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National Psoriasis Foundation Release: Clinical Study Of Drug-Free Psoriasis Treatment Under Way


4/4/2006 10:27:10 AM

PORTLAND, Ore., April 3 /PRNewswire/ -- Clinical studies of a drug-free treatment for psoriasis are under way to investigate the role of a "medical food" treatment to manage the symptoms of psoriasis, a common, chronic, inflammatory skin disorder.

Led by Steven Feldman, M.D., Ph.D., and a research team at Wake Forest University School of Medicine, the study will look at Dermal Advantage(TM) in a randomized, double-blind trial to analyze the role of Lactobacillus, or "friendly bacteria," in treating mild to moderate non-scalp psoriasis. A specific Lactobacillus strain, which is part of the Dermal Advantage formula, has proven to positively modulate the gut-triggered inflammatory response in diseases such as inflammatory bowel disease, Crohn's disease and osteoarthritis. Inflammatory diseases rely on the same biochemical mechanisms, although they manifest in vastly different symptoms. Dr. Feldman's research, funded by the National Psoriasis Foundation, will look for the same positive effect in relieving psoriasis symptoms.

"We're just beginning to understand the role of the immune system in many inflammatory diseases," explained Dr. Feldman. "Triggers of immunity, and eventually inflammation, may occur in the digestive tract because that is where the body first encounters many new pathogens and toxins in the food we eat."

According to Gail M. Zimmerman, president and CEO of the National Psoriasis Foundation, "Clinical studies are not always conducted on products such as this. We are grateful for the dedication of researchers like Dr. Feldman to conduct rigorous studies to determine if this medical food is a beneficial treatment for psoriasis patients."

Study Plan

The study will randomize approximately 40 subjects with mild to moderate plaque-type psoriasis (less than or equal to 10% body surface area), who will receive either an active nutritional supplement (Dermal Advantage) or a placebo. Subjects will take a treatment orally once per day for 12 weeks. Researchers will assess outcomes including target lesion assessment, investigator global assessment, pruritus and subject global assessment.

Need for New Treatments

Current and standard treatments for psoriasis, such as topical medications and phototherapy, have limitations, and over time psoriasis tends to resist its treatments. Patients often turn to complementary or alternative methods for psoriasis treatment. Popular dietary supplements include: fish oil capsules, evening primrose oil, milk thistle, oregano oil and shark cartilage.

About Dermal Advantage

Classified as a medical food, Dermal Advantage contains a strain of bacteria found in many common foods and is defined by the U.S. Food and Drug Administration as "generally recognized as safe" (GRAS). The benefits of good bacteria treatments for irritable bowel syndrome, Crohn's disease and other inflammatory conditions of the intestine are well-known and documented. However, two years ago, a team of researchers in Israel hypothesized that the same benefit could be achieved for non-digestive inflammatory diseases, such as psoriasis. They were able to ameliorate arthritis in rats using a strain of good bacteria known to reduce inflammation.

Dermal Advantage, manufactured by Ganeden Biotech, is available at area retailers. To find a retailer near you, visit Ganeden's Web site at www.GanedenBiotech.com.

About Psoriasis

Psoriasis is a noncontagious, genetic skin disease that results when faulty signals in the immune system prompt skin cells to regenerate too quickly, causing red, scaly lesions that itch, crack and bleed. It often affects the elbows, knees, scalp and torso but can appear anywhere on the body. Ten percent to 30 percent of people with psoriasis also develop psoriatic arthritis, which causes pain, stiffness and swelling in and around the joints. There is no cure yet for these chronic diseases, which can disrupt daily life and are debilitating for some people.

About the National Psoriasis Foundation

The National Psoriasis Foundation is a patient-driven, nonprofit organization dedicated to improving the quality of life of more than 5 million Americans diagnosed with psoriasis and/or psoriatic arthritis, and their families. For more information, contact the Psoriasis Foundation, headquartered in Portland, Ore., at 800.723.9166, or visit www.psoriasis.org.

National Psoriasis Foundation

CONTACT: Paula Fasano of National Psoriasis Foundation, +1-503-546-8413;or Gerti Soderquist of Ganeden Biotech, +1-440-229-5214



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Psoriasis

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