K. Meadows , M. Jarratt , T. Jones , A. Pollack , D. Stough , M. Leoni
Background: No current treatments are approved for
facial erythema of rosacea.
Objectives: To evaluate the effect of topical Brimonidine
tartrate (BT) gel, an α 2 -adrenergic receptor agonist with
vasoconstrictive activity, on erythema of rosacea. Methods: In this double-blind, randomized, vehicle-controlled, dose-ﬁ nding study, erythema severity was assessed using two 5-point scales, Clinician ’ s Erythema Assessment (CEA) and Patient ’ s Self-Assessment (PSA).
Results: 122 subjects with moderate to severe persistent
facial erythema of rosacea (CEA & PSA scores ≥ 3) were
randomized to receive one facial application of BT gel
0.07%, 0.18%, 0.5%, or vehicle. The response rate for a
2-grade improvement of CEA and PSA was 25.0%, 32.3%,
and 54.8% for BT gel 0.07%, 0.18%, and 0.5%, respectively,
vs. 12.5% for vehicle. Median duration of effect after a
single BT gel 0.5% application was 11.5 hours (1-grade improvement of CEA), 7.0 hours (2-grade improvement of
CEA), and 5.6 hours (2-grade improvement of both CEA &
PSA). BT gel was safe and well-tolerated. Related adverse
events were mostly transient, dermatological, and mild
[from 6.5% (2 subjects) for BT gel 0.5% to 14.3% (4 subjects)
for BT gel 0.07%].
Conclusion: BT gel reduces facial erythema of rosacea in
a dose-dependent fashion, with BT gel 0.5% providing
superior strength and duration of effect.