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Healthpoint Initiates Randomized, Double-Blind Study to Evaluate Effectiveness of Collagenase SANTYL(R) Ointment on Wound Healing
Date:8/26/2008

FORT WORTH, Texas, Aug. 26 /PRNewswire/ -- Healthpoint today announced that it has initiated a clinical trial to evaluate the effectiveness of a widely prescribed enzymatic debriding agent on healing cutaneous wounds and resulting scars. The pilot study was prompted, in part, by clinical reports of the reduced incidence of hypertrophic scars and beneficial healing properties associated with Collagenase SANTYL(R) Ointment.(1,2)

"Given the findings from the peer-reviewed literature, as well as anecdotal reports Healthpoint has received from clinicians, we determined that formal scientific exploration was an appropriate course of action to more fully characterize the therapeutic properties of collagenase," commented Bert Slade, MD, FAAAAI, Chief Medical Officer at Healthpoint. "We hope the findings from this pilot study will inform future research as part of our ongoing collagenase development program."

Collagenase SANTYL(R) Ointment is a selective enzymatic debriding agent that contains 250 collagenase units per gram of white petrolatum USP. It is indicated for debriding chronic dermal ulcers (e.g., pressure ulcers, vascular ulcers, and diabetic ulcers) and severely burned areas. The enzyme collagenase is derived from the fermentation by Clostridium histolyticum and possesses the ability to liquefy collagen in necrotic tissue. Collagenase SANTYL(R) Ointment is now the most widely used brand of enzymatic debrider in the United States.*

The study is double-blind, site randomized and placebo controlled involving 30 healthy adult volunteers between the ages of 18 and 50. Site randomized means that each subject receives both active (Collagenase SANTYL(R) Ointment) and placebo (white petrolatum ointment) with one test article applied to each of two dermatome-induced skin wounds according to the randomization scheme. The study objectives are to compare the rate of complete wound closure within 21 days, and quality of resulting scar at 3, 6, and 9 months, between the active and placebo treatments. The study is being conducted at the University of Texas Southwestern Medical Center in Dallas, with Shai M. Rozen, MD, serving as the principal investigator.

"This study is another example of Healthpoint's ongoing commitment to scientific evaluation and clinical research designed to provide healthcare professionals with evidence-based therapies that contribute to improved clinical and quality of life outcomes," said Robert Bancroft, General Manager of Healthpoint.

About HEALTHPOINT, Ltd.

HEALTHPOINT(R) is dedicated to bringing innovative technologies for the prevention and treatment of diseased and traumatized skin and related soft tissue to the wound care market. Since 1992, the company focus has been on research, development and marketing of branded biologics, pharmaceuticals, over the counter drugs, and medical devices. Current HEALTHPOINT(R) products include: Collagenase SANTYL(R) Ointment, OASIS(R) Wound Matrix, and HYRODFERA BLUE(TM) Bacteriostatic Wound Dressings. HEALTHPOINT(R) is also committed to advancing the care and treatment of wounds through support of industry leading continuing education from THE WOUND INSTITUTE(R). To learn more about this comprehensive and award winning educational resource, please visit http://www.TheWoundInstitute.com. HEALTHPOINT(R), with over 300 employees, is a DFB Pharmaceuticals, Inc. affiliate company, and is based in Fort Worth, Texas. For more information, visit HEALTHPOINT's website at http://www.healthpoint.com.

References

(1.) Zimmerman WE. The importance of collagenase for the local treatment of major burns. In: Mandl I, editor. Collagenase. New York: Gordone & Breach, Science Publishers, 1972: 131-141.

(2.) Frye KE, Luterman A. Decreased incidence of hyptertrophic burn scar formation with the use of collagenase, an enzymatic debriding agent. Wound, 2005; 17[12]: 332-336.

*Occasional slight transient erythema has been noted in surrounding tissue when applied outside the wound. One case of systemic hypersensitivity has been reported after 1 year of treatment with collagenase and cortisone. See complete prescribing information online at: http://www.healthpoint.com/divisions/tm/images/Santyl-PI-Update(Final-Clien t- 11Dec07).pdf


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SOURCE Healthpoint, Ltd.
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