title: Improvement in facial erythema within 30 minutes of initial application of brimonidine tartrate in patients with rosacea.
abstract: BACKGROUND
  Brimonidine tartrate (BT) 0.5% gel demonstrated significantly greater efficacy versus vehicle gel once-daily for the treatment of moderate to severe erythema of rosacea.
  
  
  OBJECTIVE
  To assess the 30-minute speed of onset of topical BT 0.5% gel in reducing facial erythema in Phase III studies as measured by subject and clinician assessments of erythema.
  
  
  METHODS
  Two Phase III, randomized, controlled studies with identical design in which subjects with moderate erythema of rosacea (study A: n=260; study B: n=293) were randomized 1:1 to apply topical BT 0.5% or vehicle gel once-daily for 4 weeks. Evaluations included severity of erythema based on Clinician's Erythema Assessment (CEA) and Patient's Self-Assessment (PSA) prior to study drug application and at 30 minutes after application on days 1, 15, and 29.
  
  
  RESULTS
  97.7% and 96.6% of subjects reported normal study completion for studies A and B, respectively. The percentage of subjects achieving a 1-grade improvement in both CEA and PSA was significantly increased at 30 minutes post-dosing with BT 0.5% gel compared to vehicle gel on visit days (day 1: 27.9 vs 6.9%, P <0.001; day 15: 55.9 vs 21.1%, P <0.001; Day 29: 58.3 vs 32.0%, P <0.001 for BT 0.5% gel vs vehicle) in study A. Similar results were shown for study B.
  
  
  CONCLUSIONS
  Once-daily topical BT gel 0.5% is not only efficacious at reducing facial erythema but also exhibits response within 30 minutes of application in a significant number of patients throughout both Phase III studies.
authors.forename: J Mark
authors.initials: JM
authors.lastname: Jackson
authors.forename: Joseph
authors.initials: J
authors.lastname: Fowler
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 / Q000627:therapeutic use*; D004311:Double-Blind Method; D004890:Erythema / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D011810:Quinoxalines / Q000008:administration & dosage / 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