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Study Results Published in CUTIS Demonstrate Long-Term Safety and Efficacy of Vectical(TM) (calcitriol) Ointment 3 mcg/g in the Management of Mild-to-Moderate Plaque Psoriasis
Date:4/30/2009

- 52-Week Data Supports Long-term Use of Vectical(TM) Ointment, Satisfying an Unmet Need Among Psoriasis Patients -

FORT WORTH, Texas, April 30 /PRNewswire/ -- Galderma Laboratories, L.P. today announced results from a newly published clinical trial in this month's issue of CUTIS regarding the safety, tolerability and efficacy of Vectical(TM) (calcitriol) Ointment 3 mcg/g in the long-term management of mild-to-moderate chronic plaque psoriasis. Of those patients that completed the trial, nearly 50 percent (47.1 percent) reported an improvement in psoriasis symptoms over the course of the 52-week trial.

The trial established the favorable long-term safety of Vectical(TM) Ointment over a 52-week time period. Adverse events included abnormal laboratory test values, abnormal urinalysis, skin irritation and psoriasis. Additionally, Vectical(TM) Ointment demonstrated no significant clinical effect on calcium homeostasis when used continuously over one year by 116 people who were evaluated. Also during the study, patients reported a noticeable improvement in psoriasis symptoms from baseline at week 26 (52.6 percent/249 patients) for those who completed the full year, and at the completion of a year (week 52, 63.8 percent/130 patients), confirming the long-term efficacy of the therapy.

"Psoriasis takes both a physical and an emotional toll on the millions of patients who suffer from it," said Mark Lebwohl, M.D., Department of Dermatology, Mount Sinai School of Medicine, New York, and lead author of the study. "For years, patients and physicians have been waiting for a safe and effective long-term treatment. This clinical data confirms that Vectical Ointment can provide continued control in a long-term psoriasis treatment plan - satisfying an important unmet need for patients."

The study involved 324 patients with psoriasis affecting a body surface area (BSA) of up to 35 percent. During the y
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SOURCE Galderma Laboratories, L.P.
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