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Brimonidine gel 0.33% rapidly improves patient-reported outcomes by controlling facial erythema of rosacea: A randomized, double-blind, vehicle-controlled study
Layton, A. M. Schaller, M. Homey, B. Hofmann, M. A. Bewley, A. P. Lehmann, P. Nohlgård, C. Kerrouche, N. Ma, Y. M.
Layton, A. M.
Schaller, M.
Homey, B.
Hofmann, M. A.
Bewley, A. P.
Lehmann, P.
Nohlgård, C.
Kerrouche, N.
Ma, Y. M.
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Journal article
Date
2015-09
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Social and Behavioral Sciences
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https://doi.org/10.1111/jdv.13305
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%. Objectives: 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.
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Layton AM, Schaller M, Homey B, et al. Brimonidine gel 0.33% rapidly improves patient-reported outcomes by controlling facial erythema of rosacea: a randomized, double-blind, vehicle-controlled study. J Eur Acad Dermatol Venereol. 2015;29(12):2405–2410. doi:10.1111/jdv.13305
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John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology
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Journal of the European Academy of Dermatology and Venereology (JEADV), Vol. 29, Issue 12
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