Anti-Inflammatory Dose Doxycycline Safe, Effective for Rosacea

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NEW YORK (Reuters Health) May 08 - Results from two phase III clinical trials show that a once-daily anti-inflammatory dose of doxycycline is a safe and effective treatment for moderate to severe papulopustular rosacea.

Dr. James Q. Del Rosso, of the University of Nevada School of Medicine, Las Vegas, and colleagues report the results of the studies in the May issue of the Journal of the American Academy of Dermatology.

Overall, 269 patients received 40-mg of controlled-release doxycycline and 268 received placebo for 16 weeks. The main efficacy end point was the mean change from baseline in facial inflammatory lesion count. Secondary end points were the mean changes in the Clinician's Erythema Assessment (CEA) scale and the Investigator's Global Assessment (IGA) scale scores.

The mean lesion counts at baseline were 19.9 and 20.8 for patients in the two studies, respectively, and the mean CEA scores were 9.6 and 9.3. Approximately half of the participants in each study had an IGA score of 3. Approximately 90% of the subjects had a score of 3 to 4.

At week 16, the mean change from baseline in total lesion count was -11.8 and -9.5 in the active-treatment groups in the two studies, compared with -5.9 and -4.3 in the placebo arms. The results were significant in both trials at p < 0.001.

The reduction from baseline in CEA score was significantly (p = 0.017) greater at week 16 in active-treatment patients in one study when compared with the placebo group, but not in the other study.

"The active-treatment group demonstrated significantly greater improvement in IGA scores by study end point when compared with the placebo group in both studies," Dr. Del Rosso's team reports.

Anti-inflammatory-dose doxycycline was well tolerated in both studies and adverse events were mild or moderate. The most common adverse events were nasopharyngitis (4.8%), diarrhea (4.4%), and headache (4.4%).

The investigators note that the reduction in lesion count did not plateau within the 16-week time frame of the studies, and that rosacea is often treated for months or years.

J Am Acad Dermatol 2007;56:791-802.

Source: http://www.medscape.com/viewarticle/556223?src=mp