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permanent
Hallo Herr Nettersheim,
haben die im nachfolgenden Bericht beschriebenen Ergebnisse Einfluß auf das Geschäft von Medigene?
Mit freundlichen Grüßen
Dirk
Positive Results of Phase 4 Clinical Study Evaluating Effects of Oracea(TM) (doxycycline, USP) Capsules, 40 mg, in Combination with MetroGel(R) (metronidazole gel), 1%, as Treatment for Rosacea Presented at Annual Meeting of the AAD
Patients in the Oracea + MetroGel Group Experienced a Mean Reduction of 13.9 Inflammatory Lesions Compared to 8.5 in the Placebo + MetroGel Group
NEWTOWN, Pa.--(BUSINESS WIRE)--Feb. 2, 2007--CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI) today announced results of a Phase 4 clinical study designed to evaluate the efficacy of combining Oracea(TM) capsules and topical MetroGel in the treatment of rosacea. Study results were presented at the American Academy of Dermatology (AAD) Annual Meeting in Washington D.C. by the lead investigator, Joseph Fowler, MD, Clinical Professor of Dermatology, University of Louisville, Louisville, Kentucky. The trial also evaluated the effectiveness of Oracea for maintenance therapy in the treatment of rosacea.
The double-blind, placebo-controlled trial enrolled a total of 72 rosacea patients at 3 centers. The patients were administered either Oracea capsules + MetroGel or Placebo capsules + MetroGel once a day for 12 weeks. MetroGel was discontinued at Week 12, and patients continued to receive either Oracea or Placebo through Week 16. Measurements of the changes in the number of inflammatory lesions were taken at Weeks 4, 8, 12 and 16. The primary efficacy endpoint of the study was the Mean Change in Inflammatory Lesions at Weeks 12 and 16. The study successfully met this endpoint and demonstrated a statistically significant, greater reduction in inflammatory lesions at Weeks 12 and 16 in the Oracea + MetroGel group compared to the Placebo + MetroGel group.
Combination Therapy
At baseline, the patients in the Oracea + MetroGel group had a mean total inflammatory lesion count of 21.3. At Week 12, this group experienced a reduction in inflammatory lesions of 13.9. In the Placebo + MetroGel patient group, baseline mean total inflammatory lesion count was 18.7. At Week 12, this group experienced a reduction of 8.5 inflammatory lesions. The difference between the two groups was statistically significant (P=0.002). The mean percent reduction in inflammatory lesions was 66.4% in the Oracea + MetroGel group compared to 48.2% in the Placebo + MetroGel group (P=0.008). The difference in the inflammatory lesion count reduction was statistically significant as early as Week 4, when Oracea + MetroGel demonstrated a reduction in inflammatory lesions of 9.7 while Placebo + MetroGel demonstrated a reduction in inflammatory lesions of 2.9 (P=0.0008).
"This trial demonstrates that the combination of Oracea and MetroGel results in a faster and greater reduction in the inflammatory lesions of rosacea than MetroGel alone," said Dr. Fowler. "Dermatologists have limited their use of systemic antibiotics, like doxycycline, in rosacea because of concerns about safety. Oracea contains a dose of doxycycline that is too low to produce an antibiotic effect, but is enough to reduce the inflammation associated with rosacea. The safety profile of Oracea and the results of this study suggest that combination therapy of a topical agent and Oracea should be considered as a first-line treatment for rosacea patients."
"Topical metronidazole has been the leading rosacea therapy for many years, with over 2 million prescriptions written annually," said David Pfeiffer, Senior Vice President, Sales and Marketing, CollaGenex Pharmaceuticals. "A significant portion of these prescriptions are written along with an oral agent. Rosacea patients want to see treatment results quickly. The results of this study suggest that combination therapy with Oracea may be a good approach to enhance patient satisfaction."
Maintenance Therapy
At Week 16, after MetroGel had been discontinued for four weeks, the patients treated with Oracea alone generally maintained their level of improvement, while the improvement receded in the patients on Placebo. In the Oracea group at Week 16, the patients experienced a mean total reduction of 13.4 inflammatory lesions compared to baseline, while the patients treated with Placebo experienced a mean total reduction of 6.5 inflammatory lesions (P=0.0006).
"Maintenance therapy for rosacea should take into account patient acceptance as well as safety and efficacy," commented Dr. Fowler. "This study suggests that the results of combination therapy will be maintained for a period of time with Oracea alone. Oracea may be a good maintenance therapy for rosacea patients who prefer to take pills rather than apply gels or creams."
About Rosacea
Rosacea is a condition that affects approximately 14 million adults in the U.S. It affects primarily the face and is characterized by the appearance of inflammatory lesions (papules, pustules and nodules), erythema (skin redness) and telangiectasia (spider veins). If allowed to progress to a moderate to severe condition, rosacea can cause itching, pain and thickening of the skin.
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