Safety was excellent. There was no difference in safety or tolerability between genders.
The study, named the CLEAR trial (A Community-based TriaL of MEtroGel in the TreAtment of Rosacea), enrolled 612 males and females with mild to moderately severe papulopustular rosacea. The inclusion criteria required patients to have between eight and 30 inflammatory lesions and mild to moderate erythema. The participants had a mean age of 50 years (range, 18-89) and were mostly female (75 percent), Caucasian (95 percent) and affected by moderate to moderately severe disease (75 percent).
"For more than two decades, this metronidazole gel product has been widely used by physicians to treat rosacea with good results. However, as new drugs are being introduced into the marketplace fairly rapidly, there may be a tendency for clinicians to forget about older, time-tested agents," Dr. Wolf says, professor and chairman, department of dermatology, Baylor College of Medicine.
"A community-based study provides a setting for understanding performance of a medication in the conditions of actual clinical practice, and the results of this trial remind us that metronidazole offers sustained efficacy for improving all of the findings of papulopustular rosacea across a spectrum of patients typically encountered in clinical practice and irrespective of geographical location and associated climate variations."
The study was conducted at 133 clinical sites. Patients had to be at least 18 years old and have had rosacea for at least one month. Other topical or oral treatments had to be discontinued for appropriate intervals prior to the baseline visit and were not allowed during the 12-week study.
The efficacy analyses at study completion showed topical metronidazole 0.75 percent gel decreased papule and pustule counts by 70 percent and 75 percent, respectively. Erythema severity was rated for the cheeks, forehead, chin and nose separately and for the entire face by summing the individual scores. Erythema improved in all facial regions, with the greatest improvements noted on the cheeks and nose, which were most severely affected at baseline. At study conclusion, the erythema severity score for the entire face declined by almost 50 percent in the overall population, and the magnitude of response was similar across all subgroups when patients were categorized by rosacea severity at baseline.
"Erythema can be a particularly disturbing disease sign for patients affected by rosacea, and so it is worth noting the benefit associated with metronidazole gel," Dr. Wolf says.
The mean telangiectasia score at baseline for the entire face was consistent with mild to moderate severity. The score was significantly reduced by four weeks and declined 38 percent by study completion. Males and females showed similar positive responses.
The DLQI results showed statistically significant improvements in a number of domains with the greatest benefits seen in reduction of embarrassment or self-consciousness (53 percent improvement) and greater participation in social or leisure activities (31 percent improvement). Scores for disease-related symptoms of itching, soreness and pain also improved by 25 percent, and the change was statistically significant.