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news.CollaGenex Pharmaceuticals has reported positive research from a phase IV study evaluating the efficacy of combining Oracea capsules and topical MetroGel in the treatment of the skin condition rosacea.
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The trial also evaluated the effectiveness of Oracea for maintenance therapy in the treatment of rosacea. Rosacea is characterized by the appearance of inflammatory lesions, skin redness and spider veins.
The primary efficacy endpoint of the study was the mean change in inflammatory lesions. The study successfully met this endpoint and demonstrated a statistically significant, greater reduction in inflammatory lesions at weeks 12 and 16.
The mean percent reduction in inflammatory lesions was 66.4% in the Oracea plus MetroGel group compared to 48.2% in the placebo plus MetroGel group. MetroGel is a trademark of Galderma Laboratories.
“Dermatologists have limited their use of systemic antibiotics, like doxycycline, in rosacea because of concerns about safety,” said Joseph Fowler, clinical professor of Dermatology, University of Louisville.
“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.”
CollaGenex also suggested that the results of combination therapy will be maintained for a period of time with Oracea alone and may be a good maintenance therapy for patients who prefer to take pills rather than apply gels or creams.