title: Once-daily topical brimonidine tartrate gel 0·5% is a novel treatment for moderate to severe facial erythema of rosacea: results of two multicentre, randomized and vehicle-controlled studies.
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% or vehicle. In study B (4-week treatment and 4-week follow-up), 269 subjects were randomized to receive BT 0·5% once daily, BT 0·18% once daily, vehicle once daily, BT 0·18% twice daily or vehicle twice daily. Evaluations included Clinician's Erythema Assessment (CEA), Patient's Self-Assessment (PSA), Chroma Meter measurements and adverse events.
  
  
  RESULTS
  In study A, a single application of topical BT gel reduced facial erythema in a dose-dependent fashion. A significant difference between BT 0·5% and vehicle in Chroma Meter redness value was observed from 30min to 12h after application. In study B, BT 0·5% once daily had a statistically superior success profile (defined as a two-grade improvement on both CEA and PSA over 12h) compared with vehicle once daily on days 1, 15 and 29 (all P<0·001). 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.
authors: University of Louisville, Louisville, KY, USA. fowlerjoe@msn.com
authors: J
authors: J
authors: Fowler
authors: M
authors: M
authors: Jarratt
authors: A
authors: A
authors: Moore
authors: K
authors: K
authors: Meadows
authors: A
authors: A
authors: Pollack
authors: M
authors: M
authors: Steinhoff
authors: Y
authors: Y
authors: Liu
authors: M
authors: M
authors: Leoni
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D058647:Adrenergic alpha-2 Receptor Agonists / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D000068438:Brimonidine Tartrate; D003879:Dermatologic Agents / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004890:Erythema / Q000188:drug therapy*; D005148:Facial Dermatoses / Q000188:drug therapy*; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D011810:Quinoxalines / Q000008:administration & dosage*; D012393:Rosacea / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D058647:Adrenergic alpha-2 Receptor Agonists; D003879:Dermatologic Agents; D005782:Gels; D011810:Quinoxalines; D000068438:Brimonidine Tartrate