Chicago — CollaGenex Pharmaceuticals, Inc. announced results from two, phase 3 clinical trials with Oracea, its drug for the treatment of rosacea, at the American Academy of Dermatology's Academy '05, here.
Chicago - CollaGenex Pharmaceuticals, Inc. announced results from two, phase 3 clinical trials with Oracea, its drug for the treatment of rosacea, at the American Academy of Dermatology's Academy '05, here.
The lead investigator for the trial, James Q. Del Rosso, D.O., clinical assistant professor, department of dermatology, University of Nevada School of Medicine, Las Vegas, presented the results.
"Oracea provides therapeutic efficacy in rosacea through anti-inflammatory and anti-collagenolytic effects and is devoid of antibiotic activity," Dr. Del Rosso explains. "Therefore, even with long-term use, development of antibiotic resistance is not an issue. Many rosacea patients will benefit from a once-daily formulation of doxycycline that has been optimized to treat rosacea effectively and safely."
The two, double-blinded, placebo-controlled phase 3 clinical studies were identical in design and conducted concurrently.
Patients were administered either Oracea or placebo once a day for 16 weeks. A total of 537 patients were enrolled in 28 centers across the United States. At baseline, Oracea and placebo patients had a mean lesion count of 20.0 and 20.8 respectively. Using the Investigator's Global Assessment (IGA) score, a subjective five-point scale measuring disease severity, more than 90 percent of all patients in both treatment groups were characterized as moderately to severely affected.
Both studies achieved their primary endpoint by demonstrating a greater reduction in inflammatory lesion count from baseline for the Oracea-treated patients compared to the placebo controls. In the two studies, patients receiving Oracea experienced a 61 percent and 46 percent mean reduction in inflammatory lesions compared to 29 percent and 20 percent respectively, in patients receiving placebo. According to the company, the differences were clinically and statistically highly significant (p<0.0001 in each study).
Dr. Del Rosso also presented results of the secondary endpoints of change in IGA score and the dichotomized IGA at week 16.
In the analysis of dichotomized IGA, there was a statistically significant greater number of patients who were clear or near clear at the end of the study in the Oracea group compared to the placebo group.
Results presented for the secondary endpoint of improvement in erythema were also favorable.
In one study, erythema showed a trend towards improvement. In the second study the reduction in erythema achieved a statistical significance as erythema scores improved from 9.7 at baseline to 7.0 at week 16 (p = 0.017).