J. Fowler Jr. , A. Moore , K. Meadows , K. Grande , M. Steinhoff , M. Leoni
Background: Brimonidine tartrate (BT), a selective α 2 adrenergic receptor agonist with vasoconstrictive activity, reduces facial erythema of rosacea after topical use.
Objectives: To assess safety and efﬁ cacy of BT gel in this
Methods: In this double-blind Phase 2 study (4 weeks daily treatment/4 weeks follow-up), 269 subjects with moderate to severe erythema (CEA & PSA scores ≥ 3) were random- ized to receive BT 0.5% once-daily (QD), BT 0.18% QD or twice daily (BID), or vehicle QD or BID. Erythema severity was assessed using two 5-point scales (0 = clear to 4 = severe): Clinician ’ s Erythema Assessment (CEA) and Patient ’ s Self-Assessment (PSA).
Results: BT 0.5% QD had a signiﬁ cantly superior success proﬁ le (deﬁ ned as a 2-grade improvement proﬁ le on both CEA and PSA over 12 hours) compared to vehicle QD on Days 1, 15 and 29 (all P < 0.001). Success rates at hours 3, 6, 9, and 12 on Day 29 were 30.2%, 28.3%, 32.1%, and 18.9% respectively for BT 0.5% QD, compared to 3.6%, 7.3%, 3.6%, and 3.6% for vehicle QD. BT 0.18% was more efﬁ cacious than vehicle. No evidence of tachyphylaxis, rebound, or aggravation of other disease signs (telangiectasias, inﬂ ammatory lesions) was observed and all regimens had a similarly low incidence of adverse events. Conclusion: BT gel 0.5% is safe and efﬁ cacious for daily treatment of moderate to severe facial erythema of rosacea.