(12) Patent Application Publication (10) Pub. No.: US 2015/0328259 A1 SHANLER Et Al
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US 2015 0328259A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2015/0328259 A1 SHANLER et al. (43) Pub. Date: Nov. 19, 2015 (54) PEROXIDE FORMULATIONS AND Publication Classification METHODS AND APPLICATORS FORUSING THE SAME (51) Int. Cl. A633/40 (2006.01) (71) Applicant: ACLARIS THERAPEUTICS, INC., A619/00 (2006.01) Malvern, PA (US) A6M 35/00 (2006.01) (72) Inventors: Stuart D. SHANLER, Malvern, PA A647/10 (2006.01) (US); Christopher POWALA, Radnor, (52) U.S. Cl. PA (US); Christopher PHILLIPS, CPC ................. A61K 33/40 (2013.01); A61K 47/10 Doylestown, PA (US); Brian BEGER, (2013.01); A61 K9/0014 (2013.01); A61M Newtown, PA (US); Charles Rodney 35/003 (2013.01); A61M 2205/7545 (2013.01) GREENAWAY EVANS, Surrey (GB); Sian Tiong LIM, Surrey (GB); Marc Barry BROWN, Watford Hertfordshire (57) ABSTRACT (GB); Michael A. BOTTA, Ridge, NY (US); Thomas NAGLER, Greenlawn, NY (US) Embodiments are directed to a stable composition compris ing stabilized hydrogen peroxide and 2-propanol and appli (21) Appl. No.: 14/692,665 cators configured to store, dispense, and apply Such stable (22) Filed: Apr. 21, 2015 compositions. Such compositions may be used to treat skin conditions such as warts, condyloma accuminatum, mollus Related U.S. Application Data cum contagiosum, acrochordons, seborrheic keratosis, or a (60) Provisional application No. 61/982.217, filed on Apr. combination thereof. Some embodiments also describe take 21, 2014, provisional application No. 62/085,466, home compositions, in office compositions, over-the-counter filed on Nov. 28, 2014. compositions, and kits for the use of Such compositions. 1300 / 1335 1340 1305 3. 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S--- -3----. -------- 888. 8:8: $8x88: 8888:x: F.G. 17A Patent Application Publication Nov. 19, 2015 Sheet 19 of 20 US 2015/0328259 A1 s s Patent Application Publication Nov. 19, 2015 Sheet 20 of 20 US 2015/0328259 A1 US 2015/0328259 A1 Nov. 19, 2015 PEROXDE FORMULATIONS AND fying agent is an agent stable in compositions comprising METHODS AND APPLICATORS FORUSING concentrations of hydrogen peroxide disclosed in embodi THE SAME ments herein. In some embodiments, the Surface tension modifying agent is in a quantity Sufficient to enhance the BRIEF SUMMARY therapeutic efficacy of the composition. In some embodi 0001 Embodiments in this disclosure are directed to a ments, the Surface tension modifying agent is in a quantity composition comprising hydrogen peroxide and an alcohol. Sufficient to modify the Surface tension while maintaining In some embodiments, the hydrogen peroxide is stabilized stability of the composition Sufficient for use as a commer hydrogen peroxide. In some embodiments, the hydrogen per cially viable formulation. In some embodiments, the surface oxide may be a standard grade, food grade, chemical synthe tension modifying agent is an alcohol. In some embodiments, sis grade, semiconductor grade, high-test hydrogen peroxide the Surface tension modifying agent is 2-propanol. grade, antimicrobial grade, drinking watergrade, pharmaceu 0005 Embodiments herein also describe a method of tical grade or cosmetic grade hydrogen peroxide. In some treating a skin condition comprising administering a compo embodiments, the alcohol may be selected from a primary sition having up to about 50% hydrogen peroxide and an alcohol, a secondary alcohol, a tertiary alcohol, or a combi alcohol to a subject in need thereof. The skin condition may nation thereof. In some embodiments, the alcohol may be be a virally induced or non-virally induced cutaneous growth selected from 2-propanol, methanol, butanol. 1-propanol, or proliferation. The skin condition may be a benign neo pentanol, hexanol, octanol, nonanol, decanol. 2-pentanol, plasm, premalignancy or malignancy. The skin condition may 2-butanol, benzyl alcohol, ethanol, an isomer thereof, or a be an inflammatory condition. The skin condition may be a combination thereof. In some embodiments, the hydrogen hyperproliferative condition. The skin condition may be peroxide is in an amount up to about 50% of the composition. aging including intrinsic (e.g., chronological) and extrinsic In some embodiments the alcohol is in a quantity Sufficient to changes (e.g., photoaging, ultraViolet light induced changes). decrease the Surface tension of the composition. In some pigmentary changes, fine lines and rhytides. In some embodi embodiments, the alcohol is in an amount up to about 5% of ments, the skin condition may be selected from Human Pap the composition. In some embodiments, the composition is a illoma Virus induced lesions e.g., warts, common warts, pal Solution. In some embodiments, the composition is a gel moplantar warts, flat warts, recurrent warts, recalcitrant formulation. In some embodiments, the composition com warts, treatment naive warts, epidermodysplasia Verrucifor prises two or more separate components that may be admixed mis related warts, anogenital warts, condyloma accumina before, at, or near the time of use. tum, cervical dysplasias or neoplasias, e.g., cervical intraepi 0002 Some embodiments are directed to a topical com thelial neoplasia (CIN); Herpesvirus related lesions including position comprising up to about 50% hydrogen peroxide and those induced by HHV-1 (HSV-1), HHV-2 (HSV-2), HHV-3 up to 5% 2-propanol. In some embodiments, the hydrogen (varicella-Zoster virus) e.g., chicken pox, Herpes Zoster, peroxide is a stabilized hydrogen peroxide. In some embodi shingles; Poxvirus induced lesions e.g., molluscum contagio ments, the topical composition further includes a stabilizer. Sum, orf callus, cutaneous horns, corns, acrochordons, The stabilizer may be selected from stannate, sodium pyro fibroepithelial polyps, prurigo nodularis, actinic keratoses, phosphate, organophosphonate, nitrate, phosphoric acid, col squamous cell carcinoma, squamous cell carcinoma in situ, loidal silicate, any stabilizer known in the art, or a combina keratoacanthoma, basal cell carcinoma, cutaneous lympho tion thereof. In some embodiments, the 2-propanol is in an mas and benign lymphocytic infiltrates & hyperplasias of the amount Sufficient to decrease the Surface tension while mini skin, clear cell acanthoma, large cell acanthoma, epider mizing spread of the composition onto non-targeted skin molytic acanthoma, porokeratosis, hyperkeratosis, keratosis when applied to a targeted lesion. The composition may be pilaris lichenoid keratosis, acanthosis, acanthosis nigricans, stable for at least two years at 5°C., at least one year at 30°C., confluent and reticulated papillomatosis, nevi, including e.g., at least 6 months at 40°C., or a combination thereof. dermal nevi, epidermal nevi, compound nevi, ILVEN (in 0003. In some embodiments, the topical composition flammatory linear Verrucous epidermal nevi), nevus Seba comprises about 45% stabilized cosmetic-grade hydrogen ceous, nevus comedonicus, and the like; acne, e.g., come peroxide and about 5% 2-propanol, and wherein the topical donal acne, inflammatory acne, papular acne, pustular acne, composition has a surface tension of about 42 mNim-1 to cystic acne; cysts, e.g., epidermoid cysts, milia, trichilemmal about 55 mNim-1 at 37°C. In some embodiments, the topical cysts, follicular cysts, proliferating cysts, dermoid cysts, composition comprises about 40% stabilized cosmetic-grade pilonidal cysts, apocrine cysts, eccrine cysts, sebaceous cysts, hydrogen