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Epithera® General Information
Technical Bulletin June 2003 TB9-03
Introduction
Agricultural, cosmetic, veterinary and medical use of emu-based products has soared in the last decade. This Technical Bulletin addresses the use of EpiThera® , which is a new, patented emu-oil based topical spray for use in human applications of wound healing. University laboratory testing has proven EpiThera® to have anti-microbial, bactericidal, antiseptic, and antifungal properties. EpiThera® , originally tested for human use under the label TopicAid® was patented in 2002, and is being used extensively in a variety of professional and in-home settings with superior results in promoting wound healing and reducing scarring.
How Skin Wounds are Healed
Healing of a skin wound in humans is a mixture of regeneration (creation of the same cell types as originally damaged) and replacement (substitution of a new cell type for an old one). Scarring is the result of replacement, so the more regeneration that can occur, the less scarring will be left behind after wound healing.
Wound healing typically follows a fairly typical time course in mammals, though the presence of pathogens can lengthen the recovery time (Hackam and Ford, 2003). Generally, within a few minutes of the initial damage to the tissue, which almost always results in trauma to blood vessels, a plug of platelets and other blood products (blood clot) forms at the site of tissue damage and stops further loss of blood.
Within hours of receiving the wound, debris-eating white blood cells called neutrophils have invaded the area of damage, signaling the start of the inflammation response. Inflammation is a series of events that includes increased blood flow, increased blood vessel permeability, activation of pain receptors and intense consumption of cell debris and bacteria by neutrophils and other white blood cells. Neutrophils ingest introduced bacteria and dead and dying cells in the wound, and are themselves killed in the process. The accumulating mixture of dead neutrophils and fluid forms pus. Typically within a few days, the surface of the clot has dried to form a scab. Now macrophages (another type of specialized white blood cell) infiltrate the wound, where they ingest dead neutrophils and other cellular debris.
Within a week after the wound occurred, tough, fibrous cells called fibroblasts move in from surrounding connective tissue and start to multiply at the wound site. The fibroblasts begin to secrete collagen fibers. At the same time, new epidermis begins to regenerate. New endothelial cells from neighboring undamaged tissue begin to form new capillaries that grow into the repairing wound site to supply blood to the newly forming epidermis.
Within a few weeks, the rapidly dividing epidermis completely lines the original wound site. The fibroblasts generate new connective tissue (scar tissues), which replaces the epidermis destroyed by the wound. Scar tissue persists after the healing of particularly severe wounds.
The rapidity and effectiveness of skin wound repair depends on several factors (Burns et al., 2003). Proper nutrition is essential (Russell 2001). Vitamins C, D, E, and K all play important roles at some stage in the tissue repair process (Casey, 2003). Agents that increase cell division, such as the emu oil found in EpiThera®, will also hasten wound healing (Snowden et al., 1997; Politis and Dmytrowich, 1998; Lopez et al., 1999).
Background: Emu Oil in Healthcare
A growing appreciation of the superior nutritional characteristics of emu meat (Fukushima et al., 1999; Daniel et al., 2000; Beckerbauker, 2001) has led to a considerable increase in the number of emus raised in both the US and abroad (especially Australia, where he emu is indigenous). Associated with the rising popularity of emu meat as a food product is an increase in the production of commercial and fully refined oil rendered from the copious amounts of subcutaneous fat in the slaughtered bird.
Emu oil based cosmetic and health products, which have burgeoned in recent years, derive their popularity from the numerous positive properties of emu oil. These include scientifically supported descriptions of cosmetic applications as a skin moisturizer (Zemtsov, 1996) and skin restorer. (Snowden et al., 1997; Politis and Dmytrowich, 1998; Lopez et al., 1999).
The Emu Oil Institute additionally provides anecdotal reports on their web site (www.emu-oil.com) of emu oil's benefits in symptomatic relief and treatment of a variety of skin ailments, including eczema, psoriasis, rosacea, ichthyosis, alopecia areata, as well as other skin and superficial diseases that can be treated with anti-inflammatory substances.
Introduction of Products
Lucid Med Tec II, Ltd. a Texas-based veterinary and medical pharmaceutical company introduced TopicAid® for human use in late 2002. The name was changed to EpiThera® in 2004. EpiThera® is a patented, topically applied, spray containing emu oil and other active ingredients. EpiThera® is effective in the symptomatic relief and treatment of chronic cutaneous ulcers, burns, mechanical wounds and abrasions in humans. This patented product is also suitable for application to fresh wounds and surgical incisions. It can also be used to accelerate already healing wounds.
Mode of Action
The oleic-rich emu oil within EpiThera® enables epidermal tissue to regenerate, restore, and rebuild in the wound itself and in underlying dermal and subcutaneous tissue, thereby fortifying non-necrotic epidermal and dermal cells, and revitalizing potential necrotic cells. (Snowden et al., 1997; Politis and Dmytrowich, 1998; Lopez et al., 1999). A major clinical benefit of EpiThera® is reduced wound sepsis rates due to the formulation's proven antibacterial properties (D. Kunz, unpub.).EpiThera®also provides improved rates of wound closure (including surgical incisions) and reduced healing times. The formula reduces wound debridement and increases epidermal cell proliferation, while maintaining and feeding skin cells. Reduced scarring is evident, leading to improved function (e.g. range of motion, contour and profile of healed skin, normalization of skin pigmentation).
Product Formulation
EpiThera® is a proprietary health product made from fully refined emu oil as a transdermal facilitator. Also containing benzyl alcohol, C12-15 alkyl benzoate, allantoin, methylparaben and propylparaben, EpiThera® is formulated into convenient topical spray.
The composition of purified, fully refined emu oil is well characterized, and comprises approximately 70% unsaturated fatty acids. The primary fatty acid by % composition is oleic acid (49%), a known penetration enhancer (PE) for transportation of compounds through dermal pores in human skin, and thus, in delivering the active ingredients into the highly perfused subcutaneous layers (Touitou et al., 2002; Jiang, and Zhou, 2003). The lipid composition of emu oil is presented in the following table:
Emu oil closely reflects the lipid composition of mammal skin (including that of humans), which likely contributes to its rapid and effective transdermal migration.
The considerable similarity between the fatty acid composition of emu oil and human skin, combined with the large concentration of oleic acid, contributes to the skin penetrating powers of emu-oil based products, including EpiThera®
Research Studies
Lucid Med Tec II, Ltd. has developed a patented line of veterinary (equine and dog) and human wound healing products. A major R&D goal is to expand and improve upon the relatively few numbers of professionally conducted biomedical experiments that currently support the voluminous anecdotes and testimonials accompanying non-patented emu- oil based health products.
Lucid Med Tec II recently sponsored an investigation at a microbiology laboratory at the University of North Texas (Denton, Texas). This investigation has conclusively proven that EpiThera® has statistically significant, and potent, anti-bacterial properties. It is especially effective against Staphylococcus aureus, Escherichia coli and Pseudomonas sp. ( all common pathogens in human wounds; Jacks et al., 2003).
A second investigation funded by Lucid Med Tec II, Ltd. and currently underway involves a clinical trial at a respected Midwestern School of Veterinary Medicine, to determine the effectiveness and mechanism of action of EpiThera® in small mammals.
Product Application & Dosage
EpiThera® is designed to be applied as a drenching spray directly onto the affected area twice daily or as needed. More frequent applications may be indicated when a partial thickness wound is large, or for a surgical incision.
Shelf Life
The shelf life of EpiThera® has been determined to be at least 2 years at 60?-86? F (15?-30? C). Products may be refrigerated, but should be warmed to room temperature for application.
Contraindications
No contraindications have emerged in two years of field trialsof EpiThera® . Lucid Med Tec II does not know of any product failure such as adverse reactions, non-performance, or environmental hazards.
Production of Emu Oil For EpiThera®
Emu oil, a food byproduct, is an all-natural substance obtained from the fat of the emu, a ratite bird related to the ostrich, rea and cassowary. Many emu oil products currently used in medical and veterinary medicine have not been refined, but instead are simply rendered. In the rendering process, the oil is only filtered, leaving contaminants within the final product.
EpiThera® , on the other hand, uses high quality, fully refined emu oil produced through an expensive, multi-step process of refinement and deodorization. This yields a pure, creamy white and odor-free oil. Additionally, the emu oil in EpiThera® has been formulated for use as a preparation for treatment of open, potentially septic wounds.
Conclusion
EpiThera® is a cost-effective, easily applied topical spray that promotes healing of surgical incisions, mechanical wounds and abrasions, and burns. Wound healing is accelerated, and the ultimate appearance of the wound site is such that scar tissue formation is greatly reduced.
References
Beckerbauer, L.M., Thiel-Cooper, R., Ahn, D.U., Sell, J.L., Parrish, F.C. Jr., Beitz, D.C. 2001. Influence of two dietary fats on the composition of emu oil and meat. Poultry Science Feb;80(2):187-94.
Burns, J.L., Mancoll, J.S., Phillips, L.G. 2003. Impairments to wound healing. Clinical Plastic Surgery. 30(1):47-56.
Casey, G. 2003. Nutritional support in wound healing. Nursing Standards 17(23):55-8.
Daniel, D.R., Thompson, L.D., Hoover, L.C. 2000. Nutrition composition of emu compares favorably with that of other lean meats. Journal American Diet. Association. Jul;100(7):836-8.
Fukushima, M., Ohashi, T., Sekikawa, M., Nakano, M. 1999. Comparative hypocholesterolemic effects of five animal oils in cholesterol-fed rats. Bioscience, Biotechnoogicy and Biochemistry. Jan;63(1):202-5.
Hackam, D.J., Ford, H.R. 2002. Cellular, biochemical, and clinical aspects of wound healing. Surgical Infection (Larchmt). 3 Suppl 1:S23-35.
Jacks, S.S., Giguere,S., Nguyen, A. 2003. In vitro susceptibilities of Rhodococcus equi and other common equine pathogens to azithromycin, arithromycin, and 20 other antimicrobials. Antimicrob Agents Chemother. 47(5):1742-5.
Jiang, S.J., Zhou, X.J. 2003. Examination of the mechanism of oleic Acid-induced percutaneous penetration enhancement: an ultra structural study. 2003. Biological and Pharmacological Bulletin. 26(1):66-8.
Lopez, A., Sims, D.E., Ablett, R.F., Skinner, R.E., Leger, L.W., Lariviere, C.M., Jamieson, L.A., Martinez-Burnes, J., Zawadzka, G.G. 1999. Effect of emu oil on auricular inflammation induced with croton oil in mice.
American Journal of Veterinary Research Dec;60(12):1558-61.
Politis, M.J., Dmytrowich, A. 1998. Promotion of second intention wound healing by emu oil lotion: comparative results with furasin, polysporin, and cortisone. Plastic Reconstructive Surgery Dec;102(7):2404-7.
Russell, L. 2001. The importance of patients' nutritional status in wound healing.
British Journal of Nursing. 10(6 Suppl):S42, S44-9.
Snowden, J.M., Whitehouse, M.W. 1997. Anti-inflammatory activity of emu oils in rats. Inflammopharmacology ;5:127-132.
Touitou, E., Godin, B., Karl, Y., Bujanover, S., Becker, Y. 2002. Oleic acid, a skin penetration enhancer, affects Langerhans cells and corneocytes. Journal of Controlled Release. 23;80(1-3):1-7.
Zemtsov, A., Gaddis, M., Montalvo-Lugo, V.M., Zemstov, A. 1996. Moisturizing and cosmetic properties of emu oil: a pilot double blind study. Australasian Journal of Dermatology Aug;37(3):159-61.
EpiThera® is a registered trademark of Lucid Med Tec II, Ltd.
