CORAL GABLES, Fla., March 3 /PRNewswire/ -- Stiefel Laboratories, the world’s largest independent pharmaceutical company specializing in dermatology, announced that a recent study shows MimyX(TM) Cream extends the remission period of atopic dermatitis (AD) by 48 percent when used in conjunction with an emollient compared to emollient alone. MimyX(TM) Cream, Stiefel’s new product for managing the signs and symptoms of atopic dermatitis, is a steroid-free, topical Rx therapy for the management of the disease, commonly referred to as eczema.
Most eczema patients will experience periods of “flares” where they have noticeable signs and symptoms of AD alternating with periods of remission where no symptoms are present. According to the 12-week MimyX study involving 74 individuals, MimyX(TM) Cream extends AD remission by 48 percent and may actually reduce the total number of flares a person experiences. The study also shows a 25 percent greater incidence of AD flare-ups on the side of the body where only an emollient was used, as opposed to the side of the participant’s body where MimyX(TM) Cream was used in conjunction with an emollient.
“The data collected in this study is very beneficial for understanding and managing atopic dermatitis,” said Dr. Joseph Fowler, University of Louisville. “By extending the remission of eczema, we can reduce the total number of flares a patient may experience, and quite possibly lessen the need for adjunctive therapy such as steroids, immunomodulators and systemic antihistamines.”
MimyX(TM) Cream is unique from other eczema treatments in that it can be used throughout the AD continuum. MimyX(TM) Cream can be used along with a short-term anti-inflammatory agent during flares and it can also be used without the anti-inflammatory for daily management during remission. (1)
According to Jim Hartman, Vice President, U.S. Marketing, Stiefel, this is a significant finding.
“This study justifies MimyX(TM) as a potential foundation therapy for atopic dermatitis,” Hartman said. “Not only is it useful for the management of the signs and symptoms of AD, it has also been shown clinically to extend remission periods of the disease.”
Time To Flare Study Background
The objective of the MimyX(TM) Cream Time to Flare (TTF) study was to determine the efficacy of twice daily application of MimyX(TM) Cream added to twice daily emollient maintenance therapy in reducing the risk of relapse of chronic AD. Specifically, the addition of MimyX(TM) Cream to emollient therapy was compared to emollient therapy alone with regard to time until flare.
This was a six-center, investigator-blinded, randomized bilateral study in which subjects with AD were assigned to one of two groups. Group 1 applied MimyX(TM) Cream twice daily to all affected areas on the right side of the body. Group 2 applied MimyX(TM) Cream twice daily on all affected areas on the left side of the body. After applying MimyX(TM) Cream, subjects in both groups applied a non-medicated emollient (Eucerin(R) Cream) twice daily to the same areas on both sides of the body and any other areas of dry skin. Therapy occurred over a 12-week period with examinations of the subjects initially (week 0, visit 1) and at weeks 2, 4, 6, 8, 10 and 12 (visits 2-7). Rescue medication (Triamcinolone Cream 0.1%) was provided in the event of flare.
Approximately 4 percent of patients experienced adverse events (possibly or probably) related to the use of MimyX Cream like burning (n=1), uticaria (n=1) and headache (n=1) during the study.
About Atopic Dermatitis
Atopic dermatitis is often simply referred to as “eczema.” It is characterized by extremely itchy skin that leads to persistent scratching. That scratching produces redness, swelling, cracking, “weeping” of clear fluid, and finally, crusting and scaling.
According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), more than 15 million people in the U.S. have symptoms of atopic dermatitis. In addition, children are more commonly affected than adults, with 90 percent of atopic dermatitis cases diagnosed by age 5. Roughly 60 percent of infants affected continue to have one or more symptoms of atopic dermatitis into adulthood. (2)
NIAMS researchers project that U.S. health insurance companies spend more than $1 billion per year on atopic dermatitis. Atopic dermatitis has also been found to affect patient quality of life due to its uncomfortable symptoms and how it alters physical appearance.
About MimyX(TM) Cream
MimyX(TM) Cream’s unique approach is clinically proven to relieve the signs and symptoms of atopic dermatitis. In addition, essential ingredients found within MimyX(TM) Cream mimic natural components of the stratum corneum, thus helping repair and restore skin barrier function. The end result is a safe, effective, hypoallergenic product that restores barrier function while relieving the signs and symptoms of atopic dermatitis without adversely affecting the patient’s immune system. The product also contains no emulsifiers, perfumes or dyes that might affect sensitive/allergic patients.
MimyX(TM) Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. MimyX(TM) Cream is contraindicated in patients with known hypersensitivity to any of the components of the formulation. In radiation therapy, MimyX(TM) Cream may be applied as indicated by the treating Radiation Oncologist. Do not apply 4 hours prior to a radiation session. MimyX(TM) Cream does not contain a sunscreen and should not be used prior to extended exposure to the sun. For external use only.
About Stiefel Laboratories, Inc.
Founded in 1847, Stiefel Laboratories is the world’s largest independent pharmaceutical company specializing in dermatology. Its wholly-owned global network is comprised of more than 30 subsidiaries, including: manufacturing plants in six countries; R&D facilities on three continents; and products marketed in over 100 countries worldwide.
Stiefel supplements its R&D by aggressively seeking acquisitions of dermatological product lines and companies around the world. To learn more about Stiefel, visit www.stiefel.com.
References
1. 2006 MimyX Medical Education Slide Kit, data on file.
2. U.S. Department of Health and Human Services National Institutes of Health. Atopic Dermatitis (A type of eczema). Available at: http://www.niams.nih.gov/hi/topics/dermatitis/AtopicDerm.pdf. Accessed July 26, 2005.
Stiefel Laboratories
CONTACT: Erin Bacher of Ogilvy Public Relations Worldwide,+1-404-881-2324, or erin.bacher@ogilvypr.com, for Stiefel Laboratories
Web site: http://www.stiefel.com/