NEWTOWN, Pa. CollaGenex Pharmaceuticals released the results of a Phase 4 dose comparison study designed to evaluate the safety and efficacy of Oracea once daily versus doxycycline 100 mg once daily for the treatment of rosacea. Oracea is a delayed release formulation of doxycycline. 40 mg. High doses of doxycycline are prescribed off-label by dermatologists for the treatment of rosacea.
The results of the study showed that the higher dose of doxycycline did not provide a greater benefit than Oracea, but did lead to a significantly higher incidence of adverse events. Gastrointestinal adverse events, including nausea, vomiting, diarrhea and stomach discomfort, were observed in 26 percent of patients administered 100 mg of doxycycline versus only 5 percent in the Oracea group.
The study consisted of 91 patients at seven centers across the U.S. over a 16 week time period. Both treatments were administered as an adjunct to topical MetroGel 1 percent.
Klaus Theobald, chief medical officer of CollaGenex, said, “We are extremely pleased with the outcome of our Phase 4 study. The study clearly demonstrates that increasing the dose of doxycycline above the anti-inflammatory levels provided by Oracea does not provide any additional benefit but significantly adds to the adverse event profile.”