months at 40°C, or a combination thereof. [0003] In some embodiments, the topical composition comprises about 45% stabilized cosmetic-grade hydrogen peroxide and about 5% 2-propanol, and wherein the topical composition has a surface tension of about 42 mN m-l to about 55 mN m-l at 37 °C. In some embodiments, the topical composition comprises about 40% stabilized cosmetic- grade hydrogen peroxide and about 5% 2-propanol, and wherein the topical composition has a surface tension of about 42 mN m-l to about 55 mN m-l at 37 °C. In some embodiments, the topical composition comprises about 32.5% stabilized cosmetic-grade hydrogen peroxide and about 5% 2-propanol, and wherein the topical composition has a surface tension of about 42 mN m-l to about 55 mN m-l at 37 °C. In some embodiments, the topical composition comprises about 25% stabilized cosmetic-grade hydrogen peroxide and about 5% 2-propanol, and wherein the topical composition has a surface tension of about 42 mN m-l to about 55 mNm-1 at 37 °C. [0004] Some embodiments are directed to a composition comprising hydrogen peroxide and a surface tension modifying agent. In some embodiments, the surface tension modifying agent is an agent stable in compositions comprising concentrations of hydrogen peroxide disclosed in embodiments herein. In some embodiments, the surface tension modifying agent is in a quantity sufficient to enhance the therapeutic efficacy of the composition. In some embodiments, the surface tension modifying agent is in a quantity sufficient to modify the surface tension while maintaining stability of the composition sufficient for use as a commercially viable formulation. In some embodiments, the surface tension modifying agent is an alcohol. In some embodiments, the surface tension modifying agent is 2-propanol. [0005] Embodiments herein also describe a method of treating a skin condition comprising administering a composition having up to about 50% hydrogen peroxide and an alcohol to a subject in need thereof. The skin condition may be a virally induced or non- virally induced cutaneous growth or proliferation. The skin condition may be a benign neoplasm, premalignancy or malignancy. The skin condition may be an inflammatory condition. The skin condition may be a hyperproliferative condition. The skin condition may be aging including intrinsic (e.g., chronological) and extrinsic changes (e.g., photoaging, ultraviolet light induced changes), pigmentary changes, fine lines and rhytides. In some embodiments, the skin condition may be selected from Human Papilloma Virus induced lesions e.g., warts, common warts, palmoplantar warts, flat warts, recurrent warts, recalcitrant warts, treatment na ve warts, epidermodysplasia verruciformis related warts, anogenital warts, condyloma accuminatum, cervical dysplasias or neoplasias, e.g., cervical intraepithelial neoplasia (CIN); Herpesvirus related lesions including those induced by HHV- 1 (HSV-1), HHV-2 (HSV-2), HHV-3 (varicella-zoster virus) e.g., chicken pox, Herpes zoster, shingles; Poxvirus induced lesions e.g., molluscum contagiosum, orf,; callus, cutaneous horns, corns, acrochordons, fibroepithelial polyps, prurigo nodularis, actinic keratoses, squamous cell carcinoma, squamous cell carcinoma in situ, keratoacanthoma, basal cell carcinoma, cutaneous lymphomas and 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 and reticulated papillomatosis, nevi, including e.g., dermal nevi, epidermal nevi, compound nevi, ILVEN (inflammatory linear verrucous epidermal nevi), nevus sebaceous, nevus comedonicus, and the like; acne, e.g., comedonal acne, inflammatory acne, papular acne, pustular acne, cystic acne; cysts, e.g., epidermoid cysts, milia, trichilemmal cysts, follicular cysts, proliferating cysts, dermoid cysts, pilonidal cysts, apocrine cysts, eccrine cysts, sebaceous cysts, mucous cysts, myxoid cysts, ganglion
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