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| |  Betamethasone Valerate Foam Effective In Some Psoriasis Patients DETROIT, MI -- February 9, 2000 -- A foam formulation currently used for corticosteroid-responsive dermatoses of the scalp also effectively treats psoriasis on other parts of the body, according a study presented today at the Skin Disease Education Foundation's 24th Annual Hawaii Dermatology Seminar.
Seventy percent of study participants demonstrated a good-to-excellent improvement in psoriasis located on elbows, knees or the torso when treated with Luxiq(TM) (betamethasone valerate) Foam, 0.12%. In comparison, only 24 percent of the same patients showed similar results with placebo treatment. "These findings on betamethasone valerate foam should provide encouragement for those seeking an effective and convenient treatment for psoriasis throughout the body. Clinicians could potentially offer their patients a single, cosmetically elegant product that does not interfere with their appearance in any appreciable way," said Linda Stein, MD, Associate Director of Clinical Research, Department of Dermatology, Henry Ford Hospital, who presented the study findings today. "In the past, we've had to prescribe The other investigator in the study was Alice B. Gottlieb, MD, PhD, Director, Clinical Research Center, W.H. Conzen Chair in Clinical Pharmacology, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, New Brunswick, New Jersey. The two-center, double blind, placebo-controlled, paired-comparison study evaluated 37 patients with mild-to-moderate, plaque-type psoriasis in the same anatomical region on both sides of their body. Participants were treated simultaneously with the betamethasone valerate (BMV) foam and placebo foam, which were randomly assigned to either the right or left side of the body and administered twice daily for 12 weeks. At the end of the treatment period, a Global Assessment of Response to Treatment was used to evaluate the severity of the signs and symptoms of psoriasis (erythema, scaling, plaque thickness and pruritus) on each side of the body. Overall, 70 percent of subjects had a good-to-excellent response (or a greater than 50 percent improvement) on the side treated with the BMV foam compared to 24 percent of subjects with a similar response on the side treated with placebo. In another significant finding, a composite severity score evaluating erythema, scaling and plaque thickness on the elbows (a common site for psoriasis) was reduced from 7.0 to 4.0 among patients treated with the BMV foam. In contrast, the reduced score among patients treated with placebo, from 7.0 to 6.3, was not significant. Previous clinical trials have shown that 72 percent of patients using BMV foam experienced a 90 percent complete or almost complete clearance of scalp dermatoses. In comparison, only 47 percent treated with a BMV lotion and 21 percent treated with placebo experienced a similar clearance rate. BMV foam (Luxiq) is a novel formulation that was granted marketing clearance by the Food and Drug Administration last year for treatment of corticosteroid-responsive scalp dermatoses, including psoriasis. The foam delivery system was developed to enhance efficacy by maximizing bioavailability to the skin and to improve patient compliance by reducing the objectionable aspects of the traditional delivery systems, such as creams, ointments, lotions and gels. The foam treatment does not stain clothing and leaves no appreciable residue on the skin because it is not oily or greasy. The most frequent side effects associated with the use of the foam include mild and transient burning, stinging or itching at the site of application. Psoriasis is a chronic skin disorder that affects over 6.4 million people in the United States. Although the exact cause of the disease is unknown, psoriasis is marked by the rapid growth of too many skin cells. A normal skin cell matures in 28 to 30 days but a psoriatic skin cell takes only 3 to 6 days. Plaque psoriasis, the most common form of the condition, is characterized by inflamed lesions topped with silvery white scales.
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