title: Efficacy and safety of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: results of two randomized, double-blind, and vehicle-controlled pivotal studies.
abstract: BACKGROUND
  Brimonidine tartrate, a highly selective α2-adrenergic receptor agonist with potent vasoconstrictive activity, was shown to reduce erythema of rosacea.
  
  
  OBJECTIVE
  To assess the efficacy and safety of topical brimonidine tartrate gel 0.5% for the treatment of erythema of rosacea.
  
  
  METHODS
  Both studies were randomized, double-blind, and vehicle-controlled, with identical design. Subjects with moderate to severe erythema of rosacea were randomized 1:1 to apply topical brimonidine tartrate gel 0.5% or vehicle gel once-daily for 4 weeks, followed by a 4-week follow-up phase. Evaluations included severity of erythema based on Clinician's Erythema Assessment and Patient's Self-Assessment, as well as adverse events.
  
  
  RESULTS
  Topical brimonidine tartrate gel 0.5% was significantly more efficacious than vehicle gel throughout 12 hours on days 1, 15, and 29, with significant difference observed as early as 30 minutes after the first application on day 1 (all P<.001). No tachyphylaxis, rebound or aggravation of other disease signs were observed. Slightly higher incidence of adverse events was observed for topical brimonidine tartrate gel 0.5% than for vehicle; however, most of the adverse events were dermatological, mild, and transient in nature.
  
  
  CONCLUSIONS
  These data generated in controlled trials may be different from those in clinical practice.
  
  
  CONCLUSIONS
  Once-daily brimonidine tartrate gel 0.5% has a good safety profile and provides significantly greater efficacy relative to vehicle gel for the treatment of moderate to severe erythema of rosacea, as early as 30 minutes after application.
authors.affiliation: University of Louisville, Louisville, KY, USA. fowlerjoe@msn.com
authors.forename: Joseph
authors.initials: J
authors.lastname: Fowler
authors.forename: Mark
authors.initials: M
authors.lastname: Jackson
authors.forename: Angela
authors.initials: A
authors.lastname: Moore
authors.forename: Michael
authors.initials: M
authors.lastname: Jarratt
authors.forename: Terry
authors.initials: T
authors.lastname: Jones
authors.forename: Kappa
authors.initials: K
authors.lastname: Meadows
authors.forename: Martin
authors.initials: M
authors.lastname: Steinhoff
authors.forename: Diane
authors.initials: D
authors.lastname: Rudisill
authors.forename: Matthew
authors.initials: M
authors.lastname: Leoni
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000068438:Brimonidine Tartrate; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005148:Facial Dermatoses / Q000188:drug therapy / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D011810:Quinoxalines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012393:Rosacea / Q000188:drug therapy* / Q000473:pathology; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003879:Dermatologic Agents; D005782:Gels; D011810:Quinoxalines; D000068438:Brimonidine Tartrate