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Transepidermal Waterloss (Tewl) 50 45 40 35 30 25 20 15 10 US 20080254150A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2008/0254150 A1 Rheins et al. (43) Pub. Date: Oct. 16, 2008 (54) MANAGEMENT OF DERMATITIC (60) Provisional application No. 60/920,604, filed on Mar. SYMPTOMIS OF MAMMALIAN 29, 2007. INTEGUMENT WITHEMIOLLENT DISINFECTANT FORMULATIONS Publication Classification (51) Int. Cl. (76) Inventors: Lawrence A. Rheins, Glendale, AZ A6IR 36/36 (2006.01) (US); John C. Hill, Mesa, AZ (US); A63L/045 (2006.01) David Ashley, Phoenix, AZ (US); A63L/047 (2006.01) James S. Brown, Gilbert, AZ (US); A6IP 700 (2006.01) John Reinhardt, Riverside, CA (US); James H. Brown, Phoenix, (52) U.S. Cl. .......................... 424/725; 514/724; 514/738 AZ (US) (57) ABSTRACT Correspondence Address: Botanically-sourced and botanically-derived emollient sani International Flora Technologies, Ltd. tation compositions for topical use are disclosed. Represen C/O Intellevate LLC tative compositions generally aid reconstitution of the lipid P.O. Box 52OSO profile of the stratum corneum by providing botanical lipids Minneapolis, MN 52050 (US) and/or lipid-derivatives that resemble human sebum these components being ordinarily diminished with the use of con ventional hand sanitizer products. Disclosed features and (21) Appl. No.: 12/080,070 specifications may be variously controlled, adapted or option ally modified to realize, for example, improved hand sanitizer (22) Filed: Mar. 31, 2008 formulations. Representative embodiments of the present invention generally provide anti-microbial compositions Related U.S. Application Data blended with botanically sourced lipids and/or lipid-deriva (63) Continuation-in-part of application No. 10/61 1,775, tives to control or otherwise improve dermatitic symptoms filed on Jun. 30, 2003, Continuation-in-part of appli associated with frequent use of conventional hand sanitizer cation No. 09/478,071, filed on Jan. 3, 2000. products. TRANSEPIDERMAL WATERLOSS (TEWL) 50 45 40 35 30 25 20 15 10 BASELNE DAY 7 DAY 14 Patent Application Publication Oct. 16, 2008 Sheet 1 of 4 US 2008/0254150 A1 TRANSEPIDERMAL WATERLOSS (TEWL) BASELINE DAY 7 DAY 14 FIG.1 Patent Application Publication Oct. 16, 2008 Sheet 2 of 4 US 2008/0254150 A1 TRANSEPIDERMALWATER LOSS (TEWL) 35 30 SF S 25 a 20 S. 15 m ... - : g 10 t 5 O BASELNE DAY 7 DAY 4 FIG.2 Patent Application Publication Oct. 16, 2008 Sheet 3 of 4 US 2008/0254150 A1 mu Ks foy s ...A. S. " FIG.3 Patent Application Publication Oct. 16, 2008 Sheet 4 of 4 US 2008/0254150 A1 400 US 2008/0254150 A1 Oct. 16, 2008 MANAGEMENT OF DERMATITC they generally operate to remove various Surface lipids from SYMPTOMS OF MAMMALIAN the uppermost region of the skin known as the stratum cor INTEGUMENT WITHEMIOLLENT neum. These lipids typically function to maintain homeo DISINFECTANT FORMULATIONS static balance of the skin. The chronic stripping of the lipid barrier usually results in Xerosis, Scaling, erythema, rough RELATED APPLICATIONS skin, and tight skin. More serious and painful side effects include inflammation, fissures, allergic contact dermatitis, 0001. This application claims the benefit of U.S. Provi and the harboring of transient pathogenic organisms that may sional Patent Application Ser. No. 60/920,604 filed in the cause infections. Common sensations associated with de United States Patent and Trademark Office on Mar. 29, 2007 lipidization include itching, tingling, burning, stinging, and by Lawrence A. Rheins, John C. Hill, Grace Hastings, James the like. Non-compliance that results from experiencing these H. Brown, and John Reinhardt, and is a continuation-in-part types of side effects with the use of conventional hand sani of U.S. patent application Ser. No. 10/61 1,775 filed in the tizers actually leads to further spread of diseases that hand United States Patent and Trademark office on Jun. 30, 2003 hygiene guidelines are promulgated with the intent of pre by John C. Hill and U.S. patent application Ser. No. 09/478, Venting. 071 filed in the United States Patent and Trademark Office on 0006. As a mechanism for addressing adverse side effects, Jan. 3, 2000 by James H. Brown, Lee Roy Copeland, Robert many individuals turn to moisturizers, corticosteroids, and Kleiman, Sambasivarao Koritala, and Melanie K. Cummings. the like; however, these mechanisms for replenishing mois ture and/or combating dryness and other skin irritations are of FIELD OF INVENTION limited efficacy when multiple hand cleansing cycles 0002 The present invention generally relates to emollient throughout the day are required. This is due to each cleansing and sanitation compositions; and more particularly, represen cycle operating to remove the previously applied moisturizers tative embodiments of the present invention generally con as they sit on the uppermost surface of the skin—thereby cern delivery of emollients in topically applied disinfectant reducing the exposure of the skin to the moisturizer and the formulations. moisturizer's overall effectiveness. Accordingly, there is a need for alternative sanitizer formulations to reduce the nega BACKGROUND OF INVENTION tive effects associated with frequent washing while maintain 0003. The spread of infectious disease due to inadequate ing effective disinfectant function. hand hygiene is generally acknowledged by the scientific community and accepted by the public at large. As reported SUMMARY OF THE INVENTION by the United States National Institute of Allergy and Infec 0007. In a representative aspect, the present invention pro tious Diseases in 2006, the escalating incidence of nosoco vides compositions and methods for providing botanically mial acquired infections by patients lead to approximately Sourced and/or botanically-derived topical emollient compo two million (2,000,000) hospital acquired infections per year sitions with disinfectant properties to ameliorate dermatitic and approximately ninety thousand (90,000) deaths in the symptoms of mammalian integument. The sanitizing compo United States alone, as compared to about thirteen thousand nent of the composition may include an anti-microbial sani (13,000) deaths in 1992. This is especially disturbing due to tizer. The emollient component of the composition may the rapid development and spread of antibiotic-resistant bac include botanical lipid materials (and/or their derivatives) teria, fungi, and parasites as well as antiviral, drug-resistant selected to demonstrate properties at least partially analogous viruses. Antibiotic resistant strains of disease-causing bacte to mammalian sebum. The combination of Sanitizing and ria, Such as Staphylococcus aureus, are now commonly emollient components of the resulting formulations may be acquired in hospital settings due to close contact of patients employed to manage dermatitic symptoms and sanitize mam who are more susceptible to infection and the extensive use of malian integument. antibiotics, which generally provide selection pressure for 0008 Advantages of the present invention will be set forth these strains of bacteria. Consequently, people infected with in the Detailed Description which follows and may be appar these microbes are likely to have longer hospital stays and ent in view of the Detailed Description or may be learned by may require treatment with second- and third-choice antibi practice of exemplary embodiments of the invention. Still otics that may be less effective and more expensive. other advantages of the invention may be realized by means of 0004. Despite the knowledge that frequent hand washing any of the instrumentalities, methods or combinations par is an effective preventative measure against the spread of ticularly pointed out in the claims. disease-causing microbes, a significant level of healthcare worker non-compliance persists. Although most workers in BRIEF DESCRIPTION OF THE DRAWINGS the healthcare industry are regulated by policies requiring frequent hand washing and/or the use of liquid hand sani 0009 Representative elements, operational features, tizers, non-compliance with these policies has been reported applications and/or advantages of the present invention reside to be between 45% and 70%. A prominent reason cited for in the details of construction and operation as more fully non-compliance is the incidence of acute and chronic irritated hereafter depicted, described and claimed reference being skin and, to a lesser extent, contact allergic hand dermatitis made to the accompanying drawings forming a part hereof, due to repeated use of antibacterial Soaps and the use of wherein like numerals refer to like parts throughout. Other alcohol-based (either ethanol or isopropanol, 60%-95% elements, operational features, applications and/or advan wit/wt) hand sanitizers. The use of these sanitizers can be as tages may become apparent in light of certain exemplary high as fifty or more times during each work day. embodiments recited in the Detailed Description, wherein: 0005. A negative side effect of the use of conventional 0010 FIG. 1 illustrates clinical data relating to transepi ethanol hand sanitizers, upon application to the skin, is that dermal water loss (TEWL) associated with use and non-use of US 2008/0254150 A1 Oct. 16, 2008 an emollient sanitizing formulation in accordance with a rep cosmetic, a pharmaceutical, a topical medicament, a personal resentative embodiment of the present invention; care product, a shampoo, a conditioner, a leave-in condi 0011 FIG. 2 illustrates clinical data relating to TEWL tioner, a hair product, a hair-styling product,
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