PubMed RSS Feed - - Once-daily topical brimonidine tartrate gel 0.5% is a novel treatment of moderate to severe facial erythema of rosacea: results of two multicenter, randomized and vehicle-controlled studies.

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Once-daily topical brimonidine tartrate gel 0.5% is a novel treatment of moderate to severe facial erythema of rosacea: results of two multicenter, randomized and vehicle-controlled studies.

Br J Dermatol. 2011 Nov 2;

Authors: Fowler J, Jarratt M, Moore A, Meadows K, Pollack A, Steinhoff M, Liu Y, Leoni M,

Abstract
Background:  Erythema of rosacea is thought to result from abnormal cutaneous vasomotor activity. Brimonidine tartrate (BT) is a highly selective α(2) -adrenergic receptor agonist with vasoconstrictive activity. Objective:  To determine the optimal concentration and dose regimen of topical BT gel for the treatment of erythema of rosacea and to evaluate its efficacy and safety. Methods:  In Study A, 122 subjects were randomized to receive a single application of BT 0.07%, 0.18%, 0.5% and vehicle. In Study B (4-week treatment and 4-week follow-up), 269 subjects were randomized to receive BT 0.5% once-daily (QD), BT 0.18% QD, vehicle QD, BT 0.18% twice-daily (BID) or vehicle BID. Evaluations included Clinician's Erythema Assessment (CEA), Patient's Self Assessment (PSA), chromameter measurements and adverse events. Results:  Study A - A single application of topical BT gel reduced facial erythema in a dose-dependent fashion. Significant difference between BT 0.5% and vehicle in chromameter redness value was observed from 30 minutes to 12 hours after application. Study B - BT 0.5% QD had a statistically superior success profile (defined as 2-grade improvement on both CEA and PSA over 12 hours) compared to vehicle QD on Days 1, 15 and 29 (all P<.001). No tachyphylaxis, rebound of erythema or aggravation of other disease signs (telangiectasia, inflammatory lesions) was observed. All regimens were safe and well-tolerated with similarly low incidence of adverse events. Conclusions:  Once-daily BT gel 0.5% is well-tolerated and provides significantly greater efficacy than vehicle gel for the treatment of moderate to severe erythema of rosacea.

PMID: 22050040 [PubMed - as supplied by publisher]

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