title: Brimonidine gel 0.33% rapidly improves patient-reported outcomes by controlling facial erythema of rosacea: a randomized, double-blind, vehicle-controlled study.
abstract: BACKGROUND
  Facial redness contributes to impaired psychosocial functioning in rosacea patients and the only approved treatment for erythema is topical brimonidine gel 0.33%.
  
  
  OBJECTIVE
  To evaluate patient-reported outcomes, as well as efficacy and safety, in subjects with self-perceived severe erythema treated with brimonidine gel 0.33% compared to vehicle.
  
  
  METHODS
  An 8-day multicenter, randomized study comparing once-daily brimonidine gel 0.33% with vehicle gel using a facial redness questionnaire, subject satisfaction questionnaire and a patient diary of facial redness control to assess patient-reported outcomes.
  
  
  RESULTS
  Of the 92 included subjects with self-perceived severe erythema, very few were satisfied with their appearance at baseline (4.2% brimonidine group, 0 vehicle group). On Day 8, significantly more brimonidine group subjects were satisfied with their facial appearance compared to vehicle group (36.9% vs. 21.5%; P < 0.05), with the overall treatment effect (69.6% vs. 40.4%; P < 0.01), and with the improvement in their facial redness (67.4% vs. 33.3%; P < 0.001). More brimonidine group subjects were able to control their facial redness daily (e.g. 83.0% vs. 38.9% on Day 1). On Day 8, significantly more brimonidine group subjects than vehicle group had at least a one-grade improvement from baseline in the Clinician Erythema Assessment score (71.7% vs. 35.7%; P = 0.0011) and Patient Self-Assessment score (76.1% vs. 47.6%; P = 0.004). More subjects in the brimonidine group (29.2%) reported treatment-related adverse events than in the vehicle group (15.9%) but most were mild and transient.
  
  
  CONCLUSIONS
  Once-daily brimonidine gel 0.33% allowed patients to rapidly control their facial redness and significantly improved patient-reported outcomes in the treatment of persistent facial erythema of rosacea.
authors.affiliation: Harrogate and District NHS Foundation Trust, Harrogate, UK.
authors.forename: A M
authors.initials: AM
authors.lastname: Layton
authors.affiliation: Department of Dermatology, Tübingen University Hospital, Tübingen, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Schaller
authors.affiliation: Department of Dermatology, Medical Faculty, University of Düsseldorf, Düsseldorf, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Homey
authors.affiliation: Department of Dermatology, Venerology and Allergology, Charité Medical School, Berlin, Germany.
authors.forename: M A
authors.initials: MA
authors.lastname: Hofmann
authors.affiliation: Whipps Cross University Hospital and the Royal London Hospital, London, UK.
authors.forename: A P
authors.initials: AP
authors.lastname: Bewley
authors.affiliation: Center for Dermatology, Allergology, and Surgical Dermatology, Helios Clinic Wuppertal, Wuppertal, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Lehmann
authors.affiliation: Läkarhuset Odenplan, Stockholm, Sweden.
authors.forename: C
authors.initials: C
authors.lastname: Nohlgård
authors.affiliation: Departments of Psychiatry and Surgery, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: D B
authors.initials: DB
authors.lastname: Sarwer
authors.affiliation: Galderma R&D SNC, Sophia Antipolis, France.
authors.forename: N
authors.initials: N
authors.lastname: Kerrouche
authors.affiliation: Galderma R&D SNC, Sophia Antipolis, France.
authors.forename: Y M
authors.initials: YM
authors.lastname: Ma
mesh_terms: D058647:Adrenergic alpha-2 Receptor Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000068438:Brimonidine Tartrate / Q000009:adverse effects / Q000627:therapeutic use*; D004890:Erythema / Q000188:drug therapy* / Q000209:etiology; D005148:Facial Dermatoses / Q000188:drug therapy*; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D012393:Rosacea / Q000150:complications*; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D058647:Adrenergic alpha-2 Receptor Agonists; D005782:Gels; D000068438:Brimonidine Tartrate