CollaGenex launches Phase 3 study of Periostat as Rosacea treatment
NEWTOWN, PA., Aug 13, 2002 -- CollaGenex Pharmaceuticals announced that it has initiated a multi-center, double-blinded, placebo-controlled Phase 3 clinical study to evaluate the efficacy of Periostat (doxycycline hyclate tablets) 20 mg, for the treatment of rosacea.
There is currently no FDA-approved systemic treatment for rosacea.
This study, which will enroll up to 210 patients, is being conducted by James Leyden, MD, Professor of Dermatology at the University of Pennsylvania, Robert Skidmore, MD, Associate Professor of Dermatology at Shands Medical Center of the University of Florida, Diane Thiboutot, MD, Professor of Dermatology at the Milton S. Hershey Medical Center of the Pennsylvania State University, Joseph Fowler, MD, Clinical Dermatologist, Louisville, KY, and Brian Berman, MD, PhD, Professor of Dermatology and Internal Medicine at the University of Miami School of Medicine.
The study design calls for four months of dosing with either Periostat or placebo, with primary end points including the number of facial lesions apparent at the end of the study compared with baseline, and an assessment by the investigator of the patient's facial redness.
"Rosacea is a chronic inflammatory disease, with no cure," said Dr. James Leyden. "The primary mode of treatment is to administer topical and systemic antibiotics for long periods of time. This treatment regimen often leads to significant side effects, primarily nausea, diarrhea and dry skin.
"Another potential risk of current therapeutic regimens is the development of microbial resistance associated with long-term administration of antibiotics. Anecdotal evidence suggests that Periostat, a subantimicrobial formulation of doxycycline, may be effective in treating rosacea without the side effects or the risk of developing microbial resistance."
"The potential to treat rosacea with Periostat is based on our understanding of its biological properties, as well as anecdotal reports from current patients that their rosacea improved while being treated with the drug for periodontitis," said Brian M. Gallagher, PhD, chairman, president and chief executive officer of CollaGenex.
"A recent study demonstrated that Periostat, the first FDA-approved and commercialized product from our IMPACS technology, has the potential to treat moderate acne vulgaris, a disease with similar inflammatory symptoms to rosacea. We look forward to developing a novel treatment for patients suffering from this potentially disfiguring disease."
Rosacea is an increasingly common diagnosis affecting more than 12 million people in the United States. The disease is characterized by the appearance of erythema (a characteristic pattern of persistent redness of the skin that is frequently exacerbated by spicy foods and alcohol) which usually affects the nose, cheeks and forehead, and is often combined with small spider veins called telangiectasia near the surface of the skin of the cheeks and nose.
As the disease progresses, inflammatory lesions appear and accompany the erythema. As rosacea becomes more severe, itching and pain can occur.
Posted: August 2002