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(12) United States Patent (10) Patent No.: US 7,399,783 B2 Rosenbloom (45) Date of Patent: Jul

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(12) United States Patent (10) Patent No.: US 7,399,783 B2 Rosenbloom (45) Date of Patent: Jul US007399.783B2 (12) United States Patent (10) Patent No.: US 7,399,783 B2 Rosenbloom (45) Date of Patent: Jul. 15, 2008 (54) METHODS FOR THE TREATMENT OF SCAR Quercetin: Implications for the Treatment of Excessive Scars.” TSSUE Internet Web Page, vol. 57(5); Nov. 2004. Marilyn Sterling, R.D., Article: Science Beat, Internet Web Page, (75) Inventor: Richard A. Rosenbloom, Elkins Park, Natural Foods Merchandiser vol. XXIV, No. 10, p. 50, 2003. PA (US) Phan TT. See P. Tran E. Nguyen TT, Chan SY. Lee ST and Huynh H., PubMed, Internet Web Page, “Suppression of Insulin-like Growth (73) Assignee: The Quigley Corporation, Doylestown, Factor Signalling Pathway and Collagen Expression in Keloid-De rived Fibroblasts by Quercetin: It's Therapeutic Potential Use in the PA (US) Treatment and/or Prevention of Keloids.” Br. J. Dermatol., Mar. 2003, 148(3):544-52. (*) Notice: Subject to any disclaimer, the term of this Crystal Smith, Kevin A. Lombard, Ellen B. Peffley and Weixin Liu; patent is extended or adjusted under 35 "Genetic Analysis of Quercetin in Onion (Allium cepa L.) Lady U.S.C. 154(b) by 440 days. Raider.” The Texas Journal of Agriculture and Natural Resource, vol. 16 pp. 24-28, 2003. (21) Appl. No.: 11/158,986 Skin Actives Scientific L.L.C., Internet Web Page, “Quercetin.” Quercetin by Skinactives, printed on Apr. 10, 2006. (22) Filed: Jun. 22, 2005 Saulis, Alexandrina S. M.D.; Mogford, Jon H. Ph.D.; Mustoe, Tho mas A., M.D., Plastic and Reconstructive Surgery, “Effect of (65) Prior Publication Data Mederma on Hypertrophic Scarring in the Rabbit Ear Model.” Jour US 2006/O293257 A1 Dec. 28, 2006 nal of the American Society of Plastic Surgeons, vol. 110, No. 1, pp. 177-183, Jul. 2002. Ageless Herbal Products, “Herbal Stretch Mark Gel.” Internet Web (51) Int. Cl. Advertisement, printed Apr. 11, 2006. AOIN 43/16 (2006.01) Advanced Stretch Marks Lotion with Top Firming Ingredients, A6 IK3I/35 (2006.01) "Stretch Marks Solved by Botanical Body.” Internet Web Advertise AOIN 43/04 (2006.01) ment, printed Apr. 11, 2006. A61 K3 L/70 (2006.01) What VitaminsareRightforYou.com; Stretch Marks; Internet Webpp. (52) U.S. Cl. ......................... 514/457; 514/27: 514/449; 1-4, 2004. 514/451; 514/453: 514/456 Removal Treatment for Stretch Marks, “StretchRenew.com': (58) Field of Classification Search ........... ... None Internet Web Advertisement, pp. 1-6, 1998. See application file for complete search history. Revitol: Stretch Mark Cream: Review; Stretch-Mark-Guide.com; Internet Web Advertisement, 1 page, printed Apr. 10, 2006. (56) References Cited Stretch Mark Solutions, Internet Web Page/Advertisement, 3 pages, U.S. PATENT DOCUMENTS Jan. 24, 2006. Elliott Middleton, Jr., Chithan Kandaswami and Theoharis C. 5,639,740 A * 6/1997 Crandall ...................... 514,78 Theoharides, The effects of Plant Flavnoids on Mammalian Cells. 5,928,659 A 7/1999 Moy Implications for Inflammation, Heart Disease and Cancer, vol. 52, 6,753,325 B2 * 6/2004 Rosenbloom ............... 514,167 Issue 4, 673-751, Dec. 2000. 7,083,813 B2 * 8/2006 Rosenbloom .. 424,725 2003/0049283 A1* 3/2003 Vandell ...................... 424/401 * cited by examiner 2004/O151793 A1 8/2004 Paspaleeva-kuhn et al. Primary Examiner Patrick T Lewis (74) Attorney, Agent, or Firm—Knoble, Yoshida & Dunleavy, OTHER PUBLICATIONS LLC Mohamed Hany El-Tonsy, MD and Arthur C. Huntley, MD, Egyptian Dermatology Online Journal, 2005, Internet Web Page, pp. 1-3, vol. (57) ABSTRACT 1. No. 1. Published by Mohamed Hany El-Tonsy, MD, Egypt. Maha F. El Goweini, MD and Nagwa M. Nour El Din, MD, Egyptian Dermatology Online Journal 1 (1):5: “Effect of Quercetin on Exces A topical composition and method for the reduction of scar sive Dermal Scarring.” Internet Web Page, pp. 1-9, vol. 1, No. 1, tissue and/or improving the appearance of scar tissue after it 2004. has formed. The topical composition includes one or more Toan-Thang Phan, MD, LiSun, MD, Boon-Huat Bay, PhD, Sui-Yung flavonoids formulated in a pharmaceutically acceptable topi Chan, PhD, and Seng-Teik Lee, FRCS, FAMS; The Journal of cal carrier. The method includes the step of topically applying Trauma Injury, Infection and Critical Care, "Dietary Compounds a composition including one or more flavonoids formulated in Inhibit Proliferation and Contraction of Keloid and Hypertrophic a pharmaceutically acceptable topical carrier to Scar tissue to Scar-Derived Fibroblasts. In Vitro: Therapeutic Implication for reduce the amount of, or improve the appearance of the scar Excessive Scarring.” vol. 54, No. 6, pp. 1212-1224. Jun. 2003. tissue. The topical compositions and methods of the present Phan, Toan-Thang MD, PhD; Lim, Ivor Jiun MD, FRCS; Chan, invention reduce Scar tissue after it has formed as well as Sui-Yung PhD; Tan, Ee-Kim BSc; Lee, Seng-Teik MD, FRCS and improving the appearance of the remaining scar tissue. Longaker, Michael T. MD, FRCS, The Journal of Trauma Injury, Infection and Critical Care, “Suppression of Transforming Growth Factor Beta Smad Signaling in Keloid-Derived Fibroblasts by 14 Claims, No Drawings US 7,399,783 B2 1. 2 METHODS FOR THE TREATMENT OF SCAR process of healing, e.g. application to already formed scar TSSUE tissue that forms part of a healing wound. The term "scar tissue' is used to refer to the connective BACKGROUND OF THE INVENTION tissue that forms a scar and which consists primarily of fibro blasts in new scars, and collagen fibers in older Scars. Scar 1. Field of the Invention tissue is generally characterized by red discoloration, edema, The present invention relates to compositions and methods irritation and dehiscence. Patients afflicted with scar tissue for the cosmetic treatment of scar tissue. More specifically, typically have visible indications of past wounds located on the method of the present invention, relates to the topical their skin. application of at least one flavonoid to Scar tissue. 10 The term "derivatives, as used herein, refers to structurally 2. Brief Description of the Prior Art similar compounds that exhibit a common activity (e.g., anti Damage or injury to skin tissues and/or organs is a common oxidant) and contain at least one significant, common struc occurrence. The body is most often able to isolate the dam tural element with the compound from which it is derived, aged area and then repair itself by removing and replacing which common structural element provides the common damaged tissue. Injury to tissues and organs can originate 15 activity. from a great variety of sources such as, for example, trauma, The expression “therapeutically effective amount as used UV degradation, toxic and/or pathogenic degradation, ther herein, refers to a nontoxic amount of a compound, which is mal degradation (e.g. excessive heat or cold) and so forth. sufficient to provide the desired therapy to promote the cos While the body has an impressive array of response mecha metic improvement of scar tissue. A therapeutic amount may, nisms that limit tissue damage and promote repair, methods of for example, reduce the amount of scar tissue, or affect one or increasing the speed and degree of repair are continually more characteristics of the scar tissue to thereby render the being sought out. Additionally, the presence of scar tissue can scar tissue less visible or noticeable. The exact amount be unsightly, and the reduction of scar tissue is aesthetically required may vary, depending on the species, age, and general desirable. In this regard, increasing the speed and/or degree condition of the patient, the nature of the complications, the that scar tissue is removed is beneficial in that it (i) decreases 25 particular combination of compounds, the mode of adminis the visibility of unsightly tissue; (ii) decreases the chances of tration, and the like. developing an infection or other ailment through re-injury of As used herein, a “pharmaceutically acceptable' compo the scarred area or the Surgical removal of scar tissue; and (iii) nent is one that is Suitable for use with humans and/or animals reduces health costs associated with treating such conditions. without undue adverse side effects (such as toxicity, irritation, Although compounds exist for promoting the healing of 30 and allergic response) commensurate with a reasonable ben wounds, there exists a continuing need for additional and/or efit/risk ratio. improved compounds for treating and/or reducing scartissue. The term "stable” as used herein refers to the property of Accordingly, it is an object of certain embodiments of the retaining at least a portion of the intended activity over a present invention to provide a composition that is effective for certain period of time. the treatment of scar tissue. 35 The terms “mixture.” “composition” and “formulation' as It is an object of other embodiments of the present inven used herein refer to stable mixtures, compositions, and for tion to provide a method that is effective for the treatment of mulations, respectively. Preferred mixtures, compositions, scar tissue and formulations are stable over a period of at least about three months. SUMMARY OF THE INVENTION 40 Scar tissue may be formed as a result of injury or damage to the human body caused by a break in the skin. Such injury In a first aspect, the invention relates to a method for the or damage may include cuts and bruises, or skin damage reduction or treatment of scar tissue comprising the step of caused by infections, burns, scrapes, allergic reactions, acne, topically applying to scar tissue, a composition which com bites Such as animal, human or insect, Surgical incisions, and prises a therapeutically effective amount of one or more fla 45 the like. Scar tissue forms as skin heals after an injury or vonoids.
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