Brimonidine gel 0.33% rapidly improves patient‐reported outcomes by controlling facial erythema of rosacea: a randomized, double‐blind, vehicle‐controlled study

Abstract

BackgroundFacial redness contributes to impaired psychosocial functioning in rosacea patients and the only approved treatment for erythema is topical brimonidine gel 0.33%.ObjectivesTo 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.MethodsAn 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.ResultsOf 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.ConclusionsOnce‐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.

Inhibition of mast cell infiltration in an LL‐37‐induced rosacea mouse model using topical brimonidine tartrate 0.33% gel

“…[2] Several clinical studies have demonstrated that brimonidine rapidly improves facial flushing and erythema. [2,3] However, the molecular and histological effects of brimonidine on rosacea remain largely unknown. Although the vasoconstrictive property of brimonidine gel has been suggested to contribute to the therapeutic effect, it was assumed that not only contracting the expanded blood vessels would act on the therapeutic mechanism.…”

Rosacea Management: Update on general measures and topical treatment options

“…An 8‐day multicenter, randomized study comparing once‐daily brimonidine 3 mg/g gel with vehicle gel proved that brimonidine allows patients with self‐perceived severe erythema to rapidly control their facial redness. In addition, brimonidine significantly improved patient‐reported outcomes in the treatment of persistent facial erythema of rosacea .…”

“…Daher kann eine adäquate Behandlung der persistierenden Gesichtsröte die Lebensqualität verbessern [ 21,22 ] . So konnte in einer 8-tägigen multizentrischen, randomisierten Studie, in der Brimonidin 3 mg/g Gel mit einem Vehikel-Gel verglichen wurde, erwiesen werden, dass Patienten mit einem von ihnen selbst als schwer eingestuftes Erythem mit Hilfe von Brimonidin ihre Gesichtsröte schnell unter Kontrolle bringen konnten [ 23 ] .…”

Rosazea‐Management: Update über allgemeine Maßnahmen und topische Therapieoptionen

“…Daher kann eine adäquate Behandlung der persistierenden Gesichtsröte die Lebensqualität verbessern . So konnte in einer 8‐tägigen multizentrischen, randomisierten Studie, in der Brimonidin 3 mg/g Gel mit einem Vehikel‐Gel verglichen wurde, erwiesen werden, dass Patienten mit einem von ihnen selbst als schwer eingestuftes Erythem mit Hilfe von Brimonidin ihre Gesichtsröte schnell unter Kontrolle bringen konnten .…”