Improvement in facial erythema within 30 minutes of initial application of brimonidine tartrate in patients with rosacea.

BACKGROUND

Brimonidine tartrate (BT) 0.5% gel demonstrated significantly greater efficacy versus vehicle gel once-daily for the treatment of moderate to severe erythema of rosacea.

OBJECTIVES

To assess the 30-minute speed of onset of topical BT 0.5% gel in reducing facial erythema in Phase III studies as measured by subject and clinician assessments of erythema.

METHODS

Two Phase III, randomized, controlled studies with identical design in which subjects with moderate erythema of rosacea (study A: n=260; study B: n=293) were randomized 1:1 to apply topical BT 0.5% or vehicle gel once-daily for 4 weeks. Evaluations included severity of erythema based on Clinician's Erythema Assessment (CEA) and Patient's Self-Assessment (PSA) prior to study drug application and at 30 minutes after application on days 1, 15, and 29.

RESULTS

97.7% and 96.6% of subjects reported normal study completion for studies A and B, respectively. The percentage of subjects achieving a 1-grade improvement in both CEA and PSA was significantly increased at 30 minutes post-dosing with BT 0.5% gel compared to vehicle gel on visit days (day 1: 27.9 vs 6.9%, P <0.001; day 15: 55.9 vs 21.1%, P <0.001; Day 29: 58.3 vs 32.0%, P <0.001 for BT 0.5% gel vs vehicle) in study A. Similar results were shown for study B.

CONCLUSIONS

Once-daily topical BT gel 0.5% is not only efficacious at reducing facial erythema but also exhibits response within 30 minutes of application in a significant number of patients throughout both Phase III studies.